Growth of indian pharmaceuticals in the world market

89
Growth of Indian pharmaceuticals in the world market CONTENTS Sr. No. chapter Page no. 1. Introduction 3-11 2. Reasons for Growth 12- 17 1. Cost advantage 13 2. Contract Manufacturing 14 3. Research and Development 16 4. Mergers and Acquisitions 17 3. SWOT Analysis 18- 23 1. SWOT Analysis 19 2. Trends and Strategies 24 4. Efforts Taken by the government 25- 35 1. Experience Drawn from Past Pharmaceutical Policies 25 2. Important Developments after liberalization process in 1991 27 3. Research and Development 30 4. Pharma Parks/SEZs for Pharma industry 33 5. Greater Thrust on Pharma Exports 34 5. Efforts Taken by the industry 36- 37 6. Major Players 38- 43 - 1 -

Transcript of Growth of indian pharmaceuticals in the world market

Page 1: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

CONTENTS

Sr

No

chapter Page

no

1 Introduction 3-11

2 Reasons for Growth 12-17

1 Cost advantage 13

2 Contract Manufacturing 14

3 Research and Development 16

4 Mergers and Acquisitions 17

3 SWOT Analysis 18-23

1 SWOT Analysis 19

2 Trends and Strategies 24

4 Efforts Taken by the government 25-35

1 Experience Drawn from Past Pharmaceutical Policies 25

2 Important Developments after liberalization process in 1991 27

3 Research and Development 30

4 Pharma ParksSEZs for Pharma industry 33

5 Greater Thrust on Pharma Exports 34

5 Efforts Taken by the industry 36-37

6 Major Players 38-43

1 Ranbaxy Laboratories 39

2 Dr Reddys Laboratories 40

3 Nicholas Piramal 41

4 Cipla 41

5 Biocon 42

6 Serum Institute of India 42

7 Strides Arcolab 43

7 India vs China in pharmaceuticals 44-47

1 The Chinese edge 45

2 Where India scores 46

3 The equation Present and future 47

- 1 -

Growth of Indian pharmaceuticals in the world market

8 Some important articles 48-55

1 Tweaking drugs wont help cos skip price control 49

2 Cracking Japans generics market code 50

3 India as offshore pharma destination 51

4 Dr Reddys net profit triples 53

9 Conclusion 56

10 Recommendations 58

11 Bibliography 60

- 2 -

Growth of Indian pharmaceuticals in the world market

Introduction

- 3 -

Growth of Indian pharmaceuticals in the world market

The Indian pharmaceutical sector has come a long way being almost non-

existent before 1970 to a prominent provider of healthcare products meeting almost

95 of the countrys pharmaceuticals needs The domestic pharmaceutical sales have

increased from Rs4bn in 1970-71 to Rs214bn in 2002 at a CAGR of 137 per

annum The total Indian production constitutes about 13 of the world market in

value terms and 8 in volume terms The per capita consumption of drugs in India

stands at US$3 is amongst the lowest in the world as compared to Japan- US$412

Germany- US$222 and USA- US$191

Indian pharmaceutical industry is mounting up the value chain From being a

pure reverse engineering industry focused on the domestic market the industry is

moving towards basic research driven export oriented global presence providing

wide range of value added quality products and services Government policies will

play an important role in defining the future of the pharmaceutical industry The

product patent regime which came into effect from January 2005 will lead to long-

term growth for the future

In the present scenario the growth of a domestic pharmaceutical company is

critically dependent on its therapeutic presence The old and mature categories like

anti-infectives vitamins analgesics are de-growing while new lifestyle categories

like Cardiovascular Central Nervous System (CNS) and Anti Diabetic are expanding

at double-digit growth rates

Increased generic penetration intense competition fragmentation of the

industry has negatively impacted the overall value growth of the domestic

pharmaceutical market In this scenario to grow in the domestic market

pharmaceutical companies are constantly eyeing for innovation introduction of new

value added products product life cycle management and enlarging their market

reach

Indian companies are putting their act together to tap the generic drugs

markets in the regulated high margin markets of the developed countries The US

- 4 -

Growth of Indian pharmaceuticals in the world market

market will remain the most lucrative market for the Indian companies led by its

market size and the intensity of blockbuster drugs going off patent An estimated

US$45bn of drugs expected to go off patent by 2007 in US alone

Outsourcing in the fields of RampD and manufacturing is the next best event in

the pharmaceutical industry Spiraling cost expiring patents low RampD cost and

market dynamics are driving the MNCs to outsource both manufacturing and research

activities India with its apt chemistry skills and low cost advantages both in research

and manufacturing coupled with skilled manpower will attract a lot of business in the

days to come

The Indian Pharmaceutical Industry today is in the front rank of Indiarsquos

science-based industries with wide ranging capabilities in the complex field of drug

manufacture and technology A highly organized sector the Indian Pharmaceutical

Industry is estimated to be worth $ 45 billion growing at about 8 to 9 percent

annually It ranks very high in the third world in terms of technology quality and

range of medicines manufactured From simple headache pills to sophisticated

antibiotics and complex cardiac compounds almost every type of medicine is now

made indigenously

Playing a key role in promoting and sustaining development in the vital field

of medicines Indian Pharmaceutical Industry boasts of quality producers and many

units approved by regulatory authorities in USA and UK International companies

associated with this sector have stimulated assisted and spearheaded this dynamic

development in the past 53 years and helped to put India on the pharmaceutical map

of the world

The Indian Pharmaceutical sector is highly fragmented with more than 20000

registered units It has expanded drastically in the last two decades The leading 250

pharmaceutical companies control 70 of the market with market leader holding

nearly 7 of the market share It is an extremely fragmented market with severe price

competition and government price control

- 5 -

Growth of Indian pharmaceuticals in the world market

The pharmaceutical industry in India meets around 70 of the countrys

demand for bulk drugs drug intermediates pharmaceutical formulations chemicals

tablets capsules orals and injectibles There are about 250 large units and about 8000

Small Scale Units which form the core of the pharmaceutical industry in India

(including 5 Central Public Sector Units) These units produce the complete range of

pharmaceutical formulations ie medicines ready for consumption by patients and

about 350 bulk drugs ie chemicals having therapeutic value and used for production

of pharmaceutical formulations

Following the de-licensing of the pharmaceutical industry industrial licensing

for most of the drugs and pharmaceutical products has been done away with

Manufacturers are free to produce any drug duly approved by the Drug Control

Authority Technologically strong and totally self-reliant the pharmaceutical industry

in India has low costs of production low RampD costs innovative scientific manpower

strength of national laboratories and an increasing balance of trade The

Pharmaceutical Industry with its rich scientific talents and research capabilities

supported by Intellectual Property Protection regime is well set to take on the

international market

The Indian patent act of 1970 amended on March 22 2005 marks the end of a

protected era and signals a new phase in the integration of India into the global

pharmaceutical market The new amendment seeks to make copying of post-1995

patented drugs illegal As India enters product patent regime how will it affect the

Indian pharmaceutical industry (IPI) health care industry legal machinery enforcing

the regulations and most importantly patients in India and the developing world given

the fact Indian drugs are exported to more than 65 countries

With a regulatory system focused only on process patents helped to establish

the foundation of a strong and highly competitive domestic pharmaceutical industry

which in the grip of a rigid price control framework transformed into a world supplier

of bulk drugs and medicines at affordable prices to common man in India and the

developing world Introduction of product patents will however mark the end of a

golden age for IPI The new regulations will reshape the landscape of IPI forcing

- 6 -

Growth of Indian pharmaceuticals in the world market

significant changes and divide within the industry A look into organization of

pharmaceutical producers of India (OPPI) directory shows only 300 units out of

10000 registered companies are in the organized sector While process patent helped

to flourish IPI into a world-class generics industry product patent regime will filter

the best from the pack and would be favorable to players with built-in scientific and

technical resources The impact of the new regulations will not deter the Indian

pharmaceutical majors as they are already doing roaring business in the very countries

where these patent laws are strictly in force

Driven by the knowledge skills growing enterprise low costs improved

quality and demand (domestic and international) the pharmaceuticals sector has

witnessed a tremendous growth over the past few years - from a turnover of Rs 5000

crores in 1990 to over Rs 50000 crores during 2004-05 Exports have also grown

very significantly to over Rs 16700 crores during this period

Exports of Drugs Pharmaceuticals and Fine Chemicals

1999-2000 2000-01 2001-02 2002-03 2003-04

Rs 723016

Crore

($ 160

billion)

Rs 857547

Crore

($195 billion)

Rs 98347

Crore

($218

billion)

Rs 11925 4

Crore

($2 65

billion)

Rs 1410000

Crore

($313 billion)

Growth of Pharmaceutical Exports

1999-

2000

2000-

01

2001-

02

2002-

03

2003-

04

1557 2073 1113 212 1824

- 7 -

Growth of Indian pharmaceuticals in the world market

Export markets increasingly drive IPI in a turnover of US$5 billion exports

constitute $32 billion and the industry is poised to grow to $25 billion by 2010

(McKinsey) The share of IPI in world pharmaceutical market is 10 (ranks 13th) in

value and 8 (ranks 4th) in volume terms The global market for generic drugs is

estimated at $27 billion (2001) and the expiry of patents on drugs will be worth $80

billion (2005) offers a huge opportunity to IPI The industry has developed Good

Manufacturing Practices (GMP) facilities for the production of different dosage

forms The pharmaceutical industry exports drugs and pharmaceuticals worth over $

38 billion It ranks 17th in terms of export value of bulk actives and dosage Indian

exports cover more than 200 countries including the highly regulated markets of

USA Europe Japan and Australia

It is also recognized that the cost of drugs produced in India is amongst the

lowest in the world It is estimated that by the year 2010 industry has the potential to

achieve Rs 1 00000 crores in formulations with bulk drug production going up from

Rs 8000 crores to Rs 25000 crores Indiarsquos rich human capital is believed to be the

strongest asset for this knowledge-led industry Various studies show that the

scientific talent pool of 4 million Indians is the second largest English speaking group

worldwide after the US

India today has the largest number of US Food amp Drug Administration (FDA)

approved drug manufacturing facilities outside the US In addition Drug Master Files

(DMFs) filed by Indian companies with the FDA is 126 higher than Spain Italy

China and Israel put together DMF has to be approved by FDA for a drug to enter the

US market

Research amp Development (RampD) is a key to the strength of pharmaceutical

industry especially in the product patent period The global pharmaceutical industry

spent $304 billion (2001) on RampD The RampD expenditure (as a percentage of

turnover) by the IPI is low (19) when compared global giants (10 - 16) With

transition into the new regime many Indian companies are mobilizing their resources

war chest with an increase in their RampD budget Government of India (GOI)

- 8 -

Growth of Indian pharmaceuticals in the world market

encouraged the RampD in pharmaceutical companies by extending 10 year tax holiday

to this sector Besides planning commission has earmarked $34 million towards drug

industry RampD promotion fund for the tenth plan

Globally pharmaceutical industry grew at a compounded annual growth rate

of 91 per cent in the last 23 years to $491 billion propelled by a string of innovative

blockbusters Multinationals were reshaped by mergers and acquisitions as a way of

fattening their research pipelines This at best represents a short-term solution With a

slew of brand name drugs losing patent protection in the next few years and the

pressure building for pharmaceuticals to cut price these giants find themselves under

immense strain to find new drugs and reduce price Bringing a new drug into the

market costs a company an average of about $800 to $900 million Some estimates

show that patient recruitment and medical personnel account for nearly 70 per cent of

the clinical costs that are required to bring a drug to market The less expensive means

to raise research productivity is outsourcing research to low cost havens such as India

and China The global pharmaceutical outsourcing market stands at $10 billion

(2004)

Pharmaceutical multinationals have maintained a low-key presence in Indian

market due to absence of product patents and rigid price controls Pharmaceutical

industry did not receive significant foreign direct investment (FDI) From August

1991 to December 1998 this industry accounted for a meager 044 of the total FDI

Introduction of product patents will see multinationals strengthening their presence in

the country The second largest population in the world a growing economy and

rising income levels makes Indian market difficult to ignore

In the domestic market the share of Indian companies has steadily increased

from around 20 per cent in 1970 to 70 percent now Ranbaxy Laboratories is the

market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories

Glaxo is the only multinational to figure among the top ten pharma companies in

India

- 9 -

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 2: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

8 Some important articles 48-55

1 Tweaking drugs wont help cos skip price control 49

2 Cracking Japans generics market code 50

3 India as offshore pharma destination 51

4 Dr Reddys net profit triples 53

9 Conclusion 56

10 Recommendations 58

11 Bibliography 60

- 2 -

Growth of Indian pharmaceuticals in the world market

Introduction

- 3 -

Growth of Indian pharmaceuticals in the world market

The Indian pharmaceutical sector has come a long way being almost non-

existent before 1970 to a prominent provider of healthcare products meeting almost

95 of the countrys pharmaceuticals needs The domestic pharmaceutical sales have

increased from Rs4bn in 1970-71 to Rs214bn in 2002 at a CAGR of 137 per

annum The total Indian production constitutes about 13 of the world market in

value terms and 8 in volume terms The per capita consumption of drugs in India

stands at US$3 is amongst the lowest in the world as compared to Japan- US$412

Germany- US$222 and USA- US$191

Indian pharmaceutical industry is mounting up the value chain From being a

pure reverse engineering industry focused on the domestic market the industry is

moving towards basic research driven export oriented global presence providing

wide range of value added quality products and services Government policies will

play an important role in defining the future of the pharmaceutical industry The

product patent regime which came into effect from January 2005 will lead to long-

term growth for the future

In the present scenario the growth of a domestic pharmaceutical company is

critically dependent on its therapeutic presence The old and mature categories like

anti-infectives vitamins analgesics are de-growing while new lifestyle categories

like Cardiovascular Central Nervous System (CNS) and Anti Diabetic are expanding

at double-digit growth rates

Increased generic penetration intense competition fragmentation of the

industry has negatively impacted the overall value growth of the domestic

pharmaceutical market In this scenario to grow in the domestic market

pharmaceutical companies are constantly eyeing for innovation introduction of new

value added products product life cycle management and enlarging their market

reach

Indian companies are putting their act together to tap the generic drugs

markets in the regulated high margin markets of the developed countries The US

- 4 -

Growth of Indian pharmaceuticals in the world market

market will remain the most lucrative market for the Indian companies led by its

market size and the intensity of blockbuster drugs going off patent An estimated

US$45bn of drugs expected to go off patent by 2007 in US alone

Outsourcing in the fields of RampD and manufacturing is the next best event in

the pharmaceutical industry Spiraling cost expiring patents low RampD cost and

market dynamics are driving the MNCs to outsource both manufacturing and research

activities India with its apt chemistry skills and low cost advantages both in research

and manufacturing coupled with skilled manpower will attract a lot of business in the

days to come

The Indian Pharmaceutical Industry today is in the front rank of Indiarsquos

science-based industries with wide ranging capabilities in the complex field of drug

manufacture and technology A highly organized sector the Indian Pharmaceutical

Industry is estimated to be worth $ 45 billion growing at about 8 to 9 percent

annually It ranks very high in the third world in terms of technology quality and

range of medicines manufactured From simple headache pills to sophisticated

antibiotics and complex cardiac compounds almost every type of medicine is now

made indigenously

Playing a key role in promoting and sustaining development in the vital field

of medicines Indian Pharmaceutical Industry boasts of quality producers and many

units approved by regulatory authorities in USA and UK International companies

associated with this sector have stimulated assisted and spearheaded this dynamic

development in the past 53 years and helped to put India on the pharmaceutical map

of the world

The Indian Pharmaceutical sector is highly fragmented with more than 20000

registered units It has expanded drastically in the last two decades The leading 250

pharmaceutical companies control 70 of the market with market leader holding

nearly 7 of the market share It is an extremely fragmented market with severe price

competition and government price control

- 5 -

Growth of Indian pharmaceuticals in the world market

The pharmaceutical industry in India meets around 70 of the countrys

demand for bulk drugs drug intermediates pharmaceutical formulations chemicals

tablets capsules orals and injectibles There are about 250 large units and about 8000

