Notification regarding restriction of sale of drug products containing alcohol content under the Drugs Rules, 1945

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-09072026-274311 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 549] NEW DELHI, THURSDAY, JULY 9, 2026/ASHADHA 18, 1948 5167 GI/2026 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 8th July, 2026 G.S.R. 607(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. 760 (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; And whereas, copies of the said Gazette were made available to the public on the 18th October, 2025; And whereas, no objections and suggestions received from the public on the said draft rules; 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. (i) These rules may be called the Drugs (Tenth Amendment) Rules, 2026. (ii) They shall come into force after the 6 months of publication of these rules in the Official Gazette. 2. In the Drugs Rules, 1945, — (i) in Schedule K, under the heading Extent and Conditions of Exemptions, against the serial no. 10, after the words "Act and rules thereunder", the words, figures, symbols, letters and brackets “except for all oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.”, shall be inserted; (ii) in Schedule H1, after the entry "51. Pregabalin", the following entry shall be inserted, namely: - "52. All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.". [F. No. X.11014/07/2025-DR-Part(3)] HARSH MANGLA, Jt. Secy. Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45H(1), dated the 21st December, 1945 and last amended vide notification number G.S.R. 561(E), dated the 2nd July, 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.