Authors:

Vidhi Singh, Nimisha Droach

ABSTRACT

Background:  AMR has long stopped being a background clinical concern. It is now a direct threat to healthcare systems and national economies, and India sits at a particularly difficult intersection of high antibiotic consumption, variable health infrastructure, and limited regulatory reach. Two policy instruments were introduced to address this — the National Action Plan on Antimicrobial Resistance (NAP-AMR) and the Schedule H1 Regulation — though how well either has worked on the ground remains an open and contested question.

Objective: This paper examines where NAP-AMR and Schedule H1 are falling short in practice and traces how those enforcement failures, surveillance gaps, poor inter-agency coordination, and limited stewardship capacity have produced measurable economic damage — for patients, hospitals, and India’s broader economy.

Methods: A qualitative secondary data analysis was conducted using academic literature, surveillance reports, and policy documents from WHO, NCDC, ICMR, and the Ministry of Health and Family Welfare.

Results: A consistent pattern emerged: surveillance systems are too heavily concentrated in urban tertiary hospitals, coordination between the Centre and the states is fractured, stewardship programmes are understaffed, and antibiotics continue to be sold without prescriptions despite Schedule H1. Treatment costs have risen as a result, hospital stays have lengthened, and families — particularly lower-income ones — are bearing financial burdens they cannot absorb.

Conclusion: Tightening enforcement, digitising prescription records, expanding surveillance beyond tertiary facilities, and protecting households from catastrophic out-of-pocket costs are priorities India cannot continue to defer.

INTRODUCTION

AMR has moved well past the point of being a specialist clinical concern. The resistance crisis is reshaping healthcare economics, threatening basic medical procedures, and — in a country with India’s population size and disease burden — doing so at a scale that should alarm policymakers far beyond the health ministry.

India’s position in this story is not incidental. It is one of the world’s largest consumers of antibiotics. Urbanisation has outpaced sanitation infrastructure in many parts of the country. The public health system, though large, is deeply uneven in capacity. The burden of infectious disease remains substantial. These factors don’t simply coexist; they interact and reinforce one another, accelerating resistance. Highly drug-resistant strains are now documented across Indian hospitals, and the practical consequences are real — routine surgeries carry added infection risk, neonatal care has become more clinically complex, and cancer treatment outcomes are increasingly compromised by resistant co-infections.

Two major regulatory interventions were put in place to counter this. Schedule H1 came into force in 2014, covering 24 antibiotic classes including the most clinically critical ones. Dispensing requires a valid doctor’s prescription, and pharmacies must maintain three years of purchase and sales records. The purpose was to create accountability where there had been almost none.

NAP-AMR provided the longer-horizon strategic architecture. Designed around One Health principles, it set goals for surveillance expansion, professional and public awareness campaigns, and antimicrobial stewardship programme development in hospitals. On paper, the two instruments work in tandem — Schedule H1 supplying the regulatory teeth, NAP-AMR supplying the strategic framework.

The reality on the ground is considerably more complicated. The policies themselves are not the core problem. The gap lies in execution, and that gap is wide. Across Indian states, implementation has been uneven. Antibiotics listed under Schedule H1 are still regularly obtained without prescriptions in many communities. Stewardship programmes are largely absent from primary and secondary care settings. Surveillance data is dominated by large urban teaching hospitals and reflects little of what is happening in rural areas or primary care.

This review examines those gaps from two angles.

Policy Implementation Gaps and Regulation Challenges: Why does over-the-counter antibiotic dispensing persist even where legal restrictions apply? How do staffing shortages and missing diagnostic infrastructure outside major cities erode compliance? What does the published evidence say about the distance between what Schedule H1 requires and what pharmacies actually do?

Economic Implications of India’s AMR Policies: Drug-resistant infections cost more to treat — more days in hospital, more expensive drugs, more tests. In India, where most healthcare spending is out-of-pocket, those extra costs don’t get absorbed by insurance; they fall directly on patients. This section maps that financial burden and examines what it means for lower-income households, hospitals managing constrained budgets, and India’s broader economic position.

The aim is to connect weak implementation to real-world harm in a way that is useful for policymakers. Understanding precisely where and how enforcement breaks down is a prerequisite for designing fixes that actually hold.

Theoretical Framework

This study draws on Public Policy Implementation Theory as its interpretive lens. The theory’s core argument is straightforward but often overlooked in practice: whether a policy succeeds depends on how it is operationalised, not merely how it is designed. Institutional capacity, governance arrangements, resource availability, cross-sector coordination, enforcement quality, and the actual behaviour of stakeholders — these are the variables that determine what policies achieve. Applied to NAP-AMR and Schedule H1, this framework focuses attention on the structural and institutional factors

that have limited their impact, and helps explain why the gap between policy intent and public health reality has persisted for over a decade.

