INDEPENDENT ETHICS COMMITTEETel. : 079-26586152/7152Fax: 079-26585741E-mail: independentec57@gmail.com

57, Brahmin Mitra Mandai Society,BIW Paldi Bus Stop & Jalaram Mandir,

Paldi, Ahmedabad 380 006.

Dr. Preeti Mehta

Member SecretaryMembers:I I. Dr. Shashank Desai2. Mrs. Ushaben Pathak3. Dr. Himanshu Shah4. Mr. Deepak Kolsawala5. Mr. Nishith Mehta

Deputy Chairman Chairman

Mr. Guarang ShelatMr. Niranjan Bhagat

Date: 23/AUG/2011Ref.: IEC/08-11104To,Dr. Bakul BuchSri Hatkesh Healthcare Foundation,Opp. Buthnath temple,MGRoad,Junagadh- 362 001, Gujarat

Reference: PROTOCOL NO. DI050298:A LONG-TERM, MULTICENTER, OPEN-LABEL, FLEXIBLE-DOSE CONTINUATION STUDY IN SUBJECTS WHO HAVECOMPLETED A PRIOR LURASIDONE STUDY.

Subject: Ethics Committee approval for the conduct of the referenced study at Sri HatkeshHealthcare Foundation, Junagadh and approval ofthe study related documents.

Sri Hatkesh Healthcare Foundation

We have received from you 10 copies of each of the following study related documents videyour letter dated: 5-Aug-2011.

1. Protocol No. DI050298 - Amendment #1121 April 2011

2. Investigator's Brochure 22 DEC 2010 - Edition 11.00

3. India Informed Consent Form V1.3IND02.160vOI dated 01 July 2011

4. Hindi India Informed Consent Form V1.3IND02.160v01 dated 07 July 2011(Along with translation certificate)

5. Gujarati India Informed Consent Form V1.3IND02.160vOl dated 07 July 2011(Along with translation certificate) .

6.Protocol NO: D1050298 Emergency Patient Card (Master VI 18-Mar-20ll)

7.Protocol No: D1050298 Emergency Patient Card (Master VI 18-Mar-20 11)/ translated byTransperfect from English to Hindi on 11 May 2011

(Along-with translation certificate)

8.Protocol No: DI050298 Emergency Patient Card (Master VI 18-Mar-20ll)! translated byTransperfect from English to Gujarati on 11 May 2011

(Along with translation certificate)

9. Protocol D1050298: Clinical Global Impression - Severity (CGI-S)/ CGI-Ssource_FINAL _20 ll-May-19

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7Tel. ; 079-26586152 / 7152

II> Fax; 079-26585741E-mail ;independentec57@gmail.com

INDEPENDENT ETHICS COMMITTEE57, Brahmin MitraMandai Society,

BIWPaldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad 380 006.

Members:1. Dr. Shashank Desai2. Mrs. Ushaben Pathak3. Dr. Himanshu Shah4. Mr. Deepak Kolsawala5. Mr. Nishith Mehta

Dr. Preeti Mehta

Member SecretaryDeputy Chairman Chairman

Mr. Guarang ShelatMr. Niranjan Bhagat

10. Protocol D1050298 :Columbia - Suicide Severity Rating scale (C-SSRS) Baseline:Version 1114/09

11. Protocol D1050298: Columbia - Suicide Severity Rating scale (C-SSRS) Since Last Visit:Version 1114/09.

Please also find enclosed one copy of the following documents for your reference:

• Your current, signed and dated CV as a token of credentials for the conduct of the studyas Principal Investigator.

• A list of the proposed study members, who will be working under your supervision.• A copy of Investigator's Undertaking 17May 2011• Global Insurance Certificate dated 6/06/2011• e-CRF binder Version 2 dated 27June2011

At the Ethics Committee meeting held on 16-Aug-2011 your referenced letter and the abovedocuments were examined and discussed. After consideration, the Committee has decided toapprove the aforementioned study-related documents as well as the study to be conducted underyour direction at Sri Hatkesh Healthcare Foundation, Junagadh.

Please inform us, in case if any serious adverse event is observed during the conduct of thestudy and also let us have a periodic report on the progress of the study annually.

We approve the assessments as specified in the clinical study protocol.

The members who attended the meeting held on 16-Aug-2011 at which your proposalwas discussed are listed below:

I ---------r--------------------------- ---------!!I Member name I Designation I Role I Gender !i Mr. Niranjan Bha~a~-----------r-Ch~i~;~--------- I Lay Person fr~~ th~-~o~~~i~----------rM~-I-~---- Ir-M;:·-G~~;~~~-Sh~i~;------------....--T-M~~b~;-S~~;~~~;;---iLa;-·p~;~~~--fr~;--~h~---;;~~;;~~-i;;;,--f M~i~-------li ! i Accountant !II! . . . . ._.. . ~.:-------....---.-------1,:,'r---·--·------······-········-··-·----------------r----------------------.-----------;-! Dr. Shashank Desai I Member ! Basic Medical Scientist I Male i! Mrs. Ushaben P;h~~~~==~lM~~b~-~~~=~~~---- i Legal Ex~e~_ -------------~~~~=~---r----~~-~-lI Mr. Niranjan Bhagat I Member i Lay P~rson from the community , Male ;!Dr. Himanshu Shah ---------rM~u{b~~------------- i Clinician ---i-Male-----i~}2~E~J~0Is~~~!~-~~~=~==~~~~~~~~~~~~~~~~~=~~~~~~~lSociaL§£ientist----~=~~=--==-~~~=~~~~==~~L¥jt]~==---Ji Mr. Nishith Mehta I Member ! Social Scientist I Male !L_. .... ...__. ._. .... . .. . ....._...._......1•• --_. • • ._._ ••• __ • ,•••••••••••• _._._, ••.••.••.••• __ ••••• _. ••• _._ ••••• __ ,.

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~--~--------------~---.---------------.,.--.-.-----------------------------=----~~~----~----~

/Tel. : 079-26586152/7152Fax: 079-26585741E-mail: independentec57@gmail.com

INDEPENDENT ETHICS COMMITTEE57, Brahmin Mitra Mandai Society,

B/W Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad 380 006.

Members:1. Dr. Shashank Desai2. Mrs. Ushaben Pathak3. Dr. Himanshu Shah4. Mr. Deepak Kolsawala5. Mr. Nishith Mehta

Dr. Preeti Mehta

Member SecretaryDeputy Chairman Chairman

Mr. Guarang ShelatMr. Niranjan Bhagat

It is to be noted that neither you nor any of your proposed study team members were presentduring the decision-making procedures of the Ethics Committee.

"We approve the trial to be conducted in its presented form subjected to theI DCGI approval of the above mentioned study and further notification of

DCGI approval to us."

Please note that the Ethics Committee is formed and operating in compliance with the ICH-GCP and local regulatory requirements.

Yours truly,

Date:~1

ChairmanIndependent Ethics committee,57, Brahmin Mitra Mandai Society,B/W Paldi Bus-stop & Jalaram Mandir, Paldi,Ahemdabad-380 006

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