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Transcript of SIP Report Final
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Chapter 1
Overview of
pharmaceutical
industry
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1. OVERVIEW OF PHARMACEUTICAL INDUSTRY:1.1 An Introduction
The Indian pharma industry currently tops the graph amongst India's science-
based industries with wide ranging capabilities in the field of drug technology and
manufacture. A well-organized sector, the Indian p’cal industry is estimated to be
worth $ 4.5 billion and growing at about 8 to 9 % annually. Indian pharma industry
ranks 3rd amongst all the world countries, when it comes to quality, technology and
the vast range of medicines that are manufacturing in India. Medicine ranges from
simple headache tablet to sophisticated antibiotics and complex cardiac NDDS
compounds; almost each type of medicine is now manufactures in the Indian
pharmaceutical industries. The Indian pharma sector is highly fragmented with more
than 20,000 registered pharma companies in 2010. It has expanded drastically in the
last 20 years. The Chemical and Pharmaceutical industry in India is an extremely
fragmented market with serious price competition and government price control
(DPCO). The Pharmaceutical industry in India meets around 70% of the India's
demand for drug intermediates, bulk drugs, pharmaceutical formulations, tablets,
chemicals, capsules, injectables and orals. There are approximately 250 large units
and about 8000 Small Scale units including 5 Central Public Sector Units, which form
the core of the pharmaceutical industry in India. The Government plays a vital role in
the development of the Indian Software Industry. The Indian government announced a
new software policy in 1986 which was assigned to serve as a catalyst for the
software industry in India. This was followed in 1988 with the establishment of the
Software Technology Parks of India (STP) scheme and The World Market Policy. In
addition to that, to attract foreign direct investment (FDI), the Indian Government
allowed foreign equity of up to 100 % and duty free import (DFI) on all inputs and
medicinal products.
1.2 Current Scenario
Indian pharma industry is expected to grow at 19% in 2013. Today, India is
among the top 5 pharmaceutical emerging markets. There will be new drug filings,
new drug launches and Phase II clinic trials throughout the year 2013. Apart from
increasing sales of generic medicines, continued growth in chronic therapies and a
greater penetration in rural markets. The domestic pharmaceutical market is expected
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to show a strong double-digit growth of 13-14 % in 2013 end. In addition, the
increasing population of the higher-income group will establish a potential US $ 8
billion market for multinational companies (MNCs) selling costly drugs by 2015.
Apart from this, the domestic pharmaceutical market is estimated to touch US $ 20
billion by 2015 end. It will make India a lucrative host for clinical trials for MNCS.
Further estimates that the healthcare market in India will reach to US $ 31.59 billion
by end of 2020.
1.2.1 Diagnostics Outsourcing / Clinical Trial
According to the estimates, the Indian diagnostics and labs test services is
expected to reach Rs.159.89 billion by the end of 2013. The domestic market for both
therapeutic and diagnostic antibodies is expected to rise exponentially in the future.
More than 60% of the total antibodies market is presently dominated by diagnostic
antibodies. Few of the major Indian pharmaceutical firms including Cadila
Healthcare, Piramal Life Sciences and Sun Pharma, had applied for carrying out
clinical trials on at least 12 new drugs in 2010 which indicates a growing interest in
new drug discovery research.
1.2.2 Generics
Generics will always continue to dominate the market while patent-protected
products are supposed to constitute 10 % of the pie till the end of 2015, according to
the McKinsey’s report, “India Pharma 2015 - Unlocking the potential of Indian
Pharmaceuticals market”.
Dr Reddy's Lab has launched a new Finasteride tablets which is a bio-
equivalent generic version of Propecia (Finasteride) tablets, in the US market. These
tablets are prescribed to treat male pattern hair loss.
1.3 Growth of Import-Export
Imports: - As per the data collected by Directorate General of Commercial
Intelligence and Statistics (D.G.C.I.S.) Kolkata, the value of imports of “Medicinal
and pharmaceuticals Products” for the latest period 2007-‘08 to 2010-‘11 is as under:
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Year Value of import of “Medicinal and
Pharmaceutical products” (Rs. In bn.)
Growth (%)
2007-08 67.34 14.79
2008-09 86.49 28.43
2009-10 99.59 15.15
2010-11 109.37 9.82
Table No. 1.1
The country is almost self-sufficient in production of most of formulations/
pharmaceuticals products. Manufacturers of Drugs & Pharmaceuticals are free to
produce any drugs approved by the Drug control authorities.
Exports: - As Per D.G.C.I.S. Kolkata Exports of “Drugs and Pharmaceuticals
and Fine Chemicals” for the period 2007-08 to 2010-11 are below:-
Year Value of Export of “Medicinal and
Pharmaceutical products” (Rs. In bn.)
Growth
(%)
2007-08 293.54 14.37
2008-09 398.21 35.66
2009-10 424.56 6.62
2010-11 475.51 12.00
Table No. 1.2
1.4 Major Pharmaceutical Companies in India
Some of the Indian pharmaceutical player by their sales volume in INR Billion:
Company Name Sales in INR Billion
Cipla 69.77
Ranbaxy lab 76.86
Dr Reddy’s lab 66.86
Sun pharma 40.15
Lupin Ltd. 53.64
Aurobindo Pharma 42.84
Jubilant Life 26.41
Cadila Health 31.52
Ipca Lab 23.52
Wockhardt 26.50Table No 1.3
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1.5 Government Initiatives and Investments
1.5.1 Government Initiatives
The Union Finance Minister spotted few points in union budget of 2012-13:
It is proposed to extend the concessional basic customs duty of 5% with fully
exempted excise duty/CVD to six specified vaccines / life-saving drugs. These
are used for the treatment or prevention of diseases such as renal cancer, HIV-
AIDS etc.
Probiotics are a cost-effective means of battling bacterial infections. It is
expected to lower down the basic custom duties on these items from 10 % to 5
%.
Basic customs duty and excise duty lower down on Soya products to target
protein deficiency among women and children in domestic market. Basic
customs duty and excise duty lowered on Iodine too.
In the Indian pharma sector, marking a new trend of investments by foreign
players, the need for foreign investors to receive a no-objection from their JV (joint
venture) partner before spending out on their own or leashing in another local firm has
been wiped out by the Pharmaceuticals Export Promotion Council (Pharmexcil).
The Dept. of Pharmaceuticals has made a 'Pharma Vision 2020' document for
emerging India as one of the leading destinations for end-to-end drug discovery,
research and innovation and for that purpose, the Dept. provides required support by
way of internationally competitive scientific manpower for pharma research and
development (R&D), venture fund for research in the public, world class
infrastructure and private domain and such other measures.
1.5.2 Investments
Israel-based Teva Pharmaceuticals in JV with Procter & Gamble (P&G) plans
to set up world's largest over-the-counter (OTC) medicine production facility
at Sanand near Ahmedabad, Gujarat.
‘GlaxoSmithKline (GSK)’ and the Hyderabad based ‘Biological E Ltd’ have
collaborated for early stage research and development (R&D) of a 6 in 1
combination pediatric vaccine against the polio and other infectious diseases.
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Claris Life-sciences has entered into joint venture (JV) with 2 Japan based
drug makers Mitsui & Co Ltd and Otsuka Pharmaceutical for its injectable
business in Indian and other emerging markets.
Nipro Corporation has settled up India's 1st dialyser production facility at
Shirwal near Pune. This investment cost them Rs.700 cr. (US $130.60 mn).
Aurobindo Pharma Ltd has got approval from the US Food and Drug
Administration (USFDA) to produce and promote various medicines namely
Rizatriptan Benzoate tablets and Oxacillin injections in the US, apart from
Nafcillin and Ondansetron injection.
Eli Lilly and Strides Arcolab have covered a pact to increase delivery of
cancer medicines in the emerging markets. Agila Specialties which is the
specialties division of Strides Arcolab will make cancer medicines and Eli
Lilly will promote them in emerging markets.
1.6 Challenges
Over the past 10 years, pharmaceutical companies have entered into a difficult
period where the market, regulators and Shareholders have created remarkable
pressures for reform within the industry. The main issues for most of pharma
companies are patent expiration of number of block buster drugs, reduced
productivity of in-house R & D, increasing legal and regulatory concern and pricing
issue. As consequences larger pharmaceutical companies are reforming to new
business model with more outsourcing of clinical research, manufacturing and
discovery services.
Presently global financial conditions and a threat of a globe wide recession
accelerated the schedule for applying transformational changes in MNCs, as the
industry on fronts reduce corporate stock prices and an increasingly cost-sensitive
customer. Executives of the largest global pharmaceutical companies realised the
need for transformational change in their organizations, but will need wisely to move
swiftly to ensure sustained growth in company.
Transformations in the business model of global pharmaceutical industry spell
more Opportunities for Indian pharmaceutical companies. Pharma production costs
are almost 50 % lower in India than in western countries, while clinical trial expenses
around one-tenth and overall R&D costs are about one-eighth of western levels.
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The Indian stock market may fear a possible recession but Indian pharma
companies seem unfazed by slowdown dreads. Achieving on better sales in the
domestic and export markets, Indian pharma industry is expected to go on with its
good performance. Currently, Indian pharma Industry can look forward to the years to
come, with many expectations. The opportunities in expanding the area of generic
products as more molecule come off patent, outsourcing and above all, in
concentrating into drug discovery because more profits come from traditional plays.
