- REGULATORY AFFAIRS(RA) PROFESSION,- DIFFERENT REGULATORY BODIES  AND- INDIAN   PHARMACEUTICAL INDUSTRY,OVERVIEW         ...
DISCLAIMER Contents   of this presentation are the presenters    personal views and do not necessarily represent    any c...
AGENDA RA Profession • What is RA? • What is role of RA Professionals? • Why RA Required? • What is Regulation? • What is ...
WHAT IS RA?    Regulatory Affairs (RA) is a profession within the health care industry     namely, Pharmaceutical, Medica...
ROLE OF RA PROFESSIONALS   RA as profession is broader than registration of products, they advise    companies both strat...
ROLE OF RA PROFESSIONALS CONT..   In an organization their prime responsibilities involves    preparation and presentatio...
WHY RA??   The Pharmaceutical sector has been ever growing and with    globalization the race to lead to be first is no m...
WHY RA??   On an average it takes 15-20 years for a new drug    development, and it cost around $800-1000 million.    Wit...
RA CAREER LADDER   1-3 Years of Experience - Officer to Executive level   3+ years – Exe; Sr. Exe; to Asst. Manager leve...
Skills & Attributes required formaking a good RA Skills   Influence IT Literate   Negotiate Work independently   Persua...
WHAT IS A REGULATION ?? Regulation is a binding instruction issued by an agency that tells howto interpret and comply wit...
LAWS AND REGULATIONSWhat is the difference between a Law and a Regulation?They come from different branches of government ...
LAWS AND REGULATIONS   Laws       The Federal Food, Drug and Cosmetic Act           http://www.fda.gov/opacom/laws/fdca...
GUIDANCE DOCUMENTSGuidance documents represent the Agencys current thinking on aparticular subject but is not binding. Tha...
SUBMISSIONSSubmissions to Regulatory authorities are the ultimate„‟product‟‟ created by a Regulatory Department, and theya...
Different Regulatory Bodies                              16
REGULATORY AFFAIRS FUNCTIONSDIVIDED MAINLY IN 2 PARTSLocal   or DomesticInternational   or Import- Exports              ...
LOCAL (DOMESTIC MARKET) Registration   of products in our own country India for selling to Local market Regulatory   Aut...
LOCAL (DOMESTIC MARKET) NEW MOLECULE Registration   of new products in our own country -India for selling to Local market...
REGULATED MARKET- INTERNATIONAL• US FDA: UNITED STATES FOOD AND  DRUG ADMINISTRATION• WHAT IS US FDA? – Food and Drug Admi...
REGULATED MARKET EU:      EMA;European Medicines Agency   The European Medicines Agency (EMA) is a decentralized body of...
REGULATED MARKET Health Canada Health Canada is the Federal department responsible for  helping Canadians maintain and i...
OTHER REGULATORY & SEMI-    REGULATORY MARKET   Japan: MHLW(Ministry of Health, Labor, and Welfare )   Australia: Austra...
OTHER REGULATORY & SEMI-REGULATORY MARKET   CIS: Russia,   India (CDSCO),   China (SFDA)   ASEAN (Association of South...
Indian Pharmaceutical  Industry, Overview                   25                   25
PHARMA INDUSTRY OF INDIA80  years history in IndiaBengal Chemicals – 1930Patents Act in 1970 with amendment in 2005 reg...
Indian capability to be the R&D services hub                                                27                            ...
GLOBAL   Global mkt size is approx $770-780 bn with low growth of 3-    4% in 2009.   US sales is approx 14 times of Ind...
GLOBAL TOP 10 PHARMA COMPANIESRevenue Rank                          Company     Country      MKT SHARE %2008      1       ...
INDIAN PHARMACEUTICAL EVOLUTION                                                                                           ...
INDIA   India pharma Mkt size FY09 Rs 93881 ($19 bn) cr on the basis of sales,    g=13%   India is the world‟s 4th large...
<200 manufacturing facilities approved by the USFood and Drug Administration (FDA)                                        ...
Strengths1.       India is regarded as having the edge over China in terms of:          Qualified, English-speaking emplo...
