- REGULATORY AFFAIRS(RA) PROFESSION, - DIFFERENT REGULATORY BODIES AND - INDIAN PHARMACEUTICAL INDUSTRY, OVERVIEW

RAJASHRI OJHAMD, RAAJ GPRAC

DISCLAIMER

Contents of this presentation are the presenters personal views and do not necessarily represent any companies policies and position.

Some images are taken – freely available from the internet for a diagrammatic representation of the content and the source is acknowledged.

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AGENDA

• What is RA?• What is role of RA Professionals?• Why RA Required?• What is Regulation?• What is the difference between a Law and Regulation?• What is Guidance Document? How do I find current

guidance document?• What is Submission?

RA Profession

• USFDA, EU, HealthCanada, Japan, MHRA, MCC, TGA, CIS, Row etc..

• ASEAN Countries• ICH

Different Regulatory Bodies

• Current Scenario

Indian Pharmaceutical Industry

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WHAT IS RA?

Regulatory Affairs (RA) is a profession within the health care industry

namely, Pharmaceutical, Medical Device, Biologics, & Functional Food.

Regulatory Affairs is a profession which has developed from the desire of

governments to protect public health, by controlling the safety and

efficacy of products in areas including pharmaceuticals, veterinary

medicines, medical devices, pesticides, agrochemicals, cosmetics and

complementary medicines.

RA profession at its heart is all about Collecting, Analyzing and

Communicating the Risks and Benefits of health care products to

regulatory agencies and public all over the world.

RA can be defined as :

It means government affairs 4

ROLE OF RA PROFESSIONALS

RA as profession is broader than registration of products, they advise

companies both strategically and technically at the highest level. Their role

begins right from development of a product to making, marketing and post

marketing.

They advice at all stages both in terms of legal and technical requirements

and restrains help companies save a lot of time and money in developing the

product and marketing the same.

They have a major contribution in company’s success both commercially and

scientifically.

Their main role is to comply with Safety & Efficacy of the products as

per regulation laid down by the government.

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ROLE OF RA PROFESSIONALS CONT..

In an organization their prime responsibilities involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned.

They need to keep a track on ever changing legislation in all countries where the companies is looking to market their product.

They are responsible for the presentation of registration documents to regulatory agencies in India and importing countries and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned in country of origin as well as importing countries

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WHY RA??

The Pharmaceutical sector has been ever growing and with globalization the race to lead to be first is no more restricted by boundaries, companies need to dominate on a global level to stay on top. As a result of this competitiveness companies success lies in the “time taken” by the product to reach the market.

The companies responsible for the discovery, testing, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have special departments of Regulatory Affairs professionals

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WHY RA??

On an average it takes 15-20 years for a new drug development, and it cost around $800-1000 million. With such an expensive and time consuming activity

Companies cannot afford a single day delay in getting the product to the market. RA Professional play the very important role in getting the product to market, improper data reporting can delay evaluation of a positive marketing authorization. 

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RA CAREER LADDER

1-3 Years of Experience  - Officer to Executive level

3+ years – Exe; Sr. Exe; to Asst. Manager level

5+ years – Manager to Senior Manager level 10 + years – DGM, GM to HoD 15+ years -- Associate director Director Vice President President

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                                                                            Influence IT Literate Negotiate Work independently Persuade Accuracy Present Quality Communicate articulately Listen actively Interpret and consolidate data

Skills & Attributes required for making a good RA Skills   

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WHAT IS A REGULATION ??

Regulation is a binding instruction issued by an agency that tells how to interpret and comply with a law.

Regulations are must follows - i.e., if you fail to follow a regulation, and you have an inspection, the FDA inspector must write up your failure on a FDA Form 483, which is referred to as “Notice of Inspectional Observations.”

Failures to follow the regulations may end up in the “issued warning letter” section of the FDA website, which is not a good place to be.

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What is the difference between a Law and a Regulation?

They come from different branches of government and have different functions.

Laws come from legislative bodies, like the congress and set policy in broad terms.

Regulations come from the executive branch, and provide details on how the laws are to be implemented, or obeyed.

