OSMANIA MEDICAL COLLEGEKoti, Hyderabad-500 095 A.P. India.

Phones:(040)24656992,24656193,24656664,24656936Direct: (040) 24651936, F~: (040) 24651936

ETHICS COMMITTEE(ESTD. .1846)

Chairman : Justice P.C. ReddyRetd. Chief Justice. Hjsh Court of A.P.

Convenor : Dr.(Capt) C. Siddappa GowravPrincipal.Osmania Medical College, Hyd.

Member ; Dr. C.S. BhaskaranFormer Vice Chancellor NTR UHSRetd. DME & HOD of Microbiology

Member

: Dr. Suhasini ReddyRetd. Dirctor of IPM

: Sri. V. K. Srinivasan IAS'Retd. Special Chief Secldary

: 8m'!. C.V. Vinitha ReddyAdvocate

: Smt. N. Usha ReddyCommittee MemberAndhra Mahila Sabha

Member

Member

Member

---

MINUTES OF ETHICS COMMITTEE: OSMANIA MEDICAL CO LEGEHYDERABAD HELD ON 28-05-2011 5

Title ofProiect "An Open Label, Randomized, comparison of the Immunogenlcity andSafety ofWockhardt's Human Insulin Basal Bolus Regimen {IntensifiedConventional Insulih Therapy with Soluble Insulin and Isophane Insulin(Wosulin R, Wosulin Nand Wosulin 70/30)} with the Novo Nordisk'syeast based Human Insulin Basal Bo: 3Regimens, marketed in UnitedStates (Novolin@ R, Novolin@ Nand Novolin@ 70/30) in Type 1Diabetics ."

Protocol No. P3- WOS-IMS-Ol

Investigator

MIs Wochardt Ltd

Wockhardt Towers, Bandra Kurla ComplexBandra (East), Mumbai - 400 051

Dr. Rakesh Kumar SahayProfessor of EndocrinologyOsmania Medical College 1Osmania General Hospital, Hyderabad

. . Sponsor

Co-investigator ------------

Investigation site : Department of EndocrinologyOsmania General Hospital, Hyderabad

Duration of trial : 1yearDrug Controller General ofIndia Permission Ref: F.No: CT/294/l0-DCG (1)

Dated: 22-03-2011

The following members of the ethics committee were present at the meeting held on 28-05-2011 at 11.00am at Osmania Medical College, Hyderabad. :

Justice P. C. Reddy, Chairman, Ethics committeeDr. (Capt) C. Siddappa Gowrav, Convenor (Member Secretary).Dr. C. S. Bhaskaran, MemberDr; Suhasini Reddy, MemberSmt. C. V. Vinitha Reddy, MemberDr. N. Usha Reddy

'-The following documents were reviewed:

Document Version date l identifier

1. Protocol Version 5, dated 22M Sep 2010

2. Investigator Brochure Edition No. IB/US-02-00 dated 15111Feb 2010

3. Pack Inserts for Wosulin Wosulin N, Wosulin R, Wosulin 30/70

Chairman

Convenor

Member

OSMANIA MEDIC,AL COLLEGEKoti, Hyderabad-500 095 A.P. India.

Phones :(040)24656992,24656193,24656664,24656936Direct: (040) 24651936, Fax: (040) 24651936

ETHICS COMMITTEE

Member : Dr. Suhasini ReddyRetd. Dirctor of IPM

: Sri. V. K. Srinivasan IASRetd. Special Chief Secldary

: 8m'!. C.V. Vinitha ReddyAdvocate

: Smt. N. Usha ReddyCommittee MemberAndhra Mahila Sabha

Member

Member

Member

The committee after critical review and discussion of the documents, approved the clinical trial at

the Department of Endocrinology, Osmania General Hospital, Hyderabad by Dr. Rakesh Kumar Sahay,

Professor of Endocrinology, Osrhania Medical College 1 Osmania General Hospital, Hyderabad,

(Principal Investigator). The permission is valid till 30thJune 2012.I

Terms of aoproval:

1. The Principal investigator is further requested to follow the Ethical aspects of the clinical trial asdescribed in the booklet "Ethical Guide Line for Bio-Medical Research on Human subjects"published by Indian Council of Medical Research, New Delhi. Ethics Committee works as per theICHIGCP guidelines and their SOP's

..2. If the biological samples collected from patients in the study are to be sent overseas for any

,purpose, the necessary permission should be obtained from the appropriate authorities of the Govt.ofIndia. The Prindpal Investigator shall ensure that this condition is fulfilled as and when requiredand the same to be informed to the IEC by the Principal Investigator.

4. Pack Inserts for Novolin Novolin N, Novolin R, Novolin 30/70 - Version5, dated 14thMay 2010

5. Informed Consent Document -Version 1, dated 27''' Sep 2010English, Hindi, Telugu & Translation

Certificate6. Back Translations ofICD from Hindi, Version 1, dated 27th Sep 2010

Telugu & Back Translation Certificate- - __ . -0--

7. Patient Diary - English, Hindi, Telugu, Dated 20th Sep 2010& Translation Certificate ..

8. Patient Card sample

9. Case Report Form Dated Iltl1Dec 2010

10. Insurance Policy 4067/61446586/001000

11. Indemnity Policy 4022/63172197/001000

12. .DCGI Approval letter Dated 22"°-March-2011

13 Investigators Undertaking Dated 04tl1_March-2011

14. CV of Principal Investigator 19t\ -August- 2010

15. Confidentiality Agreement 28tl1-Feb-2011

16. Clinical Trial agreement Version 10-12-2010

OSMANIA MEDICAL COLLEGEKoti, Hyderabad-500 095 A.P. India.

Phones :(040)24656992,24656193,24656664,24656936Direct: (040) 24651936, Fax: (040) 24651936

ETHICS COMMITTEE

Member

(ESTD. .1846)

: Justice P.C. Red6yRetd. Chief Justice. High Court of A.P.

: Dr.(Capt) C. Siddappa GowravPrincipal, Osmania Medical College, Hyd.

: Dr. C.S. BhaskaranFormer Vice Chancellor NTR UHSRetd. DME & HOD of ~icrobiology

Member

Member

: Dr. Suhasini ReddyRetd. Dirctor of IPM

: Sri. V. K. Srinivasan IASReId. Special Chief SeGidary

: Sm1. C.V. Vinitha ReddyAdvocate

: Smt. N. Usha ReddyCommittee MemberAndhra Mahila Sabha

Chairman

Convenor Member

Member

3. The Principal investigator shall communicate any adverse events occurring at his/her

investigational site or other SAEs brought to his/her notice by the sponsor during the course of the

study to the IEC immediately,

4. The lEC shall review the progress of the study every lyear till completion report at the end of the

clinical trial.

5. In informed consent form, it is provided that the patient will be informed that he/ she will be

reimbursed for traveling expenses per visit. Therefore the patient should be informed before his/her

participation in the study in that he/she will be paid towards his/her travel expenses Rs : 200/- pervisit.

.~Justice P. 'to ReddyChairmanEthics Committee

r. (Capt) C. Siddappa GowravMember secretaryEthics Committee

~ k -cA ~ '-~-LtVlDr. Sushasini Reddy . ~. - (Member

Dr. C. S. BhaskaranMember

r) .v.u~~"-

Smt. C. V. Viriitha ReddyMember

r/. ~ 16-r-yj, \

Smt. N. Usha Reddy f

Member

Copy to: Dr. Rakesh Kumar Sahay, Professor of Endocrinology, OMC/ OGH, Hyderabad.