Last Updated on October 14, 2024 by
Download the notification: The Union health ministry has issued a final notification amending the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to add cell derived products under the definition of new drug, along with stem cell derived products, vide notification GSR No. 14(E) dated 13-01-2022.
This is in tune with the regulatorโs efforts to be with the growing new drug research and development trends in the industry.
In the rules, under the definition of “new drugs,” the government has the provision for โa vaccine, recombinant deoxyribonucleic acid (r-DNA) derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product, or xenograft intended to be used as a drugโ to be considered as a new drug.
It explains that these drugs will always be deemed new drugs.
The Ministry has now amended this rule, and for the words โstem cell derived products,โ the words โcell or stem cell derived product,โ are substituted.
The rules are called the New Drugs and Clinical Trials (Amendment) Rules, 2022.
The draft rule for the same was published on October 27, 2021, to 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.
In the notification issued on January 13, 2022, the ministry said that the objections and suggestions received from the public on the draft rules have been considered by the Central Government.
Cell-based products have been considered the most advanced therapy methods and have the potential to change the natural ways of some of the most 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 that 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 personalized treatment and improve the chances of saving human lives.
The principal New Drugs and Clinical Trials Rules were published in the Gazette of India thru a notification on March 19, 2019.
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