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:-

Click here to Download the Document

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

Click here to Download the Document

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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•     Guidelines Document
  
  1. CDSCO GCP Guidelines  
•     Sugam User Manual
•     FAQ
•     Checklist Documents
  1. Undertaking Format 
  2. Check-List_Regsitration
  3. Check-List_Re-Regsitration