Notice regarding Invitation for Inclusion of Professionals in the Subject Expert Committee Panels under CDSCO

CentralF i Dl re u N go s. 1 S2 t- a0 n1 d/ a1 r4 d- CD oC n t(P rt o- l2 0 O) rganization Directorate General of Health Services (ExpM ei rn ti Cs ot mry m io tf t H ee ea l Ct oh o ra dn id n aF ta im oi nl y C eW le l)l fare FDA Bhawan, K No et wla D R eo la hd i, NOTICE Dated: Q| (i! |2011 Subject: Invitation for inclusion of professionals in the expert panels / subject expert c M mo e em d dm i ii c cIt a ant l loe re Dd es e xe v pru ei n t rcod te e sesr v oaaC flnD u d vS a atCC relO i ia on. p uipc sla l ti c hTa ert rii aao pln ess u tar ie n cl d a t aoe rtd eh a t e so r , a r wp e hp lar oto ev d aa dl i v s io s sf u ee N s, De Cw C G D (D ISru )Cg Os in i mn eac vil anu ltd uai ain tng i sB o i npo al ono feg i l sc s ua cl o, hf a /p Ip nl stiC ic taD ut tiS io oC n ns sO . / Ni as ti in o nt ah le Lp ar bo oc re as ts o ro if e se x / p Ra en sd ei an rg c ht h Ie n sl ti is tt u to ef s e fx op r e ir nt cs l uf sr io om n iv na tr hi eo u fs o lG lo ov wt i. nH go s pp ai nt ela sl :s [ A AP V H D N P P B CN N AU EE SE E I EA A C N YL P D OU LL E CC TM I SA R LG S HI I TAO T O ITE S AN ATON AH LS TT RE NLA TEI O IIR DROR T SC CGY I G TIY CY C IC Y E C LI LA N _ |G O H C U N A A R T GY N E A ER N N H O EN C RM TPO T XE NA O D IA H IL IU EVC IL MT RO CM IOO TO IO OG OARL C HL G LL Y LA TRO EO Y OO OL OOG RG G GG B LY AY Y YY I O P A G YL Y _ [| RO G O D E P OB VAR PA P E N TH E1DT HS T R D HTAI OH YT H OM EEO RO — TR A C RA RDP M O O ML R II TE A P RE E NIA MD O HC EN D AG NOI L A LO IT N ROLC O R ACLE O YLO G M TAOR S OG S AY ELO GI GY C C D SL Y EY I E NO AE UGG RN TIY C EIN E AE CS SE AR LI SNG BASED THERAPY For evaluation of the applic:a (t Si Eo Cn ss ) of a rN e e cw on sD tr iu tug ts e, d M be yd i ic na cl l uD de iv ni gc e es x, p eC rl ti sn i fc ra ol mT r ti ha els s. e Subject Experts Committees p 1a . in .Se IEl cns C l. - i' nds ie cpa atd lhv t i e rs iv ae a l l D du aaC ttG ai o ( n( P 1 ho) af si nn eo m n 1-a ,c t 1lt 1ie ,nr is Ic I a Ir ,le l ada nat dti a n I g Vi )t no ,c: l eu td e.i n fg u rp nh ia sr hm ea dc bol yo tg hi ec a al pp t lo ix ci ac no tl fo og ri c aa pl p rda ot va a, l o «f fo Nil nel to wrw o i ddn rug cu: egd s fuobrs ttahen cfei rostf t cihmeem ii nc tal h ea n cod u b ni to rl yo g ii nc ca ll u o dr ii ng gi vn a a cn cd in n ee s w & m red -i Dc Na Al d de ev ri ic ve e dto be e pS ru ob ds ue cq tsu .ent approval of biological products including vaccines & r-DNA derived e« p GFr lio oxd beu dac lt D s oc lsa il enr ie Cca oad mly b ta irp niap alr tso .iv oe nd s i on f t th we oc o ou rn t mr oy r. e drugs to be introduced for the first time in the country.ii. « P m r aeC ro pa kf au e rMs tiia innl ngii g st G t ay ur p ia py dn r ea o oll f viy anHs lei e s sa o, l ff t s o nha r e f a c we n l t id dy n r F i uo ca gf am sl d i t or l r fu y i g a dW l is e f il fo n er f d r a u ea r s nn e t ty r to y ho r e t iD rnh aC e e pr G ev uot I te l ic w v ch ih n cnii agcc t h eaa gl cr o ce rm eq ia u p et i t st r .ae e nsr c e ei x n cp ret irh tte e rao idp av i i fn s oi e r.on iii. D rW wee ih lf li e li l v n eaei n x n c t ag o mt nr o is o nIia endd de eim r saia sn enp ng p tf o iao p apr u l p ilr r tae o yts v ie aa oa nl nr d .c o h df ei snn ied ru aws b it d lr r iy u t yf g o s or f aa nnp d ep r wco l p dir n ri i ua c gat sle itd nre i tav ele rol mfo s p N om C fe :En st /o Gf Cn Te sw td hr eu g Ss EC's e e A Is ns noe vs as tm ie on nt v o if s- R ai -s vik s v ee xr is su ts i nB ge n te hef ri at p t eo u tt ih ce op pa tt ii oen nt iv. A» n y oU tn hem re it s sm uee sd i wc ha el r en ee xe pd e ri tn aI dn vd ii ca e is needed by CDSCO. 