Small Scale Units which form the core of the pharmaceutical industry in India

(including 5 Central Public Sector Units) These units produce the complete range of

pharmaceutical formulations ie medicines ready for consumption by patients and

about 350 bulk drugs ie chemicals having therapeutic value and used for production

of pharmaceutical formulations

Following the de-licensing of the pharmaceutical industry industrial licensing

for most of the drugs and pharmaceutical products has been done away with

Manufacturers are free to produce any drug duly approved by the Drug Control

Authority Technologically strong and totally self-reliant the pharmaceutical industry

in India has low costs of production low RampD costs innovative scientific manpower

strength of national laboratories and an increasing balance of trade The

Pharmaceutical Industry with its rich scientific talents and research capabilities

supported by Intellectual Property Protection regime is well set to take on the

international market

The Indian patent act of 1970 amended on March 22 2005 marks the end of a

protected era and signals a new phase in the integration of India into the global

pharmaceutical market The new amendment seeks to make copying of post-1995

patented drugs illegal As India enters product patent regime how will it affect the

Indian pharmaceutical industry (IPI) health care industry legal machinery enforcing

the regulations and most importantly patients in India and the developing world given

the fact Indian drugs are exported to more than 65 countries

With a regulatory system focused only on process patents helped to establish

the foundation of a strong and highly competitive domestic pharmaceutical industry

which in the grip of a rigid price control framework transformed into a world supplier

of bulk drugs and medicines at affordable prices to common man in India and the

developing world Introduction of product patents will however mark the end of a

golden age for IPI The new regulations will reshape the landscape of IPI forcing

- 6 -

Growth of Indian pharmaceuticals in the world market

significant changes and divide within the industry A look into organization of

pharmaceutical producers of India (OPPI) directory shows only 300 units out of

10000 registered companies are in the organized sector While process patent helped

to flourish IPI into a world-class generics industry product patent regime will filter

the best from the pack and would be favorable to players with built-in scientific and

technical resources The impact of the new regulations will not deter the Indian

pharmaceutical majors as they are already doing roaring business in the very countries

where these patent laws are strictly in force

Driven by the knowledge skills growing enterprise low costs improved

quality and demand (domestic and international) the pharmaceuticals sector has

witnessed a tremendous growth over the past few years - from a turnover of Rs 5000

crores in 1990 to over Rs 50000 crores during 2004-05 Exports have also grown

very significantly to over Rs 16700 crores during this period

Exports of Drugs Pharmaceuticals and Fine Chemicals

1999-2000 2000-01 2001-02 2002-03 2003-04

Rs 723016

Crore

($ 160

billion)

Rs 857547

Crore

($195 billion)

Rs 98347

Crore

($218

billion)

Rs 11925 4

Crore

($2 65

billion)

Rs 1410000

Crore

($313 billion)

Growth of Pharmaceutical Exports

1999-

2000

2000-

01

2001-

02

2002-

03

2003-

04

1557 2073 1113 212 1824

- 7 -

Growth of Indian pharmaceuticals in the world market

Export markets increasingly drive IPI in a turnover of US$5 billion exports

constitute $32 billion and the industry is poised to grow to $25 billion by 2010

(McKinsey) The share of IPI in world pharmaceutical market is 10 (ranks 13th) in

value and 8 (ranks 4th) in volume terms The global market for generic drugs is

estimated at $27 billion (2001) and the expiry of patents on drugs will be worth $80

billion (2005) offers a huge opportunity to IPI The industry has developed Good

Manufacturing Practices (GMP) facilities for the production of different dosage

forms The pharmaceutical industry exports drugs and pharmaceuticals worth over $

38 billion It ranks 17th in terms of export value of bulk actives and dosage Indian

exports cover more than 200 countries including the highly regulated markets of

USA Europe Japan and Australia

It is also recognized that the cost of drugs produced in India is amongst the

lowest in the world It is estimated that by the year 2010 industry has the potential to

achieve Rs 1 00000 crores in formulations with bulk drug production going up from

Rs 8000 crores to Rs 25000 crores Indiarsquos rich human capital is believed to be the

strongest asset for this knowledge-led industry Various studies show that the

scientific talent pool of 4 million Indians is the second largest English speaking group

worldwide after the US

India today has the largest number of US Food amp Drug Administration (FDA)

approved drug manufacturing facilities outside the US In addition Drug Master Files

(DMFs) filed by Indian companies with the FDA is 126 higher than Spain Italy

China and Israel put together DMF has to be approved by FDA for a drug to enter the

US market

Research amp Development (RampD) is a key to the strength of pharmaceutical

industry especially in the product patent period The global pharmaceutical industry

spent $304 billion (2001) on RampD The RampD expenditure (as a percentage of

turnover) by the IPI is low (19) when compared global giants (10 - 16) With

transition into the new regime many Indian companies are mobilizing their resources

war chest with an increase in their RampD budget Government of India (GOI)

- 8 -

Growth of Indian pharmaceuticals in the world market

encouraged the RampD in pharmaceutical companies by extending 10 year tax holiday

to this sector Besides planning commission has earmarked $34 million towards drug

industry RampD promotion fund for the tenth plan

Globally pharmaceutical industry grew at a compounded annual growth rate

of 91 per cent in the last 23 years to $491 billion propelled by a string of innovative

blockbusters Multinationals were reshaped by mergers and acquisitions as a way of

fattening their research pipelines This at best represents a short-term solution With a

slew of brand name drugs losing patent protection in the next few years and the

pressure building for pharmaceuticals to cut price these giants find themselves under

immense strain to find new drugs and reduce price Bringing a new drug into the

market costs a company an average of about $800 to $900 million Some estimates

show that patient recruitment and medical personnel account for nearly 70 per cent of

the clinical costs that are required to bring a drug to market The less expensive means

to raise research productivity is outsourcing research to low cost havens such as India

and China The global pharmaceutical outsourcing market stands at $10 billion

(2004)

Pharmaceutical multinationals have maintained a low-key presence in Indian

market due to absence of product patents and rigid price controls Pharmaceutical

industry did not receive significant foreign direct investment (FDI) From August

1991 to December 1998 this industry accounted for a meager 044 of the total FDI

Introduction of product patents will see multinationals strengthening their presence in

the country The second largest population in the world a growing economy and

rising income levels makes Indian market difficult to ignore

In the domestic market the share of Indian companies has steadily increased

from around 20 per cent in 1970 to 70 percent now Ranbaxy Laboratories is the

market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories

Glaxo is the only multinational to figure among the top ten pharma companies in

India

- 9 -

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 3: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Introduction

- 3 -

Growth of Indian pharmaceuticals in the world market

The Indian pharmaceutical sector has come a long way being almost non-

existent before 1970 to a prominent provider of healthcare products meeting almost

95 of the countrys pharmaceuticals needs The domestic pharmaceutical sales have

increased from Rs4bn in 1970-71 to Rs214bn in 2002 at a CAGR of 137 per

annum The total Indian production constitutes about 13 of the world market in

value terms and 8 in volume terms The per capita consumption of drugs in India

stands at US$3 is amongst the lowest in the world as compared to Japan- US$412

Germany- US$222 and USA- US$191

Indian pharmaceutical industry is mounting up the value chain From being a

pure reverse engineering industry focused on the domestic market the industry is

moving towards basic research driven export oriented global presence providing

wide range of value added quality products and services Government policies will

play an important role in defining the future of the pharmaceutical industry The

product patent regime which came into effect from January 2005 will lead to long-

term growth for the future

In the present scenario the growth of a domestic pharmaceutical company is

critically dependent on its therapeutic presence The old and mature categories like

anti-infectives vitamins analgesics are de-growing while new lifestyle categories

like Cardiovascular Central Nervous System (CNS) and Anti Diabetic are expanding

at double-digit growth rates

Increased generic penetration intense competition fragmentation of the

industry has negatively impacted the overall value growth of the domestic

pharmaceutical market In this scenario to grow in the domestic market

pharmaceutical companies are constantly eyeing for innovation introduction of new

value added products product life cycle management and enlarging their market

reach

Indian companies are putting their act together to tap the generic drugs

markets in the regulated high margin markets of the developed countries The US

- 4 -

Growth of Indian pharmaceuticals in the world market

market will remain the most lucrative market for the Indian companies led by its

market size and the intensity of blockbuster drugs going off patent An estimated

US$45bn of drugs expected to go off patent by 2007 in US alone

Outsourcing in the fields of RampD and manufacturing is the next best event in

the pharmaceutical industry Spiraling cost expiring patents low RampD cost and

market dynamics are driving the MNCs to outsource both manufacturing and research

activities India with its apt chemistry skills and low cost advantages both in research

and manufacturing coupled with skilled manpower will attract a lot of business in the

days to come

The Indian Pharmaceutical Industry today is in the front rank of Indiarsquos

science-based industries with wide ranging capabilities in the complex field of drug

manufacture and technology A highly organized sector the Indian Pharmaceutical

Industry is estimated to be worth $ 45 billion growing at about 8 to 9 percent

annually It ranks very high in the third world in terms of technology quality and

range of medicines manufactured From simple headache pills to sophisticated

antibiotics and complex cardiac compounds almost every type of medicine is now

made indigenously

Playing a key role in promoting and sustaining development in the vital field

of medicines Indian Pharmaceutical Industry boasts of quality producers and many

units approved by regulatory authorities in USA and UK International companies

associated with this sector have stimulated assisted and spearheaded this dynamic

development in the past 53 years and helped to put India on the pharmaceutical map

of the world

The Indian Pharmaceutical sector is highly fragmented with more than 20000

registered units It has expanded drastically in the last two decades The leading 250

pharmaceutical companies control 70 of the market with market leader holding

nearly 7 of the market share It is an extremely fragmented market with severe price

competition and government price control

- 5 -

Growth of Indian pharmaceuticals in the world market

The pharmaceutical industry in India meets around 70 of the countrys

demand for bulk drugs drug intermediates pharmaceutical formulations chemicals

tablets capsules orals and injectibles There are about 250 large units and about 8000

Small Scale Units which form the core of the pharmaceutical industry in India

(including 5 Central Public Sector Units) These units produce the complete range of

pharmaceutical formulations ie medicines ready for consumption by patients and

about 350 bulk drugs ie chemicals having therapeutic value and used for production

of pharmaceutical formulations

Following the de-licensing of the pharmaceutical industry industrial licensing

for most of the drugs and pharmaceutical products has been done away with

Manufacturers are free to produce any drug duly approved by the Drug Control

Authority Technologically strong and totally self-reliant the pharmaceutical industry

in India has low costs of production low RampD costs innovative scientific manpower

strength of national laboratories and an increasing balance of trade The

Pharmaceutical Industry with its rich scientific talents and research capabilities

supported by Intellectual Property Protection regime is well set to take on the

international market

The Indian patent act of 1970 amended on March 22 2005 marks the end of a

protected era and signals a new phase in the integration of India into the global

pharmaceutical market The new amendment seeks to make copying of post-1995

patented drugs illegal As India enters product patent regime how will it affect the

Indian pharmaceutical industry (IPI) health care industry legal machinery enforcing

the regulations and most importantly patients in India and the developing world given

the fact Indian drugs are exported to more than 65 countries

With a regulatory system focused only on process patents helped to establish

the foundation of a strong and highly competitive domestic pharmaceutical industry

which in the grip of a rigid price control framework transformed into a world supplier

of bulk drugs and medicines at affordable prices to common man in India and the

developing world Introduction of product patents will however mark the end of a

golden age for IPI The new regulations will reshape the landscape of IPI forcing

- 6 -

Growth of Indian pharmaceuticals in the world market

significant changes and divide within the industry A look into organization of

pharmaceutical producers of India (OPPI) directory shows only 300 units out of

10000 registered companies are in the organized sector While process patent helped

to flourish IPI into a world-class generics industry product patent regime will filter

the best from the pack and would be favorable to players with built-in scientific and

technical resources The impact of the new regulations will not deter the Indian

pharmaceutical majors as they are already doing roaring business in the very countries

where these patent laws are strictly in force

Driven by the knowledge skills growing enterprise low costs improved

quality and demand (domestic and international) the pharmaceuticals sector has

witnessed a tremendous growth over the past few years - from a turnover of Rs 5000

crores in 1990 to over Rs 50000 crores during 2004-05 Exports have also grown

very significantly to over Rs 16700 crores during this period

Exports of Drugs Pharmaceuticals and Fine Chemicals

1999-2000 2000-01 2001-02 2002-03 2003-04

Rs 723016

Crore

($ 160

billion)

Rs 857547

Crore

($195 billion)

Rs 98347

Crore

($218

billion)

Rs 11925 4

Crore

($2 65

billion)

Rs 1410000

Crore

($313 billion)

Growth of Pharmaceutical Exports

1999-

2000

2000-

01

2001-

02

2002-

03

2003-

04

1557 2073 1113 212 1824

- 7 -

Growth of Indian pharmaceuticals in the world market

Export markets increasingly drive IPI in a turnover of US$5 billion exports

constitute $32 billion and the industry is poised to grow to $25 billion by 2010

(McKinsey) The share of IPI in world pharmaceutical market is 10 (ranks 13th) in

value and 8 (ranks 4th) in volume terms The global market for generic drugs is

estimated at $27 billion (2001) and the expiry of patents on drugs will be worth $80

billion (2005) offers a huge opportunity to IPI The industry has developed Good

Manufacturing Practices (GMP) facilities for the production of different dosage

forms The pharmaceutical industry exports drugs and pharmaceuticals worth over $

38 billion It ranks 17th in terms of export value of bulk actives and dosage Indian

exports cover more than 200 countries including the highly regulated markets of

USA Europe Japan and Australia

It is also recognized that the cost of drugs produced in India is amongst the

lowest in the world It is estimated that by the year 2010 industry has the potential to

achieve Rs 1 00000 crores in formulations with bulk drug production going up from