WEAKNESS   The NPPA (National Pharma Pricing Authority),    sets prices of different drugs, which leads to lower    profi...
OPPORTUNITY   The new patent product regime will bring with it new innovative    drugs. This will increase the profitabil...
HEALTHCARE INDUSTRY   Largest in the world with revenues over $3 trillion   Indian healthcare industry is worth         ...
OUTLOOK   Mature pharmaceutical market: is expected to grow at    1% ~ 4% by 2013   Emerging pharmaceutical market: is e...
OUTLOOK        Steady shift of big pharma towards biotech        It is not only an API and formulation manufacturing base...
THANK YOUFOR YOUR ATTENTION!                      39
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  • This is the famous disclaimer.
  • I have divided my presentation into three parts – Part I – RA Profession Part II – Different Regulatory Bodies Part III – Indian Pharmaceutical Industry
  • Ra profession diff ra bodies indian pharma scenario_31st oct-2010 - copy

    1. 1. - REGULATORY AFFAIRS(RA) PROFESSION,- DIFFERENT REGULATORY BODIES AND- INDIAN PHARMACEUTICAL INDUSTRY,OVERVIEW RAJASHRI OJHA MD, RAAJ GPRAC
    2. 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. 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. 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. 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. 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. 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. 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. 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. 10. Skills & Attributes required formaking a good RA Skills Influence IT Literate Negotiate Work independently Persuade Accuracy Present Quality Communicate articulately Listen actively Interpret and consolidate data 10
    11. 11. WHAT IS A REGULATION ?? Regulation is a binding instruction issued by an agency that tells howto interpret and comply with a law. Regulations are must follows - i.e., if you fail to follow a regulation, andyou have an inspection, the FDA inspector must write up your failure ona FDA Form 483, which is referred to as “Notice of InspectionalObservations.” Failures to follow the regulations may end up in the “issued warningletter” section of the FDA website, which is not a good place to be. 11
    12. 12. LAWS AND REGULATIONSWhat is the difference between a Law and a Regulation?They come from different branches of government and havedifferent 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. 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. 14. GUIDANCE DOCUMENTSGuidance documents represent the Agencys current thinking on aparticular subject but is not binding. That means you should read it todetermine what the agency‟s view on a subject is or was at a particulartime.  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 10/11/2006Newly added guidance document : Guidance Documents will be retainedin this section of the page for a period of three months. The mostrecently added appears first and they are in the order of the date theywere issued. 14
    15. 15. SUBMISSIONSSubmissions to Regulatory authorities are the ultimate„‟product‟‟ created by a Regulatory Department, and theyalso, in terms of content, format, and quality, represent thecompany and product.Regulatory submissions are complex documents in everysense from an editorial, scientific, and paper managementperspective. At the same time, these documents representthe ideal opportunity for a regulatory professional to shinenot just in quality of the final product, but in the way thedocument is brought together. 15
    16. 16. Different Regulatory Bodies 16
    17. 17. REGULATORY AFFAIRS FUNCTIONSDIVIDED MAINLY IN 2 PARTSLocal or DomesticInternational or Import- Exports 17
    18. 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. 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. 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. 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. 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 Canadas Goal? According to mission and vision, Health Canadas 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. 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. 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. 25. Indian Pharmaceutical Industry, Overview 25 25
    26. 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. 27. Indian capability to be the R&D services hub 27 27
    28. 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. 29. GLOBAL TOP 10 PHARMA COMPANIESRevenue 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. 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 •ProductionPhase I •Indian Patent Act – infrastructure •Research orientationEarly Years 1970 creation•Market share •Drug prices capped •Export initiativesdomination by •Local companies beginforeign companies to make an impact•Relative absenceof organized Indiancompanies 1970 1980 1990 2000 2010 30
    31. 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. 32. <200 manufacturing facilities approved by the USFood and Drug Administration (FDA) 32
    33. 33. Strengths1. 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. 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. 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. 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. 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. 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. 39. THANK YOUFOR YOUR ATTENTION! 39

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