The same time, the Indian Pharmaceutical Industry would have to assert with several
challenges particularly the
Effects of new product’s patent
Drug price control over (DPCO)
Regulatory reforms affair
Infrastructure development
Quality management and
Conformance to the global standards.
1.7 Future Growth
According to consulting firm Grant Thornton, India is expected the largest
number of merger and acquisitions (M&As) in the pharmaceutical and healthcare
sector. A survey conducted across the 100 companies has revealed that one- fourth of
the respondents were optimistic about acquisitions in the pharma sector.
According to a Barclays Capital Equity Research report on India Healthcare &
Pharmaceuticals, The Indian pharma market is expected to grow at a CAGR
(Compounded Annual Growth Rate) of 15.3 % during 2011- 12 to 2013-14. The
growth of Indian pharma companies will also be dragged by the fastest growing
molecules in the skincare, eye care and diabetes segment.
Moreover, the pharma companies such as Ranbaxy, Cipla, Lupin and Dr
Reddy's Labs might soon be part of the government's most expected 'Jan Aushadhi'
project. To commercialize the project, the Government is likely to rope in the private
sector units to bulk-procure generic drugs from them. Today, there are 117 “Jan
Aushadhi” stores across the country and the ambition is to expand to at least 600 in
the next 2 years and 3,000 by the end of 2016.
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Chapter 2
INTRODUCTION to
Organisation
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2. INTRODUCTION TO ORGANISATION:
Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical
companies in India. Its headquarter is at Ahmedabad, Gujarat. In the last five decades,
it has been developing and producing pharmaceutical products. It is selling and
distributing pharmaceutical Products in over 50 countries around the world. It
provides integrated healthcare solutions with pharmaceutical products; it caters to
over 45 therapeutic areas that include respiratory agents, cardiovascular, haematinics,
anti-infective and antibiotics, gastrointestinal, analgesics, anti-diabetics and
immunologicals. The company focuses on providing appropriately priced, high
quality products to its customers and supports all these with dedicated customer
service. Cadila Pharmaceuticals has a multinational, multilingual and multicultural
workforce of over four thousand employees including more than two hundred people
outside India in forty-nine countries of Africa, CIS, USA and Japan.
The company has one of the best Research and Development (R&D) setups in
India, having crewed by more than three hundred and fifty scientists and engineers
from various disciplines including pharmacology, biology, chemistry, clinical
research, toxicology, phytochemistry. The company also participates in Public-Private
partnerships (PPP) for developing curative, preventive and diagnostic pharmaceutical
and diagnostic products.
Cadila Pharmaceuticals Ltd. is the first Indian company to get IND approval by
USFDA for the clinical trials to be conducted in India. After that, the company has
filed 4 more INDs with USFDA. Of the five filed INDs filed, one is for pulmonary
tuberculosis; and the trial is supported by Department of Biotechnology, Govt. of
India. The remaining four INDs are for various types of cancers, e.g., Prostate cancer,
Lung Cancer, Bladder Cancer and Melanoma. Thus all the filed INDs are for
providing solutions to major global health care problems. The clinical trials on Lung
cancer, Prostate cancer and Bladder cancer are supported by Department of Science
and Technology to encourage innovations.
The company has “state-of-the-art” manufacturing facilities conforming to the
most stringent international cGMP norms vis-a-vis WHO, WHO-GMP, Geneva (GDF
site for Anti- TB), USFDA, TGA Australia (PIC/S), MCC-South Africa, UK- MHRA,
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ISO 9001 and ISO 14001. Spreaded over hundred acres of land, Cadila
Pharmaceuticals Ltd.’s manufacturing facility at Dholka is very well equipped with
world-class production facilities. The CPL’s two Active Pharmaceutical Ingredients’
(API) units at Ankleshwar manufacture a wide-range of APIs and intermediates
including 3 USFDA approved products. The production facility at Samba, near
Jammu started its operational activities in August 2006. The first overseas formulation
producing facility of Cadila Pharmaceuticals Ltd. has started its operations in
Ethiopia.
As a responsible corporate citizen, they are conscious of their duty towards
various sections of the society; Cadila Pharmaceuticals Ltd. nurtures young talents;
runs an ultra-modern charitable hospital in a remote area with facilities like
Telemedicine in association with Apollo Ahmedabad; works closely with NGOs by
assisting and supporting for mid-day meal programmes to village schools, among
other initiatives.
A Prelude
Cadila Pharmaceuticals Ltd. Ahmedabad, India exemplifies a spirited Indian
Enterprise. Cadila Pharmaceuticals Ltd.’s phenomenal growth is a corporate
milestone, an era in time nurtured by fifty-two years of caring, rich heritage. With a
chase of creditable milestones, Cadila Pharmaceuticals Ltd. today has emerged to
become the undisputed leader in Indian Pharmaceutical sector, with largest
therapeutic groups, its operations spanning over 50 countries. Cadila Pharmaceuticals
Ltd. is multi-locational, with its various global corporate offices and manufacturing
houses.
2.1.Milestones1951-
Shri Indravadan A Modi thinks to start a Pharmaceutical unit.
1952-
Cadila starts its production, On March 13th.
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1967-
Cadila shifts to its factory premises with operations full-fledged spanning
Marketing, Production and R&D.
1970-
Shri Indravadan A Modi represents the Indian Pharma industry and plays a
important role in shaping the Patents Act, 1970.
1982-
Karnavati Engineering Limited (KEL), Kadi (the machinery-manufacturing
arm of Cadila) commences operations.
1986-
Shri I A Modi plays a pivotal role in shaping the 1986 Drug Policy.
1992-
Tissue Culture Laboratory starts its operation at Hirapur, near Ahmedabad.
1995-
Cadila restructured and becomes Cadila Pharmaceuticals Ltd.
1997-
GUSSACON (Gujarat State Surgeons Conference) felicitates Shri I A Modi at
its 23rd Annual Conference for his outstanding contribution to the industry.
1999-
Cadila Pharmaceuticals Ltd. (CPL) ventures in the US market by establishing
CPL Inc.
2000-
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1. Cadila Pharmaceuticals Ltd. moves to an ultra-modern Corporate Campus at
Bhat, near Ahmedabad.
2. Cadila Pharmaceuticals Ltd. ties-up with various institutions for research;
Department of Biotechnology, UDSC, in New Delhi; Lala Ram Sarup Institute
of TB & Respiratory diseases, in New Delhi; IISc, in Bangalore; RRL, in
Jammu; CSIR, in New Delhi; CDRI, in Lucknow; Advanced Transfusion
Medicine Research Foundation, in Ahmedabad; National Institute of
Immunology, in New Delhi and Talwar Research Foundation, in New Delhi.
3. Cadila Pharmaceuticals Ltd. introduces World’s First IMMUVAC, an unique
Immunomodulator.
2001-
Cadila Pharmaceuticals Ltd. launches NEVA HIV, Which is world's First
whole blood Rapid HIV detection kit.
2002-
1. Cadila Pharmaceuticals Ltd. ventures in Japan and sets up Kadera Yakuhin
Ltd.
2. Cadila Pharmaceuticals Ltd. becomes India's First indigenous manufacturer of
natural Streptokinase – STPase.
2003-
Shri I A Modi honoured with the Express Pharma Pulse Lifetime Contribution
Award.
2004-
1. Cadila Pharmaceuticals Ltd. launches world's first Parenteral Formulation of
Rabeprazole (Rabeloc I.V.).
2. Cadila Pharmaceuticals Ltd. submits first IND (Investigational New Drug)
with the USFDA for pulmonary tuberculosis.
2005-
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1. KEL’s new production line becomes operational and dispatches first
machinery to USA.
2. Shri I A Modi getss a Lifetime Achievement Award by Gujarat Chamber of
Commerce and Industry for his valuable contribution to the Industry and
society.
3. Cadila Pharmaceuticals Ltd. publishes and presents a series of scientific
papers on IMMUVAC, Itza and Rabeloc I.V. at UEGW (United European
Gastroenterology Week, Prague), APDW (Asia Pacific Digestive Week,
Beijing), AGW (Australian Gastroenterology Week), DDW (Digestive
Diseases Week, Chicago, USA), ASCO (American Society of Clinical
Oncology), WCOG (World Congress of Gastro).
2006-
1. Cadila Pharmaceuticals Ltd. acquires Pfizer's API facility at Ankleshwar.
2. The formulation facility at Samba near Jammu, starts its operation.
3. Cadila Pharmaceuticals Ltd. enters into a Joint Venture with Apollo Hospitals
Group to manage Apollo Hospitals in Ahmedabad.
4. Cadila Pharmaceuticals Ltd. submits four more INDs (Investigational New
Drug) with the USFDA for Prostate cancer, Lung Cancer, melanoma and
Bladder Cancer.
2007-
1. “Divya Bhaskar” honours Shri I A Modi with Lifetime Achievement Award
2. As a part of efforts to prevent lifestyle diseases, Cadila Pharmaceuticals Ltd.
commences large clinical trials aimed at prevention of Cardiovascular disease
and stroke by using an innovative polypill.
