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: To view the official gazette notification, click the link below:
Disclaimer: This website is designed for healthcare professionals and serves solely for informational purposes.
The content provided should not be interpreted as medical advice, diagnosis, treatment recommendations, prescriptions, or endorsements of specific medical practices. It is not a replacement for professional medical consultation or the expertise of a licensed healthcare provider.
Given the ever-evolving nature of medical science, we strive to keep our information accurate and up to date. However, we do not guarantee the completeness or accuracy of the content.
If you come across any inconsistencies, please reach out to us at
admin@doctornewsdaily.com.
We do not support or endorse medical opinions, treatments, or recommendations that contradict the advice of qualified healthcare professionals.
By using this website, you agree to our
Terms of Use,
Privacy Policy, and
Advertisement Policy.
For further details, please review our
Full Disclaimer.
0 Comments
Post a comment
No comments yet. Be the first to comment!