Dr. Walavalkar K. C. P. M.B.B.S .. M.D. Clinician, Pharmacologist Chairperson Scientific

Dr. Padhyegurjar S. B. M.B.B.S" M.D. (PSM) Clinician, Bioststistician Vice-Chairman Scientific

Dr. Sinha S. R. M.B.B.S .• M.D. Clinician, Pharmacologist Member Secretary Scientific

Dr. Karkhanls R. V. M.B.B.S .• FRCOG Clinic/an, Gynaecologist Member Scientific

Adv. Valdya J . A . B.A . L.L.B .• L.L.M. Lawyer Member Legal Non-Scientific

Adv. Kulkarni V. V. B.A" L.L.B. Lawyer Member Legal Non-Scientific

Ms. Llmaye M. P. M.S.W. Social Waf Ifef Member Non-Scientific

Dr. Jawle S. M.A .. B.Ed. Ph .D. Educationist, Philosopher Member Non-Scientific

Mrs. Kulkarni S. D. MA. M.Ed . LayPerson Member Non·Sclentific

Alert EC - IEC Independent Ethics Committee

IORG0006110

Acknowledgement Letter

To, Dr. Va rsha , Principa l Investi gator, Indian Institute of Nutritional Sciences, C/o PK Japee & Co "Ankur Manor", 182 EVR Periyar Hi gh Road, Kilpauk, Chennai 6000 I 0

Sub: I Rece ipt of Protoco l

2 Schedule of the Alert EC IEC meeting.

Dear Dr. Varsha,

02.05.2012

I on behalf of Alert EC have received Protoco l, ICF and other documents.

Protoco l Number: HNS-ANDF/2011101 , dated 6th Dec 2011

In fo rmed Consent documents

The meeting of Alert EC will be convened on 23.05.201 2 at 17.30 hrs a t our office address.

It is specified that no subject should be recruited before written ex pressed favorable op inion is documented and communicated by Ethics Committee.

Please make yourself I your representat ive ava ilable in person or on telephone fo r clea ring any queri es that can be raised during meeting and if any explanation is needed.

Thanks & Regards \..-

~~\ <-> ;;;--Dr. Walavalkar K.C. P. Chai rperson Alert EC - IEC

Head Office: Snehal Hospital, Naupada, Gokhale Road, Thane (WI - 400602. Tel.: 25400321 • 1401 , E1, Hyde Park , Near Tulsldham, Thane (WI - 400 610. Tel. : 25892789. Mobile: 9819714755

Dr. Walavalkar K. C. P. M .B.B.S .. M .D. Clinic ian, Pharmacologist Chairperson Scientific

Dr. Padhyegurjar S. B. M.B.B.S .. M.D. (PSM) Clinician, Biostatistician

Vice·Chairman SCienti fic

Dr. Sinha S . R. M .B .B.S .• M.D. Clinician, Pharmacologist Member Secretary Scientific

Dr. Karkhanls R. V. M.B .B.S .. FRCOG Clinician, Gynaecologist Member Scientific

Adv. Vaidya J . A. B.A . L.L.B .. L.L. M. Lawver Member Legal Non-Scientific

Adv. Kulkarni V. V. B.A. , L.L.B. Lawyer Member Legal Non-Scientific

Ms. Limaye M. P. M .S.W. Social Waf ker Member Non-Scientific

Dr. Jawle S . M.A., B.Ed, Ph.D. Educationist, Philosopher Member NonMScientific

Mrs. Kulkarni S . D. M.A, M.Ed. Lay Person Member NonMScientific

Alert EC - IEC Independent Ethics Committee

IORG0006110

Approval Lcttel' 23.05.2012

To, Dr. Yarsha , Principa l Investigato r, Ind ian Inst itute of Nutritional Sciences, C/o PK Japee & Co "Ankur Manor", 182 EYR Peri yar High Road, Ki lpauk , Chennai 6000 10

Subject -Protocol Number: IINS-ANDF/2011 /01, dated 6th Dec 2011

Dear Dr Yarsha, Alert Ethi cs Committee reviewed and discussed your app li cation to conduct the bioequi va lence stud y I C li nica l Tria l entit led " Diabetes In India- Nutrition Guidelines Study (DINGS)."

