VADODARA ETHICS COMMITTEERace Course Medical Centre, Race Course Tower

Vadodara- 390007, IndiaV EC I

APPROVAL OF NEW PROJECT

Date: 17/08/11To,Dr. Aman Khanna,Investigator,Sun Pharmaceutical Industries Ltd.Baroda. India

The meeting of Vadodara Ethics Committee, Vadodara was held on 17/08/11 with Dr. R.V. Bhatt as the Chairperson.

Following members of VEC were resent:Name Qualification DesignationDr. R.V.Bhatt M.D. (Obs. & Gyn.) Consulting Obstetrician & Gynaecologist.Dr. G.N.Vaishnav M.D. (Gen. Med.) Consulting PhysicianDr. Vipul Desai M.D. (Gen. Med.) Consulting PhysicianMr. Atul Mehta B.A., L.L.B AdvocateDr. B.P. Udwadia M.D. (Pharmacology) ScientistDr. Ashish Sethi MD, DM (PGI) GastroenterologistDr. Vikas Ponda M.D.(Psychiatry) Consulting PsychiatristMrs. Sangita Patel B.Sc. (Zoology) Social Scientist, Member SecretaryMrs. Snehal Bhatt M.S.W. Social Scientist

The Vadodara Ethics Committee reviewed and discussed your application toconduct the clinical project entitled "Effect of 13341-I (Escalating Doses) andMoxifloxacin (400 mg) compared with placebo on QT interval using time- matched 12-lead ECG in healthy subjects: A randomized, double blind, double dummy, single dosepreliminary study. " on 17 6 August, 2011.

Meeting minutes:

â Dr. Udwadia presented the protocol. VEC has already reviewed the protocol earlier.

Doses are escalated up to 12mg and 48mg without getting any QT prolongation as per

the previous report submitted to VEC. They want to escalate the dose to 72mg on 9

subjects.

â Approved.

Page 1 of 2

CHAIRPERSON:

Dr. R. V. Bhatt M.D. (01, & Gyn )

Members of VEC:

Dr. G.N.Vaishnav M.D. (Got. !OWL

Dr. Vipul Desai M . D . (Gm. Mixt

Dr. Vikas Ponda M.11).(Psychunry)

Mr. Atul Mehta RA., L.L.B

Mrs. Sangita Patel B s,. (z,„,,„„)

Dr. B.P. Udwadia M.D.Pharntayntont

Dr. Darshak Shah M.S. (G. sff

Dr. Ashish Sethi MD, DM (PCI)

Mrs. Snehal Bhatt

With respect to above referenced study, the Vadodara Ethics Committee certifies that:The members of Vadodara Ethics Committee complies with the membership requirement for Research Ethics

Boards defined in Division 5 of the Food and Drug Regulations;This Vadodara Ethics Committee carries out its function in a manner consistent with Good Clinical Practices; and

This Vadodara Ethics Committee has reviewed and approved the Protocol/ Documents for the Clinical study which is tobe conducted at Clinical Pharmacology Unit, Sun Pharmaceutical Industries Limited, Tandalja, Vadodara with Dr.Aman Khanna, MI) as Investigator and Sun Pharma Advanced Research Company Ltd., India as Sponsor.

3. Out of .. I members who have attended the meeting N i ce. members have voted in favour of the abovementioned clinical project.

The following documents were sent for review.

Protocol CLR/B/NR/06/05

Volunteer Information Sheet &Informed Consent Form (English and Gujarati)

3. DCGI Approval letter dated August 09, 201 1

Version/date

06/30-06-11

09/10-08-11

Amendment/Date

01/10-08-11

The protocol, Volunteer Information Sheet and Informed Consent Forms are approved without any changes.

It is the policy of the Vadodara Ethics Committee to be informed any changes in the approved documents and all seriousadverse events occurring during the course of the study, for the committee to decide further plan of action.

The Vadodara Ethics Committee expects to be informed about any serious adverse event occurring in the course of thestudy, any changes in the protocol and informed consent and asks to be provided a copy of the final report.

The approval is given to conduct the study in its presented form

Yours truly,

Date: l } —e-Dr. R. V. Bhatt

CHAIR - PERSONVADODA RA ETHICS COMMITTEERACE COURSE MEDICAL CENTRE

VA DODARA - 390007

1 6 AUG 2012

I-ROTC:COL i,,PPROVAI, EXPIRES

ON ABOVE DiTE

Page 2 of 2

Page 1Page 2