Amendments to Drugs and Cosmetics Rules were published vide G.S.R.72 (E) dated 08.02.2013 specifying the requirements and guidelines for registration of Ethics Committee and re-registration under Rule 122DD to the Drugs and Cosmetics Rules 1945.

For the purpose of the Rule 122DD, an Ethics Committee is a committee comprising of medical, scientific, non-medical and nonscientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedure specified under APPENDIX XII of Schedule Y.

The Ethics Committee shall allow inspectors or officials authorized by the Central Drugs Standard Control Organization to enter its premises to inspect any record, data or any document related to clinical trial and provide adequate replies to any query raised by such inspectors or officials, as the case may be in relation to the conduct of clinical trial.

If the Ethics Committee fails to comply with any of the conditions of registration, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the registration of the Ethics Committee for such period as considered necessary.

Ethics Committee division deals with the applications seeking registration, re-registration and post approval changes of Institutional Ethics Committee. No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Licensing Authority as defined in clause (b) of Rule 21.

An application for registration of Ethics Committee shall be made to the Licensing Authority in accordance with the requirements as specified in the Appendix VIII of Schedule Y.

The Licensing Authority after being satisfied that the requirements have been complied with, may grant registration to the Ethics Committee subject to such conditions as may be stated therein.

The registration of Ethics Committees is valid for a period of three years. The re-registration applications need to be made within 3 months before the expiry of registration. Registration remains deemed continued unless otherwise orders are passed or until the registration is Suspended or Cancelled. Accordingly applicant shall apply to CDSCO for re-registration as per checklist.

Checklist of Documents for Registration of Ethics Committee can be downloaded from:-

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Checklist of Documents for Re-registration of Ethics Committee can be downloaded from:-

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Note: CDSCO is also encouraging the online applications for registration and re-registration of Ethics Committees through SUGAM - An e-Governance solution for CDSCO. Details of SUGAM registration and subsequent Ethics Committee registration procedure are available on https://cdscoonline.gov.in/CDSCO/homepage

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