Protocol Number: IINS-ANDFI2011l01, dated 6th Dec 2011

Alert EC IEC is organized and operates in compliance with guideli nes laid down for ERBs by IC H-GCP, Declarat ion of Hels inki , WHO (World Health Organization), ICMR (Indian Council of Medical Research),Central Drugs Standard Contro l Organi zation and the app li cab le laws and regulations.

The following documents were reviewed.

Document/ Lllnguage Vers ion No. & Date

Protocol Engli sh India Specific version 03 dated 16 Mar 20 12

Case Report Form Print copy of eCRF ( electronic Case Report Forms)

Informed consent Form- DINGS-IC F. ICDI llNS-ANDF/20 11 /0 1, dated English 6th Dec 20 II Informed consent Form Assamese, Bangia, Gujarati , Hindi , Malaya lam,

Marathi , Odia, Punjabi , Tami l,Telugu Principa l In vesti gator CY Dr. Yarsha & Undertaking

In vestigator Reslime & List attached Undertaking Insurance copy To be submitted at the start Of~

' ''~'- ..--. Co."'

:(7~~~~ ~ cna1f1l6isOO ~ ., s- f ..

~~y A'et\~ Head Office: Snehal Hospital, Naupada, Gokhale Road, Thane (W) - 400 602. Tel.: 25400321

• 1401 , E1 , Hyde Park. Near Tulsidham, Thane (W) - 400 610. Tel.: 25892789, Mobile: 98197147 55

Dr. Walavalkar K. C. P. M ,B,B,S" M ,D, Clinician, Pharmacologist Chairperson Scientific

Dr. Padhyegurjar S. B . M,B,B .S" M .D, (PSM) Clinician, Biostatlstic;an

Vice-Chairman Scientific

Dr. Sinha S. R. M ,B,B,S" M,D, Clinician, Pharmacologist Member Secretary Scienti fic

Dr. Karkhanls R. V. M ,B,B,S" FRCOG Clinician, Gynaecologist Member Scientific

Adv. Valdya J . A. B,A , L.L.B" L.L.M. Lawyer Member Legal Non-Scientific

Adv. Kulkarni V. V. B ,A" L.L,B, Lawyer Member Legal Non-Scientific

Ms. Llmaye M. P. M.S.w, Social Worker Member Non-Scientific

Dr. Jawle S. M ,A " B ,Ed , Ph,D, Educationist, Philosopher Member Non-Scientific

Mrs. Kulkarni S. D. M ,A " M ,Ed, LayPerson Member Non-Scientific

Alert EC - IEC Independent Ethics Committee

IORG0006110

Meeting Details The meet ing was held 23,05,201 2 at 17.30 hI's at the Venue: Snehal Hosp ital, Gokhale Rd , Naupada Thane (W), Maharashtra, India 400602 The fo llowing members of the ethics comm ittee attended the meeting and at the time of voting, required quorum was present. This is to con firm that onl y members who are independent of the Investigator and the Sponsor of the trial have voted/provided opinion on the tria l and thus none of the members of study team including Principal Investi gator for above referenced stud y were a part of the voting procedure, List of attendance and voting is attached,

DECISION on Protocol Number: IINS-ANDF/2011/01, dated 6th Dec 2011 and Opinion of the Independent Ethics Committee-We approve the study from ethics point of view, to be conducted in its presented form by the PI along with the foll owing investi gators at the ir respective sites ment ioned below,

Sr. Name of Qualifi Address Name of the Associated No Investigator cation Diabetologistl

Phvdician

I Ms, Rekha

MSc Sp Hospital II East Vell alar Street

Dr. Vamsi Mohan, MO Vamsie Adambakkam,Chennai 600086

2 Dr, Shanti 0 PhD Salem Steel Planl Dr. OThan ikai llathan, Hospital,Selem,636030 Senior Deputy Director Barman Diabetes Specialti es Pvt