Rs 8000 crores to Rs 25000 crores Indiarsquos rich human capital is believed to be the

strongest asset for this knowledge-led industry Various studies show that the

scientific talent pool of 4 million Indians is the second largest English speaking group

worldwide after the US

India today has the largest number of US Food amp Drug Administration (FDA)

approved drug manufacturing facilities outside the US In addition Drug Master Files

(DMFs) filed by Indian companies with the FDA is 126 higher than Spain Italy

China and Israel put together DMF has to be approved by FDA for a drug to enter the

US market

Research amp Development (RampD) is a key to the strength of pharmaceutical

industry especially in the product patent period The global pharmaceutical industry

spent $304 billion (2001) on RampD The RampD expenditure (as a percentage of

turnover) by the IPI is low (19) when compared global giants (10 - 16) With

transition into the new regime many Indian companies are mobilizing their resources

war chest with an increase in their RampD budget Government of India (GOI)

- 8 -

Growth of Indian pharmaceuticals in the world market

encouraged the RampD in pharmaceutical companies by extending 10 year tax holiday

to this sector Besides planning commission has earmarked $34 million towards drug

industry RampD promotion fund for the tenth plan

Globally pharmaceutical industry grew at a compounded annual growth rate

of 91 per cent in the last 23 years to $491 billion propelled by a string of innovative

blockbusters Multinationals were reshaped by mergers and acquisitions as a way of

fattening their research pipelines This at best represents a short-term solution With a

slew of brand name drugs losing patent protection in the next few years and the

pressure building for pharmaceuticals to cut price these giants find themselves under

immense strain to find new drugs and reduce price Bringing a new drug into the

market costs a company an average of about $800 to $900 million Some estimates

show that patient recruitment and medical personnel account for nearly 70 per cent of

the clinical costs that are required to bring a drug to market The less expensive means

to raise research productivity is outsourcing research to low cost havens such as India

and China The global pharmaceutical outsourcing market stands at $10 billion

(2004)

Pharmaceutical multinationals have maintained a low-key presence in Indian

market due to absence of product patents and rigid price controls Pharmaceutical

industry did not receive significant foreign direct investment (FDI) From August

1991 to December 1998 this industry accounted for a meager 044 of the total FDI

Introduction of product patents will see multinationals strengthening their presence in

the country The second largest population in the world a growing economy and

rising income levels makes Indian market difficult to ignore

In the domestic market the share of Indian companies has steadily increased

from around 20 per cent in 1970 to 70 percent now Ranbaxy Laboratories is the

market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories

Glaxo is the only multinational to figure among the top ten pharma companies in

India

- 9 -

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 4: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

The Indian pharmaceutical sector has come a long way being almost non-

existent before 1970 to a prominent provider of healthcare products meeting almost

95 of the countrys pharmaceuticals needs The domestic pharmaceutical sales have

increased from Rs4bn in 1970-71 to Rs214bn in 2002 at a CAGR of 137 per

annum The total Indian production constitutes about 13 of the world market in

value terms and 8 in volume terms The per capita consumption of drugs in India

stands at US$3 is amongst the lowest in the world as compared to Japan- US$412

Germany- US$222 and USA- US$191

Indian pharmaceutical industry is mounting up the value chain From being a

pure reverse engineering industry focused on the domestic market the industry is

moving towards basic research driven export oriented global presence providing

wide range of value added quality products and services Government policies will

play an important role in defining the future of the pharmaceutical industry The

product patent regime which came into effect from January 2005 will lead to long-

term growth for the future

In the present scenario the growth of a domestic pharmaceutical company is

critically dependent on its therapeutic presence The old and mature categories like

anti-infectives vitamins analgesics are de-growing while new lifestyle categories

like Cardiovascular Central Nervous System (CNS) and Anti Diabetic are expanding

at double-digit growth rates

Increased generic penetration intense competition fragmentation of the

industry has negatively impacted the overall value growth of the domestic

pharmaceutical market In this scenario to grow in the domestic market

pharmaceutical companies are constantly eyeing for innovation introduction of new

value added products product life cycle management and enlarging their market

reach

Indian companies are putting their act together to tap the generic drugs

markets in the regulated high margin markets of the developed countries The US

- 4 -

Growth of Indian pharmaceuticals in the world market

market will remain the most lucrative market for the Indian companies led by its

market size and the intensity of blockbuster drugs going off patent An estimated

US$45bn of drugs expected to go off patent by 2007 in US alone

Outsourcing in the fields of RampD and manufacturing is the next best event in

the pharmaceutical industry Spiraling cost expiring patents low RampD cost and

market dynamics are driving the MNCs to outsource both manufacturing and research

activities India with its apt chemistry skills and low cost advantages both in research

and manufacturing coupled with skilled manpower will attract a lot of business in the

days to come

The Indian Pharmaceutical Industry today is in the front rank of Indiarsquos

science-based industries with wide ranging capabilities in the complex field of drug

manufacture and technology A highly organized sector the Indian Pharmaceutical

Industry is estimated to be worth $ 45 billion growing at about 8 to 9 percent

annually It ranks very high in the third world in terms of technology quality and

range of medicines manufactured From simple headache pills to sophisticated

antibiotics and complex cardiac compounds almost every type of medicine is now

made indigenously

Playing a key role in promoting and sustaining development in the vital field

of medicines Indian Pharmaceutical Industry boasts of quality producers and many

units approved by regulatory authorities in USA and UK International companies

associated with this sector have stimulated assisted and spearheaded this dynamic

development in the past 53 years and helped to put India on the pharmaceutical map

of the world

The Indian Pharmaceutical sector is highly fragmented with more than 20000

registered units It has expanded drastically in the last two decades The leading 250

pharmaceutical companies control 70 of the market with market leader holding

nearly 7 of the market share It is an extremely fragmented market with severe price

competition and government price control

- 5 -

Growth of Indian pharmaceuticals in the world market

The pharmaceutical industry in India meets around 70 of the countrys

demand for bulk drugs drug intermediates pharmaceutical formulations chemicals

tablets capsules orals and injectibles There are about 250 large units and about 8000

Small Scale Units which form the core of the pharmaceutical industry in India

(including 5 Central Public Sector Units) These units produce the complete range of

pharmaceutical formulations ie medicines ready for consumption by patients and

about 350 bulk drugs ie chemicals having therapeutic value and used for production

of pharmaceutical formulations

Following the de-licensing of the pharmaceutical industry industrial licensing

for most of the drugs and pharmaceutical products has been done away with

Manufacturers are free to produce any drug duly approved by the Drug Control

Authority Technologically strong and totally self-reliant the pharmaceutical industry

in India has low costs of production low RampD costs innovative scientific manpower

strength of national laboratories and an increasing balance of trade The

Pharmaceutical Industry with its rich scientific talents and research capabilities

supported by Intellectual Property Protection regime is well set to take on the

international market

The Indian patent act of 1970 amended on March 22 2005 marks the end of a

protected era and signals a new phase in the integration of India into the global

pharmaceutical market The new amendment seeks to make copying of post-1995

patented drugs illegal As India enters product patent regime how will it affect the

Indian pharmaceutical industry (IPI) health care industry legal machinery enforcing

the regulations and most importantly patients in India and the developing world given

the fact Indian drugs are exported to more than 65 countries

With a regulatory system focused only on process patents helped to establish

the foundation of a strong and highly competitive domestic pharmaceutical industry

which in the grip of a rigid price control framework transformed into a world supplier

of bulk drugs and medicines at affordable prices to common man in India and the

developing world Introduction of product patents will however mark the end of a

golden age for IPI The new regulations will reshape the landscape of IPI forcing

- 6 -

Growth of Indian pharmaceuticals in the world market

significant changes and divide within the industry A look into organization of

pharmaceutical producers of India (OPPI) directory shows only 300 units out of

10000 registered companies are in the organized sector While process patent helped

to flourish IPI into a world-class generics industry product patent regime will filter

the best from the pack and would be favorable to players with built-in scientific and

technical resources The impact of the new regulations will not deter the Indian

pharmaceutical majors as they are already doing roaring business in the very countries

where these patent laws are strictly in force

Driven by the knowledge skills growing enterprise low costs improved

quality and demand (domestic and international) the pharmaceuticals sector has

witnessed a tremendous growth over the past few years - from a turnover of Rs 5000

crores in 1990 to over Rs 50000 crores during 2004-05 Exports have also grown

very significantly to over Rs 16700 crores during this period

Exports of Drugs Pharmaceuticals and Fine Chemicals

1999-2000 2000-01 2001-02 2002-03 2003-04

Rs 723016

Crore

($ 160

billion)

Rs 857547

Crore

($195 billion)

Rs 98347

Crore

($218

billion)

Rs 11925 4

Crore

($2 65

billion)

Rs 1410000

Crore

($313 billion)

Growth of Pharmaceutical Exports

1999-

2000

2000-

01

2001-

02

2002-

03

2003-

04

1557 2073 1113 212 1824

- 7 -

Growth of Indian pharmaceuticals in the world market

Export markets increasingly drive IPI in a turnover of US$5 billion exports

constitute $32 billion and the industry is poised to grow to $25 billion by 2010

(McKinsey) The share of IPI in world pharmaceutical market is 10 (ranks 13th) in

value and 8 (ranks 4th) in volume terms The global market for generic drugs is

estimated at $27 billion (2001) and the expiry of patents on drugs will be worth $80

billion (2005) offers a huge opportunity to IPI The industry has developed Good

Manufacturing Practices (GMP) facilities for the production of different dosage

forms The pharmaceutical industry exports drugs and pharmaceuticals worth over $

38 billion It ranks 17th in terms of export value of bulk actives and dosage Indian

exports cover more than 200 countries including the highly regulated markets of

USA Europe Japan and Australia

It is also recognized that the cost of drugs produced in India is amongst the

lowest in the world It is estimated that by the year 2010 industry has the potential to

achieve Rs 1 00000 crores in formulations with bulk drug production going up from

Rs 8000 crores to Rs 25000 crores Indiarsquos rich human capital is believed to be the

strongest asset for this knowledge-led industry Various studies show that the

scientific talent pool of 4 million Indians is the second largest English speaking group

worldwide after the US

India today has the largest number of US Food amp Drug Administration (FDA)

approved drug manufacturing facilities outside the US In addition Drug Master Files

(DMFs) filed by Indian companies with the FDA is 126 higher than Spain Italy

China and Israel put together DMF has to be approved by FDA for a drug to enter the

US market

Research amp Development (RampD) is a key to the strength of pharmaceutical

industry especially in the product patent period The global pharmaceutical industry

spent $304 billion (2001) on RampD The RampD expenditure (as a percentage of

turnover) by the IPI is low (19) when compared global giants (10 - 16) With

transition into the new regime many Indian companies are mobilizing their resources

war chest with an increase in their RampD budget Government of India (GOI)

- 8 -

Growth of Indian pharmaceuticals in the world market

encouraged the RampD in pharmaceutical companies by extending 10 year tax holiday

to this sector Besides planning commission has earmarked $34 million towards drug

industry RampD promotion fund for the tenth plan

Globally pharmaceutical industry grew at a compounded annual growth rate

of 91 per cent in the last 23 years to $491 billion propelled by a string of innovative

blockbusters Multinationals were reshaped by mergers and acquisitions as a way of

fattening their research pipelines This at best represents a short-term solution With a

slew of brand name drugs losing patent protection in the next few years and the

pressure building for pharmaceuticals to cut price these giants find themselves under

immense strain to find new drugs and reduce price Bringing a new drug into the

market costs a company an average of about $800 to $900 million Some estimates

show that patient recruitment and medical personnel account for nearly 70 per cent of

the clinical costs that are required to bring a drug to market The less expensive means

to raise research productivity is outsourcing research to low cost havens such as India

and China The global pharmaceutical outsourcing market stands at $10 billion

(2004)

Pharmaceutical multinationals have maintained a low-key presence in Indian

market due to absence of product patents and rigid price controls Pharmaceutical

industry did not receive significant foreign direct investment (FDI) From August

1991 to December 1998 this industry accounted for a meager 044 of the total FDI

Introduction of product patents will see multinationals strengthening their presence in

the country The second largest population in the world a growing economy and

rising income levels makes Indian market difficult to ignore

In the domestic market the share of Indian companies has steadily increased

from around 20 per cent in 1970 to 70 percent now Ranbaxy Laboratories is the

market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories

Glaxo is the only multinational to figure among the top ten pharma companies in

India

- 9 -

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 5: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

market will remain the most lucrative market for the Indian companies led by its

market size and the intensity of blockbuster drugs going off patent An estimated

US$45bn of drugs expected to go off patent by 2007 in US alone

Outsourcing in the fields of RampD and manufacturing is the next best event in

the pharmaceutical industry Spiraling cost expiring patents low RampD cost and

market dynamics are driving the MNCs to outsource both manufacturing and research

activities India with its apt chemistry skills and low cost advantages both in research

and manufacturing coupled with skilled manpower will attract a lot of business in the

days to come

The Indian Pharmaceutical Industry today is in the front rank of Indiarsquos

science-based industries with wide ranging capabilities in the complex field of drug

manufacture and technology A highly organized sector the Indian Pharmaceutical

Industry is estimated to be worth $ 45 billion growing at about 8 to 9 percent

annually It ranks very high in the third world in terms of technology quality and

range of medicines manufactured From simple headache pills to sophisticated

antibiotics and complex cardiac compounds almost every type of medicine is now

made indigenously

Playing a key role in promoting and sustaining development in the vital field

of medicines Indian Pharmaceutical Industry boasts of quality producers and many

units approved by regulatory authorities in USA and UK International companies

associated with this sector have stimulated assisted and spearheaded this dynamic

development in the past 53 years and helped to put India on the pharmaceutical map

of the world

The Indian Pharmaceutical sector is highly fragmented with more than 20000

registered units It has expanded drastically in the last two decades The leading 250

pharmaceutical companies control 70 of the market with market leader holding

nearly 7 of the market share It is an extremely fragmented market with severe price

competition and government price control

- 5 -

Growth of Indian pharmaceuticals in the world market

The pharmaceutical industry in India meets around 70 of the countrys

demand for bulk drugs drug intermediates pharmaceutical formulations chemicals

tablets capsules orals and injectibles There are about 250 large units and about 8000