RESEARCH METHODOLOGY

Research Design

The study uses a qualitative research design built on secondary data analysis, focused on India’s AMR policy framework with particular attention to NAP-AMR and Schedule H1. Governance, regulatory enforcement, antimicrobial stewardship, and surveillance served as the core analytical dimensions. Where quantitative data from national surveillance reports and published studies added clarity — on treatment costs, antibiotic consumption trends, or the measurable effects of specific interventions — that evidence was drawn into the analysis. 

Study Area Context

 The research centres on India’s healthcare system, examining how AMR policies have been implemented across hospitals, pharmacies, surveillance networks, and public health institutions. It also addresses the economic consequences of those policies, including rising healthcare expenditure and the financial pressures on patients and institutions.

Participants and Sampling

No human participants were involved. Sources were selected through purposive sampling based on their direct relevance to AMR, NAP-AMR, Schedule H1, stewardship, surveillance, and the economic dimensions of resistance in India. Priority was given to publications from WHO, ICMR, NCDC, and the Ministry of Health and Family Welfare, alongside recent peer-reviewed literature.

Data Collection Procedures

Literature was identified through structured searches of PubMed and Google Scholar, supplemented by direct review of official websites from WHO, ICMR, NCDC, and MoHFW. Only sources with direct relevance to the study’s themes were included, with a preference for authoritative and recent publications.

Data Analysis

A thematic analysis framework was applied to review and organise the evidence. Sources were coded around five themes — governance, regulatory enforcement, antimicrobial stewardship, surveillance, and the economic implications of AMR. Implementation gaps were identified by comparing the stated objectives of NAP-AMR and Schedule H1 with documented evidence of how they have functioned in practice. Where recurring barriers appeared consistently across multiple independent sources, they were treated as substantiated findings.

Ethical Considerations

The study drew exclusively on secondary data from publicly available sources. No human subjects were involved, and all sources are formally cited throughout.

Limitations

Reliance on secondary data is the study’s primary constraint. The analysis can only reflect what has been documented and published. Where evidence from particular regions or care settings is sparse, conclusions about those contexts must be held more tentatively. Some findings may also be shaped by the limitations inherent in the primary studies on which they rest.

LITERATURE REVIEW

Introduction

This narrative review takes a thematic approach to examining how India’s AMR policies have — and haven’t — translated into practice. The review is organised around two themes: the regulatory and governance challenges that have hampered Schedule H1 and NAP-AMR, and the economic costs that have accumulated as a result. Persistent over-the-counter antibiotic sales, surveillance that stops at the tertiary hospital gate, the household-level financial toll of resistant infections

— all are addressed. What the review is working toward, ultimately, is a clearer account of how implementation weaknesses map onto clinical and economic consequences.

Theme 1: Policy Implementation Gaps and Regulation Challenges

India does not have an AMR policy vacuum. What it has is an implementation crisis. NAP-AMR and Schedule H1 together address the key areas — stewardship, surveillance, antibiotic sales regulation, and professional awareness. The problem that research repeatedly surfaces is the distance between these frameworks and what is actually happening in clinics, pharmacies, and hospitals across the country.

On governance, Ranjalkar et al. (2019) characterise NAP-AMR as a well-constructed national strategy with appropriate goals around surveillance, stewardship, and awareness. Yet Nair et al. (2021) qualify that assessment sharply: coordination between central and state governments has been inconsistent, state-level funding has been inadequate, and structural determinants of resistance — sanitation, environmental hygiene, healthcare infrastructure — have received far less attention than behavioural interventions. This is a meaningful imbalance. Asking healthcare workers to prescribe more responsibly has limited effect in facilities that lack functional diagnostics or infection prevention resources. India’s AMR policy literature may have focused too narrowly on changing what people do without sufficiently addressing the conditions in which they work.

The regulatory enforcement picture is similarly uneven. Farooqui et al. (2020) documented a real decline in national antibiotic sales after Schedule H1 took effect — evidence that tighter regulation can produce measurable change. But Vineela et al. (2021), who used simulated client methodology to observe pharmacy behaviour directly, found restricted antibiotics being dispensed without prescriptions in a significant proportion of community pharmacies. These findings aren’t necessarily contradictory — aggregate sales data and local pharmacy behaviour can diverge — but they reveal that national-level policy effects don’t automatically translate into consistent community-level compliance.