LAWS AND REGULATIONS

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Laws The Federal Food, Drug and Cosmetic Act

http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm

Regulations Code of Federal Regulations (CFR)

Part 21 of CFR – Food and Drugs http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr

&tpl=%2Findex.tpl

LAWS AND REGULATIONS

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GUIDANCE DOCUMENTS

Guidance documents represent the Agency's current thinking on a particular subject but is not binding. That means you should read it to determine what the agency’s view on a subject is or was at a particular time.

http://www.fda.gov/cder/guidance/index.htmGuidances are arranged by the Title, Subject, Type and Issue DateFor e.g. Subject Current Good Manufacturing Practices, Type: Draft/Final, Issue Date 10/11/2006

Newly added guidance document : Guidance Documents will be retained in this section of the page for a period of three months.  The most recently added appears first and they are in the order of the date they were issued.

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SUBMISSIONS

Submissions to Regulatory authorities are the ultimate ‘’product’’ created by a Regulatory Department, and they also, in terms of content, format, and quality, represent the company and product.

Regulatory submissions are complex documents in every sense from an editorial, scientific, and paper management perspective. At the same time, these documents represent the ideal opportunity for a regulatory professional to shine not just in quality of the final product, but in the way the document is brought together.

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Different Regulatory Bodies

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REGULATORY AFFAIRS FUNCTIONS DIVIDED MAINLY IN 2 PARTS

Local or Domestic

International or Import-Exports

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LOCAL (DOMESTIC MARKET)

Registration of products in our own

country India for selling to Local

market

Regulatory Authority :Food and Drug

Administration (FDA)

Reference : Drugs and cosmetic Act

1940, Rules 194518

LOCAL (DOMESTIC MARKET) NEW MOLECULE

Registration of new products in our own

country -India for selling to Local

market

Regulatory Authority :Drug Control

General

(DCGI),Delhi

Reference : Drugs and cosmetic Act

1940. Rules 1945.19

REGULATED MARKET- INTERNATIONAL

• US FDA: UNITED STATES FOOD AND DRUG ADMINISTRATION

• WHAT IS US FDA?– Food and Drug Administration is a public

health agency charged with protecting American consumers from taking Adulterated drugs and medicines .

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EU: EMA;European Medicines Agency

The European Medicines Agency (EMA) is a decentralized body of the European Union with headquarters in London.

Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

The EMA is responsible for the scientific evaluation of applications for European marketing authorization for medicinal products (centralized procedure).

REGULATED MARKET

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Health Canada Health Canada is the Federal department

responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances.What is Health Canada's Goal?

According to mission and vision, Health Canada's goal is for Canada to be among the countries with the healthiest people in the world.

Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

REGULATED MARKET

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Japan: MHLW(Ministry of Health, Labor, and Welfare )

Australia: Australian TGA

South Africa : MEDICINES CONTROL COUNCIL(MCC)

UK: Medicines and Healthcare products Regulatory Agency(MHRA)

WHO: World Health Organization

Brazil: ANVISA (National Health Surveillance Agency)

OTHER REGULATORY & SEMI-REGULATORY MARKET

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OTHER REGULATORY & SEMI-REGULATORY MARKET CIS: Russia,

India (CDSCO),

China (SFDA)

ASEAN (Association of South East Asian Nations) Singapore, Malaysia, Thailand, Philippines, Indonesia,

Laos, Cambodia, Vietnam , Brunei Darussalam, Myanmar Middle East Countries

RoW = Rest of the World

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Indian Pharmaceutical

Industry, Overview

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PHARMA INDUSTRY OF INDIA

80 years history in IndiaBengal Chemicals – 1930Patents Act in 1970 with amendment in 2005 regarding Intellectual Property Rights

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Indian capability to be the R&D services hub

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Global mkt size is approx $770-780 bn with low growth of 3-4% in 2009.

US sales is approx 14 times of India & China sales is approx 4 times of India

India’s share approx 2% in world pharma mkt.

