Govt to amend New Drugs & Clinical Trials Rules

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Govt of India

Last Updated on November 2, 2021 by The Health Master

Download Notification: In a move to keep in tune with the growing new drug research and development trends in the industry, the Union health ministry has issued a draft notification GSR 767(E) dt 27-10-2021 to amend the New Drugs and Clinical Trials Rules, 2019 to add cell derived products under the definition of new drug, along with stem cell products.

The principal New Drugs and Clinical Trials Rules was published in the Gazette of India through a notification No. GSR 227 (E) dt 19-03-2019.

In the Rules, under the definition of new drugs, the government has included “a vaccine, recombinant deoxyribonucleic acid (r-DNA) derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug.” These drugs will always be deemed to be new drugs, it explains.

In the draft notification, the Ministry has proposed to amend this rule, and for the words “stem cell derived products,” the words “cell or stem cell derived product,” will be substituted once the draft proceeds to final notification.

The draft rules shall be taken into consideration on or after the expiry of 45 days from the date of its publication in the Gazette of India.

It has also invited objections and suggestions within the timeframe, which will be considered by the Central government.

Cell-based products have been considered as the advanced therapy methods and have the potential to change the natural ways of some of the deadly diseases, including cancers and chronic inflammatory diseases, according to experts.

Cells and derivatives can be better delivery agents of drugs, compared to synthetic carriers.

For instance, they can deliver drugs to targets which cannot be penetrated by synthetic methods, they say.

They also increase the efficacy and circulation time of these drugs in the body. This is also expected to benefit the personalised treatment and improve the chances of saving human lives.

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