Dia ry No: 3 722D ate: 15. 02.1 7

E_.---.N 0 12-11/1 7-DCGovernmen t of India

Directorate General of Health ServicesCen tral Drugs Standard Control Organiza tion

FDA Bhawan, New Delhi - 110002 IIndia)New Drugs Division

Da ted

Tele No.Oll-23236 96 5

Fax No.Oll -23235973

o J .- JJ .- 2-d) ']-ToM/ s. Cova n ce India Pharmaceu t ic a ls serv ic es Pvt. Lul .,S4 , 42 4 ,4 25, Lev el 4 , M BC Park,

Sa i Nagar , Ka sarwadavli ,

Ghod b u nder Ro ad , Than e (West),

Maharas t ra -400 6 15

Subject: Permission for condu c t ing c li n ic al study en ti t led , "Mu h icen te r Doub le: ·B linded , Ra ndomized Placebo -co nt ro lled st udy of Arimocl om ol in patie nt s diagn osedw i th Gau ch er D isease Type 1 or 3 ." - regarding.

CT NOC No.CT /ND/ 101/ 2017

Reference: You r app li ca t io n dated 08.02 .20 L7 on the su bj ec t mention ed above.

Sir ,

T h is Direct orate h as n o obj ec t ion to you r co nd uc t in g the su bj ec t m en t ion ed cl i n ic a ltria l as per th e provi si on s o f Drugs & Cos m et ic s Ru les und er su per v is ion of thefo ll ow i ng in ves ti ga tor an d as per the Protocol No: ORARIGAU-O 1 , Ve rs io n No: 1.0 ,Dated 09 .12.2016 su bm i t ted t o th is Dire c to ra te .

-S.No Investigator and Trial site Ethics Committee Name and

Registration Number.__.- - - -_..-

l. Dr. Ashish Bavdekar K E M Hospi tal Research Ce n Lre Ethi csKEM Hospital Resea rc h Cen t re Committee, K EM Hosp it al Re sea rchSarela r M ooell iar Road , Rasta Cen tre , Sa rdar M oodliar Roa d, Ra s taPelh , Pu ne - 411 011 , Pcth , Pu ne - 4 1~haras ht ra, Ind iaMaharas h t ra , India ECR/272/Inst/MH/20 13 i

I

I - i

-~~2 . Dr. Mamta Muranjan lnsutu ti onal Eth ic s Co m m i t tee, Seth n .Se tb G . S. Medical College and S . M ed ical Co llege an e! I(EM Hospi t.rl,[(EM Hospit a l , Achar ya Do nde Acharya D on de Marg, Pare l 4000 12,Marg, Pare l 4000 12, M umbai , Mum bai , M aharash tra , Ind iaM aharash t ra, Ind ia ECR/229/1nst/MH/2013

,ECR/41 7/lndt/MH/2013 I

- -- - - - ,1 3. Dr. Neeraj Gupta In stitu te Erh ics Co m m it tee. Al l l ndi a I

IAlJ India ln su ru te o f M edical In stiuue of Me dica l Sciences , [(oom ~! ()

Sc iences , Room No 111, ri r st Il l , rirst r loo r , O ld 0 1' BlOCK, (j('11Cl ~, ;r

Fl oor, O ld OT Blo ck, Ge netic Unit, New Delhi , 11 002 9 , Ind ia

I Uni t , New Delh i, 110 029 , Indi a ECR/538/Inst/DL/2014ir- .- - - --

4 . Dr. Seema Kapoor Inst ituuonal Ethic s Comm ittee , Ma u la n aI Ma u lan a Aza d Med ical ColJege Aza e! Medical Co l lege, Bahaclu r Shull

IDepartment o f Pediat r ics, Zafar Marg, New Delhi - 11002 JMau la na Azad Medical Co l lege, ECR/ 329 / Inst / DL / 20 13 / RR-16BS Z.M arg, New Delhi - 1100 02

