The draft of the rules 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. 299(E), dated April 21, 2026, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i). Objections and suggestions were invited from persons likely to be affected, before expiry of thirty days from the date the Gazette copies containing the said notification were made available to the public. Copies of the said Gazette were made available to the public on April 22, 2026. Objections and suggestions received from the public on the draft rules were considered by the Central Government. The Central Government, after consultation with the Drugs Technical Advisory Board, made the rules further amending the Drugs Rules, 1945.

The rules are titled the Drugs (Twelfth Amendment) Rules, 2026. In rule 89 of the Drugs Rules, 1945, the words and figures “Form 25 or Form 28” are substituted with the words, figures and letters “Form 25 or Form 25A or Form 25F or Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA or 28E or Form 28F”. The amendment applies to rule 89 of the Drugs Rules, 1945. The Drugs Rules, 1945 were originally published vide notification No. F. 28-10/45H(1), dated December 21, 1945, and were last amended vide notification G.S.R. 706(E), dated July 30, 2026.

“In the Drugs Rules, 1945, in rule 89, for the words and figures “Form 25 or Form 28” the words, figures and letters “Form 25 or Form 25A or Form 25F or Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA or 28E or Form 28F” shall be substituted.”