- - - - -[JDiary No: 39644 F. No 12-42/16-DC Tele No.Oll-23236965

Date: 17.09.14 Government of India Fax.No.Oll-23236973 Directorate General of Health Services

Central Drugs Standard Control Organization FDA Bhawan. New Delhi - 110002 (India)

New Drugs Division

Dated: L I ·· 09 ·-}..c j ·t To M/s. Dr. Reddy's Laboratories Ltd, 8- 2..337, Road No.3, Banjara Hills, Hyderabad-500034, Telanga, India

Subiect: Permission for conducting a clinical study entitled, "A Phase 2, multicentre, randomized, double blind , comparative study to evaluate the reduction in incident of scarring in acne vulgaris subject treated with combination of Benzoyl Peroxide (2 .5 %/5%), Polysiloxanes and Zin c oxide compared to Benzoyl Peroxide (2.5%/5%)".

cr NOC No. CT/ND/60/2017

Ref~rence: Your application no. DRL/PPRA/16-045-4, dated- 7-JuIy-2017 on th e subject mentioned above .

Sir,

This Directorate has no objection to your conducting the subject mentioned clinical trial as per the provisions of Drugs & Cosmetics Rules under supervision of the following investigators and as per the Protocol No: DRL-INDG04-BPO/2016, Version No: 02, Dated 30.06.2017 submitted to this Directorate.

S.No Investigator & Trial site TEthics Committee Name/Registration1.~.

Dr. Rohit Batra1. Sir Gangaram Hospital, SGRH

Marg, Rajinder naga r, New Delhi­11 0060

---+-::- - - --_.._ - - ­2. I Dr. K. Venkatachalam

King George Hospital Maharanipeta, Vishakapatnam­530 002, Andhra Pradesh, India

Dr. Chavan Ravindranath Brahmadeo

3 .

Department of skin a nd VD, BJ Go vt . Medical College, Pune station road, pune-o l l 001, Maharastra, India

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Number rl Sir Ganga Ram Hospital Room No. 1496 IV Floor, Old Building Old Rajinder n agar at New Delhi ECR/20/Inst/DL/20 13/RR-16

Institutional Ethics Committee Situated at Mis. King George Hospital, Vishakhapatnam-530002, Andhra Pradesh ECR/ 197/Inst/KGH/2013

BJ Govt. Med ical College and Sassoon General Hospital at Dept. of Pharmacology BJ Govt. Medical Coll ege I Sassoon Road, Pune 411001 ECR/280/Inst/ Maha/2013/RR-16

4 . Dr. Harish Prasad B.R Sri Venkateshwar Hospital #86 House Sri Venka teshwara Hos pitals , # Main Road Madiwala bangalore-5 6 0068 86, Hos ur Roa d , Madi wal a , Karnataka India Banglore-56 0068, Karnataka, ECR/298/Inst/KA/2013/RR-16 Ind ia

5 . Dr. Pinjala Padmaja Ethics Commi ttee, Osmania med ical Os mania General Hospital, College , Koti, Hyderabad -- 500059, Hyderabad, 500 002, Telangana, An dhra Pradesh In dia ECR/300/lnst/AP/2013/RR-16

Dr. Chitra Shivanand Nayak6 . Topiwala Na tional medical Coll ege And B.Y.L Nair CH , Hospital & T. N. BYL Nair Charitable Hos pital Ground Med ical college, Dr. A.L. Nair Floor G Building A L Nair Roa.d Mumbai road , Mu mbai-400 008 Cen tral Mu mbai 400008

ECR/22/lnst/Maha/2013/RR-16 7 . Dr. D. Sudha Vani Institutional Et hics Committee at

Gandhi Hos pital, Musheerabad Gandhi Medical College/ Gandhi Secunderbad-500 003 Telangana Hospital Musheerabad, Secunderabad ­

500003 Telangana In dia ECR/180/Inst/AP/2013/RR·16 All Ind ia Ins titu te of Med ical Sciences

All India Ins t itu te of Medical Dr. Neena Khanna8.

Room No. 102 1st Floor Old O.T Block sciences (AIIMSJ, Ansari Nagar, Ansari Nagar New Delh i-l 10029 India New de lh i- 110 029 ECR/538/lnst/DL/2014/RR-17

Glo bal Hospitals 6 -1-1 070 /1 to Glenea gles Global Hospitals, 6 -1­Dr. G. Praneeth9 .

