INDEPENDENT ETHICS COMMITTEETel. : 079-26586152 1 7152Fax: 079-26585741E-mail: independentec57@gmail.com

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

Paldi, Ahmedabad 380 006.

Members:1. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Me. Oeepak Kolsawala8. Mr. Nishith Mehta

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

Deputy Chairman Chairman Member Secretary

Date: 19/0312012Ref.: IEC/03-12/04To,Dr. Aarti ShahRadient Skin Clinic5, Platinum Plaza,Beside Shakti enclave, Judges Bunglow,Bodakdev, Ahmedabad-380061, Gujarat, India

Protocol No: 311-09

Reference: A Randomized, Double-Blind, Placebo-controlled, Three-ann, 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 "Radient Skin Clinic" in Ahmedabad".

Dear Dr. Aarti Shah

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 & Jalaram Mandir, Paldi, Ahmedabad 380 006.

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

. ' -:

No.' '. Document Version arid Date

I. 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 I 7152Fax: 079-26585741E-mail: independentec57@gmail.com

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

Paldi, Ahmedabad 380 006.

Members:J . Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak KoJsawaJa8. 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 2012 ,:i'"

6. Form Back Translated from Gujarati to English on21 Feb2012Patient Information Sheet and Informed Consent Dated 25th Feb 2012

7. Form Back Translated from Hindi to English on 25Feb 2012

8. Translations and Back Translations Certificates --------9. Draft E-CRF --10. Patient Diary Cards in English, Gujarati & Hindi

Final version 01dated 07th Feb 2012

11. Patient Diary Cards Back translation of Gujarati & Version 01 datedHindi 07th Feb 2012

12.PDC Translations and Back Translations Version 01 datedCertificates 07th Feb 2012

13. Investigator's Undertaking Dated: 25th Feb 2012

14.CV & Medical Registration Certificate of Principal

--------Investigator

15. Insurance OG-12-2202-3306-000000 17 Date: 22nd Feb 2012

16. Patient Instruction Card EnglishVersion: a IDated: 3-feb 12

17.Copy of DCGI acknowledgment of T-License Dated: 30 NoY 20 IIapplication

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

Sr. No. Name Role in Ethics Committee Sexl. 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 "Radient Skin Clinic,Ahmedabad".

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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.

Members:1. 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

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

Sr.Document Version and DateNo.

l. 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 certi f cates 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.

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

Date:-~o\~.

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