2.T h Ae p pT le ir cm ats i oo nf s R fe of re nr een wc de r f uo gr s m ae ndm b Gle or bs a lo f c lt ih ne ic S alE C tr’ ias l sa wr ie l la s b eu n ed ve ar lu: ated by the experts 3 4. . t F R Th o sr A.ro /u 2r Dg 5eh 0v A i 0m e / fe w o-e r wt o h ai f o tn e tsg a ees nc dui hn ip p npp r gee o rr tp hs o l eo s i n a m m il eo t,r e w tet o iah u ncr l gho d s u e g x abh p se e v wRri et sd l .e a l1o t a0t c s0eo n 0 sn d 0 if i t e on tr ig ne n n at g c h ce e s hi. am n re g gle e et si d n a wyg i. l w li bll e b pe a ip da i fd r of mee 1o Pf C 5, bTuhdeg eetx.pert nominated as a member for the SEC should not have any conflict of interest as 6 7. . e op T l f Te eh i fr vhge i ait ec lbh m e ule s me e a id em tne f imb c o nt bel hr gea r e ir r trs ra e hs t - ero i enf oo pso tn f rpmh e oig te c pni h t oacv ei sto se v ai em en lo m oi n ci wrn o it g p mt tat rh m hne oe i iie v ntzA i tasn d ah t en e a i ee d pl o sl e x n t ru h sh b ir ho a oye atl dl . d v lt oi ho r fgf e t i f u 6vi p e c ee we or etfsf h e oo w en kr ihs sra i cn e fp xho re pm r ot eii mh rno e tad ty t hc o eae of rd m ret e mh c n cr eo eoe n n ime t pti tiy n s ne a o ua t i fer e n s s dt w u.b o r cu ih ht to is pl nh rda g o l ptl a oh feb sti ae er lr g 9. , e T v Tv h i he e en ew ci etof xh mt peh m e e i r ry t te qtf cua e oi iel mr mt s eo h ima tea l tt nl et t ee esvn s ad a l wst u i h pa le r lt e em rs e t ece h vrt e iii b epn e wrg d o. t p i ho n es ta phl res o pro oef sg n au lle aw at n od drr yu g g f is vr e aa m tn e hd ew ic o rl r i rkn ei . cca ol m t mr eia nl ds ak te ie op ni sn g i ni n a 10. c I b co n y om mcp ma ao s ins e tyi t t o ee Sf e Em q sa Cu hen a r ln ay le f / t dr s e e u r la g is g bi f n ee ia rs tr at i taia els o tnp r h r ef ea vo c mr it a ei m tc wo ta d el oi. rf f ki etc eha e pt i io p nrn go / p ir noe s vv a ii ls e,i w o in tn h i en t h et aeh r e ls i p u err b o s dp e eo q cs u ia e sl n i, ot n r m /e e sc ueo gtm gi em n se g tsn i od t ne h .d e 11. The members should follow the Principle of Confidentiality with respect to the documents submitted by the applicants.12. DCG (1) on the request of any SEC, may invite a suitable expert having experience in the particular area of specialization as required by SEC, pertaining to the specified application. The interested experts from various Govt.Hospitals/ Institutions / National Laboratories Research Institutes having relevant expertise who can dedicate time for the above activities and agree to the terms of references as mentioned above may submit declaration of Conflict of Interests and Bio-Data as per the formats enclosed within six weeks of issuing of this letter to CDSCO, FDA Bhavan, Kotla Road, New Delhi — 110002 or email to dci@nic.in with a copy marked to seccdsco@gmail.com for considering their inclusion in the list of expert panels. (Dr. G .N .Singh) Drugs Controller General (India) Copy to- 1. Notice Board, FDA Bhawan 2. Guard FileANNEXURE-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:- 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 related to the subject of the meeting of work? la Employment Yes No |b 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 the subject of the meeting or work?2a Research support, including grants, collaborations, sponsorships, and other funding Yes No 2b Non-monetary support valued at more than Rs. 