GLOBAL

Market Share(approx)

Growth’09(approx)

North America 40% 2%

Europe 32% 2%

Japan 10% 3%

Latin America 6% 10%

Asia/Africa/Australia

12% 9.9%

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Revenue Rank 2008 Company Country MKT SHARE %

1 Pfizer (with Wyeth) U.S. 9.20

2 Johnson& Johnson U.S. 7.90

3 GSK UK 5.88

4 Bayer Germany 5.78

5 Hoffmann–La Roche Switzerland 5.22

6 Sanofi-Aventis France 5.17

7 Novartis Switzerland 5.15

8 AstraZeneca UK/Sweden 3.82

9 Abbott Laboratories U.S. 3.82

10 Merck & Co. U.S. 3.09

GLOBAL TOP 10 PHARMA COMPANIES

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INDIAN PHARMACEUTICAL EVOLUTION

Phase II

Government Control• Indian Patent Act –

1970• Drug prices capped• Local companies

begin to make an impact

Phase III Development Phase

• Process development

• Production infrastructure creation

• Export initiatives

Phase IV

Growth Phase

• Rapid expansion of domestic market

• International market development

• Research orientation

Phase V

Innovation and Research• New IP law• Discovery Research

1970 1980 1990 2000 2010

Phase I

Early Years• Market share

domination by foreign companies

• Relative absence of organized Indian companies

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India pharma Mkt size FY09 Rs 93881 ($19 bn) cr on the basis of sales, g=13%

India is the world’s 4th largest producer of pharmaceuticals by volume (accounting for around 8% of global production)

In value terms, production accounts for around 1.5% of the world total.

Indian company meets 95% of domestic sales Fragmented industry contributes 1.6% to GDP. 5,600 smaller licensed generics manufacturers 270 large R&D based pharmaceutical companies in India and their

share is around 70% India produces 22% of world generics Per capita consumption of drugs is very low $93 as compared to

$412(Japan), $222(Germany), $191(US) India among top 5 bulk drug producers in world Ranbaxy is 7th world’s largest generic manufacture

INDIA

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Location

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<200 manufacturing facilities approved by the US Food and Drug Administration (FDA)

1. India is regarded as having the edge over China in terms of: Qualified, English-speaking employees Fair protection of intellectual property rights supported by well-

developed judicial system.

2. Availability of skilled scientists/technicians/management personnel professionals at affordable cost.

3. Indian manufactures can produce drugs at 40% to 50% of the cost to the rest of the world. In some cases, this cost is as low as 90%.

4. Well developed chemistry R & D and manufacturing infrastructure with proven track record in advanced chemistry capabilities, design of high tech manufacturing facilities and regulatory compliance.

Strengths

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The NPPA (National Pharma Pricing Authority), sets prices of different drugs, which leads to lower profitability for the companies.

Indian pharma market is one of the least penetrated in the world: India accounts for almost 16% of the world population while the total size of industry is just 1-2% of the global pharma industry

Large no. of small players increases competition and reduces efficiency.

WEAKNESS

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The new patent product regime will bring with it new innovative drugs. This will increase the profitability of MNC pharma companies and will force domestic pharma companies to focus more on R&D

Large number of drugs going off-patent in Europe and in the US between 2005 to 2009 offers a big opportunity for the Indian companies to capture this market

Can become a global outsourcing hub for pharmaceutical products

New markets are opening

Aging of the world population, Growing incomes, Growing attention for health.

OPPORTUNITY

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HEALTHCARE INDUSTRY

Largest in the world with revenues over $3 trillion

Indian healthcare industry is worth about Rs.100,000 crores, accounting 5% of GDP

Fastest growing industry in India with CAGR of about 30%

Employs about 80 lakh people directly and indirectly – (IT industry employs only about 5 lakh)

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Mature pharmaceutical market: is expected to grow at 1% ~ 4% by 2013

Emerging pharmaceutical market: is expected to grow at 13% ~ 16% by 2013

High growth in generic segment as $123bn worth patent will expire by 2012 ($18.4bn benegit to India)

Pricing pressures and shrinking margins in the generics space and the increasing litigation instances in the US are compelling Indian companies to consider opportunities beyond US

OUTLOOK

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Steady shift of big pharma towards biotech  It is not only an API and formulation manufacturing

base, but also as an emerging hub for: Bio-technology Bioinformatics Contract research Clinical data management and Clinical trials

Growth in contract manufactiring & outsourcing of clinical trials, R&D, etc

OUTLOOK

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THANK YOU FOR YOUR ATTENTION!

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