The Ministry of Health and Family Welfare has published draft rules proposing significant amendments to the Drugs Rules, 1945, to formally incorporate the regulatory oversight of modern biological therapies, including Cell and Stem Cell derived products, Gene therapeutic products, and Xenografts.
The proposed amendment, titled the Drugs (… Amendment) Rules, 2025, integrates these advanced categories into the established regulatory framework currently governing Recombinant DNA (r-DNA) derived drugs.
Expansion of Regulatory Scope
The draft rules seek to ensure that products related to cutting-edge therapies are subjected to the same manufacturing and distribution standards as other high-risk biological drugs. The core changes involve updating existing rules and associated forms:
Rule 75 (3) and 75A (1A)
These rules, which cover the manufacturing and testing of specified biological products, will be amended to include the new categories. The original text referring only to “Recombinant DNA (r-DNA) derived drugs” will be expanded to encompass “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts, etc.”.
Rules 76 and 76A
These rules, which deal with the grant of manufacturing licenses, will also see the same substitution, bringing the new therapy classes under their direct purview.
Licensing Forms (27D, 27DA, 28D, 28DA)
The titles and content of all forms related to applications for the manufacture, sale, and distribution of these specialized drugs will be amended. The title currently referencing “Recombinant DNA (r-DNA) derived drugs” will be substituted with a combined title: “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS/ GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS, ETC.”
This regulatory update reflects the need to adapt the 1945 rules to the rapid advancement of modern medicine, ensuring patient safety and quality control for these complex biological products.
Public Consultation
The draft rules are now open for public feedback. The Central Government is soliciting objections and suggestions from all affected persons.
The draft rules will be taken into consideration on or after the expiry of a period of thirty days from the date the official Gazette copies (published on October 16, 2025) are made available to the public.
Objections and suggestions may be addressed to the Director (Drugs regulation), Ministry of Health and Family Welfare, or emailed to drugsdiv-mohfw@gov.in.