2026.01.21 G.S.R. 51(E)_ Draft Notification regarding Blue line on Label of Antimicrobial

The Central Government has issued draft rules to amend the Drugs Rules, 1945 under the Drugs and Cosmetics Act, 1940, exercising powers under sections 12(1) and 33(1). These amendments, proposed after consultation with the Drugs Technical Advisory Board, have been published in the Gazette of India for public information. Stakeholders likely to be affected are invited to submit objections or suggestions within thirty days of publication. Submissions may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Kartavya Bhawan‑1, New Delhi, or sent via email to drugsdiv-mohfw@gov.in. The draft rules, titled the Drugs (…… Amendment) Rules, 2025, will come into force on the date specified at final publication in the Official Gazette. A key amendment is proposed to Rule 96, sub‑rule (1), introducing clause (xiv). This clause mandates that antimicrobial drugs and their preparations must bear a conspicuous blue vertical strip on the left side of the label, running throughout the body, without disturbing other printed conditions. This measure aims to enhance visibility and identification of antimicrobial products, supporting regulatory oversight and public health safeguards.