Small Scale Units which form the core of the pharmaceutical industry in India

(including 5 Central Public Sector Units) These units produce the complete range of

pharmaceutical formulations ie medicines ready for consumption by patients and

about 350 bulk drugs ie chemicals having therapeutic value and used for production

of pharmaceutical formulations

Following the de-licensing of the pharmaceutical industry industrial licensing

for most of the drugs and pharmaceutical products has been done away with

Manufacturers are free to produce any drug duly approved by the Drug Control

Authority Technologically strong and totally self-reliant the pharmaceutical industry

in India has low costs of production low RampD costs innovative scientific manpower

strength of national laboratories and an increasing balance of trade The

Pharmaceutical Industry with its rich scientific talents and research capabilities

supported by Intellectual Property Protection regime is well set to take on the

international market

The Indian patent act of 1970 amended on March 22 2005 marks the end of a

protected era and signals a new phase in the integration of India into the global

pharmaceutical market The new amendment seeks to make copying of post-1995

patented drugs illegal As India enters product patent regime how will it affect the

Indian pharmaceutical industry (IPI) health care industry legal machinery enforcing

the regulations and most importantly patients in India and the developing world given

the fact Indian drugs are exported to more than 65 countries

With a regulatory system focused only on process patents helped to establish

the foundation of a strong and highly competitive domestic pharmaceutical industry

which in the grip of a rigid price control framework transformed into a world supplier

of bulk drugs and medicines at affordable prices to common man in India and the

developing world Introduction of product patents will however mark the end of a

golden age for IPI The new regulations will reshape the landscape of IPI forcing

- 6 -

Growth of Indian pharmaceuticals in the world market

significant changes and divide within the industry A look into organization of

pharmaceutical producers of India (OPPI) directory shows only 300 units out of

10000 registered companies are in the organized sector While process patent helped

to flourish IPI into a world-class generics industry product patent regime will filter

the best from the pack and would be favorable to players with built-in scientific and

technical resources The impact of the new regulations will not deter the Indian

pharmaceutical majors as they are already doing roaring business in the very countries

where these patent laws are strictly in force

Driven by the knowledge skills growing enterprise low costs improved

quality and demand (domestic and international) the pharmaceuticals sector has

witnessed a tremendous growth over the past few years - from a turnover of Rs 5000

crores in 1990 to over Rs 50000 crores during 2004-05 Exports have also grown

very significantly to over Rs 16700 crores during this period

Exports of Drugs Pharmaceuticals and Fine Chemicals

1999-2000 2000-01 2001-02 2002-03 2003-04

Rs 723016

Crore

($ 160

billion)

Rs 857547

Crore

($195 billion)

Rs 98347

Crore

($218

billion)

Rs 11925 4

Crore

($2 65

billion)

Rs 1410000

Crore

($313 billion)

Growth of Pharmaceutical Exports

1999-

2000

2000-

01

2001-

02

2002-

03

2003-

04

1557 2073 1113 212 1824

- 7 -

Growth of Indian pharmaceuticals in the world market

Export markets increasingly drive IPI in a turnover of US$5 billion exports

constitute $32 billion and the industry is poised to grow to $25 billion by 2010

(McKinsey) The share of IPI in world pharmaceutical market is 10 (ranks 13th) in

value and 8 (ranks 4th) in volume terms The global market for generic drugs is

estimated at $27 billion (2001) and the expiry of patents on drugs will be worth $80

billion (2005) offers a huge opportunity to IPI The industry has developed Good

Manufacturing Practices (GMP) facilities for the production of different dosage

forms The pharmaceutical industry exports drugs and pharmaceuticals worth over $

38 billion It ranks 17th in terms of export value of bulk actives and dosage Indian

exports cover more than 200 countries including the highly regulated markets of

USA Europe Japan and Australia

It is also recognized that the cost of drugs produced in India is amongst the

lowest in the world It is estimated that by the year 2010 industry has the potential to

achieve Rs 1 00000 crores in formulations with bulk drug production going up from

Rs 8000 crores to Rs 25000 crores Indiarsquos rich human capital is believed to be the

strongest asset for this knowledge-led industry Various studies show that the

scientific talent pool of 4 million Indians is the second largest English speaking group

worldwide after the US

India today has the largest number of US Food amp Drug Administration (FDA)

approved drug manufacturing facilities outside the US In addition Drug Master Files

(DMFs) filed by Indian companies with the FDA is 126 higher than Spain Italy

China and Israel put together DMF has to be approved by FDA for a drug to enter the

US market

Research amp Development (RampD) is a key to the strength of pharmaceutical

industry especially in the product patent period The global pharmaceutical industry

spent $304 billion (2001) on RampD The RampD expenditure (as a percentage of

turnover) by the IPI is low (19) when compared global giants (10 - 16) With

transition into the new regime many Indian companies are mobilizing their resources

war chest with an increase in their RampD budget Government of India (GOI)

- 8 -

Growth of Indian pharmaceuticals in the world market

encouraged the RampD in pharmaceutical companies by extending 10 year tax holiday

to this sector Besides planning commission has earmarked $34 million towards drug

industry RampD promotion fund for the tenth plan

Globally pharmaceutical industry grew at a compounded annual growth rate

of 91 per cent in the last 23 years to $491 billion propelled by a string of innovative

blockbusters Multinationals were reshaped by mergers and acquisitions as a way of

fattening their research pipelines This at best represents a short-term solution With a

slew of brand name drugs losing patent protection in the next few years and the

pressure building for pharmaceuticals to cut price these giants find themselves under

immense strain to find new drugs and reduce price Bringing a new drug into the

market costs a company an average of about $800 to $900 million Some estimates

show that patient recruitment and medical personnel account for nearly 70 per cent of

the clinical costs that are required to bring a drug to market The less expensive means

to raise research productivity is outsourcing research to low cost havens such as India

and China The global pharmaceutical outsourcing market stands at $10 billion

(2004)

Pharmaceutical multinationals have maintained a low-key presence in Indian

market due to absence of product patents and rigid price controls Pharmaceutical

industry did not receive significant foreign direct investment (FDI) From August

1991 to December 1998 this industry accounted for a meager 044 of the total FDI

Introduction of product patents will see multinationals strengthening their presence in

the country The second largest population in the world a growing economy and

rising income levels makes Indian market difficult to ignore

In the domestic market the share of Indian companies has steadily increased

from around 20 per cent in 1970 to 70 percent now Ranbaxy Laboratories is the

market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories

Glaxo is the only multinational to figure among the top ten pharma companies in

India

- 9 -

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 6: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

The pharmaceutical industry in India meets around 70 of the countrys

demand for bulk drugs drug intermediates pharmaceutical formulations chemicals

tablets capsules orals and injectibles There are about 250 large units and about 8000

Small Scale Units which form the core of the pharmaceutical industry in India

(including 5 Central Public Sector Units) These units produce the complete range of

pharmaceutical formulations ie medicines ready for consumption by patients and

about 350 bulk drugs ie chemicals having therapeutic value and used for production

of pharmaceutical formulations

Following the de-licensing of the pharmaceutical industry industrial licensing

for most of the drugs and pharmaceutical products has been done away with

Manufacturers are free to produce any drug duly approved by the Drug Control

Authority Technologically strong and totally self-reliant the pharmaceutical industry

in India has low costs of production low RampD costs innovative scientific manpower

strength of national laboratories and an increasing balance of trade The

Pharmaceutical Industry with its rich scientific talents and research capabilities

supported by Intellectual Property Protection regime is well set to take on the

international market

The Indian patent act of 1970 amended on March 22 2005 marks the end of a

protected era and signals a new phase in the integration of India into the global

pharmaceutical market The new amendment seeks to make copying of post-1995

patented drugs illegal As India enters product patent regime how will it affect the

Indian pharmaceutical industry (IPI) health care industry legal machinery enforcing

the regulations and most importantly patients in India and the developing world given

the fact Indian drugs are exported to more than 65 countries

With a regulatory system focused only on process patents helped to establish

the foundation of a strong and highly competitive domestic pharmaceutical industry

which in the grip of a rigid price control framework transformed into a world supplier

of bulk drugs and medicines at affordable prices to common man in India and the

developing world Introduction of product patents will however mark the end of a

golden age for IPI The new regulations will reshape the landscape of IPI forcing

- 6 -

Growth of Indian pharmaceuticals in the world market

significant changes and divide within the industry A look into organization of

pharmaceutical producers of India (OPPI) directory shows only 300 units out of

10000 registered companies are in the organized sector While process patent helped

to flourish IPI into a world-class generics industry product patent regime will filter

the best from the pack and would be favorable to players with built-in scientific and

technical resources The impact of the new regulations will not deter the Indian

pharmaceutical majors as they are already doing roaring business in the very countries

where these patent laws are strictly in force

Driven by the knowledge skills growing enterprise low costs improved

quality and demand (domestic and international) the pharmaceuticals sector has

witnessed a tremendous growth over the past few years - from a turnover of Rs 5000

crores in 1990 to over Rs 50000 crores during 2004-05 Exports have also grown

very significantly to over Rs 16700 crores during this period

Exports of Drugs Pharmaceuticals and Fine Chemicals

1999-2000 2000-01 2001-02 2002-03 2003-04

Rs 723016

Crore

($ 160

billion)

Rs 857547

Crore

($195 billion)

Rs 98347

Crore

($218

billion)

Rs 11925 4

Crore

($2 65

billion)

Rs 1410000

Crore

($313 billion)

Growth of Pharmaceutical Exports

1999-

2000

2000-

01

2001-

02

2002-

03

2003-

04

1557 2073 1113 212 1824

- 7 -

Growth of Indian pharmaceuticals in the world market

Export markets increasingly drive IPI in a turnover of US$5 billion exports

constitute $32 billion and the industry is poised to grow to $25 billion by 2010

(McKinsey) The share of IPI in world pharmaceutical market is 10 (ranks 13th) in

value and 8 (ranks 4th) in volume terms The global market for generic drugs is

estimated at $27 billion (2001) and the expiry of patents on drugs will be worth $80

billion (2005) offers a huge opportunity to IPI The industry has developed Good

Manufacturing Practices (GMP) facilities for the production of different dosage

forms The pharmaceutical industry exports drugs and pharmaceuticals worth over $

38 billion It ranks 17th in terms of export value of bulk actives and dosage Indian

exports cover more than 200 countries including the highly regulated markets of

USA Europe Japan and Australia

It is also recognized that the cost of drugs produced in India is amongst the

lowest in the world It is estimated that by the year 2010 industry has the potential to

achieve Rs 1 00000 crores in formulations with bulk drug production going up from

Rs 8000 crores to Rs 25000 crores Indiarsquos rich human capital is believed to be the

strongest asset for this knowledge-led industry Various studies show that the

scientific talent pool of 4 million Indians is the second largest English speaking group

worldwide after the US

India today has the largest number of US Food amp Drug Administration (FDA)

approved drug manufacturing facilities outside the US In addition Drug Master Files

(DMFs) filed by Indian companies with the FDA is 126 higher than Spain Italy

China and Israel put together DMF has to be approved by FDA for a drug to enter the

US market

Research amp Development (RampD) is a key to the strength of pharmaceutical

industry especially in the product patent period The global pharmaceutical industry

spent $304 billion (2001) on RampD The RampD expenditure (as a percentage of

turnover) by the IPI is low (19) when compared global giants (10 - 16) With

transition into the new regime many Indian companies are mobilizing their resources

war chest with an increase in their RampD budget Government of India (GOI)

- 8 -

Growth of Indian pharmaceuticals in the world market

encouraged the RampD in pharmaceutical companies by extending 10 year tax holiday

to this sector Besides planning commission has earmarked $34 million towards drug

industry RampD promotion fund for the tenth plan

Globally pharmaceutical industry grew at a compounded annual growth rate

of 91 per cent in the last 23 years to $491 billion propelled by a string of innovative

blockbusters Multinationals were reshaped by mergers and acquisitions as a way of

fattening their research pipelines This at best represents a short-term solution With a

slew of brand name drugs losing patent protection in the next few years and the

pressure building for pharmaceuticals to cut price these giants find themselves under

immense strain to find new drugs and reduce price Bringing a new drug into the

market costs a company an average of about $800 to $900 million Some estimates

show that patient recruitment and medical personnel account for nearly 70 per cent of

the clinical costs that are required to bring a drug to market The less expensive means

to raise research productivity is outsourcing research to low cost havens such as India

and China The global pharmaceutical outsourcing market stands at $10 billion

(2004)

Pharmaceutical multinationals have maintained a low-key presence in Indian

market due to absence of product patents and rigid price controls Pharmaceutical

industry did not receive significant foreign direct investment (FDI) From August

1991 to December 1998 this industry accounted for a meager 044 of the total FDI

Introduction of product patents will see multinationals strengthening their presence in

the country The second largest population in the world a growing economy and

rising income levels makes Indian market difficult to ignore

In the domestic market the share of Indian companies has steadily increased

from around 20 per cent in 1970 to 70 percent now Ranbaxy Laboratories is the

market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories

Glaxo is the only multinational to figure among the top ten pharma companies in

India

- 9 -

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 7: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

significant changes and divide within the industry A look into organization of

pharmaceutical producers of India (OPPI) directory shows only 300 units out of

10000 registered companies are in the organized sector While process patent helped

to flourish IPI into a world-class generics industry product patent regime will filter

the best from the pack and would be favorable to players with built-in scientific and

technical resources The impact of the new regulations will not deter the Indian

pharmaceutical majors as they are already doing roaring business in the very countries

where these patent laws are strictly in force

Driven by the knowledge skills growing enterprise low costs improved

quality and demand (domestic and international) the pharmaceuticals sector has

witnessed a tremendous growth over the past few years - from a turnover of Rs 5000

crores in 1990 to over Rs 50000 crores during 2004-05 Exports have also grown

very significantly to over Rs 16700 crores during this period

Exports of Drugs Pharmaceuticals and Fine Chemicals

1999-2000 2000-01 2001-02 2002-03 2003-04

Rs 723016

Crore

($ 160

billion)

Rs 857547

Crore

($195 billion)

Rs 98347

Crore

($218

billion)

Rs 11925 4

Crore

($2 65

billion)

Rs 1410000

Crore

($313 billion)

Growth of Pharmaceutical Exports

1999-

2000

2000-

01

2001-

02

2002-

03

2003-

04

1557 2073 1113 212 1824

- 7 -

Growth of Indian pharmaceuticals in the world market

Export markets increasingly drive IPI in a turnover of US$5 billion exports

constitute $32 billion and the industry is poised to grow to $25 billion by 2010

(McKinsey) The share of IPI in world pharmaceutical market is 10 (ranks 13th) in

value and 8 (ranks 4th) in volume terms The global market for generic drugs is

estimated at $27 billion (2001) and the expiry of patents on drugs will be worth $80

billion (2005) offers a huge opportunity to IPI The industry has developed Good

Manufacturing Practices (GMP) facilities for the production of different dosage

forms The pharmaceutical industry exports drugs and pharmaceuticals worth over $

38 billion It ranks 17th in terms of export value of bulk actives and dosage Indian

exports cover more than 200 countries including the highly regulated markets of

USA Europe Japan and Australia

It is also recognized that the cost of drugs produced in India is amongst the

lowest in the world It is estimated that by the year 2010 industry has the potential to

achieve Rs 1 00000 crores in formulations with bulk drug production going up from

