Health Ministry Mandates Blue Strip on All Antimicrobial Drugs

The Union Health Ministry has acted to reinforce India with its efforts against antimicrobial resistance (AMR) with a draft notification to make changes to the Drugs Rules, 1945. The draft also requires all antimicrobial drugs and their preparations to have a conspicuous blue vertical strip in the left section of the label that extends continuously without interrupting other printed details.

This is based on the recommendation made by the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC), which have been busy discussing ways through which the increasing AMR menace in the country can be put into check.

“After detailed deliberation, DTAB recommended that all the antimicrobials shall always be deemed to be considered as New Drug under the definition of 'New Drug' under New Drugs and Clinical Trials Rules, 2019, in public interest. Accordingly, consequential changes may be made in the Rules,” stated the minutes of DTAB’s 92nd meeting held on April 24, 2025.

The draft will be subject to public comments within 30 days of its publication in the Gazette of India, and any objections or suggestions submitted will be given a hearing by the Central Government. The DTAB also advised that antimicrobials were not to be sold to non-pharmaceutical industries without the right license, as this concerned the abuses in food, beverages and other areas.

In his recent Mann Ki Baat speech, Prime Minister Narendra Modi has emphasized indiscriminate use of antibiotics as one of the major factors playing a role in AMR, referencing an ICMR report and stating that antibiotics are not a panacea and should only be used when prescribed by the doctor. The draft notification goes in line with the increase in regulatory interest in the rational use of antimicrobials in India to safeguard human health.