Clinical Research In India

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Tutorial Material for Presentation at DIA Annual Conference

Published in: Business, Health & Medicine

Clinical Research In India

  1. 1. New Delhi Clinical Research in India DIA – Training Course Mumbai Surya Chitra, Savio Group Inc Sunder Venkatraman, Asian Clinical Trials Bangalore Chennai 1
  2. 2. Outline About India Global Scenario Domestic market Industry drivers for Change Clinical Research In India Going Forward 2
  3. 3. India Fact File Multicultural , multi-linguistic and pluralistic country Second most culturally, linguistically and genetically diverse geographical entity after the African continent 70% of population is rural Literacy rate is 64.8% (53.7% for females and 75.3% for males). Independence in 1947 Second Largest democracy Seventh largest Country Most populous democracy in World 3
  4. 4. Indian Economy Today… Optimistic Scenario Fastest growing economy in the world India's GDP in terms of USD EX exchange transfer factor for 2007-08 is US$ 1.089 Trillion . Purchasing power parity (PPP), India has the world's third largest GDP at US$4.726 trillion. World's second largest labor force GDP growth rate of 8-9% in 2006-07 Liberalization in 1991 Multiparty democracy Free enterprise Vibrant media 4
  5. 5. Government Support ……. Government would provide necessary environment to help the country emerge as an attractive destination for outsourcing in drug discovery and clinical research Indian Finance Minister- P. Chidambaram Budget 2005-2006 5
  6. 6. Big Pharma Partnering In India Collaborative Research Contract Research Big Pharma Contract Manufacturing Distribution in India 6
  7. 7. Global Industry Scenario Network Pharma …..is the emerging model for global pharma industry 7
  8. 8. Global CRO Market Clinical trials in India is growing at a 60% AAGR Crossed USD 100 million in 2004. By 2010, the industry will spend USD 300M+ on clinical trials in India. 25 20 15 G lo b a l C R O m a r k e t in m ilio n 10 5 0 2006 2007 2008 2009 2010 Source :Frost and Sullivan 2003 8
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  10. 10. Global Growth Of Indian Market Outsourced Clinical Drug trials growth more than 170% Annual Revenues USD 120 M with 40% growth in past year 240 international studies recruiting subjects = 1.2% of the total studies worldwide 66% of international clinical trials are Phase III 40,000 subjects participated in clinical trials to date (<0.02% of population) 10
  11. 11. Indian Pharma Market: Low Value, Large Volume & Growth Potential Pharmaceutical / Biotech Sales in USD Billion India’s pharmaceutical 5 market ranks 4th in unit sales but 15th in value Growth 8% per year 4 Indian companies control 70% of the market & 3 multinationals the rest Fragmented market: leading company has a 7% market 2 share Biotech sales growth driven 1 by exports and vaccines, accounts for 2% of global market, 25% growth expected 0 over next 5 yrs compared to 1996 1998 2000 2002 2004 2006 15% market average 11
  12. 12. India’s Record 12
  13. 13. Pressurized Pharma industry …. Shortage of new drug in the pipeline Imminent Expiry of the patents on numerous blockbusters Intense competition among the pharmaceutical companies Stringent FDA and Regulatory Authority demands Reduction of marketing opportunity for innovators Pressures from Government Agencies for reduction of cost Increase in scientific knowledgebase and understanding for innovators 13
  14. 14. Changing India Increasing Education Changing lifestyle and aspirations Increasing Income- Changing demands and expectations Growing middle class Changing disease pattern Improving Healthcare 14
  15. 15. Changing Disease Patterns CNS CVS Problems of Reproductive Cancers Health Diabetes Acute Infectious Disease Others Nutritional Disease 15
  16. 16. Scope of Outsourcing to India Function Current Expertise Evolving Towards Program Design & Mgmt CR Ops Monitoring Full Statistical Management Data Ops Data Mgmt CP Ops Bioequivalence Phase I, Pharmacodynamics 16
  17. 17. Can India deliver on these? Increase commitment to uphold & enforce Data privacy International Property Protection as per international standards Regulatory approval process more streamlined Regulatory Study start up 12 wks from regulatory submission Government initiatives to strengthen ethics committee approval process Ethics Recognition of critical importance of informed consent Overall benefit to healthcare delivery in India 17
  18. 18. Can India deliver on these? Data of Pivotal studies accepted by FDA/ EMEA Quality Successful FDA audit in 2005 – no findings Investment in education & training: state & private Logistics More labs been setup Training Investment in education & training: state & private 18
  19. 19. India’s Strength Heterogeneous Population >1.2 1.5 lac sub-centres, Different Ethnic Groups 23,000 primary health centres, billon 4000 community health centres Endogamous tribal population 1,600 urban family welfare centres (conserved gene pool) New Delhi 3 million graduates, 700,000 post – graduates Mumbai 200 Medical Colleges 1500 PhDs in biosciences and Research Institutes engineering Bangalore Universities Employment for 15,000 scientists Chennai 11,500 hospitals and 14,000 diagnostic exists in Indian Biotech itself. laboratories 5000 harnessed 50 R&D labs in the public sector & 200 Potential for hiring 50,000 in Govt. Sector professionals over 5 years in the Contract Research 19
  20. 20. India’s Strength Strong IT prowess English is main language of communication New Delhi Mumbai Increased investment Net connectivity Bangalore Beneficial tax environment Chennai 20
