1. - REGULATORY AFFAIRS(RA) PROFESSION,
- DIFFERENT REGULATORY BODIES
AND
- INDIAN PHARMACEUTICAL INDUSTRY,
OVERVIEW
RAJASHRI OJHA
MD, RAAJ GPRAC

2. 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.
2

3. AGENDA
RA Profession
• 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?
Different Regulatory Bodies
• USFDA, EU, HealthCanada, Japan, MHRA, MCC, TGA, CIS, Row
etc..
• ASEAN Countries
• ICH
Indian Pharmaceutical Industry
• Current Scenario
3

4. 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

5. 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.
5

6. 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
6
6

7. 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
7

8. 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.
8

9. 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
9

10. Skills & Attributes required for
making a good RA Skills
 Influence IT Literate
 Negotiate Work independently
 Persuade Accuracy
 Present Quality
 Communicate articulately
 Listen actively
 Interpret and consolidate data
10

11. 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.
11

12. LAWS AND REGULATIONS
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.
12

13. LAWS AND REGULATIONS
 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
13

14. 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.htm
Guidances are arranged by the Title, Subject, Type and Issue Date
For 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.
14

15. 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.
15

16. Different Regulatory Bodies
16

17. REGULATORY AFFAIRS FUNCTIONS
DIVIDED MAINLY IN 2 PARTS
Local or Domestic
International or Import-
Exports
17

18. 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 1945
18

19. 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

20. 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 .
20

21. REGULATED MARKET
 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).
21

22. REGULATED MARKET
 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.
22

23. OTHER REGULATORY & SEMI-
REGULATORY MARKET
 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)
23

24. 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
24
24

25. Indian Pharmaceutical
Industry, Overview
25
25

26. PHARMA INDUSTRY OF INDIA
80 years history in India
Bengal Chemicals – 1930
Patents Act in 1970 with
amendment in 2005 regarding
Intellectual Property Rights
26

27. Indian capability to be the R&D services hub
27
27

28. GLOBAL
 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.
Market Growth’09(appro
Share(approx) x)
North America 40% 2%
Europe 32% 2%
Japan 10% 3%
Latin America 6% 10%
Asia/Africa/Australia 12% 9.9%
28

29. GLOBAL TOP 10 PHARMA COMPANIES
Revenue Rank
Company Country MKT SHARE %
2008
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
29

30. INDIAN PHARMACEUTICAL EVOLUTION
Phase V
Phase IV Innovation and Research
Growth Phase •New IP law
Phase III
Development Phase •Rapid expansion of •Discovery Research
domestic market
•Process
Phase II development •International market
Government Control development
•Production
Phase I •Indian Patent Act – infrastructure •Research orientation
Early Years 1970 creation
•Market share •Drug prices capped •Export initiatives
domination by •Local companies begin
foreign companies to make an impact
•Relative absence
of organized Indian
companies
1970 1980 1990 2000 2010
30

31. INDIA
 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
31

32. <200 manufacturing facilities approved by the US
Food and Drug Administration (FDA)
32

33. Strengths
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.
33

34. WEAKNESS
 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.
34

35. OPPORTUNITY
 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.
35

36. 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)
36

37. OUTLOOK
 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
37

38. OUTLOOK
 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
38

39. THANK YOU
FOR YOUR ATTENTION!
39