Section 122DD(1) in The Drugs and Cosmetics Rules, 1945
(1)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:Provided that any Ethics Committee, existing on the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013, who has already reviewed and accorded approval to clinical trial protocol, shall obtain registration within a period of forty-five days from the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013.
