A proposal by the Union health ministry to introduce mandatory blue lines on all antimicrobial medicines has sparked stiff resistance from sections of the pharmaceutical industry, including Laghu Udyog Bharti, affiliated with Rashtriya Swayamsevak Sangh (RSS).
The ministry, through a notification last month, had proposed amending the Drugs Rules, 1945, to require a distinct blue marking on antibiotics and other antimicrobials—medicines used to treat bacterial, fungal and parasitic infections.
The goal was to make antibiotics instantly identifiable to buyers and reduce casual, uninformed consumption.
The move comes as India grapples with an acute antimicrobial resistance(AMR) crisis.
AMR occurs when bacteria evolve and stop responding to medicines meant to kill them. In India, rampant misuse and over-the-counter access to antibiotics have accelerated this silent epidemic.
A health ministry official said that although antibiotics already fall under restrictive schedules requiring red-line warnings and prescription-only sales, the current labelling does not sufficiently distinguish them from other drugs.
“Consumers often fail to recognise that they are purchasing an antibiotic,” the official noted, arguing that clearer visual cues could reinforce caution at the point of purchase.
The proposal follows recommendations from expert panels under the Central Drugs Standard Control Organisation (CDSCO).
THE SCALE OF INDIA’S AMR EMERGENCY
The urgency is not abstract. A major 2019 study estimated that between 3 lakh and 10.4 lakh people in India died due to bacterial AMR alone.
The same analysis found that nearly 29.9 lakh deaths were linked either directly to drug-resistant infections or to sepsis—an extreme and often fatal response to infection that has become harder to manage because of resistance.
Experts say the drivers are systemic: antibiotic overuse and misuse, weak infection control, substandard medicines, patchy surveillance and poor enforcement of prescription norms.
In that context, the blue line is designed as a behavioural nudge—small in appearance, but potentially significant in awareness.
WHY THE PUSHBACK
Industry bodies, including the Himachal Drug Manufacturers Association (HDMA), argue the proposal imposes disproportionate financial and environmental costs on small manufacturers.
They warn that mandatory artwork changes would force the destruction of existing packaging material, disrupt supply chains and require costly revalidation processes.
They also contend that previous labelling measures—such as red lines and boxed warnings—have failed to curb misuse. According to them, the real problem lies in weak retail enforcement and lax prescription audits, not packaging design.
Manufacturers in Himachal Pradesh, a major hub for generic drugs, argue there is no publicly available evidence that colour coding influences prescribing behaviour or meaningfully reduces misuse. AMR, they say, is driven by prescribing and dispensing practices—not secondary packaging.
Their letters further caution that no major global regulator or World Health Organization (WHO) programme mandates colour-based identifiers for antimicrobials. A country-specific visual rule, they argue, could complicate exports and undermine regulatory harmonisation.
They point out that antibiotics are already regulated under Schedule H and H1, with cautionary labelling, traceability systems, QR codes and pharmacovigilance safeguards in place.
In their view, the proposed blue line adds no substantive regulatory value.
Instead, they have urged the government to focus on stricter prescription audits and greater pharmacist accountability.
THE COUNTERARGUMENT: AWARENESS MATTERS
Not all experts agree with the industry’s objections. A pharmacologist at the All India Institute of Medical Sciences (AIIMS, Delhi said a distinct label for antibiotics could strengthen consumer awareness.
“A separate visual identifier can serve as a strong signal to buyers about what they are consuming,” the expert said.
In a country battling one of the world’s heaviest AMR burdens, even incremental interventions may matter, the pharmacologist also said.
The blue line may not fix enforcement gaps or prescribe excesses overnight. But as drug resistance tightens its grip, the question is whether India can afford to dismiss even a modest preventive step.
