Ministry of Health and Family Welfare Department of Health and Family Welfare

Proposal for providing suitable provision under Drugs Rules, 1945 for inclusion of warning caution in blue colour strip box on the label of antimicrobials

Issue Date: 22 January 2026 Published: 23 January 2026

Gazette ID: CG-DL-E-23012026-269542 Download PDF

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Core Purpose

The Central Government publishes draft rules to further amend the Drugs Rules, 1945, specifically concerning labeling requirements for antimicrobial drugs, inviting public objections and suggestions.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) has published G.S.R. 51(E) on 21st January, 2026, presenting draft rules to amend the Drugs Rules, 1945. These draft rules are proposed by the Central Government in exercise of 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. The notification is for the information of all persons likely to be affected, and a thirty-day period from the Gazette's availability is provided for considering the draft rules. Objections and suggestions can be addressed to the Under Secretary (Drugs), 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 to drugsdiv-mohfw@gov.in. The proposed amendment inserts a new clause (xiv) after clause (xiii) in sub-rule (1) of Rule 96 of the Drugs Rules, 1945, stating that "Antimicrobial drugs and their preparations shall bear a conspicuous blue vertical strip on the left side running throughout the body of the label without disturbing the other conditions printed on the label." These rules, to be called the Drugs (...... Amendment) Rules, 2025, shall come into force from a date specified by the Government at the time of their final publication in the Official Gazette. The principal rules were published via notification No. F. 28-10/45-H(1) dated 21st December, 1945.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-23012026-269542 EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 51] NEW DELHI, THURSDAY, JANUARY 22, 2026/MAGHA 2, 1947 489 GI/2026 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, 21st January, 2026 G.S.R. 51(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), 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 drugsdiv-mohfw@gov.in. DRAFT RULES 1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025. (ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette. 2. In the Drugs Rules, 1945, in Rule 96, in sub-rule (1), after clause (xiii), following clause shall be inserted, namely:- "(xiv) Antimicrobial drugs and their preparations shall bear a conspicuous blue vertical strip on the left side running throughout the body of the label without disturbing the other conditions printed on the label." [F. No. X.11014/14/2025-DR] HARSH MANGLA, Jt. Secy. Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21st the 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. GORAKHA NATH Digitally signed by GORAKHA YADAVA NATH YADAVA Date: 2026.01.23 16:00:04 +05'30'

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