3. Cadila Pharmaceuticals Ltd. inaugurates its first overseas manufacturing
facility in Ethiopia, Cadila Pharmaceuticals (Ethiopia) PLC.
2008-
1. Shri I A Modi figures in the “Gujarat Glories annual power list of 50
businessmen”.
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2. Shri I A Modi features in “Power 100: Eminent Personalities of Gujarat”.
3. Indian Pharmaceutical Association (IPA) confers Ramanbhai Patel Foundation
Lifetime Achievement Award to Shri I A Modi.
4. Cadila Pharmaceuticals with StemCyte Inc. USA and Apollo Hospitals Group
forms a Joint Venture, StemCyte India, for Umbilical Cord Blood Stem Cells
Banking and Research.
5. Dholka manufacturing plant facilities receive renewal of regulatory
accreditation from MCC in South Africa.
6. Cadila Pharmaceuticals Ltd. receives financial assistance from New
Millennium Indian Technology Leadership Initiative (NMITLI) to develop a
novel treatment for Sepsis management.
2009-
1. Cadila Pharmaceuticals Ltd. features as one of the “Most Trusted Companies
of 2008” by Sara Media and Zee Business.
2. Cadila Pharmaceuticals unveils Ltd. world’s first Polycap, which reduces the
risk of heart diseases by 68% and stroke by 48%.
3. Cadila Pharmaceuticals Ltd. acquires a significant stake in Novavax Inc. based
in USA which is basically a clinical-stage biopharmaceutical company.
4. Announces CPL Biologicals, a joint venture with Novavax Inc. USA, to
develop and produce the vaccines based on virus-like-particle (VLP)
technology.
5. TIPS, The Indian Polycap Study becomes the first Indian publication to
feature in The Lancet (Medical Journal).
6. Cadila Pharmaceuticals unveils POLYCAP, the combination drug for the
prevention of Cardiovasculardiseases.
7. Unveils the revolutionary Risorine, the world’s first anti TB- drug with
bioenhancer which is an outcome of Public Private Partnership (PPP) between
RRL Jammu and Cadila Pharmaceuticals Ltd.
8. Dholka manufacturing facility gets regulatory accreditation from INVIMA in
Columbia.
9. To strengthen the business ties between the two countries, Dr Rajiv Modi
addressed industrial delegation from Gujarat to Japan as part of VGGIS.
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10. Dr Rajiv Modi becomes youngest Fellow of National Associates of Engineers.
2010-
1. “State-of-the-art” Vaccine manufacturing facility of CPL Biologicals comes
up at Dholka near Ahmedabad in Gujarat.
2. Cadila Pharmaceuticals Ltd. receives prestigious Wellcome Trust Award
under the new R & D for Affordable Healthcare in India initiative to support a
phase III clinical trial of Polycap.
3. Cadila Pharmaceuticals receives financial assistance from New Millennium
Indian Technology Leadership Initiative (NMITLI) to develop novel treatment
for diabetes drug.
2011-
1. Ethiopia production facility receives WHO-cGMP certification, which is the
only facility in the region.
2. Dholka production facility receives Pre-Qualification approval from WHO in
Geneva.
3. Dr Rajiv Modi shared a view on the topic “Challenges Relevant to Vaccine
Virus Selection - Emerging Market Perspective” at 2nd WHO Informal
Consultation for enhancing Influenza Vaccine Virus Selection in Geneva.
2012-
1. Cadila Pharmaceuticals Ltd. announces a strategic alliance with Swedish
Bactiguard, who are world-leaders in medically proven solutions for
preventing hospital-acquired infections.
2. CPL Biologicals and the International Centre for Genetic Engineering and
Biotechnology enters into a new JV to develop novel multi-stage Malaria
Vaccine in India which is based on proprietary VPL vaccine technology of
Novavax.
3. Cadila Pharmaceuticals Ltd. completes TIPS II for Cardiovascular Diseases.
4. Dr Rajiv Modi elected as Vice Chairman by CII Gujarat State Council.
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5. Cadila Pharmaceuticals Ltd. starts multinational TIPS III for treatment of
Cardiovascular diseases maping twelve countries.
6. Cadila Pharmaceuticals Ltd. submits tenth ANDA with USFDA, where first
being submitted in 2009.
7. Dholka production facility receives regulatory approval from UK, MHRA and
TGA, Australia.
2013
1. Dr Rajiv Modiis elected as Chairman by CII Gujarat State Council.
2. Cadila Pharmaceuticals Ltd. enters into a strategic JV with Pergamum AB in
Sweden, to generate a novel treatment of infections with a unique targeting
mechanism which is clearly distinguished from classical antibiotics.
3. Dholka formulation manufacturing facility gets USFDA certification.
4. Dholka manufacturing facility gets regulatory approval from EU GMP-Latvia.
5. Cadila Pharmaceuticals Ltd. files 38th USDMFs where first being filed in
2007.
6. Cadila Pharmaceuticals Ltd. files 22nd API EDMF (EUDMF) for European
markets.
2.2. Diversifications
• Hospital Disposables which includes Fiberglass Casting Tape
• Diagnostics
• Laboratory Chemicals
• Machineries for P’cal Manufacturing
• Animal Health Formulations & Supplements for Feed
• Agro Business includes Plant Tissue Culture (PTC) and Bio-fertilizers
• Strategic Business Alliances (SBA) with world-leaders
Cadila Pharmaceuticals Ltd. is all set to create new records and scale a greater
heights. By the time, It has created new world-class production and R&D facilities,
focusing on new process innovations leading to patents, research and meeting global
standards. The CPL always places the common man at its core, who should be able to
get and afford their medicines anywhere in the world.
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2.3.Champion Brands:
ENVAS
Cadila Pharmaceuticals Ltd. makes India's No.1 ACE inhibitor “Envas”,
Which has been listed among the country's top 50 Pharmaceuticals Brands, across all
categories.
Aciloc and Haem-Up are other CPL brands in top 300 brands of Indian
Pharmaceutical Industry.
ACILOC
Aciloc, A Ranitidine preparation is one of India's best-selling brands in this
category.
LMX, SYMBIOTIK, CLAX
Antibiotics with live Lactobacilli combination are the first brands of its kind in
India, for which Cadila Pharmaceuticals Ltd. has applied for a worldwide patent.
This revolutionary innovation has already been approved in Indian, UK and US,
Eurasian & Sri Lankan patents.
RABELOC, ZASO, ACILOC RD, MONTELAST, MIXULIN AND NODON
They are some of the best-selling brands of this category.
Cadila Pharmaceuticals Ltd. is the first company in India to introduce
RABEPRAZOLE and FOSINOPRIL formulations.
2.3.1. Patents
The Formulation Development department in CPL initiates innovative processes
for a number of products. The Cadila Pharmaceuticals Ltd. has filed a host of
patent applications and several more are in a queue. Meanwhile a few patents
have already come CPL’s way:
• Lactobacillus + Antibiotic combinations (Patents granted in USA, Eurasia,
UK, Kenya, ARIPO, India, Sri Lanka).
• Topical beta blockers with improved efficacy in ophthalmology (Patent
granted in India).
2.4. Marketing Divisions
Following is an brief introduction to different divisions under Branded Strategic
Business Unit (SBU):
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Magna
Magna is a multi-specialty division. It includes consulting physicians, general
practitioners, cardiologists, surgeons, gastroenterologists, paediatricians,
gynaecologists and nephrologists. Magna's portfolio mainly covers cardiology,
gastroenterology, gynaecology and others. Magna's major brands are 'Rabeloc',
'Aciloc', 'Cadilose', 'Losium', 'Envas', 'Caditor', 'Calcirol', 'LMX', 'Haemup', 'LMX
forte', ‘Levocide’, and 'Fludac'.
Maxima
Maxima is also a multispecialty division. Its portfolio includes respiratory
inclusive of ENT, dentistry, chest (anti tuberculosis), anti-infectives and orthopaedic
therapies. Maxima targets ENT specialists, dentists, paediatricians, chest physicians,
orthopaedicians and surgeons. Major brands of this division are 'Lorfast', 'Vasograin',
'Mycobutol', 'Symbiotik', 'P-Zide', 'Emvit Plus', 'Amdepin', 'Cuga', and 'Immuvac'.
'Immuvac' is a revolutionary immuno-modulator that has various applications
including reduced duration of therapy for treatment of multi drug resistant
tuberculosis and multibacillary leprosy. This division also has certain superspecialty
brands like 'Halonix' for orthopaedics.
A special task crew for ophthalmology 'OTF' works as a sub-unit of this
division focusing on opthalmologists with brands like 'Scat', 'Loptame', 'Gatt', and
'Visial' among others.
Volta
Volta is a super-specialty division. Its portfolio includes diabetology,
cardiology, endocrinology, nephrology, gastroenterology and critical care. This
division adopts 3 therapeutic approaches which are diabetic therapy, cardiac therapy
and critical therapy. Major brands of this division are 'STPase', 'Nodon', 'Teli',
'Glyloc', 'Envas IV', 'Glista', 'Humstard', 'Caditor'.