Rs 8000 crores to Rs 25000 crores Indiarsquos rich human capital is believed to be the

strongest asset for this knowledge-led industry Various studies show that the

scientific talent pool of 4 million Indians is the second largest English speaking group

worldwide after the US

India today has the largest number of US Food amp Drug Administration (FDA)

approved drug manufacturing facilities outside the US In addition Drug Master Files

(DMFs) filed by Indian companies with the FDA is 126 higher than Spain Italy

China and Israel put together DMF has to be approved by FDA for a drug to enter the

US market

Research amp Development (RampD) is a key to the strength of pharmaceutical

industry especially in the product patent period The global pharmaceutical industry

spent $304 billion (2001) on RampD The RampD expenditure (as a percentage of

turnover) by the IPI is low (19) when compared global giants (10 - 16) With

transition into the new regime many Indian companies are mobilizing their resources

war chest with an increase in their RampD budget Government of India (GOI)

- 8 -

Growth of Indian pharmaceuticals in the world market

encouraged the RampD in pharmaceutical companies by extending 10 year tax holiday

to this sector Besides planning commission has earmarked $34 million towards drug

industry RampD promotion fund for the tenth plan

Globally pharmaceutical industry grew at a compounded annual growth rate

of 91 per cent in the last 23 years to $491 billion propelled by a string of innovative

blockbusters Multinationals were reshaped by mergers and acquisitions as a way of

fattening their research pipelines This at best represents a short-term solution With a

slew of brand name drugs losing patent protection in the next few years and the

pressure building for pharmaceuticals to cut price these giants find themselves under

immense strain to find new drugs and reduce price Bringing a new drug into the

market costs a company an average of about $800 to $900 million Some estimates

show that patient recruitment and medical personnel account for nearly 70 per cent of

the clinical costs that are required to bring a drug to market The less expensive means

to raise research productivity is outsourcing research to low cost havens such as India

and China The global pharmaceutical outsourcing market stands at $10 billion

(2004)

Pharmaceutical multinationals have maintained a low-key presence in Indian

market due to absence of product patents and rigid price controls Pharmaceutical

industry did not receive significant foreign direct investment (FDI) From August

1991 to December 1998 this industry accounted for a meager 044 of the total FDI

Introduction of product patents will see multinationals strengthening their presence in

the country The second largest population in the world a growing economy and

rising income levels makes Indian market difficult to ignore

In the domestic market the share of Indian companies has steadily increased

from around 20 per cent in 1970 to 70 percent now Ranbaxy Laboratories is the

market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories

Glaxo is the only multinational to figure among the top ten pharma companies in

India

- 9 -

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 8: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Export markets increasingly drive IPI in a turnover of US$5 billion exports

constitute $32 billion and the industry is poised to grow to $25 billion by 2010

(McKinsey) The share of IPI in world pharmaceutical market is 10 (ranks 13th) in

value and 8 (ranks 4th) in volume terms The global market for generic drugs is

estimated at $27 billion (2001) and the expiry of patents on drugs will be worth $80

billion (2005) offers a huge opportunity to IPI The industry has developed Good

Manufacturing Practices (GMP) facilities for the production of different dosage

forms The pharmaceutical industry exports drugs and pharmaceuticals worth over $

38 billion It ranks 17th in terms of export value of bulk actives and dosage Indian

exports cover more than 200 countries including the highly regulated markets of

USA Europe Japan and Australia

It is also recognized that the cost of drugs produced in India is amongst the

lowest in the world It is estimated that by the year 2010 industry has the potential to

achieve Rs 1 00000 crores in formulations with bulk drug production going up from

Rs 8000 crores to Rs 25000 crores Indiarsquos rich human capital is believed to be the

strongest asset for this knowledge-led industry Various studies show that the

scientific talent pool of 4 million Indians is the second largest English speaking group

worldwide after the US

India today has the largest number of US Food amp Drug Administration (FDA)

approved drug manufacturing facilities outside the US In addition Drug Master Files

(DMFs) filed by Indian companies with the FDA is 126 higher than Spain Italy

China and Israel put together DMF has to be approved by FDA for a drug to enter the

US market

Research amp Development (RampD) is a key to the strength of pharmaceutical

industry especially in the product patent period The global pharmaceutical industry

spent $304 billion (2001) on RampD The RampD expenditure (as a percentage of

turnover) by the IPI is low (19) when compared global giants (10 - 16) With

transition into the new regime many Indian companies are mobilizing their resources

war chest with an increase in their RampD budget Government of India (GOI)

- 8 -

Growth of Indian pharmaceuticals in the world market

encouraged the RampD in pharmaceutical companies by extending 10 year tax holiday

to this sector Besides planning commission has earmarked $34 million towards drug

industry RampD promotion fund for the tenth plan

Globally pharmaceutical industry grew at a compounded annual growth rate

of 91 per cent in the last 23 years to $491 billion propelled by a string of innovative

blockbusters Multinationals were reshaped by mergers and acquisitions as a way of

fattening their research pipelines This at best represents a short-term solution With a

slew of brand name drugs losing patent protection in the next few years and the

pressure building for pharmaceuticals to cut price these giants find themselves under

immense strain to find new drugs and reduce price Bringing a new drug into the

market costs a company an average of about $800 to $900 million Some estimates

show that patient recruitment and medical personnel account for nearly 70 per cent of

the clinical costs that are required to bring a drug to market The less expensive means

to raise research productivity is outsourcing research to low cost havens such as India

and China The global pharmaceutical outsourcing market stands at $10 billion

(2004)

Pharmaceutical multinationals have maintained a low-key presence in Indian

market due to absence of product patents and rigid price controls Pharmaceutical

industry did not receive significant foreign direct investment (FDI) From August

1991 to December 1998 this industry accounted for a meager 044 of the total FDI

Introduction of product patents will see multinationals strengthening their presence in

the country The second largest population in the world a growing economy and

rising income levels makes Indian market difficult to ignore

In the domestic market the share of Indian companies has steadily increased

from around 20 per cent in 1970 to 70 percent now Ranbaxy Laboratories is the

market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories

Glaxo is the only multinational to figure among the top ten pharma companies in

India

- 9 -

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 9: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

encouraged the RampD in pharmaceutical companies by extending 10 year tax holiday

to this sector Besides planning commission has earmarked $34 million towards drug

industry RampD promotion fund for the tenth plan

Globally pharmaceutical industry grew at a compounded annual growth rate

of 91 per cent in the last 23 years to $491 billion propelled by a string of innovative

blockbusters Multinationals were reshaped by mergers and acquisitions as a way of

fattening their research pipelines This at best represents a short-term solution With a

slew of brand name drugs losing patent protection in the next few years and the

pressure building for pharmaceuticals to cut price these giants find themselves under

immense strain to find new drugs and reduce price Bringing a new drug into the

market costs a company an average of about $800 to $900 million Some estimates

show that patient recruitment and medical personnel account for nearly 70 per cent of

the clinical costs that are required to bring a drug to market The less expensive means

to raise research productivity is outsourcing research to low cost havens such as India

and China The global pharmaceutical outsourcing market stands at $10 billion

(2004)

Pharmaceutical multinationals have maintained a low-key presence in Indian

market due to absence of product patents and rigid price controls Pharmaceutical

industry did not receive significant foreign direct investment (FDI) From August

1991 to December 1998 this industry accounted for a meager 044 of the total FDI

Introduction of product patents will see multinationals strengthening their presence in

the country The second largest population in the world a growing economy and

rising income levels makes Indian market difficult to ignore

In the domestic market the share of Indian companies has steadily increased

from around 20 per cent in 1970 to 70 percent now Ranbaxy Laboratories is the

market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories

Glaxo is the only multinational to figure among the top ten pharma companies in

India

- 9 -

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 10: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

In India 97 per cent of drugs are off patent and are manufactured by a vast

number of companies The key therapeutic segments include anti-infectives cardio

vascular and central nervous system drugs Anti-infectives comprise the largest

therapeutic segment in India accounting for about 26 per cent of the market

Lets take a look at how and whom does the new rule affect with a few specific

case A symptom of the new regulation is a dispute about the anti-blood cancer drug

Gleevac sold by Novartis for $2750 per month when the prohibited generics used to

cost less than one-tenth of the price In India 24000 new cases of this disease are

reported each year with about 18000 patients succumbing to it The country does not

have a strong health insurance sector as in the US to cushion the rising healthcare

cost In addition most patients pay for medicines through their own funding and is not

backed by medical insurance schemes Private sector provides 80 of the countryrsquos

health care and the government role is limited with a budget of only $215 million as

per the 2005-06 budget estimates

Since 1986 when the first case of AIDS was reported in India the affected

population has grown to 45 million in the late 2002 The impact of the recent

amendments will be felt in developing world as well as half the AIDS patients in the

third world rely on Indias generic drug industry Cipla Ranbaxy Laboratories Matrix

Laboratories and Hetero Drugs recently announced an agreement with the Clinton

foundation to provide drugs to four African and nine Caribbean countries at a per

capita cost of about $037 per day Indias ministry of health is negotiating a final

price with the generic drug manufacturers in an effort to obtain drugs for India at a

price even lower than that The 12 ARVs (anti retro-viral drugs) used for AIDS and

manufactured in India are pre-1995 period inventions As AIDS patients develop

resistance to old drugs new treatments will become less affordable

If a drug is desperately needed the new law allows the government like the

rest of the world to declare an emergency and cancel its patent India had never

declared such an emergency and for years resisted admitting that it had an AIDS

problem

- 10 -

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 11: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

India is also home to 25 million DementiaAlzheimers disease patients As

most of the anti- holinesterse drugs are recent the price of these medicines would

automatically go up

The government-run patent office will come under pressure for the first time

in several years to streamline the entire process As with any new administrative or

legal system transition to a new regime will not be smooth Can the enormously

strained Indian legal system bear the additional pressures as we enter the product

patent world

The decades of incubation and shielding of IPI by favorable government

policies and absence of foreign competition is over IPI is in the cross roads now and

staring at a new world full of opportunities and threats

The Indian pharmaceutical industry is fast on its road to healthy growth The

Indian pharmaceutical sector was largely positioned as a generics market But now it

is transforming to emerge as major contributor in the global perspective

The drive of the Indian pharmaceutical sector towards its greater share in the

global industry is from its introduction of product patents in 2005 In the last twenty

years patents were only granted on processes decision This being to the

disadvantages of many multi-national companies they exited from the country

However it turned advantageous to India which enabled it to become a leading

producer of generic medicines

RNCOSrsquo market research report ldquoOpportunities in Indian Pharmaceutical

Sectorrdquo tells that the pharmaceutical sector in India currently shares US $6 billion of

the total $552 billion global pharmaceutical industry And this share is poised to grow

at a rate of 12 every year compared to the annual growth of 8 in the world

market This is pointed evidence to the promising scenario of the pharmaceutical

market in India

- 11 -

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 12: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Reasons for Growth

Cost advantage

Contract Manufacturing

Research and Development

Mergers and Acquisitions

- 12 -

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 13: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Reasons for growth

21 Cost advantage

The most critical challenge facing the global pharmaceutical industry today is the

increasing cost of drug discovery and development and the increasing time to market

This is further compounded by

impending patent expirations of blockbuster molecules

pricing pressures

low public opinion

challenges to intellectual property by increasingly aggressive generic

companies

re-importation pressures

MedicareMedicaid reform

increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to

rethink their strategic options in order to exploit their core competencies across the

globe In this situation India stands a lot to gain because of its inherent advantages

like stability culture cost and educated workforce This has led to increased alliances

and collaborations thus eventually creating a win-win situation for both the parties

The growth of Indian pharma industry is also driven by the low drug

production costs which are 55 percent lower than in the western countries Another

reason of high growth rates is the system of contract manufacturing

- 13 -

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 14: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

22 Contract Manufacturing

Many global pharmaceutical majors are looking to outsource manufacturing

from Indian companies which enjoy much lower costs (both capital and recurring)

than their western counterparts Many Indian companies have made their plants

cGMP compliant and India is also having the largest number of USFDA-approved

plants outside USA

Indian companies are proving to be better at developing Active Pharmaceutical

Ingredients (APIs) than their competitors from target markets and that too with non-

infringing processes Indian drugs are either entering in to strategic alliances with

large generic companies in the world of off-patent molecules or entering in to contract

manufacturing agreements with innovator companies for supplying complex under-

patent molecules

Some of the companies like Dishman Pharma Divis Labs and Matrix Labs

have been undertaking contract jobs for MNCs in the US and Europe Even Shasun

Chemicals Strides Arcolabs Jubilant Organosys Orchid Pharmaceuticals and many

other large Indian companies started undertaking contract manufacturing of APIs as

part of their additional revenue stream Top MNCs like Pfizer Merck GSK Sanofi

Aventis Novartis Teva etc are largely depending on Indian companies for many of

their APIs and intermediates The Boston Consulting Group estimated that the

contract manufacturing market for global companies in India would touch $900

million by 2010 Industry estimates suggest that the Indian companies bagged

manufacturing contracts worth $75 million in 2004

- 14 -

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 15: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Select Contract Manufacturing Deals in India

Indian company Multinational Product

Lupin Laboratories Fujisawa Cefixime

ApotexCefuroxime Axetil Lisinopril

(Bulk)

Nicholas Piramal Allergan Bulk and Formulations

Advanced Medical

Optics Eye Products

Wockhardt Ivax Nizatidine (anti- ulcerant)

Dishman Pharmaceuticals Solvay

PharmaceuticalsEprosartan Mesylate

IPCA Labs Merck Bulk Drugs

Tillomed Atenelol

Orchid Chemicals and

Pharmaceuticals Apotex

Cephalosporin and other

injectables

Sun Pharma Eli Lilly CVS products anti-infective

drugs and insulin

Kopran Synpac

PharmaceuticalsPenicillin- G Bulk Drug

Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

Boehringer IngelheimGastrointestinal and CVS

Products

Biocon Bristol Myers Squibb Bulk Drugs

- 15 -

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 16: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

23 Research and Development

India is becoming an increasingly attractive destination for RampD activities in

the pharmaceutical industry A variety of factors from changing IP and patent laws

via favorable costskill ratios to the past success of outsourcing in the IT fields have

converged to create a compelling business opportunity for Indian companies in

pharmaceutical RampD Global pharmaceutical companies can exploit this opportunity

by developing an lsquoIndia Strategyrsquo to enhance and complement their existing RampD

efforts Indian Pharmaceutical companies are in a favourable position to develop

drugs at a fraction of the international costs due to the low manpower cost

infrastructure quality scientists and the capability to conduct path-breaking research

