RSS Affiliate Laghu Udyog Bharati Urges Govt To Drop Blue Line Plan For Antimicrobial Drugs

Last Updated:February 20, 2026, 07:30 IST

The proposal is to amend Rule 96 of the Drugs Rules, 1945, to mandate 'a conspicuous blue vertical strip on the labels of antimicrobial drugs'

A month after the central government mandated marking antimicrobial drugs with a conspicuous blue vertical line, RSS-affiliated Laghu Udyog Bharati (LUB) has urged the health ministry not to proceed with the final notification, arguing that the move would impose heavy economic and environmental costs without meaningfully addressing antimicrobial misuse.

In a letter dated February 18, seen by News18, LUB has requested the government “to reconsider the proposed amendment under global prospective and consider our above factful submission and do not go for final notification".

LUB is an all-India organisation representing micro and small enterprises (MSMEs) and claims to represent over 64,000 members across the country.

The blue line proposal was introduced through draft notification in January, proposing an amendment to Rule 96 of the Drugs Rules, 1945, to mandate “a conspicuous blue vertical strip on the labels of antimicrobial drugs".

What Are Antimicrobial Drugs and Why the Blue Line?

Antimicrobial drugs include antibiotics, antivirals, antifungals and antiparasitic medicines used to treat infections caused by bacteria, viruses, fungi and parasites. India has been grappling with rising antimicrobial resistance (AMR), largely driven by irrational use, self-medication and over-the-counter availability of antibiotics despite prescription requirements.

The proposed blue line is intended to function as a clear visual identifier, reinforcing that these medicines should be used strictly under medical supervision. It builds on earlier regulatory efforts such as the red line warning introduced in 1993 and the later red box warning under Schedule H1.

However, LUB argues that past visual labelling interventions have not significantly altered misuse patterns. In its letter, the organisation states, “Experience from earlier labelling interventions shows that such changes do not materially impact misuse." It notes that despite decades of red line and red box warnings, “irrational use and over-the-counter sale of antibiotics continue".

Industry’s Concerns Over Costs, Confusion and Compliance

In its representation, seen by News18, LUB contends that the amendment would require manufacturers to redesign labels, revise approved artworks and discard existing packaging material. “The proposed requirement will necessitate redesigning of labels, revision of approved artworks, and disposal of existing printed packaging material, resulting in significant financial and operational burden, particularly for MSME manufacturers," the letter said. It warns that sudden implementation could lead to “losses running into crores of rupees for even a single manufacturing unit".

The organisation also flags environmental implications, pointing out that pharmaceutical packaging relies on pre-printed aluminium foils and specialised printing cylinders. Large-scale destruction of these materials, it said, would generate industrial waste and increase pollution. The letter cautions that repeated labelling changes would lead to “high economic and environmental costs without delivering commensurate public health benefits".

LUB further argues that antimicrobial drugs are already governed under Schedule H and Schedule H1 with specific labelling and prescription requirements. According to the letter, “The addition of another visual identifier, such as a blue line, may create confusion among healthcare professionals and patients rather than improving rational use." It also raises concerns that mandatory domestic labelling changes could disrupt export packaging and regulatory harmonisation, potentially affecting manufacturing efficiency and India’s competitiveness.

Ultimately, the organisation maintains that the core issue lies in weak enforcement at the distribution and retail level. “Antimicrobial misuse is primarily driven by weak enforcement at the distribution and retail level, where antibiotics continue to be available over the counter despite existing legal restrictions," the letter stated, suggesting stronger enforcement and accountability measures rather than additional visual markers.

Concluding the letter, LUB has urged the ministry to take a broader view before proceeding, stating: “In view of the above, we humbly request the ministry to reconsider the proposed amendment under global prospective and consider our above factful submission and do not go for final notification."

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