  21. 21. Growth Of Collaborative Models Within the local industry CR has evolved as an integral part of the product development cycle The top 20 Indian companies now have active NCE development programs that require clinical development capabilities Several have set up collaborative projects with global big pharmaceutical companies Collaboration along all segments of the discovery & development cycle is emerging as a viable model Collaborating partners share costs of research as well as revenues and/or market geographies Other therapeutic area and segment specific models may emerge in future 21
  22. 22. Relative Overheads Cost In CR Cost of CR Operations 400 $ '000 per m onitoring resource 300 200 100 0 Lithuania Taiwan Canada Russia India B razil UK China Source: Personal Communications 22
  23. 23. In 0 1 2 3 4 5 6 7 8 d C ia M hi n P h a la a il i y s i p S i pi n a ng e s a T h po r C ai e ze la ch n d R ep C. h C i le an ad Ba ra M z il ex P o ic o H la n u C ng d os a r t y A aR rg i c en a V i t i na et na Rm u A ss S o us i a ut t r a h li a A fri c N ew I s a Z e ra e al Offshore Attractive Index P o la n rtu d ga Sp l I re a in la n Tu d rk ey 23
  24. 24. Clinical Research Staff Costs Are Lower 2001 Annual India, 2005 Position Percent Gross Salary* Annual Gross US$ Salary US$ 52,000 5,555 11% CRA 68,000 11% 7,750 Senior CRA 74,000 24% 17,500 Project Manager 73,000 24% 17,500 Regulatory 24
  25. 25. Subject & Recruitment Rates & Quality Average patient recruitment rates in 1080 clinical trials 3-4 times faster than traditional geographies in the west Quality of data is equivalent to those in 19 traditional locations Europe India 25
  26. 26. Vendor & Service Providers Central Labs Ethical Oversight for fee Drug packaging and distribution services Data Management Document translators Document Archiving facilities Specialist Clinical trial material suppliers Education and training facilities 26
  27. 27. Vendor & Service Providers Increasing number of knowledgeable vendors who are sensitive to clinical research business At par with international providers Accreditation and certification to prove their competency and commitment 27
  28. 28. Sites Types of Diseases Disease disorder of Disease Disorder of Diseases of Tropics Primitive economy Developed Economy Cardiovascular, Acute infection, Malaria, Tuberculosis, Gastrointestinal, Nutritional–related, Leishmaniasis Cancer, CNS, Health-Related Diabetes, etc. Types of Hospitals Public funded Hospitals Tertiary Hospitals Private Hospitals e.g. Government Hospitals e.g. Super specialized & Hospitals Private Clinics 28
  29. 29. Sites Choice of sites is critical Patient load Research orientation, training and experience of investigators Infrastructure: Staffing, Documentation, Laboratory, Hardware, Equipment, IEC/IRBs 29
  30. 30. Ethics and Related issues In India ICMR is the main body for formulation, coordination and promotion of biomedical research Setting of FER-CAP Schedule Y authorizes use of Central Ethics Committee which do have their own Ethics Committee Requirement of SOP for each Ethics Committee Currently working on improvement of Ethics Committee training Planning Accreditation Of Ethics Committee 30
  31. 31. Regulatory Issues Regulatory Body – Office of the Drugs Controller General India (DCGI) Directorate General of Health Services (DGHS) Schedule Y updated Review of submission – average 3 months GCP guidelines issued Ethics Committee approvals concurrent Import License for clinical trial drug supplies to DCGI – concurrent with main submission Export License for blood and blood products to DGFT after clinical trial approval Genetically engineered drugs (live organisms in end product) to GEAC Categorization of Global trial to help streamline approval 31
  32. 32. Data Privacy Legislation to enforce protection of product patents in accordance with WTO standards passed in January 2005 Tension between wide access to low cost medicines and aspiration to develop an international life science sector India to adopt a patent regime favorable to inexpensive access to medicines by prohibiting patent “evergreening” - in spirit with WTO India has demonstrated an effective legal process for patent grant, review & challenge 32
  33. 33. Concerns & Challenges- I Regulatory Need for regulatory liaison staff Face to face meeting with officials helps Lead times longer for local NCEs Additional approvals required for exports 33
  34. 34. Concerns & Challenges- II Site-specific Orientation of investigators and site staff Source documentation at trial sites Ethics committee working practices ICH E6 compliance Operating procedures Workload and staffing 34
  35. 35. Concerns & Challenges- III People-related Staff turnover at sponsor and sites Training and experience of CR professionals Salary inflation and quality of staffing Rapid growth of training facilities Low threshold for admission Variable quality of training Unreliable output and need for re-training 35
  36. 36. Concerns & Challenges- IV Medical & therapeutic Medical practice and standard of care Use of indigenous medicines Resistance levels to anti-infectives Strain-specific variations in microbes 36
  37. 37. Glo-Local CRO Advantage Local application of Global process and systems Knowledge of local requirements and constrain Better management of vendor and service provider Understand local and country specific challenges 37
  38. 38. Going Forward….. Plans to establish Central Drug Authority on the lines of FDA Need to develop capabilities remains improved training and uniform Need for Regulatory guidelines for remaining area and effective implementation of those guidelines Data privacy laws to be diligently enforced to win confidence Site infrastructure to be developed in perirural areas to bridge urban rural of physician and subjects Improve and ongoing investigator training 38
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