Health Ministry Proposes Blue Strip On Antimicrobial Drugs To Curb Resistance

In a bid to rein in the growing threat of antimicrobial resistance (AMR), the Union Health Ministry has issued a draft notification proposing mandatory labelling of all antimicrobial drugs with a distinct blue vertical strip. The move seeks to strengthen regulatory oversight and discourage irrational use of antibiotics and other antimicrobial agents.

The draft notification proposes an amendment to the Drugs Rules, 1945, making it compulsory for all antimicrobial drugs and their formulations to carry a “conspicuous blue vertical strip” on their labels. The strip will run along the left side of the label throughout its length, without interfering with other mandatory labelling information.

The proposal follows consultations with the Drugs Technical Advisory Board (DTAB), the apex statutory body on technical matters related to drugs in India. Objections and suggestions from stakeholders and the public have been invited, after which the final notification will be issued.

According to the draft, a new clause will be inserted under the labelling provisions of the Drugs Rules, stating: “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.”

The recommendation for a blue strip was first made by the DTAB during its meeting held on August 14, 2024, as part of a broader set of measures aimed at addressing the escalating problem of AMR. The visual marker is expected to help patients, pharmacists, and regulators easily identify antimicrobial medicines and promote more responsible use.

In a significant regulatory push, the DTAB has also recommended that all antimicrobials should always be treated as “new drugs” under the New Drugs and Clinical Trials (NDCT) Rules, 2019, in the interest of public health. This recommendation was reiterated during the 92nd meeting of the DTAB held on April 24, 2025.

“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 the New Drugs and Clinical Trials Rules, 2019 in public interest. Accordingly, consequential changes may be made in the Rules,” the meeting minutes noted.

The move is aimed at bringing all antimicrobials under tighter central regulatory control, ensuring that their approval, manufacture, and marketing are subject to enhanced scrutiny. The DTAB’s recommendation follows earlier deliberations by the Drugs Consultative Committee (DCC), which had proposed amending the rules to enable the Central Drugs Standard Control Organisation (CDSCO) to exercise regulatory oversight over antimicrobial approvals across the country.

Both the DCC and DTAB have been examining multiple strategies to curb the misuse of antimicrobials, which is widely recognised as a key driver of AMR. The issue has emerged as a serious and growing public health threat in India and globally, and has been flagged as a priority at several high-level international forums, including the United Nations General Assembly (UNGA), the G7, and the G20.

The DTAB has also endorsed the DCC’s recommendation to prohibit the sale of antimicrobials by traders to non-pharmaceutical industries that do not hold the requisite licences. Regulators have raised concerns that antimicrobials are being diverted for use in sectors such as food processing, beverages, and other non-medicinal industries, where their indiscriminate use can accelerate the development of drug-resistant pathogens.

“Antimicrobial resistance can be caused due to misuse of antibiotics, antivirals, antifungals and other antimicrobial agents,” the DTAB noted in the minutes of an earlier meeting, adding that the issue warranted detailed deliberation at the level of the DCC before regulatory action.

The draft notification also comes against the backdrop of renewed political and public focus on AMR. Prime Minister Narendra Modi recently flagged the dangers of indiscriminate antibiotic use in an episode of Mann Ki Baat, warning against the widespread belief that a single pill can cure all illnesses.

Citing findings from the Indian Council of Medical Research (ICMR), the Prime Minister cautioned that antibiotics are not a quick fix and should only be taken on a doctor’s advice. He underscored that misuse and overuse of such medicines not only reduce their effectiveness but also pose long-term risks to public health.