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INSTITUTION ETHICS COMMITTEE (IEC)(AN INSTITUTIONAL ETHICAL ISSUES REVIEW BOARD)

Dr. B.R.Ambedkar Medical College & HospitalK.G. Halli, Bangalore -560 045. Off. : 080-25476498, Fax: 080-25471784

CHAIRPERSON

Dr. RADHAS. MURTHY,MBBS., MIFA., MIGS.,

Managing TrusteeNightingale's Medical Trust,Ravindranath Tagore Nagar,Bangalore - 560 032.Mob. : 9844037381

MEMBERS:

BASIC SCIENTISTS:·Dr. B.R. Ramesh., M.S.,9448889607Dr. R. Hemalatha, M.D.9845019684

CLINICAL PHARMACOLOGIST:Dr. L. Padma, M.D,944824882

PHYSICIAN:Dr. N. Bhakthavatchalam, M.D,9845015873

SURGEONDr. Stanley John M.S.9845176912

REPRESENTATIVE OF NGO·Mr. Prem Kumar Raja9243100560

LEGAL EXPERT:Mr. B.C. Thiruvengadam, LL.B.,9844092926

PHILOSOPHER:Dr. M. Sreenivas, M.Phil., PhD9886676720

COMMUNITY LEADER:Mr. Lakshmi Narayan9945689830

.==-====.MEMBER SECRETARY

Dr. B.M. NAGARAJ,MD.,Dip. Medical Law & Ethics (NLSIU)

Professor and Head,Dept. of Forensic Medicine

Dr. B.R. Arnbedkar Medical College,Kad ugondanahalli, Bangalore.

Mob. :9844141088

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Date: 25.08.2012ToDr. Prashanth C.NDr. B.R Ambedkar Medical College,Bangalore.

From,The Chairperson,Institutional Ethics Committee,Dr. B.R Ambedkar Medical College,Bangalore.

Protocol No: CD-12-340

Subject: Approval for the study and the Study submissions.

Study Title: "A multi center, open label, randomized, parallel,single dose to compare the Pharmacokinetics of marketedproduct LotemaxTM (Loteprednol Etabonate OphthalmicSuspension 0.5%; Bausch & Lomb, Inc.) to an investigationalLoteprednol Etabonate Ophthalmic Suspension, 0.5% (Hi-TechPharmacal Co., Inc.] in Aqueous Humor in patients undergoingindicated cataract surgery".

Dear Dr. Prashanth C.N,

With reference to the above mentioned study, the followingdocuments were received from you and the same has beenreviewed by us.

"

Sl. NAMEno

VERSION & DATE

1 Study Protocol Version 1 .23-May-2012

Date of preparation 12 Jan2009

2 Product Monograph

INSTITUTION ETHICS COMMITTEE (lEC)(AN INSTITUTIONAL ETHICAL ISSUES REVIEW BOARD)

Dr. H.R.Ambedkar Medical College & HospitalK.G. Halli, Bangalore -560 045. Off. : 080-25476498, Fax: 080-25471784

CHAIRPERSONDr. RADHA8. MURTHY,

MBBS., MIFA., MIGS.,Managing TrusteeNightingale's Medical Trust,Ravindranath Tagore Nagar,Bangalore - 560 032.Mob. : 9844037381

MEMBER SECRETARYDr. B.M. NAGARAJ, MD.,

Dip. Medical Law & Ethics (NLSIU)Professor and Head,

Dept. of Forensic MedicineDr. B.R. Ambedkar Medical College,

Kadugondanahalli, Bangalore.Mob. :9844141088

MEMBERS:

BASIC SCIENTISTS:Dr. B.R. Ramesh., M.S.,9448889607Dr. R. Hernalatha, M.D.9845019684

