The escalating threat of antimicrobial resistance (AMR), where essential medications lose their efficacy against increasingly resilient pathogens, has prompted India’s primary drug regulator to initiate a comprehensive overhaul of its policies governing antibiotic development, sales, and monitoring. This decisive action underscores a national recognition of AMR as not merely a health concern but a profound public health and economic crisis demanding immediate and multi-faceted intervention.
The human cost of AMR in India is staggering, with the National Centre for Disease Control (NCDC) attributing approximately 267,000 deaths annually directly to drug-resistant infections. Beyond the tragic loss of life, the economic repercussions are projected to be monumental. A 2017 World Bank report cautioned that unchecked AMR could cost the global economy trillions of dollars in healthcare expenditure and lost productivity. More specifically for India, a 2024 study by the Center for Global Development (CGD) estimates potential economic losses of an additional $21 billion by mid-century if the rise of "superbugs" remains uncontained. This grim forecast highlights the urgent need for a robust and effective national strategy to mitigate the crisis.
Globally, the World Health Organization (WHO) has consistently identified AMR as one of the top ten global health threats facing humanity. The interconnected nature of this challenge, often encapsulated by the "One Health" approach, recognizes that the health of humans, animals, and the environment are inextricably linked. Misuse of antibiotics in human medicine, livestock, and agriculture, coupled with inadequate infection prevention and control, limited access to diagnostics, and poor waste management, are widely acknowledged drivers of resistance. As a major pharmaceutical manufacturing hub and a nation with a vast population, India’s actions have significant global implications for controlling the spread of resistant strains.
Responding to this exigency, the Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory body, has adopted a forward-looking framework based on an expert report submitted by a high-level sub-committee of the Drugs Consultative Committee (DCC). This strategic shift signifies an active governmental intervention across the entire lifecycle of a medicine, from its initial research and development phases to its dispensing at local pharmacies. The recommendations, discussed and noted at the 67th DCC meeting, reflect a determined effort to implement the National Action Plan on Antimicrobial Resistance (NAP-AMR), with its Phase 2.0 (2025-29) already underway.
A cornerstone of the proposed framework is a substantial push to bolster the ecosystem for the research and development (R&D) of new antibiotics. The current pharmaceutical landscape offers limited commercial incentives for developing novel antimicrobials due to their specific use cases and shorter treatment durations compared to chronic disease drugs, creating a phenomenon known as the "valley of death" in antibiotic R&D. To counteract this, the expert panel has stressed the urgent need for an innovation ecosystem capable of developing targeted antimicrobial profiles specifically tailored for the Indian context. This includes streamlining regulatory and procedural changes to accelerate the R&D of "watch and reserve" antimicrobials – those designated for treating critical-priority pathogens. The report calls for distinct guidelines for clinical trial approvals and for the manufacture and import of various categories of new antimicrobial drugs, emphasizing coordinated information exchange among academic institutions, industry, and research bodies to expedite discovery.
Parallel to fostering innovation, the new regulations aim to rigorously curb the widespread misuse and over-the-counter (OTC) sales of existing antibiotics, a significant driver of resistance. Key recommendations include an outright prohibition on OTC sales of antibiotics, mandating prescription stamping to prevent re-use, and implementing advanced tracking mechanisms for sales. These mechanisms involve computerized billing systems and mandatory CCTV monitoring at both wholesale and retail pharmacy outlets. Furthermore, the development of state-specific software models for real-time tracking of antimicrobial sales is envisioned to provide unprecedented transparency and control over distribution, allowing authorities to identify and address hotspots of misuse.
Beyond sales, the framework introduces more stringent control over prescription drugs. It mandates the prominent display of legal warnings at all drug shops, clearly stating that Schedule H and H1 drugs – which include common antibiotics and critical third and fourth-generation antibiotics, respectively – cannot be sold without a valid prescription. Pharmacies will also be required to maintain dedicated registers detailing patient and doctor information for Schedule H and H1 drug sales for a period of three years. An annual review of antimicrobial categorization is also proposed to ensure that high-end and newly researched molecules are swiftly reclassified into Schedule X or H1, thus subjecting them to strict restricted marketing protocols, including duplicate prescription requirements and meticulous documentation for narcotic and psychotropic substances. To bolster enforcement and minimize the proliferation of substandard or spurious antimicrobials, which directly contribute to resistance, the appointment of nodal officers in each state has been recommended.
Environmental protection constitutes another critical pillar of the national strategy. The indiscriminate disposal of unused or expired antibiotics into waste streams and sewage systems contributes significantly to the presence of antibiotic residues in the environment, fostering the development of drug-resistant pathogens. To address this, the DCC report advocates for an ‘Extended Producer Responsibility’ (EPR) policy for the safe disposal of pharmaceutical waste, ensuring manufacturers bear responsibility for their products’ end-of-life cycle. This is complemented by stricter inspections of manufacturing units to ensure adherence to bio-medical waste management rules, mitigating the discharge of antibiotic-laden effluent into ecosystems.
The misuse of antibiotics in animal agriculture, which accounts for a substantial portion of global antimicrobial consumption, is also a major focus. The expert panel has recommended restricting the use of antibiotics in animal feed and a phased elimination of their use as growth promoters and for routine disease prevention in livestock. To ensure comprehensive oversight, the plan proposes mandatory registration of all relevant entities, including farms, factories, slaughterhouses, wet markets, aquaculture units, food processing units, feed manufacturers, healthcare facilities, and veterinary facilities. This "farm-to-fork" approach underpins the holistic "One Health" philosophy, acknowledging that resistance originating in animal populations or the environment can readily transfer to humans.
Despite the robust regulatory framework, the battle against AMR faces formidable challenges on the ground. From the patient’s perspective, the high cost of medical consultations and diagnostics often leads individuals to bypass doctors, resort to self-medication, or prematurely discontinue antibiotic courses once symptoms alleviate, directly fueling resistance. As Dr. Suranjeet Chatterjee, a senior consultant at Apollo Hospital, notes, "By the time patients reach a hospital, the bugs have already become resistant to advanced drugs. We are reaching a point where there is almost nothing left in the arsenal." This clinical desperation is corroborated by a November 2024 report from the Indian Council of Medical Research (ICMR), which found alarming resistance levels in hospital intensive care units, with common bacteria causing pneumonia and urinary tract infections frequently resistant to once-reliable drugs like imipenem and meropenem. Even common infections like typhoid are becoming nearly untreatable with standard oral medications, with resistance levels climbing above 95%.
The pharmaceutical industry, represented by leaders like Sheetal Arora of Mankind Pharma, generally supports these proposed regulations, acknowledging that antibiotics are not routine medicines and must be used judiciously. Arora emphasized that "Tackling antimicrobial resistance requires collective action across industry, doctors, policymakers, and patients." This consensus is crucial for the successful implementation of the new policies. Prime Minister Narendra Modi has also underscored the severity of the issue, using his "Mann Ki Baat" broadcast to warn citizens against the dangers of self-medication and the misuse of life-saving antibiotics, indicating the high-level governmental commitment to addressing this crisis.
As Payden, the WHO acting representative to India, highlighted, "The challenge is balancing access to life-saving antibiotics with curbing their misuse across human health, agriculture and the environment." The drivers of AMR are well-known, and the solution lies in addressing this intricate balance. Effective state-level implementation, sustained public participation, and a steadfast commitment to the "One Health" approach, linking human, animal, and environmental health, are paramount. India’s ambitious regulatory overhaul represents a critical step in this global fight, striving to protect the efficacy of these vital medicines for current and future generations, while simultaneously navigating the complexities of public health, economic realities, and scientific innovation.
