The Ministry of Health and Family Welfare (MoH&FW) on June 30, 2026, notified the Drugs (Eighth Amendment) Rules, 2026, further to amend the Drugs Rules, 1945.
The following has been stated:-
•The amendment to the Drugs Rules, 1945, expands the regulatory framework to include Cell or Stem Cell-derived products, Gene therapeutic products, and Xenografts alongside Recombinant DNA (r-DNA) derived drugs.
•It revises Rules 75, 75A, 76, and 76A to extend licensing and regulatory provisions to these additional categories of biological products.
•Corresponding amendments have been made to Schedule A by updating the headings and contents of Forms 27D, 27DA, 28D, and 28DA.
•The changes ensure that these advanced therapeutic products are subject to the same manufacturing and licensing requirements as r-DNA-derived drugs.
•Overall, the amendment broadens the scope of the existing regulatory regime to cover emerging biotechnology-based therapies.
These rules shall come into force on July 02, 2026.
The detailed notification is given in the document below.
[Notification No.: G.S.R. 530(E)]
