Draft New Drugs and Clinical Trials (Amendment) Rules, 2021

The Central Government through notification dated 2nd August, 2021 has issued draft amendment to the New Drugs and Clinical Trials Rules, 2019. The amendment has revised Form CT-03 in which Registration certificate of Ethics Committee related to biomedical and health research shall be granted. The amendment provides that the registration may be granted by any Designated Registration Authority and not Central Licensing Authority.

Objections and suggestions from the stakeholders, if any, shall be emailed to the official mail id of the ministry.

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