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I-F'TSNo: 65597 ]i'. No 12-2 8 / 1 6 -D C Te!e No.Oll-23236965 ]Gat ::: 04 .1:2.15 Gove:rnme ~"lt of J:ndi2. := ax.No.Oll-23236973

Directorate General o f Health Services Central Drugs Standard Con trot Organization

FDA Bhawan., New Delh1- 110C02 iIndia) New Drugs Division

Dated 1-'" - 01- J-O I :1-To

Mis. Hetero Labs Ltd., 7 -2-A2, Hetero corporate Industrial Estates, Sanathnagar, Hyderabad-5000 18

Subject: Permission for conducting clinical study entitled, "A Comparative, Phase III , multicenter study to evaluate the efficacy, tolerability and safety of Azilsartan plus Chlorthalidone fixed-dose combination in Indian Adult patient of Hypertension" - regarding.

CT NOC No.CT/ND/48/2017

Reference: Your application No. HILL/DCGI/NDA/015-33 dated 27.11.2015 on the subject mentioned above.

Sir,

This Directorate has no objection to you r conducting the subject mentioned clinical t r ial as per the provisions of Drugs & Cosmetics Rules under supervision of the followin g investigator and as per the Protocol No: HCR/III/AZICHLOR/05/2015, Version No: 2.0, Dated 28.04.2016 submitted to this Directorate.

S.No lnvestigator and Trial site

l. Dr.B.Thrilok Chander Hospital ,Musheerabad, Secunderabad-500003

2 . ~

~

Dr. Chirag Rathod GMERS Medical College and

I General 390021 Hospital, Gotri ,Vadodara

I 3 . Dr. K. Sunil Naik

Dept. of Gen. Medicine , Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital , Srikakulam-53200 1, Andhra Pradesh, India.

I

Ethics Committee Name and Registration Number

Institutional Ethics Committee,

Gandhi Medical College,

Musheerabad,Secunderabad-500003

ECR/ 180/Inst/AP/2013

Institu tional HUman Ethics

Committee (In sti tu tional Review

Board) GMERS Medical College and

General Hospital, Gotri, Vadodara 390021

ECR/28/lnst/GJ /2013

Institutional Ethics Committee

Rajiv Gandhi Institute of Medical

Sciences & RIMS Govt. General Hospital, Srikakulam-53200 1, Andhra Pradesh, India.

ECR/492/Inst/AP/2013

FOI (ND-P-02)/Page 1 of 5

I

Ins titution al Ethics Commit tee, Nirrnal Dr. Deo Ni dhi Mish m

4. Hospital In stitu tion al E thics

Nir rnal Hospital Opp .NILB Medic al Comm ittee , NirE1aJ Hos pital Campu s . Coll ege , Ga te n o.3 J h ~o.I1 Si(U . P) Opp .NILB Medical College , Ga t e n O.;3 284 128 Karrpur Road, J Ofu"'1si(U.P)-28 4 12 8

ECRj325/Inst/ UP/ 2 013 /R. highway, Vil-Bhat, Gand hi n a garBhat, Gandhinagar-382428

382428 ECR/620 /Inst/GJ/2014

Ethics Committee Noble Hospital Pvt6. , Dr.Jagtap Namdeo Sakharam Noble Hospital Pvt Ltd 153, Ltd 15 3, Magarpatta City Road Magarpatta City Road Hadapsar,Pune-4 11 0 13 Hadapsar, Pune-411 0 13 ECR/259/Inst/MH/2013/RR-2016

7. Ethics Committee Down TownDr. Rupam Das Hospital, Dispur, Guwahati-781006

Gawahati-781006 Down Town Hospital, Dispur,

ECR/549/Inst/AS/2014

8.1 Dr. Deepak Gupta Institutional Ethics Committee, Baral a Barala Hospital & Research Center Hospital & Research Center Opp radhaswami bagh,NH-11 Opp radhaswami bagh,NH-11 chornu , ch omu , Jaipur, Raj asthan 303702 Jaipur,Rajasthan 303702

