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Clinical Trials New Horizon – India Dr. Surinder Singh Drugs Controller General (India) E-mail: dci@nb.nic.in/ www cds

Clinical Trials New Horizon – India Dr. Surinder Singh Drugs Controller General (India) E-mail: dci@nb.nic.in/ www cdsco.nic.in. PRIORITIES. Establish Single Window clearance for approvals Fix timelines for each application (2-6 Weeks)

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Clinical Trials New Horizon – India Dr. Surinder Singh Drugs Controller General (India) E-mail: dci@nb.nic.in/ www cds

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  1. Clinical Trials New Horizon – India Dr. Surinder Singh Drugs Controller General (India) E-mail: dci@nb.nic.in/ www cdsco.nic.in

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

  3. Clinical Trials in India “Broad regulatory reforms, a sizable and growing pharmaceutical market, combined with highly attractive professional and patient populations, make India a compelling new region for conducting global clinical trials.” CenterWatch (Aug 2003) “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)

  4. The journey towards becoming an attractive new destination for clinical research Acceleration Attraction 1992 1996 2000 2004 2008 2012 61 Companies Acceptance 100 CROs 80 Hospitals 150 Investigators registered with US FDA

  5. Overall Country attractiveness index : India 2ndmost preferred destination China 6.10 5.58 India Russia 5.55 Brazil 5.26 5.00 Czec. Rep. 5.00 U.K. Argentina 4.90 Poland 4.84 Hungary 4.81 Germany 4.69 South Africa 4.56 Taiwan 4.46 Israel 4.28 Scale : 1-10 Singapore 4.27 Ireland 3.86 United USA 6.88 Patient pool Cost efficiency Regulatory conditions Relevant expertise Infrastructure & environment Notes: Higher scores indicate higher levels of attractiveness. The 15 countries analyzed were selected based on size, diversity & geographical distribution. CDSCO A.T.Keamey

  6. Indian Clinical Research Market • The Indian pharmaceutical industry is growing at an annual rate of 11 % while the clinical research industry is growing an annual rate of whopping 84 %. • *McKinsey estimated that clinical research in the country would be a $1bn ($1000m or €800,000m) industry by 2010 whereas Ernest & Young indicates around $1.5 -2 billion by 2010. • **Market value for clinical trials outsourced to India is estimated at around $300 million, having increased by 65% in 2006, it is expected to touch $1.5-2 billion by 2010. By 2010, the industry will spend USD 300M+ on clinical trials in India *Goldman Sachs, Centre watch, Goldman Sachs and McKinsey (2008) **Report of the High Level Group on Services Sector, pg. 105, Government of India, Planning Commission, New Delhi, March 2008.

  7. Growth of Indian Clinical Trial Industry As per FICCI - Ernst & Young Survey Report 2008, India can attract between 5 - 10% of the global contract research outsourced market (all services including chemistry, toxicology and clinical research) over next 5 years.

  8. Clinical Trials from India(www.clinicaltrials.gov; 15 Apr08)

  9. CLINICAL TRIAL ACTIVITIES IN ASIA ALL STUDIES CDSCO www.clinicaltrials.gov-Snapshot: 7 Feb 2008 Countries with more than 100 studies listed

  10. India : Resource advantages • Large No. of specialists in different therapy segments • Medical Training In English • 600,000 Eng. Speaking physicians • PG training from Europe/US • Treatment Protocols in line with West • Large no. of ICH/GCP compliant Investigators / sites Investigators • Large, Diverse, therapy-naïve • Advantage of having 6 out of 7 genetic varieties • Large pt. pool in acute/chronic disease segment • Increasing no. of pts in life style disorders segment, HIV, Oncology Patient population

  11. Composition of R&D Budget of Pharmaceutical Companies Sr. No. Item % 1. Clinical Development 38.2 1a. Phase I 18% 1b Phase II & II 67% 1c Phase IV 16% (Break of Clinical Development %) 2. Discovery 26.9 3. Non Clinical 19.5 4. Regulatory 4.1 5. Others 11.5 Total 100% Source : ZinnovAnnalysis

  12. India : Resource advantages • 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 computer savvy biomedical work force Clin. Res. Infrastructure • Highly developed IT / ITES • Motivated & committed personnel IT Support Connectivity • High quality digital connectivity • Excellent air/surface transport facilities across country

