Spandan-Independent Ethics Committee Spandan . lEe

8 -5. Siddhi Sarjan Appt ., Nr. Seema Hall, Anandnagar, Satellite, Ahmedabad-380 015 . E-mail : spandaniec@gmail.com

Date: 13 th May 2013 Ref No: SIEC/AL/05-13/005 To, Dr. Akhil Mukim, ALL WELL Mukim Medical Nursing Home & Heart Clinic 235, Platinum Plaza, Judges Bunglow Road, Vastrapur, Ahmedabad - 380015, Gujarat, India

Dear Dr. Akhil Mukim,

Subject: Review and approval of Protocol entitled "A Randomized, Open-label, Balanced, Two­period, Two-treatment, Two way Cross-over Study For Studying the Absorption of Test Product: D-LIGHTTM (Vitamin 03 Oral Spray) in comparison with Reference Product: Uprise-D, (Vitamin 03 Capsule 1000 IU) In Healthy and Unhealthy Subjects Under Fed Conditions After One Month Dose Administrations."

Protocol No: ECTS/13/003, Version No. 01; Dated 13 APR 2013

In response to your letter dated 20-Apr-2013 for review and approval of above referred clinical study documents, Spandan - Independent Ethics Committee conducted a meeting for review of Protocol the meeting was held on Saturday, 11-May-2013, 5:00 pm at B-5, Siddhi Sarjan Appt., Near Seema Hall, Anandnagar, Satellite, Ahmedabad - 15 in which the following Quorum of members was present:

I. Dr. Gaurav Chhaya - Deputy Chairperson 2. Mr. Milan Rachh - Pharmaceutical Scientist/Member Secretary 3. Dr. Bhoomika Patel - Pharmacologist 4. Mr. Manish Shah - Lay Person 5. Mrs. Arunaben Shah - Legal Advisor 6. Dr. Gopal Bhatt - Social Scientist

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Following documents, as per the regulatory requirements were reviewed:

Sr. No. Documents Version No. / Date

1. Study Protocol - ECTS113/003 01 / 13 APR 2013

2. Investigator Brochure or Prescribing Information -

Informed Consent Form - English 00 / 18 APR 2013

3.

Informed Consent Form - Gujarati

(Translated from English to Gujarati On 19 APR 2013)

00/18 APR 2013

Informed Consent Form - Hindi

(Translated from English to Hindi On 19 APR 2013)

00/18 APR 2013

4. Screening Case Report Form 00/19APR2013

5. Case Report Form 00/19 APR 2013

6. Subject diary 00/19 APR 2013

7. Protocol Approval and Consent From Investigator,

Undertaking by the Investigator, CV and MRC of

Investigators -

8. Insurance Certificate -

All of the above documents were reviewed, and conditional approval was given to the study

under consideration. The following suggestions/recommendations for alterations to study

Protocol under consideration were made by Spandan - Independent Ethics Committee members:

1. Product Brochure of Inhaled drug need to submit.

2. Typographical error in page no. 8 of 40 (consume in place of assume).

3. BP range to be specified for uncontrolled hypertension in exclusion criteria.

Based on the favorable opinion given by Spandan - IEC members who participated in the meeting

Spandan - Independent Ethics Committee grants conditional approval to the conduct of the proposed

clinical study at Site of: Dr. Akhil Mukim, ALL WELL, Mukim Medical Nursing Home & Heart

Clinic, 235, Platinum Plaza, Judges Bunglow Road, Vastrapur, Ahmedabad - 380015, Gujarat, India

subject to following conditions of compliance:

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I. That the study will be conducted in full compliance to good clinical practice guideline

and applicable regulatory requirements,

II. The Spandan - lEC shall do a continuing review of the progress of the trial, for which

you will provide periodic updates on the progress of the same as a part of your

responsibility at every 6 months and yearly summary report.

iii. The Spandan - lEC shall provide, according to the applicable regulatory requirements,

expedited review and approval/favorable opinion on minor change(s) in the trial during

the course of its conduct, if required,

IV. That no deviation from, or changes in, the protocol would be initiated without written

Spandan - IEC approval/favorable opinion of an appropriate amendment, except when

necessary to eliminate immediate hazards to the subjects or when the change(s) involve

only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone

number(s))

v. That you would promptly report to the Spandan - lEC: (a) deviation from, or changes in,

the protocol to eliminate immediate hazard to the trial subject, (b) changes increasing the

risk to subject and/or significantly affecting the conduct of the trial, (c) all adverse events

including, serious and unexpected, and (d) new information that may adversely affect the

safety of the subjects or the conduct of the trial, and

vi. That the Spandan - IEC would promptly notify in writing the investigator/institution

concerning: (a) its trial related decisions/opinions, (b) the reason for its

decisions/opinions, and (c) procedures for appeal on its decisions/opinions.

VII. That Spandan - IEC shall be submitted a copy of Final Study Report

Best regards, ~

C~~<~ Dr. Gaurav Chhaya, Deputy Chairperson,

Spandan - IEC

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Spandan-Independent Ethics Committee Spandan • lEe

8-5, Siddhi Sarjan Appt.. Nr. Seema Hall , Anandnagar, Satellite, Ahmedabad-380 015 . E-maIl: spandaniec@gmail.com

Date: 14th May 2013 Ref No: SIEC/ALl05-13/012

To,

Dr. Akhil Mukim, ALL WELL Mukim Medical Nursing Home & Heart Clinic 235, Platinum Plaza, Judges Bunglow Road,

Vastrapur, Ahmedabad - 380015, Gujarat, India

Dear Dr. Akhil Mukim,

Subject: Review and approval of amendment for Protocol entitled "A Randomized, Open-label ,

Balanced, Two-period, Two-treatment, Two way Cross-over Study For Studying the Absorption

of Test Product: D-LIGHTTM (Vitamin 03 Oral Spray) in comparison with Reference Product:

Uprise-D) (Vitamin 03 Capsule 1000 IV) In Healthy and Unhealthy Subjects Under Fed

Conditions After One Month Dose Administrations,"

Protocol No: ECTSI13/003, Version No. 01; Dated 13 APR 2013

In response to your letter dated 13-May-20 13 for review and approval of above referred clinical

study amendment, Spandan - Independent Ethics Committee Deputy Chairperson carried out

expedited review for the Protocol amendment.

Protocol amendment no. 01 dated is" May 2013 was reviewed by Deputy Chairperson, Dr.

Gaurav Chhaya and given expedited approval for continuation of the study.

Based on the favourable opinion given by Deputy Chairperson, Spandan - lEC grants approval to

the conduct of the proposed clinical study at Site of: Dr. Akhil Mukim, ALL WELL, Mukim

Medical Nursing Home & Heart Clinic, 235 , Platinum Plaza, Judges Bunglow Road , Vastrapur,

Ahmedabad - 380015, Gujarat, India subj ect to conditions of compliance as stated in the

approval letter dated n" May 2013, Ref No.: SIEC/AL/05-13/005

Best regards,

c,-~c,~~rn~\~ Dr. Gaurav'C h aya, ()../

Deputy Chairperson,

Spandan - lEC

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