Draft Proposal for amendment under Rule 89 of Drugs Rules 1945, for obtaining licence under Form 29 for different categories falling under Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-22042026-271969 EXTRAORDINARY PART II-Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 275] NEW DELHI, TUESDAY, APRIL 21, 2026/VAISAKHA 1, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 21st April, 2026. G.S.R. 299(E). — The following draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or emailed at [email protected]. DRAFT RULES 1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2026. (ii) They shall come into force after the 3 months of publication of the final rules in the Official Gazette. 2. In the Drugs Rules, 1945, under rule 89, the words “Form 25 or Form 28" shall be substituted with the words "Form 25 or Form 25A or Form 25F or Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA or Form 28F". [F. No. X.11014/03/2026-DR] HARSH MANGLA, Jt. Secy. Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45-H (1) dated 21st December, 1945 and last amended vide notification number G.S.R.... (E), dated.... Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.