The Government has taken various policy initiatives in order to strengthen

Research and Development in the pharma sector

Fiscal incentives are awarded to Research and Development units in the

pharma sectors towards the development of new drug molecules clinical

research new drug delivery systems new Research and Development set ups

and infrastructure provision

Certain leading Research and Development companies have increased their

Research and Development spending to over 5 percent of their turnover in

comparison to an average spending of 2 per cent

Pharma units interested in obtaining Income Tax Exemption under Section

35(2AB) need to get their Research and Development unit recognized by

CSIR

A Pharmaceutical Research and Development Promotion Fund to the tune of

Rs 150 crores has been established for promoting Research and Development

in the pharma sector

- 16 -

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 17: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

24 Mergers and Acquisitions

The pharmaceutical sector leads the MampAs wave after information technology

This trend is fuelled by the need to explore newer markets and products for future growth

in this industry Further acquisitions also act as mechanisms to alleviate regulatory

constraints in penetrating overseas markets Hence Indian pharmaceutical companies are

increasingly focusing on global acquisitions and are adopting the strategy of acquiring

existing generic drug marketing companies that hold valid drug licenses The

pharmaceutical companies have been aggressively making acquisitions overseas

especially in the US and Europe in the past two to three years Most of the acquisitions

have been in the generics space and have resulted in Indian firms gaining access to

manufacturing facilities in potential areas like the European Union Industry

consolidation is considered to be a better option for inducing growth Many organised

companies like Ranbaxy Sun Pharma Wockhardt DRL and Cipla have already adopted

the consolidation strategy in an attempt to strengthen their base in the regulated markets

by acquiring small companies in Europe and the US

- 17 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 18: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Trends and Strategies

- 18 -

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 19: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

SWOT Analysis

Strengths

1048707 Low cost - Indian manufacturers are one of the lowest cost producers of drugs in the

world With a scalable labor force Indian manufactures can produce drugs at 40to

50 of the cost to the rest of the world In some cases this cost is as low as 90

1048707 Strong technical skills ndash Indian pharmaceutical industry posses excellent chemistry

and process reengineering skills This adds to the competitive advantage of the Indian

companies The strength in chemistry skill help Indian companies to develop

processes which are cost effective

1048707 Fluency in English speaking - Most people in India especially those who are

educated and have advanced degrees are fluent in English This aptitude allows them

to communicate with most of the outside world which is an important asset to the IPI

The health statistics of India make it clear that India produces a sufficient number of

medical and pharmacy graduates which contributes to the strengthening of the IPI

1048707 Patent ndash The Patent Act and Drug Price Control Order of the 1970s forced MNCs to

shrink their operations in India thus providing space for indigenous pharmaceutical

companies to expand in the local market As a result in the past two to three decades

domestic pharmaceutical companies have established operations and are self

sufficient in all aspects For example Cipla Limited could provide the generic version

of the AIDS triple cocktail to impoverished South African people at $350patientyear

or at a price that is one-thirtieth its cost in the United States Indian patent laws

allowed local companies to set up operations to produce bulk drugs that are still under

patent by various synthetic routes The prevalence of this reverse engineering is

controversial but it suggests that the IPIrsquos chemists have a strong showing in organic

medicinal chemistry The IPIrsquos tremendous potential to produce bulk drugs will be a

major asset in future drug discovery programs

- 19 -

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 20: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Weaknesses

1048707 Poor RampD expenditure -Compared to the global pharmaceutical industry Indian

RampD expenditure is still minuscule which could have a negative effect in the long

run especially in Product Patent regime The average R amp D spend in India though

growing at a CAGR of 18 over last five years is just 19 of sales as against 10-

16 spend by global pharma companies Even if 25 of gross sales are invested in

RampD the IPIrsquos total RampD budget is comparatively very small Individual RampD

budgets of many US companies probably amount to much more than the cumulative

RampD budgets of all the companies in India Thus availability of funds is a major

weakness of the IPI

1048707 Tag of being ldquoCopy Catsrdquo ndash Majority of the Indian companies are dependent on

replicating drugs developed by MNCs hence Indian companies are viewed in not so

good light

1048707 Price Regulation - The Indian pharma companies are marred by the price

regulation Over a period of time this regulation has reduced the pricing ability of

companies The NPPA (National Pharma Pricing Authority) which is the authority to

decide the various pricing parameters sets prices of different drugs which leads to

lower profitability for the companies The companies which are lowest cost

producers are at advantage while those who cannot produce have either to stop

production or bear losses

1048707 Slow growth - Indian pharma market is one of the least penetrated in the world

However growth has been slow to come by As a result Indian majors are relying on

exports for growth To put things in to perspective India accounts for almost 16 of

the world population while the total size of industry is just 1 of the global pharma

industry

- 20 -

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 21: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

1048707 Low entry barriers - Due to very low barriers to entry Indian pharma industry is

highly fragmented This makes Indian pharma market increasingly competitive

The industry witnesses price competition which reduces the growth of the industry in

value term To put things in perspective in the year 2003 the industry actually grew

by 104 but due to price competition the growth in value terms was 82 (prices

actually declined by 22)

1048707 Labour laws - Outdated and restrictive labour laws are hampering all the industries

in India and making it unviable for the MNCs to set up production base in

India

1048707 Animal rights - Animal experiments are an essential part of pharmaceutical RampD

Every drug molecule must be screened using animals first to determine its efficacy

and side or toxic effects If Indian animal rights activists block the use of animals in

RampD experimentation the IPI will be forced to turn to other countries for animal

studies A great need exists to provide appropriate information to animal activists in

India so a balance can be struck between animal rights and human rights

1048707 Infrastructure - The infrastructure in India is good but could be improved The

development of infrastructure is a key to success and the IPI must take more

definitive steps to overcome this weakness

- 21 -

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 22: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Opportunities

1048707 Off patent drugs - Large number of drugs going off-patent in Europe and in the US

between 2005 to 2009 (approx $80 billion) offers a big opportunity for the Indian

companies to capture this market Since generic drugs are commodities by nature

Indian producers have the competitive advantage as they are the lowest cost

producers of drugs in the world

1048707 Expansion - Opening up of health insurance sector and the expected growth in per

capita income are key growth drivers from a long-term perspective This leads to the

expansion of healthcare industry of which pharma industry is an integral part

1048707 Outsourcing - Being the lowest cost producer combined with FDA approved plants

Indian companies can become a global outsourcing hub for pharmaceutical products

1048707 Patent - A patent is granted to an invention that is novel nonobvious and useful

The IPI has a clear opportunity to be part of the international patent community in the

acquisition of patents This process will stimulate economic development provide job

opportunities and help India build a global reputation as a nation with a strong

scientific community It will also make modern medicines available to the entire

Indian population More important indigenous RampD activities will help domestic

companies discover drugs to treat tropical diseases

- 22 -

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 23: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Threats

1048707 Transition from ldquoProcessrdquo patent to ldquoProductrdquo patent ndash This is the major threat

Indian pharmaceutical industry is facing Indian companies especially medium and

small sized do not have capabilities to develop new molecules and they may succumb

to the giants

1048707 Counterfeit drugs ndash The extent of the problem of counterfeit drugs is unknown

Counterfeiting is difficult to detect investigate and quantify So it is hard to know or

even estimate the true extent of the problem What is known is that they occur

worldwide and are more prevalent in developing countries It is estimated that

upwards of 10 of drugs worldwide are counterfeit and in some countries more than

50 of the drug supply is made up of counterfeit drugs

1048707 Other low cost countries - Threats from other low cost countries like China and

Israel exist However on the quality front India is better placed relative to China So

differentiation in the contract manufacturing side may wane

- 23 -

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 24: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Trends and Strategies

The Indian domestic pharmaceutical industry is increasingly becoming

globally competitive to counter the weaknesses and threats The key trends and

strategies being adopted by the local pharmaceutical industry are

Increased RampD Focus

Driven by the imminent change to a product patent regime at home from 2005

the leading pharmaceutical companies in India have been increasing their RampD

budgets over the yearsIndian pharmaceutical companies are likely to double their

expenditure on RampD over the next 2 years

Exports driven growth

Indian pharmaceutical companies are on a global beat Currently exports

contribute more than half the total revenues for most of the Indian pharmaceutical

majors Exports have increased in recent years as Indian pharmaceutical companies

have made deep inroads into the regulated generic markets of the US and Europe in

addition to unregulated markets

- 24 -

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 25: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Efforts Taken by the government

Experience Drawn from Past Pharmaceutical Policies

Important Developments after liberalization process in 1991

Research and Development

Pharma ParksSEZs for Pharma industry

Greater Thrust on Pharma Exports

- 25 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 26: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian government

In the year 2002 Government had formulated a new Drug Policy but the same

could not be implemented due to litigation involving it hence the policy of 1994 still

continues to be in force The present Policy known as the National Pharmaceuticals

Policy 2005 has been necessitated due to several developments that have taken place

during the course of last few years as well as to address some of the major concerns as

highlighted above Price regulation of the essential medicines is an important

component of this policy However several other matters having a close bearing on

the pharmaceuticals sector have also been included in the policy

41 Experience Drawn from Past Pharmaceutical Policies

The first comprehensive Drug Policy of 1978 and thereafter the Drug Policy of

1986 together with the application of process patent under the Patent Act of 1970

successfully paved the way for development of indigenous pharmaceutical industry

which went into the production of generic drugs in a big way A conducive

environment for success was provided by the then prevailing trade and economic

policies During the period from 1978 to 1990 indigenous industry acquired a

respectable status in terms of product range and market share RampD was confined to

process developmentinnovation of existing molecules As regards pricing the span of

control inclusionexclusion of drugs under price control methodologies adopted etc

continued to be debated The Government developed principles of selectivity from

time to time to keep the price control manageable and focused as would be observed

from declining trend in number of drugs under price control In 1970 almost all bulk

drugs and their formulations were under price control In keeping with the economic

policies of the country the number got reduced to 347 bulk drugs in 1979 142 in 1987

and finally to 74 in 1995 It would have got reduced further under the criteria adopted

in the Pharmaceutical Policy 2002 however the same could not be implemented due

to litigation involving it

- 26 -

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 27: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

42 Important Developments after liberalization process in 1991

Following are some of the important developments that have taken place in

pharmaceutical sector after the process of liberalization of the Indian economy was

initiated by the Government in the year 1991

1) Industrial Licensing

Industrial licensing for all kinds of drugs has been abolished (it has recently been

done for the last remaining bulk drugs produced by the use of recombinant DNA

technology bulk drugs requiring in-vivo use of nucleic acids and specific cell-tissue

targeted formulations)

However the need for obtaining manufacturing license under Drugs and Cosmetics

Act 1940 continues for all units whether organized or small scale The State Drug

Controllers are authorized to issue such licenses in most cases

2 Foreign Direct Investment

FDI up to 100 is permitted subject to stipulations laid down from time to time in

the Industrial Policy through the automatic route in the case of all bulk drugs cleared

by the Drug Controller General (India) all their intermediates and formulations

Recently bulk drugs produced by the use of recombinant DNA technology bulk drugs

requiring in-vivo use of nucleic acids as the active principles and special celltissue

targeted formulations have also been allowed this facility

3 Foreign Technology Agreement

Automatic approval for Foreign Technology Agreement (FTA) is already available in

the case of all the bulk drugs cleared by Drug Controller General (India) all their

intermediates and formulations except bulk drugs produced by the use of

recombinant DNA technology bulk drugs requiring in-vivo use of nucleic acids as the

active principles and specific celltissue targeted formulations

- 27 -

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 28: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

4 Imports

Imports of drugs and pharmaceuticals are regulated through EXIM Policy in force and

presently all items except those requiring clearance under The Narcotics and

Psychotropic Substances Act 1985 are allowed under OGL Further a centralized

system of registration has been introduced under the Drugs amp Cosmetics Act and

Rules made there under administered by Ministry of Health and Family Welfare

These arrangements may continue to regulate imports of Drugs and Pharmaceuticals

5 Exports

Exports are permitted in accordance with the EXIM Policy and relevant

proceduresrules formulated for the purpose by the Directorate General of Foreign

Trade Exports are also subject to laws prevalent in importing countries Also the

exporters are allowed imports of inputs on duty-free basis for export production The

industry has shown commendable export performance the trade balance being

positive Over the last few years the compounded annual growth rate in exports has

been 227 percent

6 Constitution of Pharmaceutical Export Promotion Council (Pharmexil)

In order to provide a boost to pharmaceutical exports Government constituted a

separate Export Promotion Council for Pharmaceuticals (Pharmexil) in the year 2004-

05 This Council works closely with the Department of Commerce and the Export

Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports preparing country-profiles assessing export

potential across the countries and to have greater degree of interaction internationally

7 Research amp Development

As recommended by the Mashelkar Committee in 1999 a Pharmaceutical Research

and Development Support Fund (PRDSF) with a corpus of Rs 150 crores has been set

up under the administrative control of the Department of Science and Technology A

Drug Development Promotion Board (DDPB) to administer the utilization of PRDSF

has also been set up

- 28 -

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 29: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

8 Product Patent in Pharmaceuticals -

Product patent in pharmaceuticals has been introduced in the country with

effect from 1st January 2005 by amending the Patents Act 1970 in conformity with

the TRIPS agreement The physical infrastructure in the four patent offices in the

country (Kolkata Delhi Chennai and Mumbai) has been substantially strengthened

and computerization has been introduced Steps are now being taken to further

augment and improve the software and human resources in these offices to enable

them to deal with the new responsibilities

9 Schedule M of Drugs and Cosmetics Act 1940-

The revised Schedule M of the Drugs and Cosmetics Act 1940 related to Good

Manufacturing Practices (GMP) has come into effect from 1stJuly 2005This would in

the long run strengthen the pharmaceutical industry as a producer of quality medicines

10 Introduction of Value Added Tax (VAT)

VAT has been introduced in India with effect from 1st April2005 Already 22 States

have implemented it The remaining States are likely to implement it in the near

future VAT on medicines has been kept at 4

11 Excise Duty payable on MRP (Maximum Retail Price)

A Notification was issued on 7th January 2005 under which Excise duty became

leviable on MRP with an abatement of 40

- 29 -

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 30: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

43 Research and Development ndash

A Fiscal Incentives

India is emerging as the most favored destinations for collaborative RampD

bioinformatics contract research and manufacturing and clinical research as a result

of growing compliance with internationally harmonized standards such as Good

Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP ) and

Good Clinical Practices (GCP) With the application of product patent in the case of

pharmaceuticals it is imperative for the Indian industry to accelerate its efforts in

