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Clinical Research in India

Dr Dilip Pawar MD, PhD, MCSEPI, DPBM, DCA, MASCPT(USA), MASPET(USA), FCP(USA), MBA Fellow Of American Society Of Clinical Pharmacology. Clinical Research in India. Drivers for changing perceptions. Director & Chief Scientific Advisor

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Clinical Research in India

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  1. Dr Dilip Pawar MD, PhD, MCSEPI, DPBM, DCA, MASCPT(USA), MASPET(USA), FCP(USA), MBA Fellow Of American Society Of Clinical Pharmacology Clinical Research in India Drivers for changing perceptions Director & Chief Scientific Advisor Institute of Clinical Research Education and Research Chief Executive Officer & Global Medical Director Drug Research Laboratory; MUMBAI, INDIA Dr Dilip Pawar

  2. WELCOME Dr Dilip Pawar

  3. Dr Dilip Pawar

  4. INDIA POPULATION URBAN 345 million Total 1 billion LIFE EXPECTANCY 68 YEARS INDIA EXPENDITURE ON HEALTH 6%OF GDP (1.2% Government Spend) URBAN LITERACY MALES 82% FEMALES 64% • Fourth largest economy in the world • Second fastest growing economy in the world • Projected GDP growth rate – 8% • Healthcare, Pharma, Biotech, IT, BPO, telecom are fastest growing sectors BIRTH RATE 27 per 1000 DEATH RATE 8 per 1000 INFANT MORTALITY 77 per 1000 Dr Dilip Pawar

  5. 119 120 100 80 72 62 58 60 Population >65 years (million) 42 Life Expectancy 32 40 20 0 1991 2025 1947 1980 1998 2020 Life Span Dr Dilip Pawar

  6. Population – Pronounced Rural to Urban Migration 1990(846 mn) 2000 (1000mn) 2025 (1400 mn) 218 mn 340 mn Prevalence of Illness 10% 22% • Rapid recruitment • (20-30% time advantage if studies are conducted in India – Ernst & Young) 15-60 years > 60 years URBAN POPULATION PREVALENCE OF ILLNESS Dr Dilip Pawar

  7. Changing Disease Patterns PROBLEMS OF REPRODUCTIVE HEALTH ACUTE INFECTIOUS DISEASES NUTRITIONAL DISEASES AIDS CHRONIC DISEASES LIFESTYLE-RELATED CARDIO-VASCULAR CANCERS DEGENERATIVE DISEASES DISEASES OF DEVELOPED WORLD DISEASES OF DEVELOPING COUNTRIES Epidemiologic Transition • Varied Disease Patterns • of developing and • developed world Dr Dilip Pawar

  8. Diseases and Patients Patient Population • 8 million Epileptics • 40 million Asthmatics • ~34 million Diabetics • 8-10 million HIV +ve • 3 million Cancer patients • > 2 million Cardiac deaths • 1.5 million Alzheimer patients • 1 million PD patients • 15% Hypertensive • 1% Schizophrenia patients Changing Disease Patterns Cardiovascular diseases • Degenerative neurological diseases • Diabetes • Cancer • Psychiatric illnesses • Gastro Intestinal Disorders • Infectious Diseases • Tropical diseases • India has diseases of the tropical world plus diseases of the developed countries Dr Dilip Pawar

  9. India – Ethnic Diversity Successive waves of visitors / invaders from the North – Dravidians driven southwards • Aryans from Central Asian steppes – 1500 BC (pale skinned and light-eyed) • Greeks (Yavanas) • Scythians • Parthians • Iranians (Persians) • Also Turks, Huns, Chinese, Ethopians Later Portuguese, Dutch, French, Moghuls (Mongols), English Today Caucasians 80% Dravidians 20% • Ethnic diversity • - majority Caucasian Dr Dilip Pawar

  10. The ‘Language’ Advantage Languages - 15 official languages Hindi - National language - Mother tongue of 30% of people English - Language for communication • Hospital Management • Source documents Teaching - Medical, Nursing & Pharmacy ENGLISH Communication with Regulatory Authorities Labeling of Medicines Dr Dilip Pawar

  11. Medical Practice in India • Multiple systems • Ayurveda • Other traditional Indian systems • Homeopathy • Western system; most widely practiced • Multiple systems of therapies Dr Dilip Pawar

  12. Pharmaceutical industry- Past • Clinical trials not mandatory till 1987 • Market of branded generics • No incentive for research • Innovator companies indifferent • Local industry not serious about clinical trials • No data exclusivity & patent protection Dr Dilip Pawar

  13. Medical profession • Did not question source of references • Did not demand local evidence • Patient care Ist priority • Not familiar with GCP needs • Did government funded research • Lack of appreciation of mutual needs Dr Dilip Pawar

  14. IRBs • Very few in number • Mainly reviewed animal studies & post graduate theses • Not US FDA compliant • No SOPs • Not much attention paid to ICF • Patient reimbursement not permitted Dr Dilip Pawar

  15. Why Not India until recently? • High importation duty (55%) • No provision in drug laws for global studies • No incentive for PI’s; academic institutions suspicious of clinicians • No Data Exclusivity • Long start up times Dr Dilip Pawar

  16. Changing perceptionsand a new environment • Drivers: • WTO • Need to globalize • Encourage Private public partnership • Intense lobbying by MNCs • Shift of focus of the indigenous industry; from process to product • Economic sense Dr Dilip Pawar

  17. OUTSOURCING OPPORTUNITIES - INDIA Bulk Drugs & Formulations Manufacturing Contract Marketing & Sales Contract R&D International Clinical Trials Medicinal Chemistry Outsourcing Opportunities - India Plant Machinery & Pharma Equipment Technical Services Herbals Neutraceuticals Primary Packaging Materials Bioinformatics Biostatistics Software Development Dr Dilip Pawar

  18. Why India Now? • No importation duty • Patent act amended; IPR in place • Data Exclusivity – • Export procedures simplified • Drug laws amended to permit global studies Dr Dilip Pawar

  19. Why India….. • GCP compliant IRB’s • Untapped patient population • English business language • GCP guidelines ICH compliant • Start up time reduced to 8-12 weeks • CAP certified central labs Dr Dilip Pawar

  20. Clinical Trial EnvironmentChange Drivers • Government and Regulatory Environment more conducive to clinical research • GCP guidelines introduced by ICMR and DGHS • Customs levies on clinical trial drug supplies eliminated Patent rules harmonised • Healthcare and Healthcare delivery improvements • Tertiary Hospital Infrastructure • GCP awareness • Healthcare Industry - Rs.100,000 crores • Growing demand by Middle Class Epidemiological Transition of Disease - Patterns changing • Good connectivity • Increasing use of IT and Internet • Transfer of ECGs and Imaging - now routine Health Insurance expansion - private participation emphasis on preventive care Good Courier Systems within India and to other countries Dr Dilip Pawar

  21. Skilled workforce with domain expertise High quality research Maintenance of time schedules Shortening time to market INDIA Therapeutic Expertise Technology support Dr Dilip Pawar

  22. Regulatory milestones • Mandatory clinical trials for the first applicant – 1987 • BE for subsequent applicants – 1987 • GCP committee formed – 1995 • Ethical guidelines - 2000 • GCP guidelines released – 2001 • Drug laws amended to permit simultaneous phase global trials - 2005 Dr Dilip Pawar

  23. Recipe for success in India • MOH approval easy if US IND/ EMEA application • Understand PI behavior – financial negotiations • Invest in training PIs, IRBs • Promote young, enthusiastic PIs Dr Dilip Pawar

  24. Nascent but Fast Growing - India’s Clinical Development Sector - • 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 • 207 sites FDA registered • 40,000 subjects participated in clinical trials to date (<0.02% of population) Dr Dilip Pawar

  25. Recent India Regulatory Reform makes Approvals Possible within 6 weeks. Dr Dilip Pawar

  26. Meticulously Following Prescribed Process Is Key. Regulatory & IRB Approval Process:India Consent Letter from PIs PI submits application to EC reply to queries Queries from EC Approvals from EC CDA signed, Site Selected, Release Protocol Contract/LOI executed All documents received Approvals from EC to PI Sponsor / CRO Internal review of dossier Regulatory Approval from DCGI DGFT Export License Application Regulatory dossier compilation Regulatory submission to DCGI Export License Obtained from DGFT Submission to DGFT Dr Dilip Pawar

  27. Don‘t set too ambitious deadlines Deadline is deadline ! Dr Dilip Pawar

  28. India — Gradually Building a Track Record Dr Dilip Pawar

  29. Clinical Trials Outsourced to India Dr Dilip Pawar

  30. India offers Cost Saving Potential Source: FastTrack Systems Global Cost Databases Dr Dilip Pawar

  31. Mckinsey Report Indian CR market will grow to US $1.5 billion in value by 2010. Dr Dilip Pawar

  32. Choose Good InvestigatorsNeed local understanding and global experience • India has experienced Investigators • Concern factors : • Using Investigator groups (some will be great, others might not) • When inexperienced, assess willingness and motivation to learn and then train and retrain Dr Dilip Pawar

  33. INDIA - Perceptions & Realities Dr Dilip Pawar

  34. Is Clinical Research is an attractive Option for INDIA Dr Dilip Pawar

  35. Key Messages India is well placed to provide solutions for contemporary and future clinical research • Can facilitate affordable drug research • Has required patient populations and qualified scientists and clinicians • Has the information technology competitive advantage • Has a regulatory framework which is moving towards regulatory harmonization • The socio-economic transformation in urban India understands contemporary GCP requirements • Rapid urbanisation and exposure to developed world facilitates cross-cultural understanding • Product patents from January 1, 2005 Dr Dilip Pawar

  36. The Opportunities ahead • In Clinical Research Opportunities are many • Not Only in India but also internationally • GRAB THE OPPORTUNITY……. Dr Dilip Pawar

  37. Thank You Dr Dilip Pawar

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