New Drugs and Clinical Trials (Third Amendment) Rules, 2022


The Department of Health and Family Welfare vide notification dated 14th October, 2022 has issued the New Drugs and Clinical Trials (Third Amendment) Rules, 2022. The amendment provides that when an application for registration of ethics committee for clinical trials is submitted and where no communication has been received from the Central Licensing Authority within the period of forty-five working days, the registration of Ethics Committee shall be
deemed to have been granted by the Central Licensing Authority.

The registration shall be deemed to be legally valid for all purposes and the applicant shall be authorized to initiate clinical trial in accordance with the rules.

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