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Centre to amend Clinical Trial Rules to replace approving authority for ethics committee on biomedical research

Our Bureau, New Delhi
Wednesday, August 4, 2021, 08:00 Hrs  [IST]

The department of health and family welfare has come out with a notification with draft rules for the New Drugs and Clinical Trials Rules, 2019, to replace the approving authority to Designated Registration Authority, as against the existing Central Licensing Authority as the authority to approve the registration of ethics committee in biomedical health research.

According to the notification, in the New Drugs and Clinical Trial Rules, 2019, in Eighth Schedule, in the form in which the grant of registration of ethics committee relating to biomedical health research is stipulated, the signing authority will be a designated registration authority.

It may be noted that the signing authority for the other forms still remain to be the Central Licensing Authority, according to a copy of the New Drugs and Clinical Trial Rules, 2019.

The draft notified by the Department this week also removes the “Regulation of” from the Regulation of New Drugs and Clinical Trials Rules, 2019, mentioned in the same form. The principal rules were published in the Gazette of India through notification on March 19, 2019.

The suggested changes have been made in consultation with the Drugs Technical Advisory Board. The notification added that the said draft rule shall be taken into consideration on or after the expiry of a period of 45 days from the date on which the draft rules are notified through the Gazette of India.

Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), ministry of health and faimily welfare, New Delhi or through email, it added.


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