  13. In conclusion…. Large Scanty Patient pool India Patient Recruitment rate Highest rate Lowest rate India Low High Speed India Least expensive Most expensive Cost India Facility & Investigator pool Highest pool Smallest pool India Industry trial experience Most experience Least experience India Most Conducive Regulatory Environment Least Conducive India Unacceptable to EU/US Acceptable to EU/US Quality of data India

  14. GLP APPROVED FACILITIES IN INDIA Facility Type No. Of Facilities Toxicity studies11 Mutagenicity studies9 Analytical and clinical chemistry testing 8 Physical-chemical testing 7 Environmental toxicity studies on aquatic & terrestrial organisms4 Residue studies 3 Studies on behaviour in water, soil and air; bioaccumulation 2 Studies on effects on mesocosms and natural ecosystems 1 Studies on natural enemies and predators 1 Safety Pharmacology and Pharmacokinetic Studies 1 Others (drug metabolism & pharmacokinetics [DMPK] and tissue distribution studies) 1 TOTAL 48

  15. US FDA NEW DRUGS APPLICATION DATA GENERATED FROM INDIA

  16. Government’s facilitating initiatives Fiscal Incentives • No import duty on clinical trial supplies (2003) • Exemption from registration requirements for clinical trial supplies (2003) • Export of clinical trial related biological specimens allowed, based on protocol approval (2005) • Exemption from Service Tax on new Drug testing (2007)

  17. Timelines for Regulatory Approvals Regulatory Approval

  18. Clinical Proposal Review Timelines D A Y S YEARS

  19. Number of applications processed during year 2005-2008

  20. Permission of protocol amendment , TEST LISENCE, Ct noc issued (YEAR :2008)

  21. Global Clinical Trials Permitted

  22. Registration of CRO’s Draft guidelines and requirements for registration of such organisation in the country have been developed. Proposed to be incorporated as new schedule Y1 to drugs and cosmetics rules,1945. Also proposed to incorporate Rule 122DAB for the proposed new schedule Y1. Said guidelines and Rule will be placed before forthcoming DTAB meeting scheduled to be held on 23/02/09 for consideration.

  23. REGISTRATION OF CLINICAL TRIALS At the time of granting permission for conducting clinical trial, applicants are now being advised to get clinical trial registered at ICMR’s web based clinical trial registry (www.ctri.in) and will be made mandatory

  24. GOALS FOR CLINICAL TRIALS REGULATION Short Term Goals Year - 2008 • Training for Clinical Trials site inspections • Robust review process for clinical trial proposals • Meeting timelines

  25. Medium Term Goals Year - 2009 • Registration of CROs • Inspection of Clinical trial sites in the country. • Guidelines for Registration of Ethics Committees/IRBs • Mandatory registration of clinical trials in centralized clinical trial registry

  26. Long Term Goals Year 2010 – 2015 • Ensuring penal provisions for fraud & misconduct in clinical research • Registration of Clinical trial sites • Registration of Ethics Committees/IRBs • Creation of environment for Phase 0 and micro dosing studies.

  27. International Collaborations • WHO • USA FDA • Health Canada • ANVISA, Brazil • South Africa CDSCO

  28. Training With USFDA : • Training on GCP and clinical Research Inspection • workshops on clinical trial oversight for vaccines • advanced workshops on GCP / Clinical Research Inspection • workshops on Pharmacovigilance • workshops on medical devices • 1 Technical Officer was nominated for training in medical devices at USFDA • 1 ADC and 1 Technical officer nominated for training at CDER and CBER (USFDA) CDSCO

  29. Training & WorkSHOPrelated to Clinical Trials Following are the workshops & Trainings organized in association with WHO WR office,New Delhi: Clinical Trials Inspection Regulatory Affairs HR Development Pharmacovigilance CDSCO

  30. IT Enabled services-Drug Regulatory System • LAN / WAN connectivity of CDSCO campus • Digitalization of records • Linking of all CDSCO Zonal/Sub Zonal, Port offices. • Office Automatization Vision : Paperless CDSCO office CDSCO

  31. India : Your Gateway to Clin. Res. and R&D CDSCO

  32. We Indian believe in : “Let us not follow a path set by others Let us set a path for others to follow”

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