ECR/838/Barala/Inst/RJ/2016

9. I Dr. Ajay Bansal Institutional Ethics Committee, BansalBansal Hospital & Research Hospital & Research Center,Center, 04,Janakpuri-1st,Imli 04,Janakpuri-1st,Imli Phatak, .JaipurPhatak, Jaipur -302005, Rajasthan, 302005,Rajasthaxl,IndiaIndia ECR/ 826/Inst/ RJ /2016

1q Dr. Dhananjay Vinayak Ogale Institutional Ethics Committee, B JDept.of Medicine. Srs floor Sasoon Medical College & S asoon HospitalHospital, Station Road PunePune-411001411001 ECR/280/Inst/MH/2013/RR-2016

111 Dr. Gouranga Sarkar IPGME&R Research Oversight Institute of Post Graduate Medical Committee Institute of Post Graduate

Education & Research,244 AJC Medical "Education & Research,244 Bose Road,Kolkata-700020,West AJC Bose Road,Kolkata-700020,West Bengal , India Bengal, India

ECR/35/Inst/WB/2013/RR-16 121 Dr. Dinesh Choudhary

Department of Cardiology HRM Ethics Committee S.P. Medical Cardiovascular Science & College & AG of Hospitals HRM Research, S.P.Medical College & Cardiovascular Science & Research AG of Hospitals Bikarier- Bikaner-334003,Rajasthan 3 34 00 3 ,Rajasth an ECR/27/SP/lnst/Raj/2013

F01 (ND-P-02)jPage 2 of 5

r-~:;;- 12 -2 8 / 1 6 -DC .~.

LC'I~OC No: CT / ND / 4 g / 2 017 I oJ-, . Dr , Abh ijee t Bhaskar J oshi Niramaya Hospital Ethics Committee

Nir a m aya Hospital,S .No- Niramaya Hospital,S.No-4742 ,B ehind 4742,Beh ind jaih in d Petrol Pump,

I

j aih iri d Petrol Pump, Next to Next t o Chinchwad(E) Post Office, Chinchwad(E) Post Offic e, Pune Pun e- 41 10 19,1'IIaharashtra, India 41 10 19 ,Mahara s h tra , India

ECRj438/lnst j MH j 2013 14. Institutional Ethics Committee

Dr. Kancharla Sudhakar Siddhartha Medical College & Go vt.

New Govt. General o Hospital General Hospital Govt. Siddhartha

(As s ocia ted by Govt. Siddhartha0 Medical College Campus, Gundala,

Medical College Campus, Vijayawada-520008,Andhra Pradesh,

Gundala,Vijayawada-520008 , India

Andhra Pradesh, IndiaI ECR/633jlnst/AP /2014

15.1 Dr. Kajal Gangulyi Ethics Committee NRS MedicalI NRS Medical College & Hospital, College, 138, AJC Bose Road, Kolkata

138, AJC Bose Road, Kol kata70 00 14 , West Bengal

70001 4 , West Bengal . ECR/609/Inst/WB/2014

1.6. Dr. Barama Srihari In stitu tional Ethics Committee,

Department Of Cardiology , Osmania Medical College, Koti ,

Osmania Medical College& General HJyderabad-500095

Hospi tal ,Afzalgunj, Hyderabad, Telangana-50001 2

ECRj300jlnstjAP j2013/RR-16

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

a ) Clin ical trial shall be conducted in com p liance with the approved protocols, requirements of Schedule Y, Good Clinical Practice Guidelines issued by this Dir ec tor a t e and other applicable regulations.

b) Approval of In s titutional Ethics Committee duly registered with CDSCO (under Rule 122DD of Drugs & Cosmetics Rules) should be obtained and submitted to this Directorate before initiation of the study. 0

c) Clinical trials shall be r egistered at Clinical trials Registry of India before en rollin g the fir st patient for the s tu dy .

d) Annual status report of each clinical trial , a s to whether it is ongo ing, completed or terminated, shall be submitted to the Licensing Authority, and in case of termination of any clinical trial the detailed reasons for the same shall be co m m u nica ted to the s aid Licensing Authority.

