OSMANIA MEDICAL COLLEGE Koti, Hyderabad-500 095 A.P
OSMANIA MEDICAL COLLEGE Koti, Hyderabad-500 095 A.P. India. Phones:(040)24656992,24656193,24656664,24656936 Direct: (040) 24651936, F~: (040) 24651936 ETHICS COMMITTEE (ESTD. .1846) Chairman : Justice P.C. Reddy Member : Dr. Suhasini Reddy Retd. Chief Justice. Hjsh Court of A.P. Retd. Dirctor of IPM Convenor : Dr.(Capt) C. Siddappa Gowrav Member : Sri. V. K. Srinivasan IAS' Principal.Osmania Medical College, Hyd. Retd. Special Chief Secldary Member ; Dr. C.S. Bhaskaran Member : 8m'!. C.V. Vinitha Reddy Former Vice Chancellor NTR UHS Advocate Retd. DME & HOD of Microbiology Member : Smt. N. Usha Reddy Committee Member Andhra Mahila Sabha --- MINUTES OF ETHICS COMMITTEE: OSMANIA MEDICAL CO LEGE HYDERABAD HELD ON 28-05-2011 5 Title ofProiect "An Open Label, Randomized, comparison of the Immunogenlcity and Safety ofWockhardt's Human Insulin Basal Bolus Regimen {Intensified Conventional Insulih Therapy with Soluble Insulin and Isophane Insulin (Wosulin R, Wosulin Nand Wosulin 70/30)} with the Novo Nordisk's yeast based Human Insulin Basal Bo: 3Regimens, marketed in United States (Novolin@ R, Novolin@ Nand Novolin@ 70/30) in Type 1 Diabetics ." Protocol No. P3- WOS-IMS-Ol . Sponsor MIs Wochardt Ltd Wockhardt Towers, Bandra Kurla Complex Bandra (East), Mumbai - 400 051 Investigator Dr. Rakesh Kumar Sahay Professor of Endocrinology Osmania Medical College 1 Osmania General Hospital, Hyderabad Co-investigator ------------ Investigation site : Department of Endocrinology Osmania General Hospital, Hyderabad Duration of trial : 1year Drug 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 11.00 am at Osmania Medical College, Hyderabad.
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