RampD in this sector The present level of spend on RampD (about 5 of turnover) is

much lower as compared to most of the developed countries (15 to 20) With a view

to encourage RampD in this sector it is essential to provide suitable incentives to

industry At the same time it is also necessary that the incentives are made use of by

those units which are genuinely engaged in RampD As such the required incentives

would be made available with some safeguards to ensure that these are available to

the deserving cases only The incentives available would be as under ndash

a) The benefit of 150 weighted exemption under section 35(2AB) to be continued

till 31st March 2015

b) Section 35(2AB) to be extended to depreciation on investment made in land and

building for dedicated research facilities expenditure incurred for obtaining

regulatory approvals and filling of patents abroad and expenditure incurred on clinical

trials in India

c) Reference Standard (sample under test) would be exempted from import duty

d) Reference books to be imported for RampD would be exempted from import duty

e) Presently there are 101 specified instruments (list 28) required for RampD purposes

which are exempt from import duty With the ever changing requirements new

instruments are required to be imported These instruments based on the certification

of DSIR would also be exempt from import duty The fiscal incentives are at present

only available up to 31st March 2007 Since RampD activity has to be carried over long

periods of time fiscal incentives would be granted over a longer period of time

extending upto 10 years ie upto 31st March 2015 The above incentives would be

available to such units which fulfill the following conditions

- 30 -

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 31: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

a) The unit should be prequalified and registered with Department amp Scientific and

Industrial Research (DSIR) as RampD centre

b) The unit should submit a statement certified by the Auditors showing the total

expenses incurred on RampD

c) In case of claims for clinical trials the unit should submit approval obtained from

the Drug Regulatory Authority for carrying out the trials and certificate by the CEO or

the Auditor for completion of trials

d) In case of claims for patent filing abroad the unit should submit relevant document

(official receipt etc) showing the filing expenses duly certified by the CEO or the

Auditor

e) In case of claims related to land and buildings the unit should submit a letter

signed by the CEO confirming that the claims pertain to facilities used exclusively for

R amp D

B RampD Intensive Companies (Gold Standard Companies)

The Pharmaceutical Research and Development Committee headed by Dr RA

Mashelkar in its report submitted to Government in November 1999 recommended

that RampD intensive companies fulfilling certain conditions should be given price

benefits for the drugs under DPCO It specified certain norms in this regard and

termed these as the gold standards Since six years have elapsed since this report was

submitted it has been considered proper to revise these norms

The revised norms are as under ndash

a) Invest at least 3 of the annual sales turnover on RampD or Rs 50 crores per annum

(average of last 3 years) whichever is higher on research facilities

b) Employment of at least 200 scientists in India (MScs or Phds employed at least for

one year)

c) Own and operate manufacturing facilities in India which have been approved by at

least two reputed foreign regulatory agencies (US Europe Japan Canada Australia

Israel South Africa etc)

- 31 -

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 32: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

d) Have filed at least 10 patent applications in India based on research done in India

Companies fulfilling the above norms would be eligible for the benefit of

200 weighted deduction under 35(2AB) till 31st March 2015 Additional incentives

under price control measures may also be considered to such companies by

Department of Chemicals and Petrochemicals However in order to be eligible for any

of the additional incentives such companies would be expected to fulfill the following

norms ndash

a The unit should submit a statement signed by HRDRampD chief or CEO certifying

the number of scientists employed through the year

b The unit should submit a statement certified by the CEO and the Auditor that it has

invested at least 3 per cent of the annual sales turnover or Rs 50 cr (average of the last

three years) whichever is higher on R amp D

c The unit should submit certified true copy of the approval granted by the Drug

Regulatory Authority of the specified countries approving the manufacturing facility

for export to their country

d The unit should submit particularsdocuments evidencing patents filed in India

The inter-departmental Screening Committee constituted by DSIR may further

recommend additional safeguards to be taken for making available fiscal incentives to

various companies (Comments by DST CSIRDBTDSIR)

C Pharmaceutical Research and Development Support Fund (PRDSF)

At present the Pharmaceutical Research and Development Support Fund (PRDSF)

has a corpus of Rs 150 crores (where only interest income is available for spending)

is utilized for funding RampD projects of Research Institutions and industry in the

country It is not adequate to meet the present day and the emerging requirements of

this sector It needs to be sufficiently augmented over the next five years It has been

decided to convert it into an annual grant of Rs 150 crores and thereafter it would be

suitably increased further in a phased manner over a period of next five years Priority

would be given for RampD in case of diseases which are endemic to India like malaria

tuberculosis hepatitis-B leis mania (kala-azar) HIVAIDS etc

(Comments by HealthDSTDBTExpenditureRevenuePlanning Commission)

- 32 -

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 33: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

44 Pharma ParksSEZs for Pharma industry-

In order to enable India to achieve a leading position as the Drug Maker of the

World it is essential that a World class infrastructure is provided for the

accelerated growth of the industry Added to this are the environmental concerns due

to difficulties in hazardous waste disposal by some of the bulk drug units In order to

provide the required infrastructure it is essential to have a scheme where Central

Government State Governments and industry are participants A special scheme for

setting up 29 pharmaceutical parks in the country (separate for bulk and for

formulations) in the next 5 years is proposed This would be broadly on the lines of

Scheme for Integrated Textile Parks

a) This scheme would be based on public-private partnership model

b) Each park would be set up in a minimum area of 250 acres for bulk and 100 acres

for formulations It would be expected to have about 50 to 100 units investment of

1000 crs to Rs 2000 crs and likely employment of about 20000 persons

c) Scheme to be implemented through SPVs (Special Purpose Vehicles) with Industry

Associations to be the main promoters

d) An MOU will be signed with a leading professional body consultant to act as

Project Management Consultant

e) Where an SEZ is to be set up the minimum size criterion for pharma SEZs would

be 50 hectares for the next 3 years This would encourage quick setting up of such

parks and for demonstration effect After a successful take-off of the scheme

minimum size may be increased suitably all environmental approvals in the case of

pharma parks would be granted at the State level only

(Comments by HealthDIPPCommerceEnvironment)

(Government has recently passed an Act to facilitate setting up of Special Economic

Zones in the country Some SEZs for pharma have been sanctioned in a few states

There is need to have more of such economic zones in the country It is estimated that

an SEZ in an area of 50 hectares would require an investment of Rs 100-120 crores

on land and development It would be able to attract an investment of Rs 1000 crores

- 33 -

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 34: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

and would be able to generate exports worth Rs 2000 crores and employment of about

6000 people Looking to the attractive tax concessions and good infrastructure

available in these parks these are becoming popular with the industry)

45 Greater Thrust on Pharma Exports

Pharmaceutical Export Promotion Council (Pharmexcil) is the sole agency authorized

for issuance of Registration-cum-Membership Certificate to exporters of Drugs and

Pharmaceuticals Pharmexcil during the last over one year of its formation has

successfully completed various projects particularly sponsoring full-fledged trade

delegations to various countries Future growth of pharma sector would be largely

driven by exports to other countries Although exports of pharma products from India

are growing at a healthy rate there is need to accelerate this further in view of the vast

potential existing in some of the countries

Following steps are envisaged to be taken in this regard

a) Suitable measures would be taken to tackle the non tariff barriers to exports of

pharma products in various countries through consistent efforts and greater

interaction with the concerned agencies of the focus countries

b) Africa Latin America ASEAN and CIS countries have been put in the

category of focus countries by Commerce department These would continue to get

special attention for the purpose of exports

c) The South Asian Free Trade Area (SAFTA) an agreement between Saarc

countries comprising of India Pakistan SRI LANKA Bangladesh Nepal Bhutan

and Maldives is scheduled to come into force on January 1 2006 It will be fully

operational by 2016 The pact holds huge potential for intra-regional trade growth

which is presently only US$7 billion (only6 of the total external trade in the region

which is US$350 billion) Pharmaceuticals has a substantial potential in the intra-

regional trade of the area A detailed study would be undertaken of this potential A

study to determine the market potential for pharma products in these countries and

their registration procedures requirements would be carried out soon

d) Some more countries with good potential namely GCC European Union Japan

and Korea would also be paid special attention looking to the big potential for

pharma exports in these An action plan including a study of the pharma export

- 34 -

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 35: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

potential in these countries would be carried out to improve exports of pharma

products to these countries

e) International meetsconferencesseminars with potential countries would be

organized on a regular basis in India and abroad

f) Apart from the existing formal arrangements for export of drugs there is an urgent

need to have a government-industry standing forum for each of the high potential

markets comprising of the key industry players active in that area and concerned

government departments

g) Quality is an important issue with the importers from India It would be

worthwhile to lay down guidelines regarding the consignments of pharma products

being exported outside India A system of registration for quality products would be

worked out in consultation with industry

h) Exports may be exempted from service tax

i) Pharmexil would be suitably strengthened to meet the future challenges of export

market It would be assisted financially and otherwise for opening

warehousesoffices in some of the countries to help the Indian entrepreneurs there

for an online library organization of exhibitions in various countries and brand

building activity

(Comments by CommercePharmexcil)

- 35 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 36: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical

industry

- 36 -

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 37: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Efforts by the Indian pharmaceutical industry

The IPI seeking to take full advantage of benefits offered by the government has

been allocating money to RampD Its focal points are drug discovery development of

drug delivery systems biotechnology and bioinformatics Companies are

reevaluating their strengths and emphasizing product segments that are profitable to

the company Many companies are trimming their portfolios to focus on particular

therapeutic segments Pharmaceutical marketing is also changing rapidly and

pharmaceutical companies are making elaborate marketing efforts Companies such as

Sun Pharma Nicholas Piramal and Dr Reddyrsquos Laboratories have opted for

brandcompany acquisition to increase therapeutic reach and market penetration Such

specialization would make the entry of MNCs difficult Some theorize that companies

with a strong marketing force would be attractive for possible take-overMany

pharmaceutical companies are entering into marketing arrangements such as Hoechst

Marionrsquos agreement with Nicholas Piramal and Ranbaxyrsquos pact with Cipla Glaxo

and Hoechst Marion Recent mergers and acquisitions include Nicholas Piramalrsquos

acquisition of Roche Products a company mainly involved in diagnostic products and

Zydus Cadilarsquos acquisition of German Remedies in India Sanofi Synthelabo the

second largest pharmaceutical company in France will buy out Ahmedabad-based

Torrent PharmaceuticalsVery recently Dr Reddyrsquos Laboratories signed a definitive

agreement to acquire 100 of Meridian Healthcare and BMS Laboratories whose

primary business is manufacturing and marketing generic pharmaceuticals in the

United Kingdom

- 37 -

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 38: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Major Players

Ranbaxy Laboratories

Dr Reddys Laboratories

Nicholas Piramal

Cipla

Biocon

Serum Institute of India

Strides Arcolab

- 38 -

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 39: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Major players

61 Ranbaxy Laboratories

Tejendra Khanna Chairman

Ranbaxy Laboratories Limited is an Indian company incorporated in 1961

It is Indias largest pharmaceutical company It exports its products to 125 countries

with ground operations in 46 and manufacturing facilities in 7 countries It is ranked

among the top 10 generic companies worldwide The CEO of the company is

Malvinder Mohan Singh

In 1998 Ranbaxy entered the USA the worlds largest pharmaceuticals

market and now the biggest market for Ranbaxy accounting for 28 of Ranbaxys

sales in 2005

For the twelve months ending on December 31 2005 the Companys Global

Sales were at US $1178 billion with overseas markets accounting for 75 of global

sales(USA 28 Europe 17 Brazil Russia India and China 29)

Most of Ranbaxys products are manufactured by license from foreign

pharmaceutical developers though a significant percentage of their products are off-

patent drugs that are manufactured and distributed without licensing from the original

manufacturer because the patents on such drugs have expired

In December 2005 Ranbaxys shares were hit hard by a patent ruling

disallowing production of its own version of Pfizers cholesterol-cutting drug Lipitor

which has annual sales of more than $10 billion

It was the first Indian pharmaceutical to have a proprietary drug (extended-

release ciproflaxin marketed by Bayer) approved by the US FDA and the US

market accounts for 36 of its sales 78 of Ranbaxyrsquos sales are from overseas

markets its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100

- 39 -

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 40: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in

the world and that it is the 15th fastest growing company By 2012 Ranbaxy hopes to

be one of the top 5 generics producers in the world and it consolidated its position

with the purchase of French firm RGP Aventis in 2003 Ranbaxy also has higher

aspirations however ldquoto build a proprietary prescription business in the advanced

marketsrdquo To this end it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing It spent $75 million in RampD in 2004 a 43 increase over its 2003

expenditure

62 Dr Reddys Laboratories

K Anji Reddy Chairman

Founded in 1984 with $160000 Dr Reddyrsquos was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange It earned $446 million in fiscal year 2005 deriving 66 of this

income from the foreign market In order to strengthen its global position Dr Reddy

acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare

Although 58 of Dr Reddyrsquos revenues come from generic drugs the

company was committed to WTO-compliance long before the 2005 bill took effect

and most of these products were already off patent Dr Reddy has long been a

research-oriented firm preceding many of its peers in setting up a New Drug

Development Research (NDDR) in 1993 and out-licensing its first compound just

four years later Dr Reddyrsquos has since outlicensed two more molecules and currently

has three others in clinical trials

Although Dr Reddyrsquos is publicly-traded the Reddy family (including

founderchairman K Anji Reddy son-in-lawCEO GV Prasad and sonCOO Satish

Reddy) holds a hefty 26 share in the company1144

- 40 -

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 41: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

63 Nicholas Piramal

Ajay G Piramal Chairman

Now a company grossing $350 million per year Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers acquisitions and alliances The company has formed a name for

itself in the field of custom manufacturing It cites its 1700-person global sales force

as another core strength with its acquisition of Rhodiarsquos inhalation anaesthetics

business Nicholas Piramal gained a sales and marketing network spanning 90

countries

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath

of product patent protection The company has respected intellectual property rights

since its inception and refused to ldquosupport generic companies seeking first-to-file or

early-to-market strategiesrdquo Instead it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100000

64 Cipla

Dr Yusuf K Hamied Chairman and Managing Director

Cipla burst into the international consciousness in 2000 with Triomune an

AIDS treatment costing between $300 and $800 per year that infringed upon patents

held by several companies who were selling the cocktail for $12000 per year Long

before this news Cipla had been building a strong global presence and it now

distributes its 800-odd products in over 140 countries Privately-held Cipla holds a

prominent spot in its home country as well it is the leader in domestic sales having

just unseated GlaxoSmithKline for the first time in 28 years Revenue in 2004 totaled

$552 million (using Rs 43472 = $1) about 75 of which was derived in India Cipla

did not report having a research program

- 41 -

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 42: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

65 Biocon

Dr Kiran Mazumdar-Shaw Chairman and Managing Director

Biocon is probably best known for its founder Kiran Mazumdar-Shaw who

overcame incredible gender-based discrimination to become the richest woman in

India Originally an extension to an Irish chemicals company seeking to break into the

Indian market Biocon is now the leading biotech in India bringing in Rs 64636 crore

