Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices

F.No.12-01/12-DC (Pt-77) Central Drugs Standard Control Organization Directorate General of Health Services Office of Drugs Control General (India) FDA Bhavan, Kotla Road New Delhi-110 002 Date: NOTICE 28 AUG 2012 Subject: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials & Medical Devices — regarding. Under the provisions of Drugs & Cosmetics rules, Central Drugs Standard Control Organisation (CDSCO) is responsible for grant of statutory approvals for manufacture / import of new drugs, medical devices and clinical trials. Presently, 12 New Drug Advisory Committees (NDACs) & 6 Medical Device Advisory Committees (MDACs) of various medical specialties are advising CDSCO in the process of such regulatory approvals of New Drugs, New Medical Devices & clinical trials. In order to bring more transparency, consistency and accountability in the approval process and to have wider representation of experts of various disciplines from across the country, CDSCO is in process of expanding the pool of such experts in the areas of Oncology, Hematology, Ophthalmology, Immunology, Cardiology, Nephrology, Gastroenterology, Hepatology, Gynecology & Obstetrics, Pulmonology, Neurology, Psychiatry, Urology, Pediatrics, Rheumatology, Microbiology, Pharmacology, Medicine, Anesthesiology, Vaccines, Dermatology, Radio Diagnostics and Dentistry. The experts will evaluate the proposals under the following Terms of Reference (TOR): 1. The Terms of Reference will be as follows: > To advise DCG(I) in the matters related to regulatory approval of new drugs, Global clinical trials, Fixed Dose Combinations, Medical Devices. » Preparing Guidelines for clinical research industry in evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories. » Defining roadmap for research industry for appropriate development of new drugs relevant to Indian population. 2. Applications will be evaluated by either through meetings or by circulation.-2- _ For review of each proposal experts will be paid an honorarium of Rs. 1000/- 4. TA/DA for attending the meetings as well as honorarium will be paid as per the government rules. _ The expert nominated as a member for the committee should not have any conflict of interest as per the declaration given as per the Annexure. _ The members of the committee shall hold office for a period of three years but shall be eligible for re-nomination provided that the persons nominated continue to hold their offices in their respective organization by virtue of which they are nominated. _ In case a member retires during the terms of validity a suitable alternative member probably from the same institute or from some other institute will be nominated as member for the committee. _ The members of these committees should be in a position to give their expert opinion within a period of 6 weeks from the receipt of such proposal. - The members of these committee should follow the Principle of Confidentiality with respect to the documents submitted by the applicants. Interested experts having experience in the relevant fields working in government medical colleges / institutions and having no conflict of interest may please send their Curriculum Vitae and Conflict of Interest duly filled via e-mail ndac@cdsco.nic.in or by post to Drugs Controller general (India), CDSCO, FDA Bhavan, Kotla Road, New Delhi — 110002 within 30 days of this notice. (Dr. GJN. Singh) Drugs Controller Genéral (India)Annexure-A DECLARATION OF INTERESTS FOR EXPERTS FOR CDSCO CDSCO work on drug regulatory issues requires the assistance of external experts who may have interests related to their expertise. To ensure the highest integrity and public confidence ‘in its activities, CDSCO requires that experts serving in an advisory role disclose any circumstances that could give rise to a potential conflict of interest related to the subject of the activity in which they will be involved. Please complete this form and submit it to CDSCO (HQ) If you are unable or unwilling to disclose the details of an interest that may pose a real or perceived conflict, you must disclose that a conflict of interest may exist and the CDSCO may decide that you be totally recused from the meeting or work concerned, after consulting with you. Name of expert: Institution: Email: Contact No:- Date and title of meeting:- Meeting of expert Committee to examine issue of restricting or prohibiting marketing of sibutramine on 12-11-10 at FDA Bhawan, Kotla Road, New Delhi Please answer each of the questions below. If the answer to any of the questions is "Yes", briefly describe the circumstances on the last page of the form. 1. EMPLOYMENT AND CONSULTING Within