20,000/- overall (include equipment, facilities, research assistants, paid travel to meetings, etc.) Yes No Support (including honoraria) for being on a speakers bureau, giving speeches or training for a commercial entity or other organization with an interest related to the subject of the meeting or work? 3. INVESTMENT INTERESTS Do you have current investments (valued at more than Rs. 200000/- overall) in a commercial entity with an interest related to the subject of the meeting or work? Please also include indirect investments such as a trust or holding company. You may exclude mutual funds, pension funds or similar investments that are broadly diversified and on which you exercise no control. 3a Stocks, bonds, stock options, other securities (e.g., short sales) Yes No 3b Commercial 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_ As part of a regulatory, legislative or judicial process, have you provided an expert opinion or testimony, related to the subject of the meeting or work, fora commercial entity or other organization? Yes No 5. ADDITIONAL INFORMATION 5a__|f not already disclosed above, have you worked for the competitor of a product that is the subject of the meeting or work, or will your participation in the meeting or work enable you to obtain access to a competitor's confidential proprietary information, or create for you a personal, professional, financial or business competitive advantage? Yes No5b T a p cd e ho r iv lsy e doo r rnu s ear e nl l ,yk n oo a rpf w rf ol e sfe c ied bt sg l s ie i i nn, o gt n sew ,ar lo e ,su ctl lsd f o i st o n eh f a n e c o pio t rau h olet frc eoso sr sm w ie i b ot nuo h asf li wt nh eh ce so o s lm lm ee iy ane o gtt uu ei er n sehg s ,a t v se a d(o ms sr iu u nb c is h st taw rn ao at sr ti ik a vl y e o c uro ub nme ian tm de o uf li on tt r department)? Yes No ny payments (other then for travel costs) or honoraria for 5d - Have your received a speaking publicly on the subject of this meeting or work? Yes No 5e aIs d dt rh ee sr se e da ny a boot vh ee r tha as tp e mc it g ho tf y bo eu r peb ra cc ek ig vr eo du n ad s o ar f fp er ce tis ne gn t yoci ur rc u om bs jt eca tn ic ve is ty n oo rt independence? Yes No W oi tt hh ei rn futh ne d ip na gs t f r4 o my e oa rr s h, a dh a av ne y y' 0o tu fh ae ch r ta upd rr eo ,e f m e dp s isl si to o ry inm ba ue l t n irt oe n l o a or t r i r oe snc s ae h li i ev p e ow fd i t tr h oe , b s ae a ca n cr oc e h nt pis rtu oy dp up d co ir tr e st c to olr y r involved in the production, manu 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 circ umstances on this page. Nos. 1-3 Type Name of Belongs to Amount of Current you, a family income or Interest (or of interest, company, question organization, m eme pm lb oe yer r, v ia ntl eu re e so tf is y ce ea ar sed) cn au tm eb ge or ry a an nd d o ir nstitution research unit assumed to basic descriptive or other? be significant) details. ubject, specific circumstances, parties involved, time frame Nos.4-5: Describe the s and other relevant detailsCONSENT 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 honor 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 CDSCO and 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: SignatureCURRICULUM VITAE NAME: DATE OF BIRTH: MARITAL STATUS: CONTACT DETAILS: ACADEMIC DETAILS/ QUALIFICATION: Sr.No. | COURSE INSTITUTION UNIVERSITY/ YEAR OF BOARD PASSING AREAS OF SPECIALISATION: DETAILS OF PRESENT AND PREVIOUS POSITIONS:PROFESSIONAL EXPERIENCE: Sr. No. POST DURATION : INSTITUTION/ COMAPNY SCIENTIFIC PUBLICATIONS AND PRESENTATIONS: ANY OTHER ACHIEVEMENTS: