Draft of these rules, further amending the Drugs Rules, 1945, was published under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 vide notification G.S.R. 758(E) dated 16th October, 2025, inviting objections and suggestions from persons likely to be affected within thirty days of the Gazette copies being made available to the public. The Gazette copies were made available to the public on 18th October, 2025, and no objections or suggestions were received on the draft rules. The Central Government, in exercise of powers under sections 12 and 33 of the Act, and after consultation with the Drugs Technical Advisory Board, makes the Drugs (Eighth Amendment) Rules, 2026, effective from the date of publication in the Official Gazette.

The amendments to the Drugs Rules, 1945 insert or substitute references to “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts” alongside existing references to “Recombinant DNA (r-DNA) derived drugs,” as follows: in rule 75, sub-rule (3) — insertion after the existing phrase; in rule 75A, sub-rule (1A) — insertion after the existing phrase; in rule 76 — substitution of the phrase wherever it occurs; in rule 76A — substitution of the phrase. In Schedule A: Form 27D, Form 27DA, Form 28D, and Form 28DA are each amended by substituting the heading to read “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS,” and by inserting “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” after the existing phrase within each form.

The Drugs Rules, 1945 were published vide notification No. F. 28-10/45H(1) dated 21st December, 1945, and were last amended vide notification G.S.R. 506(E) dated 22nd June, 2026. This amendment applies to manufacturers, importers, and other persons dealing with Recombinant DNA-derived drugs, Cell or Stem Cell derived products, Gene therapeutic products, or Xenografts, and to the licensing forms specified above.