Lakdikapul Hyd erabad 500004 In dia 1070/ 1 to 4, Lakdikapool, ECR/ 158/Inst/20 13/RR-16 Hyderabad , 500 00 1

Sri Ra rnachandra University Porur Sri Ramachandra Hospital, No .1

10 . Dr. S. Anandan Chennai-600 116 Tamil nadu India

Ramachandra Nagar, Porur, ECR/203/Inst/TN/2013/RR-16 Chennai-6 00 116, Tarniln a du , In dia

Father Muller Ethics Committee situated

Father Mull er Med ical co llege , 11 . Dr. Jacintha Martis

at Fa ther Mul er Road, Kanka n ady ,

Kankanady, Magalore-57 5 002 Mangalore-575002, Karnataka, Ind ia ECR/540/Inst/KA/2014

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

conditions:

a) Clinical trial shall be co nducted in compliance with the approved pro tocols , requiremen ts of Schedule Y, Goo d Clinical Practice Guidelines issued by th is Directorate and other applicable regu lations .

b) Approval of Institutional Ethics Committee duly registered with CDSCO (under Rule ·1220 0 of Drugs & Cosmetics Ru les ) should be .obtained and submitted to this Directorate before initiation of the s tudy .

c) Clin ical t rials shall be registered a t Clinical trials Registry of In dia befor e enrolling the first patient for the s tudy.

d) An n u al s tatus report of each clin ical trial, as to whether it is ongoing, comple ted or terminated, shall be su bmi tted to the Licensing Authority , and in case of

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F. No. 12-42/16-DC CT NOC No: CT/ND/60/2017

termination of any clinical trial the detailed reasons for the same shall be communicated to the said Licensing Authority.

e) Any report of serious adverse event occurring during clinical trial study to the subject, after due analysis, shall be forwarded within fourteen days of its occurrence as per Appendix Xl and in .cornpliance with the procedures prescribed in Schedule Y.

fJ In case of an injury or death during the study to the subjects, the applicant shall provide complete medical management and compensation in the case of trial related injury or death in accordance with rule 122 DAB and the procedures prescribed under Schedule Y, and the details of compensation provided in such cases shall be intimated to the Licensing Authority within thirty days of the receipt of the order of the said authority.

g) The premises of Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial study sites shall be open to inspection by the officers authorized by the Central Drugs Standard Control Organization, who may be accompanied by an officer of the State Drug Control Authority concerned, to verify compliance to the requirements of Schedule Y. Good Clinical Practices guidelines for conduct of clinical trial in India and other applicable regulations.

h) The Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial study sites and the Investigator shall allow officers authorized by the Central Drugs Standard Control Organization, who may be accompanied by an officer of the State Drug Control Authority concerned, to enter with or without prior notice, any premises of Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites to inspect, search and seize any record, data, document, books, investigational drugs , etc. related to clinical trial and provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of clinical trial.

i) Clinical trial shall be conducted only at those sites which are institutes/hospitals having adequate emergency facilities and duly registered Institutional Ethics committees .

j ) The sponsor shall ensure that the number of c lin ical trials an investigator can undertake should be commensurate with the nature of the trial, facility available with the Investigator etc . However, under no circumstances the number of trials to be conducted by an Investigator should be more than three at a time .

k) The details of payment/honorarium/financial support/fees paid by the Sponsor to the Investigator(s) for conducting the study shall be made available to this directorate before initiation of each of the trial sites.

1) In addition to the requirement of obtaining wr itten informed consent, an aud io­video recording of the informed consent process in case of vulnerable subjects in clinical trial of New Chemical Entity or New Molecular Entity including procedure QL2roviding information to the subject and his understanding on such consent, shall be maintained by the investigator for record; provided that in case of clinical .trial of anti-HIV and anti-leprosy drugs , only audio recording of the informed consent process of individual subject including the procedure of providing information to the subject and his understanding on such consent shall be maintained by the investigator for record, as per Government of India, Gazette Notification vide G. S. R. no. 61l(E) dated 31.07.2015.

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m) The formulation intended to be used in the clinical trial shall be manufactured under GMP conditions using validated procedures and shall have ongoing stabllity programme.

n) If the clinical trial batches are different from that of the primary batches for which data have been submitted. stability reports for clinical trial batches are to be submitted as per Appendix IX of schedule Y of drugs and Cosmetics Rules for Drug substances and formulation alQIlg with Clinical study Report.

0) It may kindly be noted that merely granting permission to conduct cl inical 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 cou n try will automatically be granted to you.

Yours faithfully,

(Dr. GIN.Singh) Drugs Controller Q'eneral (II

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