Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

The Government of India has published a draft notification proposing an amendment to the Drugs Rules, 1945 (vide Gazette Notification G.S.R. 51(E), dated 21 January 2026). The amendment would require all antimicrobial drugs to display a conspicuous blue vertical strip on the left side of their label, running the full length of the packaging without disturbing other printed information.

Specifically, Rule 96, sub‑rule (1) on Labelling and Packing of Drugs other than Homoeopathic Medicines is set to be amended with the introduction of clause (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.”

Stakeholders have 30 days from the date of publication to submit objections or suggestions regarding the proposal.

This move reflects growing concern among health experts and policymakers about the widespread misuse and overuse of antibiotics in India, which has accelerated the development of antimicrobial resistance (AMR). Resistant microorganisms—such as bacteria and viruses—are increasingly rendering conventional antibiotics ineffective, forcing reliance on stronger drugs or, in some cases, leaving infections untreatable.

The blue strip is intended as a visual cue for prescribers, pharmacists, and patients, reinforcing the need for judicious use of antibiotics and supporting national efforts to combat AMR.

Gazette Notification – GSR 51E – Blue Strip on Label for Antibiotics

Leave a Comment