1. 1 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Review of work carried out by Subcommittee on Vaccines and Drug Development By Professor Ranjit Roy Chaudhury and Professor N. K. Ganguly WHO-SEA ACHR Bangkok 11 October 2011

2. 2 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 M embers of Subcommittee Professor Ranjit Roy Chaudhury Professor N. K. Ganguly Dr. Nyoman Kandun Dr. Somsak Chunharus Dr. Harun Ar. Rashid

3. 3 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Presentation Review of Regional Policy on Research aspect of Immunization – separate presentation Status of Vaccine production in region Development of Vaccines in the region Mapping of National Centres and Institutes of Tropical Diseases Research in India – An example

4. 4 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Drugs Centres of Drug Discovery in Region Centres of Clinical Trials in Region Pharmacovigilance Centres Drug Development from Traditional Medicine Harmonization of Regulations

5. 5 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 C entres of Drug Discovery India – New Molecules Thailand – Limited Research Bangladesh – New Formulations Indonesia – New Formulations

6. 6 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 India Government Sector e.g. Central Drug Research Institute, Lucknow Private Sector about 13 Pharmaceuticals Higher Education Centres National Institute of Immunology, New Delhi 2007-2008 - 30 New Chemical Entities developed

7. 7 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Weakness in Drug Development Lack of Human Resources to develop Drug from Chemistry to Pharmacovigilance Lack of facilities - Toxicology studies - Good centres for Clinical Trial Tendency to license out to foreign company as soon as interesting lead is discovered

8. 8 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Drug Discovery Much cheaper to do this in countries in the region Opportunity not being availed of Need of government support to industry to develop new drugs in SEAR countries Partnership between Indian centres and other centres

9. 9 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 One Important Discovery Piperine – A plant used in Ayurvedic Medicine when administered with Rifampicin – Increases availability of Rifampicin Reduced dose of Rifampicin from 450 mgm. to 200 mgm. – Reduced cost - Reduced side effects - Marketed CSIR – RRL – JAMMU - CADILA

10. 10 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Issues Can specific centres in countries in region be linked together for drug discovery rather than trying to develop all expertise needed in all countries Can WHO have a larger role in this at regional level

11. 11 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Clinical Trials in the Region Registered Bangladesh – 97 India – 1674 Indonesia – 140 Myanmar – 5 Nepal – 20 Sri Lanka – 65 Thailand - 920

12. 12 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Other Background Information Generally Phase II and Phase III studied India and Sri Lanka have primary Clinical Trials Registry linked to International Clinical Registry at WHO Thailand has a Registry Indonesia to begin Registry Phase I studies only in India

13. 13 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Potential Tremendous potential to become Global Centre for Clinical Trials Would result in putting countries in frontiers of Drug Development Earn tremendous resources for countries Provide a very large number of jobs

14. 14 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Cautions Trials should be Ethical Not exploit poor and illiterate in countries to participate in trials Need for strong regulatory authorities Need for strong Ethics Committees at every institute

15. 15 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Need Need for training of Clinical Investigators in good Clinical Trials conduct Need for more training programs in Ethics. Already ongoing programme of WHO and in several countries - India - ICMR - Thailand - Sri Lanka - Bangladesh - Nepal Centres carrying out trials on 5-6 patients in pharmaceutical multicentred trial improves conduct of trial but not much use to country

16. 16 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Growth of CROs (Contract Research Organizations) Growth of CROs recently They carry out clinical trials for pharmaceutical house Quality of CROs varies tremendously Need - Accreditation of CROs Careful Monitoring

17. 17 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Clinical Trials in Region SEA Countries appear favoured destination for clinical trials with China and USSR Between 40 to 50 percent of new drugs application to EU and US FDA are tested in these countries Assocham estimates that clinical trial industry in India alone is worth one billion dollars

18. 18 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Pharmacovigilance Centres in Region India – Coordinated by Indian Pharmacopoeia Commission - 22 Coordinating Centres Indonesia – National Agency of Drug and Food Control Bhutan – Run by Pharmacy Department JWINNR Hospital, Thimpu

19. 19 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Pharmacovigilance Centres in Region Maldives – Maldives FDA is centre - Reporting low at present Nepal – Centred at Department of Drug Administration - Regional Centres - 4 Sri Lanka – Centre at Department of Pharmacology. Faculty of Medicine, Colombo and Ministry of Health - Provides Drug Information Thailand - Centred at Thai Food and Drug Administration 1992 – 18 Regional Centres established 2011 – Community Based Monitoring

20. 20 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Drug Development from Traditional Medicine – An Example Myanmar requested SEARO for help to conduct Clinical Trials with a plant which is effective in treatment multi-drug resistant TB (MDR-TB). Support provided by SEARO -Study tour of Indian Centres for Research on Medicinal Plants -Consultant visit to Myanmar to prepare programme of Standardization and Clinical Evaluation -Studies in progress -Continuous technical support from SEARO and consultant

21. 21 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Harmonization of Drug Regulation in South East Asia Region ASEAN Group Thailand Indonesia Myanmar SAARC Countries IndiaSri Lanka NepalBangladesh BhutanMaldives

22. 22 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Harmonization of Drug Regulation in South East Asia Region Some activity has begun in these two groups Asean Group has planned protocol for joint use Training programme in Brunei in November 2011 Both SEARO and WPRO involved

23. 23 32nd WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand, 11-13 October 2011 Areas Not Covered Rational Use of Drugs – Antibiotic Resistance Public – Private Partnership