India to Regulate Cell and Gene Therapies Under Drug Licensing Rules
New Delhi: In a significant regulatory move, the Ministry of Health and Family Welfare (MoHFW) has proposed amendments to the Drugs Rules, 1945, to expand the scope of India's biotechnology drug regulation framework by bringing cell- and gene-based therapies under the licensing and oversight provisions currently applicable to recombinant DNA (r-DNA)-derived drugs.
This draft of certain rules that the Central Government proposes came in exercise of the powers conferred by subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board.
Published through a Gazette notification (G.S.R. 758(E)) dated October 16, 2025, the draft Drugs (Amendment) Rules, 2025, seek to update several key provisions—Rules 75, 75A, 76, and 76A, as well as Forms 27D, 27DA, 28D, and 28DA—to explicitly include:
“Cell- or Stem Cell derived products, Gene therapeutic products or Xenografts, etc.”
In line with the above, it is proposed that cell-based therapies, stem cell–derived products, gene therapy medicines, and xenografts will now be treated on par with r-DNA drugs, requiring manufacturing and import licenses, good manufacturing practice (GMP) compliance, and regulatory approval from the Drugs Controller General of India (DCGI) before being introduced into the market.
The Ministry has invited public objections and suggestions within 30 days from the publication date, addressed to the Director (Drugs Regulation), MoHFW, at Room No. 407, A-Wing, Nirman Bhavan, New Delhi–110011, or by email to drugsdiv-mohfw@gov.in
According to the gazette notification, the draft rules stated:
1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025.(ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.2. In the Drugs Rules, 1945, under the sub-rule (3) of rule 75, after the words “Recombinant DNA (r-DNA) derived drugs,” the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts, etc.” shall be inserted.3. In the Drugs Rules, 1945, under the sub-rule (1A) of rule 75A, the words “Recombinant DNA (r-DNA) derived drugs” shall be substituted with the words “Recombinant DNA (r-DNA) derived drugs’, ‘Cell or Stem Cell derived products’, ‘Gene therapeutic products or Xenografts’, etc.”.4. In the Drugs Rules, 1945, under the rule 76 and 76A, wherever the words “Recombinant DNA (r-DNA) derived drugs” occurred shall be substituted with the words “Recombinant DNA (r-DNA) derived drugs, Cell or Stem Cell derived products, Gene therapeutic products or Xenografts, etc.”.5. In the Drugs Rules, 1945, under the title of Form 27D, Form 27DA, Form 28D and Form 28DA, the words “RECOMBINANT DNA (R-DNA) DERIVED DRUGS” shall be substituted with the words “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS/ GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS, ETC.”.6. In the Drugs Rules, 1945, under the para 1 of Form 27D, Form 27DA, Form 28D and Form 28DA, the words “Recombinant DNA (r-DNA) derived drugs” shall be substituted with the words “Recombinant DNA (r-DNA) derived drugs/ Cell or Stem Cell derived products/ Gene therapeutic products or Xenografts, etc"
To view the official gazette notification, click the link below:
