Dcccynssnoia2drer Sum Cee ovement a ns of eats 2 Pony Wale Nirman Bhavea, New Delhi» Dated the 1" September, 2010, ‘ORDER Bede of Mesith & Fanily Welfare) had decdedtoconsitite rae “Calle Biclogy Based Therapeutic Drug. Evahution Commitee (CBTDECY" under the Chimanship of De. V.M. Katoch, Seeetary, Deparment of Health Research & Director General, ICMR, New Delhi to advice Druga Contller General (adi) in mates pertaining regulary patiways leltng to the approval of cia als and Maret Authorization forthe “Therapeutic products deed from Stem Cel, Human Gene manipulations and Xentanspant ecology wth be flowing compost 1 Prof, (Dr) PAN. Tandon President NBRC; Gorgion, Ex Professor & Head, y. AUIMS. Presently (Chairman National Ethics|Comminee at ICMR. 2 l, ExDivcior, SGPGL, x CMC, Vellore, Tamil Nadu... 4. Prof. N.-K. Mehra, Head, Départmeot of ‘Transpldst Immunology and Histocompaiitility, AIMS, New Deli 5. Dr. D. Balasubiamaniam, Director, LVPIE, Excouesar COMB, Ten, Hea fincas PotDs) Ma, van ~ SETIME/EXVC, Mpa Acca STi Prof, RM. ‘SxMadurai Kama Univer ‘Dr. Vinge Bal, NII, Aruna Asaf Ali Mare; New Del ‘Dr. Rita Mulheskar, ACTREC, Mural, 2, Terms of Referenes(TOR) , (9 To undertake in-depth evaluation of the te bed, by:the"applicant (an ~~~ __individual_and-lor-0-repitesed2émpany) for (Phase; 1) and ST Make Aliizaion of the “Therapie produce. derived fom Stem Cel Haran Gone ~ Manipulations and Xenciapintfeology ters reltng to reQUltx vases pot the provisions mde ies Act and Res theénf en slo during the post fcensue ie period. 2 2 oe agit 3. Time Schedule for procéising of application, ) Within 15 days of submission of TND ‘pplication along with relevant data received by the fice of DCG, the deta willbe refered to conperned experts mentioned in the;Core Pane! LisThe expers will be requested to give thei opinioncomments win 30 days with effet from the date when the complete dossier have been dopetched bythe Ofie f DCO). It sf that in case the dais locking in any particular deta, the expert may bring the same tothe notice of 10 working days by e-mail or by post which would be subsequently intimated to ja next 7 working daye Gi) Within next 30 days of complete data submission, a meting wil be convened to discuss the mancr amongst all the members of the said Commises and approval or any recommendation would be conveyed tothe applicant 4 Tits within 90 days, the complete dossier including the tral proposals (Protocol) will be reviewed, evalusted and approved on the recommendation of the Core Expect Pane (iv) After receiving the report of study as approved above by.the CBTDEC, members will be corifutted and the next phase of ection will be decided within 45 calendar days. (¥) Sirailasly, after receiving Phase-U1 study reports end consultation with members, Phase-II linical trial protocol will be cleared within 60 days. Wherever felt necessary, the pane! may co- ‘opt outside subject experts from specific field. (0) After submission of Phase-IIT study’ reports, the Panel would examine the data and would advise DCG(}) for approval of drug or otherwise 4, The Core Panel shall bold offi for two(2).years pul shale eligible for ee-nominaion Provided that the» persone nominated contin to fold their offices im their sespesive ee yeu ay eras 5. Hono 000 er ewinatn wile pid whe Bis ind TADA ste Expert ‘would be per the Central Government Rules from the DIAB Budget(PP&SS Account). 6. In order to avoid any conflict of interest, a member whip may be directly or indirectly associated with Research & Development activites related to a product under examination, would inform the office of DCG(1) and would volunteer to abstain from evaluation of such applicant. 7. PMS data will be generated as per the recommendations ofthe Experts Panel efter clearence of Phase-It1 trials and formal approval of a New “Therapeutic products derived from Stem Cell, Human Gene Manipulations and Xenotransplant technology”. 8. This issues withthe approval of IFD vide their Diary No. 2513, dated 18.08.2010 sue (Sudhir Kumar) ~ Under Secretary tothe Government of india Telefax: 23062292 To ‘Chairperson and ail membera of the Expert Panel. . PPS to Secretary(H&FWYDG, Die. GHS/AS(VVYASRFA 4S(R) Dec, Cash(Heaith) Section