INDIA AS AN EMERGING DESTINATION FOR CLINICAL TRIALS

INDIA AS AN EMERGING DESTINATION FOR CLINICAL TRIALS PowerPoint PPT Presentation


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REQUIREMENTS FOR GLOBAL RESEARCH . Infrastructure Regulatory Environment Patient Pool-Genetic DiversityI.P Protection Investigator AvailabilityBioethics Regulation Cost Advantage. CDSCO. INFRASTRUCTURE AVAILABLE . Over 200 Medical Colleges Over 22,000 graduates per year 15,622 hosp., 903,952 hosp.beds >75% in urban area 14000 diagnostic labs 700,000 scientists and engineering graduates / year World class medical / lab facilities at secondary / tertiary care centers Skilled c32645

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INDIA AS AN EMERGING DESTINATION FOR CLINICAL TRIALS

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7. DRUG DISCOVERY & DEVELOPMENT

8. LANDMARK YEAR: 2005 CLINICAL RESEARCH

9. 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.

10. TREATMENT NAIVE PATIENTS (DISEASE WISE) 45 million asthmatics 30 million diabetics 18 million hypertensive 13 million hepatitis C 10 million or more HIV patients

11. CLINICAL DATA MANAGEMENT ADVANTAGE INDIA

12. Cost of Clinical trials in USA vis-à-vis in India

13. CROS CONTRIBUTING FOR OUTSOURCING CLINICAL RESEARCH

16. THE PERCENTAGE OF CRO REVENUES FROM BIOTECH FIRMS IS RAPIDLY INCREASING

17. PHASE IV TRIAL MARKET INCREASING DUE TO SAFETY CONCERNS

18. INDIA BUILDING A TRACK RECORD Drug Company Compound Researched Indication US Launch Canagene Hepagam Hepatitis B Jan 06 Eli Lilly Alimta Cancer Feb-04 Eli Lilly Cialis Erectile dysfunction Nov-3 Jannsen Risperidal Psychosis Oct-03 Wyeth Flumist Influenza May-03 Alcon Vigamox Ophthalmic Infections Jan-03 Glaxo Lamictal Epilepsy Jan-03 Novrtis Zelcorm Irritable Bowel Syndrome Jul-02 Pfizer Vfend Fungal Infection May-02 Eli Lilly Xigris Septicemia Nov-01 Santen Quixin Ophthalmic Infections Oct-00

19. GLOBAL CLINICAL TRIALS COMPARISON INDIA : CHINA

20. Clinical Trials from India (www.clinicaltrials.gov.: 15Apr08)

21. CLINICAL TRIAL ACTIVITIES IN ASIA ALL STUDIES

24. RECENT INITIATIVES BY CDSCO FOR PROMOTING ETHICAL CLINICAL RESEARCH Review of proposal- Time lines Phase O, Phase-1 and Micro dosing trial-initiatives Registration CRO’s Registration of Clinical Trials

25. Establish Single Window clearance for approvals Fix timelines for each application (2-6 Weeks) New Drug application status on the web – Update fortnightly Subject Experts-reviewers – Internal / External Staff & Infrastructure at one site Training PRIORITIES SET BY CDSCO

28. “India’s business and regulatory climates have undergone dramatic change in the past 18 months through passage of a patent bill, regulations updated to harmonize with TRIPs and international standards, and plans for a more US FDA-like regulatory body.” CenterWatch (July 2007) CLINICAL TRIALS IN INDIA

29. CHALLENGES AHEAD Improvement in Regulatory Framework Expanding Investigators Pool Moving from Metro to Mini Cities Scale up Competence Building Making India a Vibrant Destination

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