After making the registration of Ethics Committees attached with the Clinical Trial Organisations (CROs) for conducting clinical trials mandatory in the country, the Central Drugs Standard Control Organization (CDSCO) has introduced a system for the pre-screening of the applications for registration of Ethics Committee.

This system of preliminary scrutiny to determine the acceptability of the application for registration of ethics committee will come into effect from from February 25, 2013.

This system is being introduced by the CDSCO to streamline the submission of application for registration of Ethics Committee and their examination as per Rule 122DD.  This preliminary scrutiny of applications at the time of receipt will determine their acceptability for examination by the CDSCO.

Earlier, the union health ministry had amended the Drugs & Cosmetics Rules by vide GSR no. 72 (E) dated 08-02-2013 inserting a Rule 122DD, in Schedule ‘Y’ along with other amendments. The amendment specifies the detail procedures for the registration of Ethics Committees.

As per Rule 122DD, no Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with DCGI. An application for registration of Ethics Committee shall be made to the DCGI in accordance with the requirements as specified in the Appendix VIII of Schedule Y.

The preliminary scrutiny of the applications will be done by CDSCO officers based on laid down checklist.  During the preliminary examination, the CDSCO officers will scrutinize the application to ensure that it contains all the required administrative as well as technical information in proper manner as per the checklist. If the applications are not submitted in accordance with the format and the checklist, it will not be accepted by CDSCO for further examination.  Once an application is accepted, the information in the application will be reviewed by CDSCO as per the specified procedures.

Earlier this month,  registration of Ethics Committees attached with the CROs for conducting clinical trials has been made mandatory in the country by the health ministry.  

The Ethics Committee will review every clinical trial proposal and evaluate the possible risks to the subjects, expected benefits and adequacy of documentation for ensuring privacy, confidentiality and justice. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyse and forward its opinion as per procedures specified in Appendix XII of Schedule Y.