Clinical trial regulation tightened with continued scrutiny, informed consent safeguards, and reconsideration of pending approvals.

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.

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Issues: Regulation of clinical trials, including interim supervision of new chemical entity trials, evaluation of approvals already granted, and the need for safeguards such as informed consent recording and compliance monitoring; permissibility of intervention by a pharmaceutical body.

Analysis: The Court, during the course of successive interim orders, accepted the Government's statements that clinical trials of new chemical entities would proceed under the prescribed procedure in Schedule Y of the Drugs and Cosmetics Rules, 1945, that regulatory measures had been strengthened through GSR 53(E), GSR 63(E) and GSR 72(E), and that pending approvals would be examined through the institutional mechanisms placed before the Court. The Court also accepted that additional safeguards were required for certain approvals, including proper recording and preservation of the informed consent process, and permitted intervention in the proceedings.

Outcome: Interim directions were issued for continued regulatory scrutiny, further affidavits, stakeholder consultation, and reconsideration of pending clinical-trial approvals. The matter was kept pending for further hearing.

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