Centre mandates blue strip on antimicrobial drugs to curb overuse

The Union health ministry has issued draft rules to mandate a blue vertical strip on all antimicrobial drug labels, aiming to rein in over-the-counter misuse and tackle India's growing antimicrobial resistance (AMR) problem.

The Centre on Friday notified draft rules mandating all antimicrobial drugs and their preparations to bear a blue vertical chip across its packaging label in bid to counter antimicrobial resistance (AMR) caused by their rampant over-the-counter (OTC) usage.

In a gazette notification dated January 23, the health ministry proposed adding a clause under the Rule 95 of the Drug Rules, 1945 which gives guidelines on the manner of labelling on all medicinal drugs available in India.

"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 clause states.

Stakeholders have been given 30 days to share suggestions or objections to the draft notifications, with the amendment expected to come into force from the date specified by the government at the time of final publication of the rules in the Official Gazette.

People in the know said the amendment was proposed after consultation with the Drugs Technical Advisory Board, the apex drug advisory body.

The move comes at a time when the Center has been focusing on tackling the rising prevalence of AMR in India. It had recently come out with the second version of the National Action Plan to tackle AMR (NAP-AMR 2.0), which aims to combat drug-resistant infections.

Similarly, the Directorate General of Health Services (DGHS) had recently urged all pharmacists to dispense antibiotics only on the prescription of a qualified doctor, hence limiting OTC sales.

2 million deaths likely in India due to antimicrobial resistance

Antimicrobial drugs are medicines such as antibiotics, antivirals and antifungals that kill or stop the growth of microorganism-based infections in humans.

They are the third highest therapy segment in the Indian Pharma Market (IPM), with the supergroup seeing sales worth Rs 27,500 crore in calendar year 2025.

According to market research firm Pharmarack, anti-bacterials (antibiotics) made 86 per cent of overall anti-infective sales in India in 2025. They are followed by antifungals and antivirals at a 7 and 4 per cent contribution to total anti-infective sales in India.

In June last year, the government extended its AMR net to check potential antibiotic use in animals by asking all state drug controllers to extend support for developing a reporting framework to keep the possible animal-human pathway of AMR spread in check.

According to the World Health Organisation (WHO), around 10 million deaths are projected to occur globally by 2050 due to AMR, with India's share at around 2 million.

In 2019 (the latest data on this subject), AMR was directly responsible for 1.27 million deaths globally, while 4.95 million deaths were associated with drug-resistant infections.