INSTITUTIONAL ETHICS COMMITTEEB. J. MEDICAL COLLEGE & SASSO ON GENERAL HOSPITALS, PUNE 1

REPORT OF INSTITUTIONAL ETHICS COMMITTEE

Ref.No.: BJMCIIEC/Pharmac/ND121 0166-68 Date: 23-12-2010

(Always quote this reference number & date in correspondence)

To.Dr.D. K. DamlePrinciple InvestigatorDepartment of Skin & V. DB.J. Medical College, Pune.

Reference: ND 1210 166-68 I

The INSTITUTIONAL ETHICS COMMITTEE B. J. ME6ICAL COLLEGE &SASSOON GENERAL HOSPITALS, PUl'rE 411 001 reviewed and discussed yourresearch proposal entitled "A Randomized, Double-Blind, Multi-country, Multi-center,Vehicle-Controlled Study to Compare the Safety and Efficacy of Calcitriol Ointment 3rncg/g (Paddock Laboratories,lnc.) vs. Vectical" Ointment 3 mcg/g (GaldermaLaboratories, L.P.) in Treatment of Chronic Stable Mild to Moderate Plaque Psoriasis" on 23rd December, 2010

The following documents were reviewed:

(a) Protocol Id: PAD-2010-01 Dated: 02-12-2010(b) Case Record form(Version 2.0), Informed Consent Form (English,Hindi,Marathi;

Version 1.5), Subject diary (Version 1.3)(c) Investigator's Brochure: Calcitriol(Version 1.0) Package insert(d) Insurance policy: Raheja QBE Policy No.I-P0000034-MED

(13-09-2010 to 12-09-2011)(e) Principal Investigator's current CV.(f) Clinical Study Agreement(g) Principal Investigator's Undertaking(h) DCGI Approval dated 13-12-2010(i) Certificate from Head, Department of Skin & V. D, BJMC & SGH, Pune(j) Permission from Dean, BJMC & SGH, Pune COM4?/

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(2)The following members of the Intuitional Ethics Committee were present at the meetingheld on 23-12-2010 at 3.00 pm in the Department of Pharmacology, BJMC,Pune 411 001

1)2)3)4)5)6)7)8)9)10)11)12)

Dr. D.D. Shetty,Dr. B.B. GhonganeMr. A.M. ReddyMrs. A. S. PawarDr. P.W. SambareyDr.P.S.AdhavDr. S.B. PunpaleDr. Mrs. V.S. Kelkar,Dr. S.A. Sangle,Dr. Mrs.V. S. DubeMr. P. S. KulkarniMr. S.D.Bhande

ChairmanMember Secretary

MemberMemberMemberMemberMemberMemberMemberMemberMemberMember

The trial to be conducted is\

VJ Approved in its presented form only (valid for six months only. It will berenewed by Secretary, after submission of six monthly detailed report) ..x ]Approved subject to submission of:(valid for six months only. It will be renewed by Secretary, after submissionof six monthly detailed report)

[ X ]Disapproved for reasons listed below:[ X] Terminated for reason listed below:

Subject to the Principal Investigator providing the following:• A six monthly detailed report of the clinical trial/study.• A written report of each serious or unexpected adverse event with regard to

the study.• Not to make any amendments / revisions to any study related document or

patient's safety related information, without prior approval of the IEe.• To keep the IEC informed of the study completion or discontinuation, with

reasons.• The trial be registered in Clinical Trials Registry- India (CTRI) before

enrolling first patient in the study and the assignedNumber is to be informed to the INSTITUTIONAL ETHICS COMMITTEE.

(Dr. B.B. Ghongane)Member Secretary

IEC BJMC & SGH, Pune