CLINICALPHARMACOLOGIST:Dr. L. Padma, M.D,944824882

PHYSICIAN:Dr. N. Bhakthavatchalam, M.D,9845015873

SURGEONDr. Stanley John M.S.9845176912

REPRESENTATIVE OF NGOMr. Prem Kumar Raja9243100560

LEGALEXPERT:Mr. B.C. Thiruvengadam, LL.B.,9844092926

PHILOSOPHER:Dr. M. Sreenivas, M.Phil., PhD9886676720

COMMUNITYLEADER:Mr. Lakshmi Narayan9945689830

3 lCD-English Version 1 .23-May-2012

4 lCD-Hindi Version 1 .23-May-2012

5 ICD-Marathi Version 1 .23-May-2012

6 lCD-Tamil Version 1 .23-May-2012

7 ICD-Telugu Version 1 .23-May-2012

8 ICD-Kannada Version 1 .23-May-2012

9 ICD-Malayalam Version 1 .23-May-2012

10 lCD-Urdu Version 1 .23-May-2012

11 Investigators undertaking Dated 16 June 2012

12 CV&MRC Dated 08 June 2012

The following members of the Ethics Committee were presentduring the meeting held at Dr.B.RAmbedkar Medical College &Hospital on 1st August 2012 at 12.00 AM and have decided toapprove the above mentioned documents for use in referencedstudy.

81 Name of the EC Role Designation & GenderNo Member Qualification1 Dr.Radha.S.Murthy CHAIR MBBS, Female

PERSON MIFA,MIGS2 Dr.B.M Nagaraj Member MD, Dip Male

Secretary medical law &ethics (NLSIU)

3 Dr.B.RRamesh Basic M.S Malescientist

4 Dr.RHemalatha Basic M.D Femalescientist

INSTITUTION ETHICS COMMITTEE (IEC)(AN INSTITUTIONAL ETHICAL ISSUES REVIEW BOARD)

Dr. H.R.Ambedkar Medical College & HospitalK.G. Haiti, Bangalore - 560 045. Off. : 080-25476498, Fax: 080-25471784

CHAIRPERSONDr. RADHA S. MURTHY,

MBBS., MIFA., MIGS.,Managing TrusteeNightingale's Medical Trust,Ravindranath Tagore Nagar,Bangalore - 560032.Mob. : 9844037381

MEMBER SECRETARYDr. B.M. NAGARAJ, MD.,

Dip. Medical Law & Ethics (NLSIU)Professor and Head,

Dept. of Forensic MedicineDr. B.R. Ambedkar Medical College,

Kadugondanahalli, Bangalore.Mob. :9844141088

MEMBERS:

BASIC SCIENTISTS:Dr. B.R. Ramesh., M.S.,9448889607Dr. R. Hemalatha, M.D.9845019684

CLINICAL PHARMACOLOGIST:Dr. L. Padma, M.D,944824882

PHYSICIAN:Dr. N. Bhakthavatchalam, M.D,9845015873

SURGEONDr. Stanley John M.S.9845176912

REPRESENTATIVE OF NGOMr. Prem Kumar Raja9243100560

LEGAL EXPERT:Mr. B.C. Thiruvengadam, LL.B.,9844092926

PHILOSOPHER:Dr. M. Sreenivas, M.Phil., PhD9886676720

COMMUNITY LEADER:Mr. Lakshmi Narayan9945689830

5 Dr.L.Padma Clinical MD FemalePharmacologist

6 Dr.Bhakthavatchala Physician MD Malem

7 Dr.Stanley John Surgeon M.S Male :Mr.Prem kumar Social . MaleRaja scientist / Re

p ofNGO9 Mr.B.C.Thiruvengad Legal Expert L.L.B Male

am10 Dr.M.Srinivas Philosopher M.Phil,Phd Male11 Mr.Lakshmi Community Male

Narayan leader

We confirm that neither you nor your study team membersparticipated in the deliberations of the Ethics Committee & did notvote on the proposal for this study.

Thanking you,

~L--a-'~'

Dr .Radha.S.Murthy(Chairperson)

Dr. RADHA .S. MURTHYMaas, "'FA MIGS.

Chair PersonEthical Committe.

Dr. I.R. Ambedklr Medicll Collegeaangalore-S80045.