1. Establishment of an Intersystem Ethics Committee & Capacity Building of EC members & of applicants Intersystem Biomedica Ethics Committee, Mumbai Dr Jayashree Joshi, Member Secretary FERCI Conference, TMC, Mumnbai, Mumbai,2011

2. FERCI, Mumbai,2011 Late Dr Arun Sanghani Founder Chairman

4. FERCI, Mumbai,2011 ALLOPATHY UNANI HOMEOPATHY YOGA NUTRITION YOGA NUTRITION AYURVED SIDDHA ISBEC

5. Mission To function as an independent ethics committee for encouraging scientific progress of various systems of medicine To inter exchange ethical values amongst various systems To collaborate with the ICMR, CSIR, AYUSH, CCRAS FERCI, Mumbai,2011

6. Objectives To formulate guidelines for research in inter system research To guide the industry in clinical trials To undertake training in Research Ethics in clinical medicine

7. Highlights of ISBEC SOPs Intersystem Biomedica Ethics Committee ICH GCP Guidelines ICMR guidelines FERCI Guidelines WHO Guidelines FDA DCGI Guidelines Charaka Samhita Sushruta Samhita Ashtanga Hridaya Sharangdhar Samhita Vaidyak- Sadvritta- Sadachar Homeopathy Unani FERCI, Mumbai,2011

8. ISBEC –categories of applicants: 1) Multinational companies 2) Governmental Research Organisations like ICMR, DBT, CCRAS, CSIR 3) Postgraduate students’ dissertations for MSc or PhD 4) Clinical trials by Clinical Research Organisations 5) Projects from Ayurvedic CROs 6) Questionnaire surveys by voluntary organisations, national professional bodies or Pharmaceuticals FERCI, Mumbai,2011

9. Review Process Application from Investigator, CRO, Student 1 st wk Primary reviewer + Other members ISBEC Meeting Suggestions / Rejection Modified protocol submitted Approval letter issued with a validity date Expedited review Special Meeting Suggestions / Rejection FERCI, Mumbai,2011 4th wk Primary reviewer + Other members

10. Asthma – Phase II-Comparative with placebo DM- Phase I – antisecretory compound- use of placeboPhase Phase IV-multicountry; Ayurvedic - for multicentric studies TB –Existing approved product-Multinational Co I H D- Homeopathy- Total revision of protocol Malaria Leucorrhoea, Menorrhagia Neurogenic pain FERCI, Mumbai,2011 Types of Diseases

11. Range of Topics for studies More than 80 projects evaluated New molecules for DM, BPH - NCE- Phase 1, 2 PKPD studies Phase 3 studies- DM, Arthritis New indications for a drug or vitamin Pilot studies- Ayurved based Questionnaire surveys Nutrition- analysis of foodgrains Nutrition- anthropometry Nutrition education Herbal/ Ayurveda based Dietary interventions- genetically selected foodgrains FERCI, Mumbai,2011

12. Review of ADRs & Action Taken Hepatotoxicity in CSIR-NMITLI project- wrongly attributed to the herbal product Gastrointestinal side effects – wrongly attributed to herbal product Injectable product for neurological pain relief- multinational study - consent form modified as per the recommendation

13. Dissemination of Intersystem values & principles Full Day ICMR supported Seminar - proceedings- published- ISBEC, ICMR, Industry, academia Half Day- Seminar – FERCI President,ISBEC, MRC-KHS participation ICMR Reverse Pharmacology Training Workshop- session on ethics in research- Ayurvedic, allopathic, basic scientists-delegates from all over India Chapter on clinical trials in pregnant & lactating women FERCI, Mumbai,2011

14. Future Plans Training Seminars Workshops Monitoring FERCI, Mumbai,2011

15. Thank You ! FERCI, Mumbai,2011