https://www.taxtmi.com/caselaws?id=289578 Clinical trials of new chemical entities were to continue under the prescribed procedure in Schedule Y of the Drugs and Cosmetics Rules, 1945, while strengthened regulatory measures under GSR 53(E), GSR 63(E) and GSR 72(E) were treated as applicable safeguards. Pending trial approvals were to be examined through the institutional mechanisms placed before the Court, with further scrutiny directed where informed consent required proper recording and preservation. The Court also permitted intervention by a pharmaceutical body and required further affidavits, stakeholder consultation, and reconsideration of pending approvals under continuing regulatory supervision. en-us Mon, 16 Dec 2013 00:00:00 +0530 Fri, 07 Aug 2020 10:09:55 +0530 TaxTMI RSS Generator https://www.taxtmi.com/caselaws?id=289578 Clinical trials of new chemical entities were to continue under the prescribed procedure in Schedule Y of the Drugs and Cosmetics Rules, 1945, while strengthened regulatory measures under GSR 53(E), GSR 63(E) and GSR 72(E) were treated as applicable safeguards. Pending trial approvals were to be examined through the institutional mechanisms placed before the Court, with further scrutiny directed where informed consent required proper recording and preservation. The Court also permitted intervention by a pharmaceutical body and required further affidavits, stakeholder consultation, and reconsideration of pending approvals under continuing regulatory supervision. Case-Laws Indian Laws Mon, 16 Dec 2013 00:00:00 +0530 https://www.taxtmi.com/caselaws?id=289578