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5 . Dr. Apoorba Ghosh Institute Eth ics Com m ittee , Institute ofIn stitu te of Ch ild Health , 11 , Dr. Ch ild Health , 11, Dr. Biresh Gu ha S treet,Biresh Guh a St ree t, Kolkat a Kolkata 7000 17 , West Bengal, India700017, West Bengal , India ECR/359 /Inst/WB/20 13

-_.6 . Dr. Sumita Danda Institutiona l Review Boards, Chris tia n

Ch ris tia n Med ica l College & Medical College & Hospi tal Vell ore , TamilHospital Vell ore Clin ical Gen et ics Nadu , Ind ia - 63 2004Unit , OT block, 5' h Floor ECR/326/Inst/TN /2013Ch ristia n Medical Col lege &Hospi tal Vellore, Ta mil Na du ,India - 6 32004

7 , Dr. Ratna puri Ethics Commi ttee Sir Ga nga RamIn stitu te of Med ical Gene tics & Hos pi ta l Sir Ga nga Ra m Hospital ,Gen orn ics , Sir Ganga Ram Raj inder Nag ar , New Delhi , In dia -Hospital , Rajinder Na gar, New 110060Del hi, India - 110060 ECR/20/Inst/DL/2013

8 . Dr. Aabha Nagral Ethics Commit tee , J a slokHospital JDepartm ent of Ga s tr oen terolo gy , Rese arch Cen tre 15 , Dr. G. Desh rnu kh

J a slok Hospi tal a nd Research Marg, Mu m bai - 400026Ce n tre , 15 , Dr . Deshmukh Marg, ECR/294/Inst/MH/20 13Pedder Roa d , Mumbai,M aharashtra - 400026

Kindly note that the clinical trial permission is subject to the following

conditions:-

a) Clinical t rial sh al l be co nduc ted in co mplia nce with th e approved pro tocols ,req u ire men ts of Sc he d u le Y, Good Clin ical Practice Guidelines issued by thisDirectorate and ot he r ap plica ble re gu la tions .

b) Approval of In stitutional Ethics Comm ittee du ly regi stered with C DSCO (underRu le 12200 of Drugs & Cosmetics Ru les ) s ho u ld be obtained a nd submitted tothis Direc torate be fore in it iation of th e s tudy.

c ) Clin ical tria ls s hall be re gistered a t Clin ical tr ia ls Regis try of lndia befor e enro llingth e fir st pa tie n t for the study.

d) Annu al status report of each clinical t rial , as to wh eth er it is ongoi ng , comple te dor termin ated , s hall be s u bm itted to th e Licen s ing Authori ty , a nd in case ofterminatio n of any clin ica l tri al th e detailed re a son s for th e same s hal l becommu nicated to the said Licensing Au tho ri ty .

e) Any re port of seriou s adve rse event occu rring du ring cl inical t ria l s tu dy to th es u bjec t, after d ue a nalys is, s hall be forwarded wit hi n fourteen d ays of it.socc u rre nce a s per Ap pe ndix XI and in co mpliance with th e procedu res pre scri bedin Sc hed u le Y.

I] In c ase of a n i nj u ry or death d u r ing the s tudy to th e s ubjects, t he appl icant s hallprovide comple te m edic al mana gem ent a nd com pensatio n in th e case of trialrelated injury or death in accordance with ru le 122 DAB and th e pr ocedurespre scribed under Schedule Y, and th e de tails of compens ation provided in suc hcases s ha ll be intimated to the Licen sing Authori ty with in thi rt y days of th e receiptof th e or der of th e said a u th ority .

g} The pr emises of S pon sor inclu ding th eir employees , s ubsidia r ies a n d bra nches ,their age n ts, co n trac tors a nd s u b -con trac tors a nd clin ical t r ia l s tudy s ites s hal lbe op en to ins pec tion by the office rs a u thor ized by the Cen tral Drugs S tandardCo n trol Orga n iza tio n , who may be accompanie d by a n office r of th e S tate DrugCon tro l Au thority co ncerned, to verify co mplia nce to the re qu ire me nt s of Sched u le

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F. No. 12·11/17·DCCT NOC No: CT/ND/ 101/2017