Oncocare
Oncocare division markets products that manages and treats the cancers and
tumours. Oncocare is penetrating in haematology segment to evolve as a complete
division providing medicines for treatment of the solid tumour and the
haematological malignancies. Oncocare's major brands are 'Caditrex', 'Cadigran',
'Karplat', 'Posid', 'Paclicad', 'Kinaplat', 'Docecad', 'Cadria L', 'Filcad', 'Recovarin' and
'Platin'.
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Magna XL
Magna XL division’s objective is to widen the reach and penetration in the rural
market. Magna XL works for the aim to make available quality medicines at
affordable price for the people living in interior towns and villages. Magna XL's
portfolio includes consulting physicians, general practitioners, gynaecologists and
pediatricians. Magna XL's champion brands are 'Haem up', 'Nuflam', 'Tummy Ease',
'Lactoceff', 'Happytizer', 'Anstisept', 'LMX', 'Hepasave', 'Fleximuv' and 'Wormin A'.
Generic
Generic is the wing of pharma business. The wing covers almost all the
therapeutic segments. Generic directly deals with the stockists primarily, and
dispensing doctors’ and retailers secondarily through super distributors. A major part
of business and promotion concerntrates mainly on the stockists. Generic has 3 sub
divisions namely, 'Genvista', 'Genstar' and 'Generic'. Generic's major brands are
'DPhesic', 'Ciprodac', 'Dexasone', 'Demisone', 'Famonext', 'Campicillin', 'Mokcan',
'Oritaxim Inj.' and 'Cotrimoxazole DS'.
Vetnova
Vetnova is animal healthcare division. At present, Vetnova is to be one of the
fastest growing enterpises harnessing the opportunities across the market. A team
consists of more than 100 people take a wide range of CPL’s brands pertaining to
poultry, canine and cattle into the remotest corners of India. While some of Vetnova's
brands like 'Onfeed', 'Cal D Min' and 'Cal D Plus DS' are household names, other
brands like 'Endotrin (Ecbolic)' and 'Nolapse' (for pre-lapse) are innovative offerings
of Vetnova.
2.5. Manufacturing Excellence
With regard to its corporate philosophy of striving for continuous betterment and
improvement, the Company has re-located its production operations at the “state-of-
the-art” plant at Dholka, located 50 km away from Ahmedabad which happens to be
the commercial capital of Gujarat. Spreading over 44 acres of land and amidst lush
green lawns is a begrudged pharmaceutical installation in the Asian sub-continent.
Truly revolutionary in every sense of the term, the Plant’s standards and
facilities can match any other specifications, worldwide. 7 ‘zones of cleanliness’
have been defined and adhered to as per the 1997 GMP guidelines of the European
Union. Few of the salient features of the design concepts:
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No wood or asbestos component in plant.
Each zone has its separate AHUs (Air Handling Units), dehumidification unit
and dust extraction systems (DESs).
To avoid cross-contamination, Segregation of every critical processing
activity in each zone.
Adherence to stringent standards of USFDA, MCA (UK), MCC (South
Africa) and TGA (Australia).
Respective zones, areas and even uniforms marked with specific colours of
the rainbow, to ensure total segregation.
Air conditioned environments in each area with respect to temperature,
humidity, filtration, particle counts, etc.
Conformation of each processing stage with US Federal Standard 209E class
of cleanliness which are 100, 1,000, 10,000, 100,000 with respect to pressure,
room air changes, flow direction, particle count etc.
Duo Pass Reverse Osmosis (DPRO) water system, multi-stage distillation
plant, self-sanitizing, water for injection with online monitoring of
temperature, sanitary SS 31 6L loops water, pH, TOC and conductivity
requirements as per USP XXIV.
Zero-discharge Effluent Treatment Plant built using technology from Advent
Integrated System, in USA.
Environment-friendly VAHP chillers.
Natural Skylit system and Rigvent heat extraction devices in raw material,
packing material and finished goods stores.
Isolated production facilities for Antibiotics B-Lactum and Cephalosporin
dosage forms.
The complex also has its own full-fledged R&D center; set up at an expense of
Rs. 200 million.
The Plant is having modern high-speed machines and integrated packaging
lines to be cost effective. Excessive use of non-fill devices, collators, FFS machines,
Brevetti visual inspection machines, multi-station tablet presses, high speed
vial/ampoule filler/sealers are some of the examples of it.
21
The plant- with high capacities and scope for future expansion- is capable of
manufacturing all dosage forms viz. Capsules, Tablets, Liquid Orals, Aseptic Liquid
and Solid preparations, Dry Syrups, Sachets etc.
2.5.1. Contract Manufacturing
Generic Formulations
“State-of-the art facilities”, which stick to stringent specifications of
cGMP, TGA-Australia, and MCC-South Africa.
Production capacity of Tablets is 3900 million / year, Capsules 150
million / year, Liquids 6000 kilo-liters / year, Ampoules + Vials 168
million / year.
Capacity to produce dosage forms in general and sterile, including all
therapeutic segments along with lyophilization facility.
Dedicated and isolated production facilities for Cephalosporin, Beta-
Lactam, Rifampicin dosage form and Insulin.
Qualified and experienced technical team in the areas of production,
quality assurance, quality control, research and development (R&D) for
all range of products.
Highly qualified management and staff and Experienced professionals,
with SAP ERP and Supply Chain Management in place.
Active Pharmaceutical Ingredients (APIs)
Inspected & got approval by USFDA for Ethambutol and Fluoxetine.
US COS filed / DMF / EDMF / under process for about 20 products.
ISO 9002 / ISO 14000 certified Bulk Actives manufacturing facilities,
offering ease for the "Contract Manufacturing".
Products’ range: Anti-allergic, Active Pharmaceutical Ingredients,
Cardiovascular, Disinfectants, Anti-diabetic, CNS, Anti-TB, NSAIDs,
Gastrointestinal, Anti-histamines.
Economic Value of Strategic Alliance
Reliable supply of quality products - Validated and approved processes
and in compliance with the registration file.
Minimize the investments in capital-intensive facilities.
Improve net earnings and cash flow.
22
Divert the resources to focus on their core competencies which are R&D
and marketing.
All products are analysed and released by their Quality Control (QC)
staff before shipment.
Track and optimize the timeliness of their delivery and keep it up to
CPL’s customer's full satisfaction.
Business Opportunities And Strategic Alliance With Cadila Pharmaceuticals
Ltd.
CPL offer contract manufacturing of all dosage forms.
According on your needs, CPL’s services include purchasing of the
production, raw materials, packaging and quality control.
Through this flexible approach, CPL is able to integrate perfectly into
your supply chain for solid dosage forms.
Looking forward to partnering or JV for a mutually beneficial / Profitable
working relationship and strategic alliance.
2.5.2. International Business
In line with Cadila Pharmaceuticals Ltd.’s vision to be significant global
player by 2015 A.D., Cadila Pharmaceuticals Ltd. is fast emerging as a true
Indian multinational.
As part of Cadila Pharmaceuticals Ltd.’s strategy, they have wholly or
partially owned joint ventures, subsidiaries, strategic alliances, own marketing
offices, contract manufacturing in four countries and have remarkable presence
in over 45 countries across the globe. Cadila Pharmaceuticals Ltd.’s business
revolves around the exports of bulk actives, formulations, Veterinary
formulations, hospital disposables, and p’cal machineries manufacturing.
Apart from a significant presence in the CIS Countries, Americas, Africa,
Oceanic Countries, Central and South-East Asia, Middle East, Europe and Japan,
The company has offices in Japan, USA, Kenya, Russia, Nigeria, Ukraine and
Kazakhstan. The International Strategic Business Unit plans to expand its
operations to more than 100 countries by 2015.
The main focus is on building the brands in the following therapeutic segments:
Gastrointestinal
Anti-infective
23
Analgesic/Anti-inflammatory
Respiratory
Cardiovascular
Ophthalmology
Bio-technical Products
Bonds exist with regional majors in the form of Joint ventures,
International Marketing and Contract manufacturing. Many more such
collaborations/JVs are under progress to expand their supply chain network and
make available extensive market coverage. An ultra-modern formulations
production facility conforming to the standards of USFDA, WHO-GMP,
MHRA-UK, TGA-Australia, MCC-South Africa, ANVISA- Brazil, ISO 9002,
EU GMP and Japanese GMP is a value-addition to their International Strategic
Business Unit in flexing its energy in the overseas arena. This Strategic Business
Unit has been honoured with the “Chemexcil Award”, 2000-01 and “Niryat
Shree Award” from FIEO, for the year 2001-02.
With its basic corporate philosophy of giving the best formulations to the
world at an affordable price, Cadila Pharmaceuticals Ltd. continues to make a
difference in the lives of millions of people, while carving a niche market for
Indian Pharmaceuticals exports, globally.
2.6. Production Capacity
Main Pharma Production Capacity
2 Shift / day basis
Tablets : 3900 million/year
Capsules : 150 million/year
Liquids : 6000 kiloliters/year
Sterile vials : 84 million/year
Ampoules : 84 million/year
Granules : 15.6 Tones/year
2 Shift / day basis
Beta Lactum / Cephalosporin
Dry Sterile vials : 48 million/year
Dry Syrup bottles : 27 million/year
Capsules : 630 million/year
24
Tablets : 510 million/year
2.6.1. Soft Gelatin Manufacturing Facility
Cadila Pharmaceuticals also licensed a modern, sophisticated production facility
for Soft Gelatin Capsules at its Jammu Plant which is Designed to meet the most
stringent international standards (IS), all operations in this plant from
encapsulation to packaging are carried out under class 1,00,000 area. Each
system is validated to meet International FDA standards, and the present
capacity of 10,00,000 capsules per day can be doubled with marginal
investments.
2.6.2. Other Manufacturing Locations
Plant Tissue Culture (PTC) , Hirapur
Casil Industries Ltd., Pharma Machineries, Speciality Chemicals & Soft
Gelatin Capsules Production Facilities, Jammu
Active Pharmaceutical Ingredients (APIs), Ankleshwar
2.7. Quality Control
Quality personify the spirit of the CPL. Quality is an apparent right from the moment
you step into premises of CPL, in the numerous aspects instilles and internalised into
the CPL’s ethos.
The slogan “Cadila for Quality” was deeply engraved into all logos of the
CPL and subsequently into the minds of millions, is bind to with utmost dedication as
it was years ago. A separate Quality Management division leading the concept of
Total Quality Management, an integration of all of the functions with built-in quality.
2.8. Group Companies
2.8.1. Casil Industries Ltd. (CIL)
Casil Industries Limited (CIL) is one of the market leaders in hospital products.
The concerntration of the company is on important allied segments such as
Orthopaedic, Surgical, Wound care, Critical Care, Disinfection, patient care
systems and Diagnostic. The company now has four major divisions:
2.8.1.1. Hospicon
This wide range covers Duralite, a fibre glass-based synthetic cast bandage;
Orthoset, a leading Plaster of Paris bandage; Glotex examination gloves
and Surgitex surgical gloves, both made of high-grade double-centrifuged
latex;Dermapore hypoallergic tapes, Opstic adhesive tapes, Castinet gauze
25
bandages and Dermasilk wound dressing. Other speciality products include
Softcrepe and cotton crepe bandages; Cadi-V infusion sets and Bioflon I.V.
Cannula. Apart from these, the CPL has entered into an agreement to
launch the modern wound care products which includes Hydrogel. Few of
these plants have the approval of Statutory bodies, including the DGQA
and have been awarded ISO 9002 certification.
2.8.1.2. Kemicon
Today, CIL is the leading supplier of Tetramethylene Sulfone (Sulfolane)
for most of all the refineries in India. Newer approaches are constantly
developing to expand the market for the products, which is now widely
used in the synthesis of Cephalosporins. Tetramethylene Sulfone
(Sulfolane) is also exported to other countries.
2.8.1.3. Sofgel
CIL has “state-of-the-art” set up to produce Soft Gelatin Capsule mainly to
serve the dietary supplements market, including minerals, hematinics and
vitamins. ISO 9002 approved plant has been consult with the Quality
Award by the Indian Drug Manufacturers' Association (IDMA) and also
carries WHO-GMP certification by the Government of India. Casil
products have been approved by other p’cal organizations and are exported
to the Far-East, African markets and SAARC. CPL is in the process of
expanding its capacities to double the production.
2.8.1.4. Diacon
Casil is the alone distributor for PanBio, Australia’s dengue detection kits.
It is the only product of its kind in the country. After the success of
Accuplan and Accutest HCG, ovulation and pregnancy tests, respectively;
CHPL is going to launch dry chemistry rapid test kits for malaria, hepatites
and other infectious diseases. These unique kits will greatly reduce the time
taken for diagnosis.
2.8.1.4.1. Product list
Clinical chemistry
• Liquid Ready-for-Use Reagents
• Enzymes
• Substrates
• Electrolytes
26
• Proteins
Coagulation – Immunoturbitimetry
Rheumatology
Lipid Diagnostics
Plasma Proteins
Rapid screening
Pregnancy (Medtek Asia P Ltd., Mysore )
Urinalysis (Medtek Asia P Ltd., Mysore )
HIV (Cadila Pharmaceuticals Ltd.)
Tropical Disease ( Panbio Ltd., Australia )
ELISA
Hormones
Infectious Diseases
Tropical Diseases ( Panbio Ltd., Australia )
HIV (Cadila Pharmaceuticals Ltd.)
HCV (Cadila Pharmaceuticals Ltd.)
Makers
2.8.2. IRM Ltd.
2.8.2.1. Green channel Travel Services
With the increasing view of the world as a 'Global Village', and
elimination of a large number of boundaries and barriers, traveling has
turned easier than ever before - both international and domestic. CPL
recognized the trend years ago, when it has launched its IATA accredited
agency first in Ahmedabad, “GREEN CHANNEL TRAVEL SERVICES”,
with the aim of catering to traveling and traveling related needs of
individual, families and different companies.
From 1997, the agency has been nominated with the best agency for
domestic booking by Indian Airlines. Green Channel has also been
conferred with :
The 'Lufthansa Award for Excellence', for topping sales during
1998-99.
27
The 'Outstanding Performance Award' by Jet Airways for highest
ticket sales during 1998-99.
For Highest Sales in 2000-01, 'Singapore Airlines' Award.
'Indian Airlines' Awards for Highest Sales Performance in 2000-01.
'KLM Airlines' Awards for maximum sales in 2000-01.
Besides being the alone representative of American Express Travel
Related Services in Ahmedabad, GREEN CHANNEL also stocks Amex
and Thomas Cook travellers' cheques, outbound tours, deals in car rentals,
corporate incentive tours and money-changing business, authorized by the
Reserve Bank of India (RBI).
2.8.2.2. Rousdonmullai Tea Estates
Cashing in on the lucrative prospects in the agro business sector, CPL
has added a new dimension by acquiring a tea plantation in Tamil Nadu.
Spreaded over 900 acres of blue mountains and set amidst lush green
gardens, Rousdonmullai Tea Estates is located in Devala, in the Nilgiris,
Tamil Nadu.
With mainly focus on tea planting and processing, unadulterated tea
garden from Rousdonmullai, is being supplied to regions like Hyderabad,
Mumbai, Cochin, Coimbatore and Gujarat.
Apart from growing tea gardens, a bunch of agro-based projects are
also being intended by the company in the estate.
2.8.2.3. Karnavati Engineering Ltd.
The engineering arm of Cadila Pharmaceuticals Ltd. group, Karnavati
Engineering Ltd. (KEL) is a well-established manufacturer of precision
machinery and component for pharmaceutical and its allied industries.
Following its come out with the all-purpose Kalweka for pharmaceutical
research in academic institutions, research and development (R&D)
centers, p’cals and associated industries; KEL has been developing a set of
innovative products in production, packaging and research.
The company's has a wide range of equipments which includes
Colloid Mill, tablet compression machines of various outputs,
Communiting Mill, Automatic Blister Packing Machine, Unik Press and
others.
28
KEL has been leader in technology revolution in the field of pharma
machinery for a decade and has emerged as synonymous with tablet press
machines worldwide. The latest introduction is the UNIK-II PC, an
engineering marvel which moils out 7,75,000 tablets/hr.
On packaging front, KEL's Blister Packaging machine is already a
landmark product. The KEL also has other supporting equipment, like table
cleaning system, punches & dies, dust extraction unit, inspection &
maintenance kit etc.
KEL invests almost 20% of its turnover in R&D. The company take
part in various exhibitions and propose trial runs on its machines at its
factory and have won the appreciation of technocrats and their end-users
worldwide. The products have gained wide acceptance in domestic and
international markets, and are exported to UK, USA, CIS countries,
Belgium, Italy, South Africa, Indonesia, Columbia, Syria, Malaysia etc.
Today, it ranks No. 1 in the country in exporting pharma machinery
to the US and is all collected for a quantum leap in the precision equipment
manufacturing sector.
2.9. Cadila Pharmaceuticals Ltd. has two joint ventures:
2.9.1. Cadila Pharmaceuticals (Ethiopia) PLC
The company has established a Joint Venture Company in Ethiopia with a
local partner and put up a “state-of-art manufacturing” plant there for the
production of tablets, capsules, liquid, injectables etc. The Joint Ventured
Company (JVC) is named as “Cadila Pharmaceuticals (Ethiopia) PLC”, wherein
Cadila Pharmaceuticals Ltd. Is having 60% equity and the local partner holds
40% equity. The plant is working since last more than six years and is expected
to achieve a turnover of approx Rs. 300 million for the year 2012.
2.9.2. CPL Biologicals Private Ltd.
The company has also established a JVC (Joint Venture Company) in India
namely CPL Biologicals Pvt. Ltd. in partnership with The M/s. Novavax Inc.
USA (a NASDAC which is one of the US stock exchange listed company), with
Cadila Pharmaceuticals Ltd. havinng 80% equity and Novavax 20%. The JVC is
working in the area of development and Production of biological therapeutics,
therapeutic and prophylactic vaccines and diagnostics in India. This joint venture
company represents an important strategic alliance for vaccine development and
29
production in India and uses revolutionary vaccine technologies. JVC’s vision is
to be a leading provider of high quality, affordable biological therapeutics,
vaccines and diagnostics through world-class research and innovation in
production to target current and future global health challenges.
The JVC is now in the process of developing novel vaccines based on “Virus
Like Particles” (VLP) using cutting edge technology.
CPL Biologicals has established Production facilities in India to produce,
develop and sell products such as an influenza vaccine and other novel vaccines
based on VLP technology. The initial estimated investment for this is expected
to rise around Rs. 100 crores.
30
Chapter 3
Research
methodology
31
3. RESEARCH METHODOLOGY:3.1. Problem Statement
Objective of the study is to know the perception of the doctors’ towards
Bromelain + Trypsin + Rutoside combination drug and for which indication they
would prefer this drug.
3.2. Objective
To find out Doctors’ Perception regarding drug prescription when come to
Inflammation or Inflammatory Pain or Inflammatory oedema.
To find drug’s low acceptance by Doctors.
Try to know this drug’s competitive advantage over other competitor drugs.
To study how competitor manufacturers of same drug promote their product.
To Study doctors’ perception regarding different drug’s safety
3.3. Scope of Study
I took Doctors and Pharmacists (Chemists and Druggists) as my respondents. I made
Doctors to fill up my questionnaire and with Pharmacists I talked verbally and tried
to get competitive advantage of this drug over other competitive molecules.
3.4. Research Type
The Research which I conducted was Exploratory kind of a research. To get my
objective fulfilled, I prepared a questionnaire for doctors and for druggist I interacted
verbally.
3.5. Sample
3.5.1. Sample Size
Total 80 (30 Doctors + 50 Drug stores)
3.5.2. Sampling Method
Quota Sampling Method
3.6. Place of Study
I conducted this research in Godhra which is in Panchmahal district, Gujarat, India. I
almost went to 30 doctors who are eligible for my research sample and take into
accounts those doctors’ response who are prescribing this medicine. I also met
nearby medical stores for furthermore feedback about this drug.
32
Chapter 4
INTRODUCTION to pain,
inflammation and
oedema
33
4. INTRODUCTION TO PAIN, INFLAMMATION & OEDEMA:4.1. Pain
Pain is a feeling directly triggered in the nervous system. Pain may also be
sharp or dull. It may also come and go, or it may be constant for some time. You may
feel pain in one area of your body, such as your back, head, abdomen or chest or you
may feel pain all over, such as when your muscles ache from the flu.
Pain can also be helpful in diagnosing a problem. You might seriously hurt
yourself without knowing it, or you might not realize you have a medical problem
that needs treatment. When you take care of the problem, pain generally flew away.
Though, sometimes pain continues for weeks, months or even years on. It is also
called as chronic pain. However, sometimes chronic pain is due to continuing cause,
such as arthritis or cancer. Sometimes may be the cause is unknown.
Now a day, there are many ways to treat pain. Treatments may vary depending
on the cause of pain. Acupuncture, Painkillers and Sometimes surgery are helpful.
4.2. Inflammation
The word inflammation comes from the Latin "inflammo", meaning "I set
alight, I ignite".
Inflammation is the body's attempt to self-protection; the aim is to remove
harmful stimuli including damaged cells, irritants, or pathogens - and begin the
healing process.
When something which is harmful or irritating affects a part of body, there is
initiation of biological response to try to remove it. The signs and symptoms of acute
inflammation show that the body healing itself by this mechanism. Inflammation
does not mean infection, though an infection causes inflammation. Infection may be
caused by a virus, fungus or bacterium; while inflammation is the body's immune
response to it.
Inflammation is part of the body's immune response. At first, it is beneficial
when your knee sustains a blow and tissues need a care and protection. However, in
some cases inflammation can cause further inflammation, which can turn in to self-
perpetuating. Furthermore inflammation is developed in response to the existing
inflammation.
34
4.3. Oedema
Oedema is fluid retention, which is also called as “Dropsy”. Oedema can be
most easily seen round the ankles after you have been standing (peripheral oedema)
or lying down. After lying down for some time, your eyes may look like puffy and
swollen. Oedema can also collect in your lungs and make you short of breath in
severe cases.
Mild oedema is common and usually harmless to body. It may be due to
allergies, more serious underlying disease or medication.
It is important to seek medical attention if you have oedema history. Most often
no particular cause is to be found out.
Oedema is basically a collection of fluid in the spaces between cells of the
human body. Fluid simply leaks out of damaged cells. This fluid cannot be simply
just drained with a needle and may or may not improve if you take 'water pills'
(diuretics).
4.3.1. Types Of Oedema include:
Idiopathic - no known cause.
Localised - fluid retention in a particular part of the body. It is generally
due to an allergic reaction or injury.
Generalised - affects the whole human body. It generally causes puffy
ankles after standing and puffy reddish eyes after lying down for some
time. This may happen be due to an underlying heart condition.
Cerebral oedema - fluid on the brain, generally due to infection
(meningitis) or serious brain disease (stroke or brain tumour).
Pulmonary oedema - fluid on the lungs, usually due to heart disease.
Lymphoedema - a build-up of lymph fluid when lymph channels are
damaged - eg, after breast cancer surgery.
Women are more prone than men to oedema. Female hormones
(progesterone and estrogen) tend to cause fluid retention so some women
notice puffy ankles just before period of time. Oedema may occur for the
first time at any age if you become anaemic or suffer an allergic reaction.
Old people can acquire oedema rapidly, as they sit for longer periods of time.
35
Older people are also more prone to heart or kidney conditions that may
cause oedema.
4.3.2. Problems which cause Oedema
This list may or may not include all the possible causes of oedema but lists
some of the more common causes.
4.3.2.1. No known cause (idiopathic)
In Idiopathic oedema fluid retention happens which it not caused by a
known medical condition. It is most general in women and can sometimes
its get worsen as you get older and older. Though there is no absolute cure
for idiopathic oedema, but having a healthy diet which contains low salt
can make a real difference. Most people with idiopathic oedema are
overweight and losing weight can make a huge difference to cure the
oedema. A gradual weight loss, rather than fasting and bingeing are
recommended. Regular exercise and Support stockings are also beneficial
in this condition. Avoiding long periods of standing and lying can also
help.
4.3.2.2. Heart Failure
Pulmonary oedema, which means an excess collection of watery fluid
in the lungs, is most often caused by heart failure. The fluid collected in the
air sacs of the lung make it difficult to breathe. When a heart is not able to
pump blood to the whole body effectively, the amount of blood remaining
in the veins, that takes blood through the lungs to the left side of the heart
increases. When the pressure in these veins increases, fluid is pushed into
the air sacs (alveoli) in the lungs. This fluid retention reduces normal
oxygen movement through the lungs, which leads to shortness of breath.
4.3.2.3. Angio-oedema
Angio-oedema is a medical condition in where in swelling of the
deeper layers of the skin. This also includes the dermis and subcutaneous
tissues. It affects the tissues just underneath the lining of the airways,
mouth and gut - that is, called the sub-mucosal tissues.
In most of the cases there is no known cause and it is not clear about
why it occurs. This is also called idiopathic angio-oedema. Though the
cause is not clear, in up to 50 pecent of the cases there is a link to an
36
autoimmune disorder. This includes chronic systemic lupus erythematosus
(SLE), thyroiditis (hypothyroidism) or urticarial. In some of the cases there
are known triggers that cause the release of histamine, which triggers to
tissue swelling of angio-oedema. These also include allergic reactions and
non-allergic reactions to the medicines.
4.3.2.4. Other possible causes of oedema may also include some kidney
diseases, anaemia and pregnancy. Blood clot in a leg can lead to sweeling
of leg.
The doctor wants to know when you noticed the oedema, how long it’s
been there for and whether do you have any other symptoms of oedema. It
is very important to mention ifever you've started any new medication. You
will be under a physical examination of your blood pressure, lungs and
blood as well as the part which is puffy (swell). You may be asked for a
urine sample and a blood test. You may probably asked for further tests on
your heart and a chest X-ray.
4.3.3. Treatments:
Treatment will depend on the cause of oedema. In most of the cases, it is
managed by your GP but you may be asked for further investigation and
treatment at the hospital. Treatment includes:
Regular exercise such as gyming or walking or swimming.
Losing of weight if you are overweight.
Raising both legs on a footstool when possible.
'Water pills' (diuretics) - only if it is prescribed.
Treatment of the underlying condition - eg, heart failure, kidney failure
etc.
4.3.4. To be done
You should call a medical help / an ambulance if you are experiencing severe
shortness of breath or chest pain or vertigo. Mild puffiness / swelling of your
ankles that gets better whenever you lie down for a few hours, may not need any
treatment. In almost all cases, you should see your GP to find out if there is an
underlying cause.
37
4.3.5. How can I avoid Oedema?
You will need to find underlying cause and try to cure it if it is possible.
Idiopathic oedema has no specific cause and is common. The best treatment is to
walk regularly, avoid becoming overweight and put feet raised on a footstool
when resting.
4.3.6. Prognosis:
This depends on the underlying cause but is generally very good. Most of the
oedema is because of standing too long on the hot day, specifically if you are
overweight. Any of the increased risk depends on the underlying cause.
