Spandan-In ependent Ethics Committee Spandan . lEe

8-5. Siddhi Sarjan Appt ., Nr. Seema Hall, Anandnagar. Satellite. Ahmedabad-380 a15. E-mail : spandanieca.gmail.com

Date: 13th May 2013 Ref No: SIEC/AL/05-13/004

To,

Dr. Mahesh Shukla,

Dr . Shukla's Hospital

Behind Alankar Cinema,

M. G. Road, Bardoli-394602

Dist. Surat, Gujarat, India

Dear Dr. Mahesh Shukla,

Subject: Review and approval of Protocol entitled "A Multi-center, Prospective, Open-label,

Randomized, Active-Controlled, Parallel-Group Clinical Study of Safety and Efficacy of

Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol with Voveran'"

Thermagel" (Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol) in

Painful Musculoskeletal Conditions."

Protocol No: ECTSI13/002, Version No. 00; Dated 30 MAR 2013

In response to your letter dated 20-Apr-2013 for review and approval of above referred clinical

study documents, Spandan - Independent Ethics Committee conducted a meeting for review of

Protocol the meeting was held on Saturday, ll-May-2013, 5:00 pm at B-5, Siddhi Sarjan Appt.,

Near Seema Hall , Anandnagar, Satellite, Ahmedabad - 15 in which the following Quorum of

members was present:.

1. Dr. Gaurav Chhaya - Deputy Chairperson

2. Mr. Milan Rachh - Pharmaceutical Scientist/Member Secretary

3. Dr. Bhoomika Patel - Pharmacologist

4. Mr. Manish Shah - Lay Person

5. Mrs. Arunaben Shah - Legal Advisor

6. Dr. Gopal Bhatt - Social Scientist

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Following documents, as per the regulatory requirements were reviewed:

Sr. No. Documents Version No. / Date 1. Study Protocol 00/30 MAR 2013 2. Investigator Brochure (Product description) -

Informed Consent Form - English, Gujarati, 3. 00/04 APR 2013

Hindi 4. Screening Case Report Form 00/05 APR 2013 5. Case Report Form 00/05 APR 2013 6. Subject Diary 00/05 APR 2013

Protocol Approval and Consent From 7. Investigators, Undertaking by the Investigators, -

CV and MRC of Investigators 8. Insurance Certificate -

All of the above documents were reviewed, and conditional approval was given to the study under consideration. The following suggestions/recommendations for alterations to study Protocol under consideration were made by Spandan - Independent Ethics Committee members:

I. VAS score to be kept in between 3-8 in inclusion criteria. 2. BP range to be specified for uncontrolled hypertension in exclusion criteria. 3. Urine Pregnancy Test to be include during screening. 4. Calibrator dose strip should be used.

Based on the favorable opinion given by Spandan - IEC members who participated in the meeting Spandan - Independent Ethics Committee grants conditional approval to the conduct of the proposed clinical study at Site of: Dr. Mahesh Shukla, Dr. Shukla's Hospital, Behind Alankar Cinema, M. G. Road, Bardoli-394602 Dist. Surat, Gujarat, India subject to following conditions of compliance:

I. That the study will be conducted in full compliance to good clinical practice guideline and applicable regulatory requirements,

II. The Spandan - IEC shall do a continuing review of the progress of the trial, for which you will provide periodic updates on the progress of the same as a part of your responsibility at every 6 months and yearly summary report.

Ill. The Spandan - IEC shall provide, according to the applicable regulatory requirements, expedited review and approval/favorable opinion on minor change(s) in the trial during the course of its conduct, if required,

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IV. That no deviation from, or changes in, the protocol would be initiated without written

Spandan - IEC approval/favorable opinion of an appropriate amendment, except when

necessary to eliminate immediate hazards to the subjects or when the change(s) involve

only logistical or administrative aspects of the trial (e.g., change ofmonitor(s), telephone

number(s))

v. That you would promptly report to the Spandan - IEC: (a) deviation from, or changes in,

the protocol to eliminate immediate hazard to the trial subject, (b) changes increasing the

risk to subject and/or significantly affecting the conduct of the trial, (c) all adverse events

including, serious and unexpected, and (d) new information that may adversely affect the

safety of the subjects or the conduct of the trial, and

VI. That the Spandan - lEC would promptly notify in writing the investigator/institution

concerning: (a) its trial related decisions/opinions, (b) the reason for its

decisions/opinions, and (c) procedures for appeal on its decisions/opinions.

vii. That Spandan -IEC shall be submitted a copy of Final Study Report

Best regards, ~

~'J~U~ ~fl,\~\ V

Dr. Gaurav Chhaya, Deputy Chairperson,

Spandan - IEC

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Spandan-Independent Ethics Committee Spandan . lEe

B-5. Siddhi Sarjan Appt. .. Nr. Seema Hall. Anandnagar. Satellite. Ahmedabad-380 015. E-mail ; s pandan iec@ gm a iI.com

Date: 14th May 2013 Ref No: SIEC/AL/05-13/01l

To,

Dr. Mahesh Shukla,

Dr. Shukla's Hospital

Behind Alankar Cinema,

M. G. Road, Bardoli-394602

Dist. Surat, Gujarat, India

Dear Dr. Mahesh Shukla,

Subject: Review and approval of amendment for Protocol entitled "A Multi-center, Prospective,

Open-label , Randomized, Active-Controlled , Parallel-Group Clinical Study of Safety and

Efficacy of Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol with

Voveran" Therrnagel" (Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and

Menthol) in Painful Musculoskeletal Conditions."

Protocol No: ECTSI13/002, Version No. 00; Dated 30 MAR 2013

In response to your letter dated 13-May-2013 for review and approval of above referred clinical

study amendment, Spandan - Independent Ethics Committee Deputy Chairperson carried out

expedited review for the Protocol amendment.

Protocol amendment no. 0 I dat ed 13th May 2013 was reviewed by Deputy Chairperson, Dr.

Gaurav Chhaya and given expedited approval for continuation of the study.

Based on the favourable opinion given by Deputy Chairperson, Spandan - IEC grants approval to

the conduct of the proposed clinical study at Site of: Dr. Mahesh Shukla, Dr. Shukla's Hospital,

Behind Alankar Cinema, M. G. Road , Bardoli-394602 Dist. Surat, Gujarat, India subject to

conditions of compliance as stated in the approval letter dated 13th May 2013, Ref No.:

SIEC/AL/05-13/004

Best regards, J CA~ ..> ,~\> )13

Dr. Gaurav Chhaya,

Deputy Chairperson,

Spandan - lEC

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