3 Ms, Arati B MSc Ltd , Clini c GS Road, Dr. K.K Barman, MD Rukm inigaon, Guwahati

Ms, Anurad ha Barman Diabetes Specialt ies Pvt

4 MSc Ltd , Clini c GS Road , Dr. K.K Barm an, MO B

Rukmi niuaon, Guwahat i

Ms. Va idehi Bhakti Vedanta Hospital , Srishti

5 MSc Sector-I , Bhakti Vedanta Swami Dr. Ameya Joshi , MD Nawathe

Mare, Mi ra Road (E) Mumbai Dr. Ms, Bhopal Memorial Hospital &

6 Swarna Vyas PhD Research Center,C 76, Karond Dr, G, C, Gautam, MD, OM Road, BhoDal 462038

Ms. Yamini Metro Heart Institute with

7 Atri

MSc Multispeciality Hospital Sector 16 Dr. Ajay Beliya MD A, Faridabad, 121 00 I

Dr. Shweta Guru Nanak Hospital, S-43 I ,

8 Rastogi

PhD Gandhi Nagar, Bama (E) MUlllbai- Dr. Vijay Pallekar MD 51

l;tEIi)~ (:-1> - "C' ~ <\:"''0 0

~-(C~irp6 ,) ~ c f50n _, - l.- ~"s.-J l-. 'J-* ",Ii;

-1/&rtEC * Head Office: Snehal Hospital, Naupada, Gokhale Road, Thane (WI - 400 602. Tel. : 25400321

• 1401 , E1 , Hyde Park , Near Tuls ldham, Thane (WI - 400610. Tel. : 25892789, Mobile: 981971 4755

Dr. Walavalkar K. C. P. M.B.B .S .. M .D. Clinician, Pharmacologist Chairperson Scientific

Dr. Padhyegurjar S. B. M.B.B.S., M .D. (PSM) Clinician, Biostatistician

Vice-Chairman Scientific

Dr. Sinha S. R. M.B .B.S ., M .D. Clinician, Pharmacologist Member Secretary Scientific

Dr. Karkhanis R. V. M ,B .B.S .. FRCOG Clinician, Gynaecologist Member Scientific

Adv. Vaidya J. A . B.A . L.L. B., L L.M. Lawver Member Legal Non-Scientific

Adv. Kulkarni V. V. B .A .. L. L. B. Lawyer Member Legal Non-Scientific

Ms. Limaye M. P. M.S.W. Social Wo/ker Member Non-Scientific

Dr. Jawle S. M.A .. B.Ed , Ph .D. Educationist, Philosopher Member Non-Scientific

Mrs. Kulkarni S. D. M .A ., M .Ed . LayPerson Member Non-Scientific

Alert EC - IEC Independent Ethics Committee

IORG0006110

The valid ity of approva l is one year from the date of approval. Appropriate app licab le mandatory regu latory permiss ions be obtained prior to commencement of the study as well as GCP training of the study team members be done before commencement of the study.

The Independent Ethi cs Committee expects to be informed about the followin g which is ob li gatory for PI to report to IEC

I progress - updates of the clin ica l study 2 any SAE occurring in the course of the study in 24 hours 3 any changes - amendments in the protoco l and in fo rmed consent 4 s ignifi cant protocol deviations immed iately

and as ks to be provided a copy of the final report.

Sincerely,

Wj~~ Dr, Walava lkar K.C.P,

Chairperson Alert EC - IEC

Head Office: Snehal Hospital, Naupada, Gokhale Road, Thane (W) - 400 602. Tel. : 25400321 .1401 , E1 , Hyde Park , Near Tulsidham, Thane (W) -400 610 • Tel.: 25892789, Mobile: 9819714755

Dr. Walavalkar K. C. P. M.B.B.S .• M.D. Clinician, Pharmacologist Chairperson Scientific

Dr. Padhyegurjar S. B. M.B.B.S .. M.D. (PSM) Clinician, Biostatistic/an

Vice-Chairman SCientific

Dr. Sinha S. R. M.B.B.S .• M.D. Clinician, Pharmacologist Member Secretary Scientific

