India – A Critical Player in Global Clinical Research

1. India – A Critical Player in Global Clinical Research Dr. Anoop K. Agarwal

3. What is Outsourcing? • Transfer in full or part of the business activities to an outside entity. • This may include transfer of • Business Processes • Procedures • Responsibilities

5. WATERSHED YEAR 2005 Several major events occurred in 2005 making it watershed year. • Amendment to Schedule Y • Passage of IPR bill • Launch of CDSCO/ WHO- GCP training programmes. • First USFDA inspection of a global trial • Launch of Pharmacovigilance programme Ministry of Health & World Bank (6 centres)

6. Sponsor Investigator/ Site Patient IRB/IEC CRO SMO The Players in Clinical Research Regulators

7. India - Natural choice for CR services • Easy Access of patient recruitment • Well-trained medical community to global standards • Rapidly increasing awareness of GCP • English as a primary language of education and communication 100 million English speaking people (Largest outside US)

8. India - Natural choice for CR services • “Right” patient pool • Genetically & culturally diverse population • Treatment- naïve patients from multiethnic and multiracial backgrounds • Wide spectrum of diseases • Speed of patient recruitment • IPR / WTO, GATT on board • Cost effective operations • Presence of all Pharma majors

9. Facts & Figures • 40 million patients with cardiovascular diseases • 35 million with Type 2 diabetes • 10 million with psychiatric disorders • 2 million cases of cancer with 5,00,000 cases detected every year • Recruits for genetic studies

10. Facts & Figures • 600,000 practicing physicians • 14,000 hospitals • 7,00,000 beds • 17,000 medical graduates per year • Estimated no. of GCP trials conducted in 2010: 300 – 350 • Estimated no. of GCP trained PIs in 2010: 3000 - 3500

11. India – Favorable destination for Clinical Trials • CR industry will witness a business of Rs 10,000 crore creating a demand of 50,000 professionals in the next 5 yrs (McKinsey Report) • By 2012 up to 5% of global trials will take place outside USA & Western Europe • 2003-04, not > 20,000 patients participated in global trials, estimated that 20% of all patients in global trials could be from India

12. Projected Growth of Indian CR Industry

13. In preparation for this role… • ICMR improving facilities for CT & drug development research -10 yrs • Advanced centers in toxicology, clinical pharmacology, reproductive toxicology, CTs of medicinal plants & herbs . • No trial can be conducted in India without the approval of the DCGI • Ministry of Environment & Forests to approve genetically modified drugs, before DCGI

14. Widening Operations of CROs • No. of companies participating in CR is increasing • Large Indian pharma companies (Wockhardt, Sun Pharma, Lupin) working on NCEs. They have established their own CR units to conduct trials for their new molecules.

15. Widening Operations of CROs • Central / Referral Labs (Dr. Lal’s Lab, Metropolis Health Services, SRL Ranbaxy) are offering CT services • IT Companies (Cognizant, Eassar, HCL, IBM, Infosys & TCS), making investments in Data Management

16. CROs in India • > 250 CROs in India • Many pharma Cos. have their own CR Units conducting trials in 250-300 government & private hospitals. • E.g. Eli Lilly is conducting 17 global & local CTs in 65 locations

17. Clinical Research Market est McKinsey 2003 Assumption USD = Rs. 45

18. 3-Year Employment GrowthGlobal Pharmaceutical Industries Growth rate Source: PhRMA, CenterWatch Aanalysis

19. Staff Distribution in Indian CROs Source: Data on File

20. Key Qualifications Sought Source: CenterWatch Survey

21. Changes in Roles & Responsibilities During Past 3 Years N = 1771 Source: ACRP Outlook

22. Technologies & Clinical Trials Percent of Total Source: ACRP Outlook

23. Clinical Research-A Regulated Approach • ICH-GCP guidelines • Indian GCP • Schedule Y • Biomedical Ethics

24. New “Drug” - Indian Regulations • New device, Any intervention, Vaccine • A drug discovered abroad must be evaluated in India • Mandatory clinical trialse.g: HIV vaccine trials

25. Patent Act opens up vast business opportunities for Indian Companies • Positive transformation, will improve nation’s image in the world • Product patents • Boost R&D & will help to bring in foreign direct investment in the industry & contribute to healthcare • Major opportunity for MNC pharma by launching patented new products • “India will get an estimated revenue of US $10 billion thru’ the new patent regime”. • Dr. William Haseltine Head - MSAB

26. There is no second chance ! • Clinical research is not a BPO • Whether done in Delhi or Dallas, needs the same scientific scrutiny & ethics • No short cuts & half measures • Because…

28. Have you seen geese heading south for winter flying along in V formation? As each bird flaps its wings, it createsan uplift for the bird immediately following.By flying in V formation the whole flock addsat least 77% greater flying range, than if each bird flew on its own.

29. People who share a common direction and sense of community can get where they are going more quicklyand easily because they are travellingon the thrust of one another.

30. THANK YOU FOR YOUR KIND ATTENTION !