Drugs and Cosmetics Rules, 1945 amended for registration of Ethics Committees for Clinical Trials

The Drugs and Cosmetics Rules, 1945 have been amended vide Notification G.S.R No. 72(E) dated 8.2.2013 incorporating Rule 122DD and amending the Appendix VIII of Schedule Y for registration of Ethics Committee. This amendment provides details about the functioning of the Ethics Committee as well as the requirements and guidelines for their registration. The constitution and composition of Ethics Committee will be as per the provisions laid down in the Rule.

As per Rule 122DD, no Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Drugs Controller General (India) [DCG(I)]. The Ethics Committee shall review and accord its approval to a clinical trial and also carry out review of the trial at appropriate intervals, as specified in Schedule Y and the Good Clinical Practice (GCP) Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding the rights, safety and well- being of the trial subjects. The Ethics Committee shall allow Inspectors or officials authorised by the DCG(I) to inspect their facilities, records, documents etc. If the Ethics Committee fails to comply with any of the conditions of registration, DCG (I) may suspend or cancel the registration of the Ethics Committee.

So far, no such casesofcontravention, of the aforesaid Rule 122DD have been reported.


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