INDEPENDENT ETHICS COMMITTEETel. : 079-26'586152/7152Fax: 079-26585741E-mail: independentec57@gmail.com

57, Brahmin Mitra Mandai Society,BIW Paldi Bus Stop & Jalaram Mandir.

Paldi, Ahmedabad 380 006

Members:I. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6 Mrs. Ushaben Pathak7. Mr. Deepak Koisawaia8. Mr. Nishith Mehta

Dr. Preeti Mehta Mr. Niranjan Bhagat Mr. Guarang Shelat

Deputy Chairman Chairman Member Secretary

Date: 19/03/2012Ref.: IECI03-12/06To,Dr. Mahendra VaghasiyaShri Hari skin care, 501 Param Doctor House,Near Resam Bhavan, Lal Darwaja Station Road,Surat-395006, Gujarat, India

Protocol No: 311-09

Reference: A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1 % Topical Ointment Formulations in AdultPatients with Moderate to Severe Atopic Dermatitis.

Subject: Ethics Committee approval for the conduct of the referenced study under your direction at yourclinic "Shri Hari skin care" in Surat".

Dear Dr. Mahendra Vaghasiya

The Independent Ethics Committee has reviewed and discussed your application to conduct thereferenced study during the meeting held on 10th March 2012 at 4 pm at 57, Brahmin Mitra MandaISociety, B/W Paldi Bus Stop & lalaram Mandir, Paldi, Ahmedabad 380 006.

The following documents were reviewed and discussed during the meeting:Sr. ... '.

No. Document Version and Date

1. Study Protocol (Controlled copy no. 051 to 061) Version no. 02, Dated30th Jan 2012

2. Summary of Product Characteristics: Protopic 0.1 Dated 26-Nov-2006% ointment

3. Patient Information Sheet and Informed Consent Version no. 02, DatedForm in English 06th Feb 2012Patient Information Sheet and Informed Consent Version no. 01, Dated

4. Form in Gujarati Translated from English on 18 18th Feb 2012Feb 2012Patient Information Sheet and Informed Consent Version no. 01, Dated

5. Form in Hindi Translated from English on 18 Feb 18th Feb 20122012

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INDEPENDENT ETHICS COMMITTEETel. : 079-26586152/7152Fax: 079-26585741E-mail: independentec57@gmail.com

57, Brahmin Mitra Mandai Society,BIW Paldi Bus Stop & Jalaram Mandir.

Paldi, Ahmedabad 380 006.

Members:I Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. 1\·1r.Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Kolsawala8. Mr. Nishith Mehta

Dr. Preeti Mehta Mr. Niranjan Bhagat Mr. Guarang Shelat

Deputy Chairman Chairman Member Secretary

Patient Information Sheet and Informed Consent Dated 21 Feb 20126. Form Back Translated from Gujarati to English .;:i:/

on 21 Feb 2012Patient Information Sheet and Informed Consent Dated 25l/1Feb 2012

7. Form Back Translated from Hindi to English on25 Feb 2012

8. Translations and Back Translations Certificates --------

9. Draft E-CRF --10. Patient Diary Cards in English, Gujarati & Hindi Final version 01

dated 07th Feb 2012

11. Patient Diary Cards Back translation of Gujarati Version 01 dated 07(h& Hindi Feb 2012PDC Translations and Back Translations Version 01 dated 07th

12.Certi ficates Feb 2012

13. Investigator's Undertaking Dated: 27th Feb 2012

14. CV & Medical Registration Certificate of Principal ----Investigator

IS. Insurance OG- J 2-2202-3306-000000 17 Date: 220d Feb 2012

Patient Instruction Card EnglishVersion: 01

16.Dated :3-feb 12

17. Copy ofDCGI acknowledgment ofT-License Dated: 30 Nov 2011application

The following members of the ethics committee were present at the meeting:

Sr. No. Name Role in Ethics Committee Sex1. Mr. Niranjan Bhagat Chairman- Male

Lay person from the community2. Mr. Gaurang Shelat Member Secretary Male3. Dr. Shashank Desai Clinician Male4. Dr. Bhasker Vyas Basic medical scientists Male5. Dr. Himanshu Shah Clinician Male6. Mrs. Ushaben Pathak Legal expert Female7. Mr. Deepak Kolsawala Social scientist Male8. Mr. Nishith Mehta Social scientist Male

We approve the trial to be conducted in its presented form under your direction at "Shri Hari skin care,Surat".

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INDEPENDENT ETHICS COMMITTEETel. : 079-26586152 / 7152Fax: 079-26585741E-mail: independentec57@gmail.com

57, Brahmin Mitra Mandai Society,B/W Paldi Bus Stop & Jalaram Mandir

Paldi, Ahmedabad 380 006.

;\lembers:J. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4, Dr. Paresh Shah5, Mr. Tapesh Maheshwari6, Mrs. Ushaben Pathak7. Mr. Deepak Koisawaia8. 'vir. Nishith Mehta

Dr. Preeti Mehta Mr. Niranjan Bhagat Mr. Guarang Shelat

Deputy Chairman Chairman Member Secretary

Apart from above document we have received following documents which were notify to us aftermeeting.

..a;.'

Sr.No. Document Version andDate

1. Patient Instruction Card Gujarati Translated from Version: 01English on 12 March 2012 Dated: 3-Feb 12

2. Patient Instruction Card Hindi Translated from Version: 01English on 12 March 2012 Dated: 3-Feb 12

3, Patient Instruction Card Back Translated from Dated 12- Mar- 12Gujarati to English on 12 March 2012

4. Patient Instruction Card Back Translated from Dated 12-Mar-12Gujarati to English on 12 March 2012

5.Translation and Back Translation certificates ofGujarati and Hindi Patient Instruction card ---

Clarification letter for correction in version and6. date of Protocol in certificates by Kesen Dated 13-Mar-2012

(Translating agency)

The Ethics Committee expects to be informed about the progress of the study, any SAE occurring in thecourse of the study and Suspected Unexpected Serious Adverse Reaction (SUSAR), any changes in theprotocol and patient information/informed consent and request you to provide periodic study reports and acopy of final report of the study.

It is to be noted that neither you nor any of your proposed study team members have participated invoting/decision-making procedures of the Ethics Committee.

Kindly note that the Independent Ethics Committee is constituted in accordance with Indian GCP, ICH-GCP and Schedule Y.

Yours truly,

U~~~Mr': Niranjan BhagatChairmanIndependent Ethics Committee57, Brahmin Mitra Mandai Society,B/W Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad -380006,India

Date: - ~ 6 1 6,~ 1 Q. 6 \ ~

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