the past 2 years, have you received remuneration from a commercial entity or other organization with an interest reiated to the subject of the meeting of work? la Employment Yes No ib Consulting, including service as a technical or other advisor Yes No 2. RESEARCH SUPPORT Within the past 2 years, have you or has your research unit received support from a commercial entity or other organization with an interest related to thesubject of the meeting or work? 2a Research support, including grants, collaborations, sponsorships, and other Yes No funding 2b N eqo un i- pm mo en ne tt ,a fr ay c ilis tu ip esp ,o r rt e sev aa rl cu he d a ssa it s tam no tr s,e pat ih da n t raR vs e. l to2 0 m, e0 e0 t0 i/ n- g so ,v e er ta cl .)l (include Yes No S tru ap ip no inr gt f( oi rn c al u cd oi mng m eh ro cn io ar la r ei na t) i tf yo r o rb e oi thn eg r o on r ga a ns izp ae ta ik oe nr s w itb hu r ae na u i, n tg ei rv ei sn tg rs elp ae te edc h te os t ho er subject of the meeting or work? 3. D a w c i o o nocI vr m oyN ek pmo sV a?m tu n E e m yPS h r el .T a nc e M tv i a se aE s Y l eN toc hT u ue aa r n tlI tr siN ae mot rnT ay etE i y w bR i n i rn cE t ov lS eh aue xT dds caS e lt ln ym u ie ddi nn ien dt vt i es e r rr e m s( e c u isv t t fta iu l i er au n de le v l a d ea nsta f de tt ud m n om e dt no n so r t , w se t h h ipt se ce h u hsa nc un s yhb i o R j o uas e n. s c e t x2 a f e0 o u r0 f t c0 n r i0 t du s0 h ss e/ e t- nm ooo oe rrv e e ct hr osa oi nil tln ml rdg) i oi l lnoi a .gn r r 3a Stocks, bonds, stock options, other securities (e.g., short sales) 3b CoY me ms e rciN ao l business interests (e.g., proprietorships, partnerships, joint ventures, board memberships, controlling interest in a company) Yes No 4. PUBLIC STATEMENTS AND POSITIONS (during the past 2 years) 4a A exs p ep ra tr t o po if n ia o nr e og ru l ta et so tr iy m, o nl ye ,g i rs ela lt ai tv ee d to or tj hud ei c si ua bl j ep cr to c oe fs ts h, e h ma ev ee t iy no gu o rp r wo ov ri kd ,e d fo ra n a commercial entity or other organization? - Yes No 5. ADDITIONAL INFORMATION 5a tI mf h ean eto t t i i na s gl tr he oea r d y s w u od b ri js kec cl t eo ns aoe f bd l t ea h b eo y v ome ue, e tth oia nv oge b ty aoo ir n u ww o ao r ckr c,k e e sod sr f io w or i l lt a h e y c o oc u mo r pm ep tpe iat tri t ot i ro c 'r i sp o at ctf o ia no f n i p dr i eo n nd tu t ic h at ei l proprietary information, or create for you a personal, professional, financial or business competitive advantage? Yes NoTo your knowledge, would the outcome of the meeting or work benefit 5b adversely affect interests of others with whom you have substantial’ common personal, professional, financial or business interests (such as your adult children or siblings, close professional colleagues, administrative unit or department)? Yes No Have your received any payments (other then for travel costs) or honoraria for 5d speaking publicly on the subject of this meeting or work? Yes No Is there any other aspect of your background or present circumstances not 5e addressed above that might be perceived as affecting your objectivity or independence? Yes No Within the past 4 years, have you had employment or received research support or other funding from or had any other professional relationship with, an entity directly involved in the production, manufacture, distribution or sale of tobacco products or representing the interests of any such entity? Yes No EXPLANATION OF "YES" RESPONSES: if the answer to any above questions is “yes”, check above and briefly describe the circumstances on this page. Nos. 1-3 Name of Belongs to Amount of Current Typeof interest, | company, you, a family | income or Interest (or question organization, member value of year number and or employer, interest is ceased) category and institution research unit | assumed to basic descriptive or other? be details. significant) Nos.4-5: Describe the subject, specific circumstances, parties involved, time frameand other relevant details CONSENT TO DISCLOSURE. By completing and signing this form, you consent to the disclosure of any relevant conflicts to other meeting participants and in the resulting report or work product DECLARATION, | hereby declare on my honour that the disclosed information is true and complete to the best of my knowledge. Should there be any change to the above information, | will promptly notify to the CDSCO arid complete a new declaration of interest form that describes the changes. This includes any change that occurs before or during the meeting or work itself and through the period up to the publication of the Final results or completion of the activity concerned Date: Signature