CBP IEC has been constituted under SVKM’s Shri. C. B. Patel Research Centre. It has been constituted to review, evaluate & approve BA/BE studies protocols. The CBP IEC is constituted under the guidelines of ICMR and World Health Organization, Operational Guidelines for Ethics Committees that Review Biomedical Research, 2000 and Schedule Y of Drugs and Cosmetics Rules, 1945.
This committee is registered under U. S. Department of Health and Humans Service (HHS), Registration number being IORG0008389 and IRB00010057.
This committee is registered under Drugs Controller General (lndia) New Delhi DCG (I), Registration number being ECR/112/Indt/MH/2013.
The Ethics Committee shall review and approve the study protocols and related documents of Bioavailability/Bioequivalence studies of the approved drug molecules & also carry ongoing such studies.
The CBP IEC is consisting of members who are qualified and experienced to review and evaluate the scientific, medical and Ethical aspect of a proposed research project. The committee is established and functions in accordance with the relevant national law and regulations in force from time to time.
CBP IEC have a chairman, the member secretary and members nominated by the Director.
The composition of IEC
- One/ two persons from basic medical science area
- One / two clinicians from various institutes
- One legal expert.
- One social scientist/ representative of non-governmental agency
- One person from basic science person
- One lay person from community
- One non-scientific person
- Member Secretary
- No senior administrative officer of the institution should be a member.
- An office and office staff should be available for the secretary of the IEC.
- No outside member of the IEC should be connected with the institution or research project in any way.
Till date, we have approved several protocols for a number of MNC’s.