4.4. Drugs Used Fore It
4.4.1. Drugs used to relieve Pain:
Diclofenac
Ibuprofen
Hydroxyzine
Celecoxib
Meperidine
Ampitryptyline
Hydromorphone
Acetaminophen
Tapentadol
Oxymorphone
Oxycodone
Ketorolac
Tramadol
Diclofenac
Alfentanil
Naproxen
Aspirin
Lidocaine
Flubiprofen
38
4.4.2. Drugs used to heal Inflammation
Aspirin
Naproxen
Hydroxychloroquine
Plaquenil
Oxyphenbutazone
Tandearil
Butazolidine
Phenylbutazone
Pediapred
Prednisolone
Prelone
Deltasone
Meticorten
Orasone
Prednisone
Decadron
Dexamethasone
Dexone
Hexadrol
Oradexone
Ibuprofen
Acetaminophen
Integrin
Glucocorticoids
4.4.3. Drugs used to heal Oedema
Hydrochlorothiazide
Chlorthiazide
Bumetanide
Torsemide
Acetazolamide
39
Triameterene
Ethacrynic acid
Methychlothiazide
Furosemide
Indapamide
Amiloride
Metolazone
40
Chapter 5
INTRODUCTION to
product
41
5. INTRODUCTION TO BROMELAIN, TRYPSIN & RUTOSIDE:5.1. Bromelain
It is an extract which is derived from the stems of pineapple, although it
presents in all parts of the fresh fruit and plant. This extract has a history of folk and
modern medicinal usage. As a supplement it is supposed to have anti-inflammatory
effects. It also contains chemicals which might interfere with the growth of tumour
cells and slower down blood clotting. As a culinary ingredient it is used mainly for
tenderizer.
The term “Bromelain” may refer to either of two protease enzymes refer to a
combination of those enzymes along with other compounds produced in an extract or
it may refer to enzymes extracted from the plants of the family, Bromeliaceae.
5.2. Trypsin
Trypsin is basically a serine protease found in the digestive system of many
vertebrates, where it hydrolyses the proteins into peptides. Trypsin is produced in the
pancreas as the inactive pro-enzyme Trypsinogen. Trypsin mainly cleaves peptide
chains at the carboxyl side of the amino-acids lysine or arginine, except when either
of is followed by proline. It is generally used for numerous biotechnological
processes. This process is usually referred to as trypsinisation or trypsin proteolysis
and Proteins that have been treated / digested with trypsin are said to have been
trypsinized.
5.3. Rutoside
Rutin (also called rutoside / quercetin-3-O-rutinoside and sophorin) is the
glycoside between the flavonol quercetin and the disaccharide rutinose (α-L-
rhamnopyranosyl-(1→6))-β-D-glucopyranose). In the fava d'anta tree, the synthesis
is done via a rutin synthase activity.
Rutin is one of the phenolic compounds mostly found in the invasive plant
species Carpobrotus edulis and contributes to the antibacterial and antioxidant
properties of the plant.
Its name comes from the name of “Ruta graveolens”, a plant that also contains
rutin.
It can combine with cations supplying nutrients from the soil to the cells in
plants. In humans, it attaches to the iron ion Fe2+, preventing it from binding to
42
hydrogen peroxide, which would otherwise create a highly reactive free radical that
may damage cells. It is also an antioxidant.
Furthermore, it has been shown to inhibit vascular endothelial growth factor in
subtoxic concentrations, so it acts as an inhibitor of angiogenesis. The finding may
have potential relevance for the control of some cancers.
5.4. Studies on this Drugs
In a recent blinded study from Germany, researchers divided 90 patients with
painful osteoarthritis of the hip into two groups: one half receiving an oral enzyme
preparation containing bromelain for six weeks, while the other half received the
anti-inflammatory drug diclofenac. They found out that the bromelain preparation
was as effective as diclofenac in standard scales of pain, stiffness and physical
function, and have better tolerance than the drug comparator. The researchers
concluded, “The bromelain preparation may well be recommended for the treatment
of patients with osteoarthritis of the hip with signs of inflammation as indicated by a
high pain level.”
Another study comparing a standardized commercial enzyme preparation
containing bromelain with diclofenac reached the same conclusion. The study
reported that the supplement containing bromelain (90 mg, three times daily) to be as
effective as diclofenac (50 mg, twice daily) in improving the symptoms of
osteoarthritis of the knee. Patients reported comparable reductions in joint
tenderness, pain and swelling, and improvement in range of motion at the end of the
study. The investigators found bromelain to be as good as diclofenac on a standard
pain assessment scale and to be better than the drug in reducing pain at rest (by 41%
for bromelain versus 23% for the drug), improving restricted function (by 10% for
bromelain versus 0% for the drug), being rated by more patients in improving
symptoms (24% for bromelain versus 19% for the drug), and being evaluated by
more physicians as having good efficacy (51% for bromelain versus 37% for the
drug). In summary, the investigators determined bromelain to be an effective and
safe alternative to NSAIDs such as diclofenac for painful osteoarthritis.Together,
these findings reveal that bromelain may provide safe, effective relief from acute and
chronic joint pain caused by arthritis and other conditions.
Growing evidence of the cardiovascular and gastrointestinal risks associated
with non-steroidal anti-inflammatory (NSAID) drugs has left many people
seeking safe, effective strategies for relieving pain and inflammation.
43
Derived from the pineapple plant, the protein-digesting enzyme bromelain
demonstrates powerful effects in alleviating pain, swelling, and inflammation.
In clinical trials, bromelain-based formulations were more effective than an
NSAID drug in relieving arthritis pain. Supplementing with bromelain-based
formulations after injury or surgery also speeds healing and reduces pain.
Bromelain hastens the resolution of sinusitis, and shows promise in fighting
inflammatory bowel disorders. Preliminary studies suggest that bromelain
may even help fight cancer.
Experts suggest consuming bromelain between meals to capture its anti-
inflammatory benefits. To promote healthy digestive function, take bromelain
with meals.
Bromelain may offer important support for healing and pain relief after surgery.
Investigators administered a combination of bromelain, trypsin, and rutoside (rutin)
to patients for two weeks following surgery to fix fractured long bones. Compared
with surgical patients who did not receive the supplement, the bromelain-treated
group showed a remarkable reduction in postoperative swelling. Additionally, the
supplemented individuals required less pain medication during their recovery period,
indicating a significant analgesic effect and more rapid and comfortable recovery.
44
5.5. Competitor Companies who make this Drug
Bromelaine + Trypsine + Rutoside
Brand Name Manufacturer Price(Rs.)Xymoheal Corona remedies Pvt Ltd 115
Invilin Synokem Pharmaceuticals Ltd 149
Invillin Forte Synokem Pharmaceuticals Ltd 300
Allanz Wallace Pharmaceuticals Ltd 150
Enractin Molekule Ind Pvt Ltd 150
Enractin Plus Molekule Ind Pvt Ltd 499
Enzoheal Healthguard Pvt Ltd 156
Enzomac Plus maleods Pharmaceuticals Ltd 160
Proenza Dewcare Concept 190
Enzody Malody 160
Triobest Bestochem NA
Activin-R Waves biotech NA
Rutoheal Mankind 130
45
Chapter 6
Analysis of survey
response
46
6. ANALYSIS OF SURVEY RESPONSES6.1. How many Patients do you see in a week suffering from Inflammation or
Inflammatory pain or Inflammatory oedema?
6.2. What therapy do you initiate for these patients?
Diclo + PCM diclo
Ibuprofen
Analgesics + antibiotics
INJ Aceclofenac + Serratio
Xymoheal
Trypsin + Chymotrypsin
Diclo + PCM + Serratio
Antibiotics
PCM
Diaminic DA
PCM
NSAIDS + REST
No. of patients Responded docs %
0–30 7 22%
31–60 18 56%
61-90 7 22%
Other 0 0%
Table No 6.1
Graph No 6.1
47
Enzyme prepn
Indomethacin
Anti-inflammatory
Find etiology and prescribe accordingly
6.3. For which type of indication you would suggest Bromelain + Trypsin + Rutoside
combination:
6.4. Which strength do you prescribe and in which indications?
Strength Response %
Bromelain 90mg + Trypsin 48mg +
Rutoside 100 mg
64 58
Bromelain 180mg + Trypsin 96mg +
Rutoside 200 mg
46 42
Indication response %
Pain 2 1%
Inflammation 30 21%
Inflammatory Pain 46 32%
Inflammatory Oedema 62 44%
Other 2 1%
Graph No 6.2
Table No 6.2
Table No 6.3
48
6.5. Duration Of therapy for this combination:
6.6. What dosage would you prefer for this combination?
6.7. You use this medication as:
Duration Response %
5 38 59
6 24 38
7 2 3
Dosage Response %
Twice a day 14 22
Thrice a day 50 78
Use as Response %
Single medication 8 13
Combination with other medicines 56 87
Graph No 6.3
Table No 6.4
Graph No 6.4
Table No 6.5
Table No 6.6
49
6.8. Which other Molecule you prefer in this indication?
6.9. Your Preference for this combination Drug:
Molecule Response %
Diclofenac 64 29%
Paracetamol 52 24%
Paracetamol (IR+SR) 58 26%
Serratiopeptidase 20 9%
Ibuprofen 26 12%
Other 0 0%
Preference Response %
Starting with higher and moving
on to lower dosage
2 3
Starting with lower and moving on
to higher dosage
2 3
Combination medication 60 94
Graph No 6.5
Table No 6.7
Graph No 6.6
Table No 6.8
50
6.10. Diclofenac [Patients' safety level:]
6.11. Paracetamol [Patients' safety level:]
Safety level Response %
Safest 2 3%
Safer 52 81%
Neutral 10 16%
Unsafe 0 0%
Extremely Unsafe 0 0%
Safety level Response %
Safest 22 39%
Safer 28 50%
Neutral 3 11%
Unsafe 0 0%
Extremely Unsafe 0 0%
Graph No 6.7
Table No 6.9
Graph No 6.8
Table No 6.10
51
6.12. Paracetamol (SR+IR) [Patients' safety level:]
6.13. Serratiopeptidase [Patients' safety level:]
Safety level Response %
Safest 22 73%
Safer 30 23%
Neutral 2 3%
Unsafe 0 0%
Extremely Unsafe 0 0%
Safety level Response %
Safest 24 63%
Safer 12 32%
Neutral 0 0%
Unsafe 2 3%
Extremely Unsafe 0 0%
Graph No 6.9
Graph No 6.10
Table No 6.11
Table No 6.12
52
6.14. Ibuprofen [Patients' safety level:]
6.15. What is your Clinical Experience with this combination drug?
Safety level Response %
Safest 2 6%
Safer 6 18%
Neutral 18 53%
Unsafe 8 24%
Extremely Unsafe 0 0%
Experience Response %
Good 44 69
Neutral 14 22
Bad 6 9
Graph No 6.11
Graph No 6.12
Table No 6.13
Table No 6.14
53
6.16. Diclofenac [Considering all factors into consideration, Give your
opinion:]
6.17. Paracetamol [Considering all factors into consideration, Give your
opinion:]
Experience Response %
Excellent 50 78%
Good 14 22%
Fair 0 0%
Poor 0 0%
Very Poor 0 0%
Experience Response %
Excellent 46 79%
Good 10 17%
Fair 2 3%
Poor 0 0%
Very Poor 0 0%
Table No 6.15
Graph No 6.13
Graph No 6.14
Table No 6.16
54
6.18. Paracetamol (SR+IR) [Considering all factors into consideration, Give
your opinion:]
6.19. Serratiopeptidase [Considering all factors into consideration, Give your
opinion:]
Experience Response %
Excellent 56 93%
Good 2 3%
Fair 2 3%
Poor 0 0%
Very Poor 0 0%
Eexperience Response %
Excellent 30 83%
Good 6 17%
Fair 0 0%
Poor 0 0%
Very Poor 0 0%
Table No 6.17
Graph No 6.15
Graph No 6.16
Table No 6.18
55
6.20. Ibuprofen [Considering all factors into consideration, Give your opinion:]
6.21. What shoud be Price band for 10 tablet strip of this combination drug?
Price shoud be Rs.80-90 per 10 tablet strip (Got this price by taking mean of 32
doctors and pharmacists)
6.22. What could be advantage of these drugs over other competitior drugs?
Reduce oedema easrlier than serratiopeptidase
Comparatively less side effect
Almost nill side effect
Safe drug as it is enzyme preparation
Experience Response %
Excellent 8 24%
Good 12 35%
Fair 14 41%
Poor 0 0%
Very Poor 0 0%
Graph No 6.17
Table No 6.19
56
Chapter 7
findings
57
7. FINDINGS
Doctors in general use (Bromelain 90mg + Trypsin 48mg + Rutoside
100 mg) combination but in severe cases they also prefer (Bromelain
180mg + Trypsin 96mg + Rutoside 200 mg).
59% of the doctors use this medicine as 5 days therapy duration &
38% of doctors use this medicine as 7 days duration.
78% of doctors prescribe this medicine thrice a day & 22% of doctors
prescribe this medicine twice a day.
87% of doctors use this medicine combination with other medicines.
Most of the doctors use Diclofenac, PCM, PCM (SR+IR) or
serratiopepdidase combination to initiate therapy.
81% of the doctors rated Diclofenac as safer drug, 73% Doctors rated
PCM (SR+IR) as safest drug 63% doctors rated Serratiopeptidase as
safest drug & 77% doctors don’t prefer Ibuprofen when comes to
safety level.
When comes to clinical symptoms reduce, doctors feel PCM, PCM
(IR+SR), Serratiopeptidase and diclofenac as Excellent drug and not
ibuprofen.
According to doctors, price should be within the range of Rs.80-90 per
10 tablet strip.
BTR combination has almost nill side effect and reduce oedema
earlier than serrationpeptidase as per doctor’s opinion.
58
Chapter 8
suggestion
59
8. SUGGESTIONS
This drug should be marketed with regards to its Safety measure as it has very
strong competitiveness to its safety parameter.
It should be recommended to the doctors for inflammatory oedema as 76%
doctors believe that it reduces inflammatory oedema rapidly than any other drugs.
As we know, we can’t reduce its price drastically because other competitiors will
also get involve in price war and it will affect the other drugs’ portfolio.
According to my research, Most of the doctors don’t know about this drug and if
know, they don’t know when to prescribe and its competitive advantage so we
should first concentrate on increasing Awareness amongst doctors.
I recommend to name this drug as “BTR” as it would be easy for the doctors to
memorise and recollect the API by its name’s first alphabate.
I would also like to drag your attention towards its price which is main weakness
of this drug. To overcome this first we have make doctors trust this drug and for
that we have to distribute free sample so that doctors can give to patients and
check their satisfaction level at initial stage.
60
Chapter 9
bIBLIOGRAPHY
61
9. BIBLIOGRAPHY http://www.cadilapharma.com/
http://www.medguideindia.com/find_brand_bygeneric.php?gen_mask=,1618,2176,29
08,
http://www.medschat.com/topics/use-of-trypsin-bromelain-rutoside-trihydrate-tab/
http://www.seacoast.com/topic.php?health=trypsin+and+bromelain+rutoside+mode+
of+action
http://www.patient.co.uk/health/oedema-swelling
http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Medications_non-
steroidal_anti-inflammatory_drugs
http://www.thefreedictionary.com/anti-inflammatory+drug
http://www.rxlist.com/script/main/art.asp?articlekey=104699
http://www.drugs.com/condition/pain.html
en.wikipedia.org/wiki/Rutoside
http://en.wikipedia.org/wiki/Trypsin
http://en.wikipedia.org/wiki/Bromelain
http://en.wikipedia.org/wiki/Pharmaceutical_industry_in_India
http://www.mims.com/India
62
Chapter 10
APPENDIX
63
10.APPENDIX
Questionnaire:
Personal Profile
Name: Dr. __________________________________________________________
Qualification: ___________________________
Address: __________________________________________________________________
___________________________________________________________________
___________________________________________________________________
DOB: ____________________________
Marriage Anniversary: _________________
Contact Details:
Mobile No.: __________________________
Phone (O): ___________________________
Email ID: ______________________________________________________________
64
1. How many Patients do you see in a week suffering from pain, inflammation and
oedema? ( )
2. What therapy do you initiate for these patients?
a. _______________________________________________________
b. _______________________________________________________
3. For which type of indications you would suggest Bromelain + Trypsin + Rutoside
combination:
a. Pain
b. Inflamation
c. Inflammatory oedema
d. Inflamation with Pain
e. Others Please Specify: ______________________________________
4. Which Strength you prescribe:
Bromelain 90mg + Trypsin 48mg + Rutoside 100mg
(If yes, In which indication:_______________________________________ )
Bromelain 180mg + Trypsin 96mg + Rutoside 200mg
(If yes, In which indication:_______________________________________ )
5. Duration of therapy: ( ) days
6. What dosage would you prefer for this combination?
Twice a day
Thrice a day
Other:______________
7. You use this medication as
Single medication Combination with other medication
8. Which other molecules you prefer in this indication?
Diclofenac
Paracetamol
Paracetamol (IR+SR)
Serratiopeptidase
Ibuprofen
Other:_______________________________________
65
9. Your preference for this combination
Starting with higher dosage and moving on to the lower dosage
Starting with lower dosage and moving on to the higher dosage
Combination with other medicines
Others: ______________________________________
10. What is your Clinical experience with this combination, If any?__________________
_____________________________________________________________________
11. Patients’ safety level:
Safest Safer Neutral Unsafe Extremely unsafe
Diclofenac
Serratiopeptidase
Ibuprofen
Paracetamol
Paracetamol (SR+IR)
Other:___________________
12. Considering all the factors give rating to these molecules:
Excellent Good Fair Poor Very poor
Diclofenac
Paracetamol
Paracetamol (SR+IR)
Serratiopeptidase
Ibuprofen
Other:_________________
13. What should be the price band per 10 tablet strip of this combination drug? ( )
14. What could be advantage of this drug over other competitor drugs?_______________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
We are pleased to have your valuable part in our survey. We really appreciate
your help.
Thanking you sir.