Y, Good Clirucal Pract ices gu ide lines for cond uc t o f c linica l t ri a l in Indi a a nd o therappl icable regu lat ions .

h) The Sponsor inc lu ding their employees, s u bs id iaries a nd branches , th eir agen ts .cont ractors a nd s u b-con trac to rs a nd cli n ical tri al s tu dy s ites and the In ves tigat ors ha ll all o w o ffice rs a utho rized by the Cent ra l Dr ugs Standard Con tro lOrgan izatio n, who m ay be accompan ied by a n office r o f th e Sta te Dr u g Co nt rolAut hor ity conce rned , to e n te r with or wit hou t prio r no tice , any prem ises ofS ponso r in clud in g the ir employees, s ubs id ia ries a nd branches . the ir agents,co n tractors a nd sub-contractors a nd c lin ical tri al s ites to in spect, search and seizea ny record, data. d ocument. books , in ve s tigat ion al dru gs. e tc . rel a ted to c lin icaltr ia l a nd p rov ide ad equa te replie s to a ny querie s ra ised by the in s pec ting a u thori tyin re la t ion to the co nd u c t of cl in ical tria l.

i) Clin ical tria l s ha ll be conduc ted on ly a t those s ites which a re in st itut e s /hos pi talsh a ving adequa te e me rge ncy fac ili ties a n d d u ly regis te red In s titut io n al Eth icscom m ittees.

j) The s po nsor sh all e ns u re that th e nu mber of c linica l trial s a n in vestiga to r canundertake s hou ld be commens u rate with th e n atu re of the t r ia l, Iac ihry avai la b lewit h the In ves tiga tor e tc.

k] The details o f payme nr/ honora riu ll1/ fina nc ia l s upport j Iees paid by t he Sponsor toth e ln ves t igatorts ] fo r cond uc ting th e s tu dy s hall be made avai la b le 10 i hisdirect orate before ini tia tion of eac h of th e tri a l si res.

1) In a d d it io n to th e requiremen t of obta in ing written informed co nSe n l, a n a uelio­video reco rdin g o f the informed consen t process in case of vu lne rab le s ub jec ts inclin ica l tri a l o f New C hemical En ti ty o r New Molecular Enti ty in cl u d in g orocerlureof pr o vid ing in forma tion to the s ub jec t a nd hi s u nde rstand ing on s uc h co nse n t ,s ha ll be m ai ntai n ed by th e in ve stigato r for reco rd; provid ed tha t in case of cl inicaltr ial of a n ri- HIV a nd a n t i-le prosy dru gs , o n ly a udio record ing o f th r. ln Cnl'meclconse n t proces s o f in d ivid ual s u b jec t inc ludi ng the proced ure of provid ingin fo rm ation to th e s ub jeCTa nd hi sun derst a nd in g on s uc h co nsent s ha ll be m aintained bv th e inv es tigaw r for recQ.t:.~L

as per Govern men t of India, Ga zette Notificat ion vide G. S . R. n o . 6 I I (8) d a ted3 1.07 .20 15.

m) The bulk drug to be used in manufacturing of finished formulation intendedto be used in the clinical trial and clinical trial batches of finishedformulation shall be manufactured under GMP conditions using validatedprocedures and shall have ongoing stability programme.

n) If th e c linica l tria l bat che s a re d iffere nt fro m that of llw pl' im a ry batch es for whichd.H.. h a ve been s ub mi t tecl , s tab ility re ports for c lin ical tr ia l batches a reto be s u bmitted as per Appe nd ix IX of sched u le Y of dru gs a nd Cos me tics Rules lorDr ug s ubsta nces a nd formulation along with Clin ica l s tudy Report.

0) It m a y kindly be rio te d th at m erely gra n t ing pe rm iss io n to con d uct c linical i n al swith th e d ru g does n ot co nveyor imply th at ba s ed o n the c linic a l t rra l d at age nera ted wi th t he drug, permis s ion [Q m arket th is dru g in the co u n try willa u to mat ically he gra n ted lO yo u .

[Dr.Drugs Controller Ger

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