According to a recent media report in The Economic Times, under the proposal, all antimicrobial drugs and their formulations will be required to carry a prominent blue vertical strip on the left side of the label, extending throughout the length of the packaging, without disturbing any other statutory labelling information. The visual identifier is expected to help consumers, pharmacists and healthcare professionals easily distinguish antimicrobial medicines and promote their responsible use.
The move has been proposed through a draft gazette notification seeking an amendment to Rule 95 of the Drugs Rules, 1945, which governs drug labelling norms in the country. The amendment follows recommendations made by the Drugs Technical Advisory Board (DTAB), the apex technical advisory body on drugs, which suggested introducing a blue strip or box to clearly differentiate antimicrobial medicines from other drugs.
The Health Ministry has invited objections and suggestions from stakeholders within 30 days from the date of publication of the draft notification. Based on the feedback received, the Centre will take a final decision before notifying the amended rules in the Official Gazette.
The proposal comes against the backdrop of increasing concerns over the irrational use and over-the-counter sale of antibiotics, which experts say is a key factor driving antimicrobial resistance. AMR occurs when microorganisms such as bacteria, viruses, fungi and parasites evolve and no longer respond to medicines, making infections harder to treat and increasing the risk of prolonged illness and mortality.
Health authorities and global agencies have identified self-medication, incomplete treatment courses, poor hygiene, inadequate sanitation, weak infection control practices and environmental contamination from pharmaceutical waste as major contributors to the spread of antimicrobial resistance. The World Health Organization has consistently flagged AMR as one of the most serious global public health threats.
Antimicrobials—including antibiotics, antivirals and antifungals—constitute a major segment of India’s pharmaceutical market. The anti-infective therapy area is the third-largest segment, with the market estimated at around Rs 27,500 crore in 2025, while antibiotics alone account for nearly 86 percent of total anti-infective drug sales, followed by antifungals and antivirals.
The proposed blue strip labelling aligns with the government’s broader strategy under the National Action Plan on Antimicrobial Resistance (NAP-AMR 2.0) to promote rational drug use and strengthen awareness among consumers and healthcare providers. Authorities, including the Directorate General of Health Services, have also repeatedly advised pharmacists to dispense antibiotics strictly against valid prescriptions, ET reported.
The Centre views the labelling initiative as a simple yet effective regulatory tool to reinforce caution around antimicrobial use and preserve the effectiveness of life-saving medicines amid the growing AMR challenge.
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