GENERAL ORDER

~~1- X.19029/2/2011-DFQC , Government ofIndia 1 "Ministry of Health & Family Welfare t1~z,. t1 hl.4~ 'Z-Or Nirman Bhavan, New Delhi , z, "":: . " Dated the \0 May, 2011 Subject:- Forrrll,llatioh/creation of 'General Expert Pool' for Medical Device Advisory Committee (MDAC)to advice Drugs Controller General (India) {DCG(In in matters for Review of ~ Applications of new Medical Device & Clinical Trials- regarding. It has been decided to Formulate/create a 'General Expert Pool' for Medical Device Advisory Committees (MDAC)to advise DCG(I)in matters related to review and regulatory approval of New Medical Devices & Clinical Trials (except for Investigational New Medical DevIces) of Medical Devices. The committee is hereby Formulated/created with the following experts with immediate effect: ISr. No. Name-ofE~pert I I- --,-------------~-- [I Prof. M.V.S. l-b~:.!~han r2 ---- .. K. I I .j-'C;~_ty.?~t:.aya~ 1.- [ .3 I Dr. G.S. I j I }~~h"':§1},!~ws3hr I --I liT, N~wDelhi------- ~'!----t-I)~:-~l~~!<J~QY_--H--ead of Bio medical En ineerin --------------------------1 I [) \ Dr. V.K. Suri Head, Precision Engineering Bhabha Atomic i I Research Centre, I i I Mumbai ! + --------.._--------_._---- ~---~--_.._- i ~' L)T:_JY9t'.l~_Sokhe Director NIB, Noida i i Dr, Sathe Head, Microbiolo NIV,.fune : I, --t-i--- -----.------------ I: 1- ! 8. ' Dr. R.S. Paran'a e Director NARIPune ! [(:(),u------''g'-~.~_.-.~__ ..---_---I-T~-~---~--~-- ------------ ------'.._-_.----'--.--. --- De artment ofVirolo CMC,Vellor~ .. _ ~2~~:ham Scientist, Division ofVirology Defense Research and I Development h Establishrg~n t,-Q_~ctli_()r L .]-D~ §h_~h~_~~Q.or HOD Microbiolo AII¥S, Ne\Yl?~JJ1i I 12. Prof. Awades Director National Institute of I olQ..gy,_p_clrlL__ I Surolia Imm un 1____ ____ __ . _ The experts from General Pool will be called for Medical Device Advisory Committee(MDAC) meetings as a member, when required, to advise Drugs Controller General (Inoia) in the following matters: (i)To undertake in-depth evaluation of non-clinical data, clinical trial data, etc, furnished by the applicant for approval offollowing:• New Medical Device to be introduced for the first time in the country. • Global clinical trials (vii) Preparing Guidelines for clinical research industry in evolving acceptance criteria for marketing approval ofnew Medical Device. (viii) Defining roadmap for research industry for appropriate development of new Medical Device relevant to Indian population. (ix) While considering for approval of new Medical Device the committees will examine the essentiality and desirability ofnew Medical Device in terms of: , Assessment of Risk versus Benefit to the patient , Innovation vis- a-vis existing device option ,. Unmet medical need in India 2. Applications for new Medical Device and Global clinical trials can be evaluated hv the committee either through meeting or by circulation ofthe applications. 5. The experts nominated as a member for the committee should not have any conflict of interest as per the declaration given at Annexure-A. 6. 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 ofwhich they are nominated. 7. In case a member retires during the term of validity, an alternative member from the same Institute or from some other Institute will be nominated as member for the Pool. 8. Office of Drugs Controller General (India) {DCG(I)}will initially examine such applications, if any particular data is lacking same will be informed to the applicant within 45 working days or else the data will be forwarded to the members ofthe committee. 9. The members of the committee should be in a position to give their expert opinion within a period of 6 weeks from the receipt of such proposal. lO.The members of the committee should follow the Principle of Confidentiality with respect to the documents submitted by the applicants. 11.The members of the Committee should submit their Bio-data as per the format annexed at Annexure-B.c:::. ~.: \~ (Sudhir Kumar) Under Secretary to the Government of India Telefax: 23062292 Copy to : ~ffice of Drugs Controller General (India) - to inform all members of MDAC- General . Pool Experts. 2. Secretary(H&FW) j DG, Dte.GHS j AS&DG(CGHS) j SS&FAj JS(R) j Director (Drugs) 3. Cash(Health) SectionjIFD