Section 122DA(5) in The Drugs and Cosmetics Rules, 1945
(5)The Ethics Committee shall however inform the licensing authority about the cases approved by it and also about cases where there could be an overlap between the clinical trial for academic and regulatory purposes and where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.] [Inserted by Notification No. G.S.R. 313(E), dated 16.3.2016 (w.e.f. 21.12.1945).]
