1. I NTER S YSTEM B IOMEDICA E THICS C OMMITTEE Established in 2008 Registered with GOI - 2008 Accredited to DCGI - 2013 WEBSITE : www.isbec.india.org Established in 2008 Registered with GOI - 2008 Accredited to DCGI - 2013 WEBSITE : www.isbec.india.org

2. INTRODUCTION  ISBEC is the first independent Ethics Committee to have multisystem experts  ISBEC has a panel of experts from all systems of medicine, basic sciences, social scientists, lay person representation and legal experts  ISBEC was formed as a result of the efforts of two giants in Clinical Pharmacology in India, Dr Arun Sangani and Dr Ashok Vaidya, both pioneers in Clinical Trials in India  ISBEC is the first independent Ethics Committee to have multisystem experts  ISBEC has a panel of experts from all systems of medicine, basic sciences, social scientists, lay person representation and legal experts  ISBEC was formed as a result of the efforts of two giants in Clinical Pharmacology in India, Dr Arun Sangani and Dr Ashok Vaidya, both pioneers in Clinical Trials in India

3. Current Status  Under the Chairmanship of Dr Kiran Marthak, Inter System Biomedica Ethics Committee (ISBEC) is registered with Drug Controller General India for approval of BA/BE studies  (Registration No. CR/108/Indt/MH/2013)  Dr Kiran Marthak is an eminent Physician, Clinical Pharmacologist and Pharmaceutics expert with multinational experience  Under the Chairmanship of Dr Kiran Marthak, Inter System Biomedica Ethics Committee (ISBEC) is registered with Drug Controller General India for approval of BA/BE studies  (Registration No. CR/108/Indt/MH/2013)  Dr Kiran Marthak is an eminent Physician, Clinical Pharmacologist and Pharmaceutics expert with multinational experience