Dr. Karkhanls R. V. M.B.B.S .• FRCOG Clinician, Gynaecologist Member Scientific

Adv. Valdya J. A . B.A . L.L.B .• L.L.M. Lawver Member Legal Non-Scientific

Adv. Kulkarni V. V. B.A. . L.L.B. Lawyer Member Legal Non-Scientific

Ms. Llmaye M. P. M.S.W. Social Wal Icer Member Non-Scientific

Dr. Jawle S. M.A .• B.Ed. Ph.D. Educationist, Philosopher Member Non-Scientific

Mrs. Kulkarni S. D. M.A .• M.Ed. LayPerson Member Non-Scientific

Alert EC - lEe Independent Ethics Committee

IORG0006110

List of members present for Alert EC meeting held On 23.05.2012 at 17.30 hrs at Alert EC office.

Sr.No NlI rlu' o f M embt' r l'rucnt I Absen t l Ee l)t'lI i J,t lln tion

1. Dr. Wakwalkar .. K . C. P.

Present Chairperson

IM.B.U.S, M.D. (Medical, Scientific) (Pharmocolo2V) 1

2. Dr. Padhycglljar S. B. I'ruc"' Vice-Chairperson

M.B.Il.S , M.D. (Medical. scientific)

1. Dr. Karkhanis R. V. Prncnl (Medical, scientific) M.D. lIS, DGO.DRCOG. FRCOG

4. Dr. Sinha S.R.

" resen t Member Sccrclnry

M.Il .il.S, M.D. (Medical. scientific)

5. Aelv.Kulkarni V.V. (' resent Member

B.A,L. L.B (Le8,1)

"elv Vaidya J.A AbSl'nt

Member 6 IlA.L.L.B. {Lega l }

Dr. Jawlc S Member

7. I'resent (Non-medical , M .A .,B .Ed.,Ph.D Non-scientific)

Ms. Limayc M . r. Member 8. I' resent (Non-medic'll,

[M.S.w. j NOll-scientific)

Mrs. Ku lkarni. S. D. Member

9. I' n.-sent (Non-medica l. M.A.M.cd

NOll-scientific)

Head Office: Snehal Hospital, Naupada, Gokhale Road, Thane (WI - 400602. Tel.: 25400321 .1401 , E1 , Hyde Park, Near Tulsldham, Thane (WI -400 610 .Tel.: 25892789. Mobile: 9819714755

Alert EC IEC Independent Ethics Committee Meeting

Date & Time: 2.3-os- 2012- Protocol From: A bhO/r-tVu/...-i.;p;{t2:!' ~ /7'']0 H7'" A

Venue:Snehal Hospital,Gokhale Rd, Protocol No.: Naupada, Thane(w) 400602 /1i'lS./1NDF!2oll/0! ,c/,J;,J .

6 11. /;kc 2Ci1l '--

I ~: I N,m"'M,mb"

Voting Approval AlertECIEC Member Vote Signature Designation Present!

For Against and Date

Absent .2'301,--2,,/J

1 Dr Walavalkar K. C. P.

P -k·Sj (M,B,B.s., M.Il. Chairperson 'V (Pharmacology)!

2 Dr Padbyegujar S. B.

Vice Chairperson p ~ ~ M.B,B,S.; M.D. (p.S.M.)

~ '5' 3 Dr Karkhanis R.V. Member ~1 ,/ '~ ;;/7 M,RB,S" F,R.CO.G.

- -

4 Dr Sinha S.R. p. V- ~ M.B,RS., M.D. Member Secretary (Pharmacology)

5 Adv.Kulkarni V.V. Legal Member f V V,V,~' B,A., LL.B.

6 Adv. Vaidya J.A. Member B.A, LL.B. t\ -- --------~----'

7 Dr Jawle S.S.

Member· J t.Secretary p V ,m M,A.,B,Ed" Ph.D.

8 LimayeM.P.

Member· J t.Secretary p V rt\.Lf'~~ (M.s.W.J

Kulkarni S. D. r V Sj).k.'v-~-9 M,A"M.Ed, Member

Remark(S):,.......;,f\r..:..u.t_~~_~-c._-_\ __________ ._-'-_____ _

~e~ ~\o--~~ Dr. K.C.P.Walavalkar Chairperson AlertEC IEC

fC