e) An y report of ser iou s a dverse event occurring during clinical trial study to the s u bj ec t , after due analysis , shall be forwarded within fourteen days of its occurrence as per Appendix XI and in com p liance with the procedures prescribed in Schedule Y.

f) In cas e of an injury or death during the study to the subj ects, the a p p licant s h all provide com ple te medical management and compens ation in the cas e of

F01 (ND -P-02)j Pa ge 3 of 5

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h al relar.ed in jury or d ea th in accordan ce with rule 122 DAB an d tr-. ;; procedu r es p r es cribed u n d er Sch ed u le Y, and the details o f cornpens a tic n p rovided in such c a s es s h al l be intima t ed to th e Lic en s in g Au th o rity withir, thirty d ay s of th e receip t of the order of the said authority .

g) The p rem ises of Spon s or in cl u d in g th eir em p loyees , s ubsidiaries and b ranch es , th eir a gents, contractor s and su b-con tra c tor s and clinical t ri al s tu dy s i te s sh a ll be open to inspection by the officers authorized by the Central Drugs S ta n d ard Control Organiza ti on , who may be a ccom p a n ied by an officer of the State Drug Control Authority concerned, to verify compliance to the r equirements of Schedule Y, Good Clinical Practices guidelines for conduct of cl in ic al t ri al in India and other applicable regulations .

h ) The Sponsor including their employees, subsidiaries and branches, their' a gents , contractors and sub-contractors and clinical t r ial stu dy sites and the Investigator shall allow officers authorized by the Central Drugs Standard Control Organization, who m ay be a ccom panie d by an officer of the State Drug Control Authori ty con cerned, to enter with or w ithou t prior n otice, any premises of Sponsor including their employees , su bsid iarie s and branches, their a gen ts, contractors and s ub-contractors and cl in ical trial sites to inspect, search and seize any record, data, document, books, investigational drugs, etc. related to cl inical trial and provide adequate rep lie s to any queries raised by th e inspecting a u thori ty in rela tion to the conduct of clinical trial.

i) Clinical trial shall be con ducted only at those s ites wh ich are institutes/hospitals having adequate emergency facilities and duly registered Institu ti onal Ethics co m mittees ,

j ) The sponsor shall en su re that the number of cl in ic al trials an investigator can undertake should be commensurate with the nature of the trial , facili ty available wi th the Investigator etc .

k) The details of payment/honorarium/financial su p port / fees paid by the Sponsor to the Inves ti gatoris) for conducting the s tudy s hall be made a vailable to this directorate before in itia tion of each of the trial s it es.

I) In addit ion to th e requirement of obtainin g written informed consent, an audio video recording of the informed consent process in case of vulnerable subjects in clinical trial of New Chem ic al Entity or New Molecular Entity including procedure of providing information to the su b ject and his understanding on such consent. shall be m aintained by the inves t iga tor for r ec ord; provided that ' in ca se of clinical trial of anti-HIV and anti-leprosy drugs, only au d io r eeordi n g

of the informed con s en t process of individual subject in clu d ing the procedur e of providing in form a ti on to the subject and h is understanding on su ch co n sent shall be maintained by the investigator for record , as per Governm en t of India , Gazette Notification vide G . S . R. no . 611 (E) dated 31.07.2015.

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

F01 (ND-P-02)/Page 4 of 5

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~- ~~F. No. 12-28/16-DC . :T NOC No: CTjNDj 4 Sj2 017

:1) If the clinical trial batches are different from that of the primary batches for wh ich data h a 'le been submitted, stability reports for clinical trial batches are to be submitted 8 _S per Appendix IX of schedule Y of drugs and Cosmetics Rules for Drug substances and formulation along with Clinical study Report.

0) It may kindly be noted that merely granting permission to conduct clinical trials with the drug does not conveyor imply that based on the clinical trial data generated with the drug, permission to market this drug in the country will automatically be granted to you .

p) Bioequivalence with the reference product shall be established before initiation of the clinical trial.

Yo

(Dr. G Drugs Controller Ge

FOI (ND-P-02)jPage 5 of 5