4. ALLOPATHY UNANI HOMEOPATHY YOGA NUTRITION YOGA NUTRITION AYURVED SIDDHA ISBEC

5. Composition of ISBEC Sr. No Members Name & AddressCapacity 1Dr Kiran Marthak, MD, F.F.P.M. - D.B.M. Board member and Global Head of Clinical Development at Lambda Therapeutics Research Ltd, located at Ahmedabad and Mumbai. Member- Chairman Physician, Clincal Pharmacologist and Pharmaceutical expert 2Dr. Meena Dave M. D., M.B.B.S., Res: 703, Varun, 1054 J.P. Road, Versova, Mumbai 400061 Tel. No- (R) 26364749 Mobile-9892869378 E. mail: drmeenadave@yahoo.comdrmeenadave@yahoo.com Member Clinical Pharmacologist 3Dr. Deepak Dave M.D, D.G.O Former Vice-President of FOGSI Former President Rotary Club, Juhu, Mumbai Medical Director, Kasturba Health Society Res : Reyn Basera, 24, Vallabh Nagar, Juhu Scheme, Vile Parle (W), Mumbai- 400056 Tel: (O) 26246119 / 26715147 Tel : (R) 26104554/ 26149430 Mobile : 9820228829 E. mail : deepakdave40@gmail.comdeepakdave40@gmail.com Vice- Chairperson Cons. Obst/ Gynaecologist 4Dr. Vanlila Mehta M. B. B. S, D. G. O, DRCOG, Pharmaceutical Consultant, Former Medical Director, 44, Udadhi Tarang Co. op. Soc, Juhu, Mumbai- 400049 Tel: 26142263/ Mobile: 9819342263 E. mail: isbec.india@gmail.comisbec.india@gmail.com Member- Secretary - Clinical Pharmacologist 5Dr. Jayashree Joshi MD, Ph.D, Cons. Reproductive Medicine, (Former Deputy Director, NIRRH- ICMR), Jt Research Director, Kasturba Health Society, Tel (O): 26246119 / 26715147 Residence-Dr Jayashree Joshi, 503, Om-Shiv Housing Society, Plot No 277,, Mahim, Mumbai – 400016 Tel: 24457081® ; Mobile: 9987025059 E. mail: jayashreevjoshi@gmail.com Member- Secretary Cons. Obst/ Gynaec 6Dr. Ashok D. B. Vaidya MD, Ph.D, Former Research Director, CIBA & WHO Consultant, Recipient of Several Awards, Former Med & Res. Director- Bhavan’s SPARC, Research Director, Kasturba Health Society, Res: 501 Tanisha, L.S.Raheja Marg, 9 th,11 th cross road, Khar West, Mumbai 400052 Tel: 26246119 / 26715147 Tel No: 26488880 ®, Mobile : 98206116807 E. mail : ashokdbv@gmail.com Member Cons. Pharmacologist 7Dr. Rama Vaidya MD, Ph. D, Former Deputy Director, NIRRH, ICMR, Recipient of Several orations, Dean, Kasturba Health Society, Res:501 Tanisha, L.S.Raheja Marg, 9 th,11 th cross road, Khar West, Mumbai 400052 Tel: 26246119 / 26715147 Tel No: 26488880 ®,Mobile : 9820239947 E. mail : vaidya.rama@gmail.comvaidya.rama@gmail.com Member Cons. Obst / Gynaec 8Mrs. Neeru Kamlesh Mehta, Flat No. 301/302, 3 rd Floor, Res: Mumbai-400053 Tel No: 9821219280 E. mail : kk_mehta@hotmail.comkk_mehta@hotmail.com Member/ Lay Person 9Dr. Pradnya Talawadaker,BAMS, LLM, Res: 2 nd Flr. Trimurti, Kalanagar,Bandra (East), Mumbai-51. Mobile-9820119446 E. mail: prad_mac@yahoo.com Member / Legal Expert 10.Dr. Mrunal Marathe M.Sc(Psychology)Ph.D(H.S.S) Add-37,Mitra Milan, Sion HSG Society, Scheme 6, Road 2, Sion (e), Mumbai 400022. Tel:(022)24071579Tel:(022)24071579 Mob: 9820473490 Email: mrunals-17@yahoo.co.in Member/ Social Scientist LIST OF ALTERNATE MEMBERS 1Mr. Sharad D. Chitnis B.A., L.L.M., Chitnis Vaithy & Co. Advocate & Solicitors, 410/ 11, Gundecha Chambers,, Fort, Mumbai 400023 Tel. No- 22670014/15 Mobile- 9820069583 E. mail : chitnisvaithy@yahoo.comchitnisvaithy@yahoo.com Member/Legal Expert 2Mrs. Manisha B Naikdalal M.Com 12,Sneha,D.S.Babrekar Marg, Dadar,Mumbai 400028. Tel: 24453455 Mob: 9819394304 Email: manaikd@yahoo.co.inmanaikd@yahoo.co.in Member/ Layperson 3Dr. Helen Joseph MSW,Ph.D B-503 Bhakti Complex, Link Road Ext, Dahisar(W), Mumbai 400068. Tel: 28958313 Mob: 9820209831 Email: helenjoseph111@yahoo.com Member/ Social Scientist 4Dr. Daniel Joseph MD(Pharmacology) Address: 106, ’B’,Nibbana,Pali Hill Road, Bandra(W), Mumbai4000050. Tel No: (022)26483764. E-mail : danieljoseph@gmail.com Member/Clinical Pharmacologist 5. Mr Bharat Joshi BSc LLM Address: 24/44/48, Darshaw Bldg, 24, Jambulwadi, Kalbadevi Rd, Mumbai-400002, India. E-mail: bjoshilawyer@yahoo.inbjoshilawyer@yahoo.in Telephone No: +9122-22014357 Telefax: +9122-22051508 Member/Legal Expert

6. Composition of ISBEC

7. (Alternate members) Composition of ISBEC (Alternate members)

8. Objectives  Function as an independent ethics committee for encouraging scientific progress of various systems of medicine  Formulate guidelines for research in inter system research  Guide the industry in conducting in clinical trials as per ICH guidelines  Undertake training in Research Ethics in clinical medicine  Collaborate with the ICMR, CSIR, AYUSH, CCRAS  Function as an independent ethics committee for encouraging scientific progress of various systems of medicine  Formulate guidelines for research in inter system research  Guide the industry in conducting in clinical trials as per ICH guidelines  Undertake training in Research Ethics in clinical medicine  Collaborate with the ICMR, CSIR, AYUSH, CCRAS

9. Achievements 9

10. Publications  Proceedings of ICMR Seminar on “Ethics in Intersystem Biomedical Research- Problems, Challenges, Guidelines, Organised by ISBEC ”, at Bhavan’s SPARC, Mumbai, 23rd January, 2005  Joshi JV, Dave DD. Designing Clinical Trials Clinical Trials in pregnant & nursing women: Points to ponder! In: Regulatory Requirements for Drug Development & Clinical Research. 1st Edition, Edited by Kshirsagar NA, Published by Indian Council of Medical Research, Chapter 16 ; pp 179-198 (2013)  Proceedings of ICMR Seminar on “Ethics in Intersystem Biomedical Research- Problems, Challenges, Guidelines, Organised by ISBEC ”, at Bhavan’s SPARC, Mumbai, 23rd January, 2005  Joshi JV, Dave DD. Designing Clinical Trials Clinical Trials in pregnant & nursing women: Points to ponder! In: Regulatory Requirements for Drug Development & Clinical Research. 1st Edition, Edited by Kshirsagar NA, Published by Indian Council of Medical Research, Chapter 16 ; pp 179-198 (2013)