Notification regarding Amendment under Drugs Rules to include more categories under Schedule H2

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-25062026-273811 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 455] NEW DELHI, MONDAY, JUNE 22, 2026/ASADHA 1, 1948 4613 GI/2026 (1) 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II-SEC. 3(i)] MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 22nd June, 2026 G.S.R. 506(E). - Whereas a draft of certain rules further to amend the Drugs Rules, 1945 was published, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 757 (E), dated the 16th October, 2025, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; Whereas, copies of the said Gazette were made available to the public on the 18th October, 2025; [PART II-SEC. 3(i)] 3 And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely: 1. (1) These rules may be called the Drugs (Seventh Amendment) Rules, 2026. (2) These rules shall come into force on the 1st day of July, 2027, except serial number 2 in Table 2 of clause (b) of rule 2, which shall come into force on the 1st day of July, 2028. 2. In the Drugs Rules, 1945, in Schedule H2, — (a) the Table shall be numbered as "Table 1". (b) after the Table 1 as so numbered, the following Table shall be inserted, namely: — "Table 2 Serial Number | Therapeutic Category of drug formulations 1. | All Vaccines 2. | All Antimicrobials 3. | All Narcotic Drugs and Psychotropic Substance, listed under the Narcotic Drugs and Psychotropic Substance Act, 1985 and rules made thereunder 4. | All Anticancer drugs.". [F. No. X.11014/07/2025-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 the 21st December, 1945 and last amended vide notification number G.S.R. 496(E), dated 18th June, 2026. 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. KUMER CHAND MEENA Digitally signed by KUMER CHAND MEENA Date: 2026.06.25 10:20:43 +05'30"