(almost $150 million) in revenue for fiscal year 2004 It initially made its money by

producing enzymes but Biocon recently decided to become a research-oriented

company with the goal of bringing a proprietary new drug to market

The company went public in March 2004 and ldquoits shares were oversubscribed

by 33 times on opening dayrdquo Eight months later it launched Insugen a bio-insulin

that is its first branded product Biocon also has two wholly-owned subsidiaries

Syngene and Clinigene that perform custom research and clinical trials

66 Serum Institute of India

Dr Cyrus Poonawalla Chairman

The Serum Institute of India can make the enviable claim that 1 out of every 2

children in the world is immunized with one of their vaccines It is the worldrsquos largest

producer of measles and DTP vaccines and its portfolio includes other vaccines

antisera plasma products and anticancer compounds The Serum Institute earned Rs

565 crore ($130 million) in revenue in fiscal year 2005 selling mainly to UN agencies

and to the Indian government The Serum Institute is part of the Poonawalla Group

whose holdings include a horse stud farm and manufacturers of industrial equipment

and components

- 42 -

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 43: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

67 Strides Arcolab

Arun Kumar MD

Bangalore-based Strides Arcolab is one of Indiarsquos largest exporters of finished

pharmaceuticals with operations in over 50 countries It is amongst the top five global

manufacturers of soft gelatines and a leading sterile injectables manufacturer in India

The company has 13 manufacturing plants spread across the US Brazil Mexico

Italy Poland Singapore and India Strides is the first one to enter the Latin American

market The Latin American (Latam) pharmaceutical market is a semi-regulated

market but the regulatory framework is similar to advanced pharmaceutical markets

Their Latin operations have grown rapidly and we have become the largest Indian

pharmaceutical company in that region

- 43 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 44: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

The Chinese edge

Where India scores

The equation Present and future

- 44 -

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 45: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

India vs China in pharmaceuticals

In the global economy both India and China have staked claims as nations to

watch out for in the future Both these countries along with their counterparts Russia

and Brazil (labeled as the BRIC nations) have been touted to emerge as the fastest

growing economies by 2050 While much has been said about the impact of India and

China on the dynamics of the global economy here we shall attempt to find out as to

which country has the edge in the global pharmaceutical space

71 The Chinese edge

China has proven its capabilities in the manufacturing space and the same

advantage extends to the pharmaceutical segment as well Being a cost-efficient

country it has emerged as the preferred destination for outsourcing intermediates

(used in the manufacture of APIs) and Active Pharmaceutical Ingredients Chinese

companies have forged growing relationships with top global pharma companies

(referred to as Big Pharma) in custom manufacturing and also for outsourcing older

APIs Besides this China also has the edge over India in the biotech field due to the

presence of high quality research institutions and the Chinese governments

commitment

The number of DMF (Drug Master File) filings made by Chinese companies

have also been witnessing a rise in recent times highlighting the growing interest of

multinationals in the country In fact India too has been sourcing intermediated from

China for the purpose of manufacturing low cost APIs

- 45 -

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 46: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

72 Where India scores

That said while China is set to provide stiff competition to India in the API

space it still lags behind in the formulations segment This can be gauged by the fact

that in the global generics market while India accounts for 25 of the Abbreviated

New Drug Applications (ANDA) filed in the US market China has yet to file a single

ANDA Indias advantage vis-agrave-vis China lies in RampD availability of scientific

manpower laws that have begun to recognize intellectual property and Indian

companies having alliances with global pharma companies in research generics and

manufacturing Even in the API space while China has been growing at a fast pace it

still falls behind India in terms of overall filings made until now

India is making increasing strides in the global generics space as can be

evinced by the progress made by Tier-I companies such as Ranbaxy and DrReddys

Ranbaxy is already ranked amongst the top ten generic companies in the world Both

of them have emerged as major contenders in the consolidation activity gaining

momentum in the generics market and have also been aggressive in challenging

innovator patents (Para IV) In contrast the Chinese Tier -I company Zhejiang Hisun

has yet to make a significant mark in the global generics market

India VS China Top company comparison

Ranbaxy Hisun

Formulations presence in US Yes No

Formulations presence in EU Yes No

API presence in the US Yes Yes

API presence in the EU Yes Yes

Local formulations presence Yes Yes

Drug discovery research Yes No

DMF filings Yes Yes

ANDA filings including Para IV Yes No

- 46 -

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 47: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Source Newport Strategies

73 The equation Present and future

Given the fact that the low cost distinction is no longer a trait unique to the Indian

pharmaceutical sector with the resurgence of Chinese companies in this area Indian

companies will have to focus more than ever on moving up the value chain This has

to be by capitalizing on the generics opportunity (in both plain vanilla and value

added products) strengthening efforts on the NDDS and NCE research front and

continuing relationships with global pharma in research and manufacturing At

present on an overall basis India does have the edge over China in terms of relevance

to the global pharmaceutical industry That said Indian companies need to capitalize

on the window of opportunity currently available before the competition from China

begins to pose a significant threat

- 47 -

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 48: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Some Important Articles

Tweaking drugs wont help cos skip price control

Cracking Japans generics market code

India as offshore pharma destination

Dr Reddys net profit triples

- 48 -

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 49: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Some Important articles from Economic times

81 Tweaking drugs wont help cos skip price control OCTOBER 25 2006

The game may soon be up for drug-makers who dodge price control by

effecting minor changes in the composition of a drug or by changing its brand name

or strength

The proposed Drugs (Price Regulation and Control) Bill of rsquo06 will arm the

government or a designated authority the power to forestall such changes in a drug

sold under an approved brand name without a therapeutic justification

Some companies have in the past got the composition of drugs altered without

any significant therapeutic value addition after National Pharmaceutical Pricing

Authority (NPPA) fixed the prices Doxycycline a broad-spectrum antibiotic which

is under price control is a classic case which now comes in combination with lactic

acid bacillus mdash a source of bacteria that helps in digestion

In some cases this practice leads to even irrational combination of medicines

said a trade source Drug approvals and compositional changes fall under the domain

of the Union and state health ministries while pricing is the turf of the central pricing

agency NPPA an attached office of the chemicals and fertilisers ministry

NPPA fixes prices of specified strengths of medicines and when a company

changes either the strength or the composition there is no government-fixed price for

the changed entity till the drug regulator catches up

Although the drug is still under price control companies make gains by selling

the product at their own price till NPPA intervenes again After a recent ET report on

this practice the investigating wing of the Monopolies and Restrictive Trade Practices

(MRTP) Commission had swung into action and ordered a probe into the matter

The director general of investigation and registration (DGIR) has asked as

many as 16 major drug makers including MNCs to furnish details about their

- 49 -

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 50: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

productsrsquo composition and recent alterations in them to see if they escaped price

control by such means

82 Cracking Japans generics market code FRIDAY OCTOBER 27 2006

Indian generic makers have traditionally looked west mdash to the US and Europe

mdash for new markets But those markets are becoming less attractive with generic

penetration already high competition is intense

And moves by retailers such as Wal-Mart to slash prices and profit margins on

generics in the US only add to the pressure The next big opportunity lies to the east

in Japan where changes in drug regulations will create a large and potentially

lucrative market for generics in the next few years

Like its US and European counterparts Japan has struggled to bring rising

health-care costs under control In 2004 cheaper generics made up just 17 of the

total volume of the Japanese drug market (and 5 of the value) dramatically lower

than other developed countries (53 and 46 of drug volume in the US and

Germany respectively)

Japanrsquos fiscal situation and demographic profile also add urgency Healthcare

spending has increased from 6 to 9 of Japanese GDP between 1990 and 2004 The

future healthcare burden will be exacerbated as the elderly population balloons and

has medical costs four times that of the non-elderly

Not only will Japanrsquos share of people over 65 years be among the highest in

developed countries mdash projected to be 30 as against 19 for US and 26 for

Germany mdash but the Japanese will also live longer Japan has among the highest life

expectancy in the world especially for women

So far the governmentrsquos belt-tightening efforts have focused on reducing the

$65 billion in pharmaceutical costs which represents 23 of Japanrsquos National Health

Insurance expenditures and accounts for the second-largest pharmaceutical market in

the world

- 50 -

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 51: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Regulations passed recently aim to create the right incentives to stimulate both

supply of and demand for generics To increase generic demand patients will now

face lower direct costs for using generics due to lower prices and out-of pocket

spending compared with branded products

Hospitals will also have an incentive to use cheaper generics as they will

receive a single lump sum payment that will cover all medical costs And doctors and

pharmacists will receive a small cash incentive for prescribing and dispensing

generics

Similarly to increase the supply of generic products suppliers will now be

able to apply for approvals twice a year rather than annually and will be required to

sell a full range of product dosages but need to only prove bio-equivalence for the

highest-dosage strength

The strategies to increase generic substitution should yield results over the

longer term as they embody the tried-and-tested approaches used by other developed

countries Evidence from places like the UK and Germany with comparable health

system and incentive programmes suggest that a pro-generics approach can boost

demand significantly

- 51 -

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 52: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

83 India as offshore pharma destination FRIDAY NOVEMBER 03 2006

The global pharmaceutical industry is desperate to improve its productivity

when researching and developing new drugs Over the last 10 years or so

multinational pharmaceutical companies (MPCs) have accordingly been off-shoring

more and more of their RampD to emerging countries to accelerate output and reduce

costs

The two main beneficiaries of this trend have been unsurprisingly India and

China And equally unsurprisingly they are in constant though unpublicised

competition to claim a still greater share of the bounty

The two countries must have a great deal in common from an MPCrsquos

perspective Both boast remarkable new technical capabilities at least in some phases

of the RampD value chain

Both have a deep pool of talent and a vast treatment-naiumlve population of

patients for clinical trials On the negative side both raise much the same concerns for

MPCs notably over the security of data and other intellectual property (IP) and over

administrative and regulatory roadblocks

Given such similarities how is an MPC to differentiate the two countries

when weighing its off-shoring options Well for a start their skills do vary from

phase to phase India is still clearly ahead of China in data management and probably

in chemistry-phase activities as well while China has more advanced biology

capabilities

Such considerations might sway an MPCrsquos ad hoc outsourcing decisions but

its strategic thinking would be influenced more by the difference in ldquovalue

propositionrdquo put forward by each country

The Chinese pharmaceutical market will be worth US $25 billion in 2010

(nearly three times Indiarsquos market in 2010)) MPCs mdash in the hope of increasing their

access to that treasure-chest mdash are tempted to place a long-term strategic bet by

- 52 -

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 53: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

outsourcing high-tech projects there or even setting up a fully-fledged captive RampD

centre

India by contrast offers a shorter-term as well as ongoing payoff Its vendor

base is far broader than Chinarsquos and being quick-footed and resourceful can churn out

abundant high-quality work at short notice Jointly these Indian service-providers

offer a rapid turbo-charge to an MPCrsquos RampD engine The MPC secures not just time-

and cost-savings but also a smoother flow to its entire RampD pipeline

This unique advantage is something that Indian pharma companies cannot

afford to ignore let alone jeopardise They need to play it to maximum effect

promoting the image on the one hand and nurturing the reality on the other

After all the great competitor China is hardly sitting idle MPCs are fast

establishing a captive base there Recent case in point AstraZenecarsquos $100 million

investment in China Its vendor base is increasing in number and advancing

remorselessly in capabilities

- 53 -

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 54: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

84 Dr Reddys net profit triples FRIDAY OCTOBER 27 2006

Dr Reddys Laboratories Ltd said on Friday quarterly net profit more than

tripled beating forecasts helped by strong growth in the key US market and gains

from drugs exclusivity

But the company said it may not be possible to repeat the exceptional

performance in the October to December quarter and beyond as the exclusivity for

two generics -- prostate cancer treating Proscar and cholesterol drug Zocor -- end in

December

Authorised generics 180-day period ends December To that extent the

revenue will diminish very significantly but the other aspects of our business will

continue to perform GV Prasad Dr Reddys chief executive told Reuters in an

interview

Analysts said it would gain from other authorised generics

Although pricing pressures are existing their authorised generic deals could

keep the revenues flowing said Kavita Thomas an analyst at First Global Securities

which has an outperform rating on the stock

Other Indian drug makers have also reported a strong performance in the July

to September quarter helped by a surge in sales of generic drugs and strong growth in

the domestic market

The Hyderabad-based company Indias only New York-listed drug maker

said net profit according to US accounting standards rose to 280 billion rupees

($6196 million) from 890 million rupees reported a year earlier

A Reuters poll of 10 brokerages had predicted a median profit of 157 billion

rupees for the firm Indias fourth-largest pharmaceuticals company

US SALES

Total revenue jumped to 20 billion rupees from 58 billion rupees while

revenue from its core businesses excluding the contribution from authorised generics

and acquisitions grew 42 percent to 82 billion rupees

- 54 -

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 55: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Revenue from North America generics finished dosage business jumped to

908 billion rupees from 299 million rupees helped by authorised generic versions of

Zocor and Proscar which contributed 39 percent of the total revenue

Third-ranked Ranbaxy Laboratories Ltds quarterly net profit rose by more

than six times while number one Cipla Ltd reported 47 percent growth and second-

ranked Sun Pharmaceutical Industries said net profit rose 26 percent

Shares in Dr Reddys valued at $24 billion rose about 15 percent in the

quarter lagging the Mumbai exchanges healthcare index which rose about 18

percent

Its shares ended 26 percent higher at 73035 rupees in a firm Mumbai market

on Friday

Dr Reddys said in October that it may exclusively distribute the generic

version of GlaxoSmithKline Plcs Imitrex tablets in the United States as it had settled

a legal dispute

- 55 -

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 56: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Conclusion

- 56 -

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 57: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

CONCLUSION

The achievements of the Indian pharmaceutical industry are spectacular in recent

times and are praise worthy which has evolved as model industry of the country in

performance India has a strong infrastructure for pharmaceutical business environment

But in the 21st century the pharmaceutical value chain would depend on the ability of

pharmaceutical companies to make the technological shift necessary to maintain and

increase their competitive positions

- 57 -

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 58: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Recommendations

- 58 -

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 59: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

RECOMMENDATIONS

1 With the second-largest population in the world a highly educated population

that is fluent in English and with technical skills and well-developed buying

power India has great potential for industrial growth

2 Since India has an edge over China tapping the world generics market before

China is very important for Indian pharmaceutical industry

3 Combining information technology with the pharmaceutical industry is also a

good tool which can be utilized by the IPI

4 The government and the economy of India have also helped the IPI to grow

- 59 -

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 60: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Bibliography

- 60 -

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma
Page 61: Growth of indian pharmaceuticals in the world market

Growth of Indian pharmaceuticals in the world market

Bibliography

Analysis of the Indian Pharmaceutical Industry With Emphasis on Opportunities in 2005 - Hemant N Joshi

National Pharmaceuticals Policy 2006 Part-A - Department of Chemicals and Petrochemicals Government of India

httpwwwresearchandmarketscomreportinfoaspreport_id=41589ampt=eampcat_id=

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Indian Pharmaceutical Industry - Dhruv Sagar

httpwwwdgciskolnicin

httpenwikipediaorgwikiPharmaceuticals_28India29

httpwwwpharmaceutical-drug-manufacturerscompharmaceutical-industry

Arpit Jhunjhunwala

Contact no9867367199

- 61 -

  • Lupin Laboratories
  • Sun Pharma