Stewardship and surveillance present parallel difficulties. Rajendran et al. (2025) identified shortages of infectious disease specialists, clinical pharmacologists, and microbiology capacity as central barriers to stewardship implementation in primary and secondary care — precisely the settings where most Indians access healthcare. The ICMR AMR Surveillance Report (2024) adds another uncomfortable finding: reliance on WHO “Watch” antibiotics continues to outpace recommended use of “Access” options, suggesting that inappropriate prescribing persists in spite of national stewardship programmes. India’s surveillance infrastructure, as Nair et al. (2021) note, remains disproportionately concentrated in large urban hospitals — leaving resistance patterns in rural and primary care settings largely unmeasured.

The existing literature has examined these issues individually, and in reasonable depth. What has been largely missing is an analysis that holds them together — that asks how governance fragmentation, regulatory inconsistency, stewardship gaps, and surveillance limitations combine to produce a policy framework that is weaker than the sum of its parts. Most published studies also treat NAP-AMR and Schedule H1 as separate objects of analysis rather than examining how they interact. This review addresses that gap directly.

Theme 2: Economic Implications of India’s AMR Policies

Drug resistance is expensive. Extended hospital stays, second-line antibiotics that may cost multiples of first-line equivalents, repeat diagnostic testing — the financial arithmetic of AMR-related illness is punishing. In India, where out-of-pocket payments account for roughly 70% of total health spending, those costs land directly on patients and their families.

Kadam et al. (2024) quantified this in the hospital setting, finding that patients with resistant bloodstream infections faced substantially higher treatment expenditure than those with susceptible infections, with drug costs among the largest contributors across public and private facilities alike. What their study does not fully capture — because of its design focus on hospitalised patients — is the financial picture in rural settings, primary care, and at household level through income loss and reduced work capacity. The hospital data is important, but the economic burden of AMR in India extends well beyond the hospital bed.

The evidence on Schedule H1’s economic effects adds a complementary angle. Farooqui et al. (2020) recorded a significant national decline in antibiotic sales after the regulation’s introduction, suggesting that policy intervention has real economic potential — not just clinical benefit. The durability of that effect is the issue. Studies on pharmacy practices document continuing over-the-counter dispensing despite the regulation, which means the financial gains from better stewardship are being partially eroded at the point of sale. Regulation can shift national behaviour; inconsistent local enforcement limits how long that shift holds.

The household-level impact deserves more direct attention than the existing literature typically gives it. When a family member develops a drug-resistant infection, the costs compound — extended admissions, repeated consultations, follow-up investigations, expensive antibiotics that fall outside standard coverage. For households already close to the poverty line, this can mean borrowing money, selling assets, or cutting treatment short. That last outcome is worth pausing on: a patient who cannot afford to complete a course of last-resort antibiotics is not just experiencing financial hardship; their incomplete treatment actively contributes to resistance.

A clear gap in the literature is the absence of research that links implementation failures directly to these economic outcomes. Studies have assessed the economic burden of AMR, and studies have evaluated individual policy interventions, but these two bodies of work have rarely been brought together. This review attempts to bridge that gap.

Research Gap

The AMR literature in India has covered stewardship, enforcement, surveillance, and economic burden in reasonable depth — but largely as separate enquiries. How implementation gaps in NAP-AMR and Schedule H1 collectively generate economic consequences has not been adequately analysed. This study addresses that by treating the policy and economic dimensions as interconnected.

FINDINGS

1.  Regulatory Asymmetry and Structural Execution Gaps in India’s AMR Framework

India’s AMR policies face a structural problem that goes deeper than enforcement failure. The national framework is coherent in design, but its translation into practice follows a recognisable and troubling pattern — one rooted in how health governance is structured across India’s federal system. 

NAP-AMR’s emphasis on behavioural change — awareness campaigns, stewardship messaging, professional education — has not been matched by equivalent investment in the physical conditions through which those behaviours are supposed to change. A primary care facility without a functional microbiology laboratory cannot meaningfully implement antibiotic stewardship, regardless of how clearly the national guidance is written. Basic sanitation deficits in many healthcare settings add to this; resistance spreads in environments where infection prevention is weak, and prescribing guidance cannot substitute for that.

India’s surveillance infrastructure carries the same structural imprint. Coverage is concentrated in large tertiary-care hospitals in major cities. Primary facilities, district hospitals, and rural settings — where a substantial proportion of India’s clinical burden is managed — contribute comparatively little to national data. This is not a minor methodological limitation. It means that AMR trends in the settings furthest from urban specialist care are essentially invisible to the monitoring systems that inform national policy. Emerging resistance patterns in those areas will go undetected until they reach the facilities that are being watched.

On enforcement, Schedule H1 has produced national-level changes in antibiotic sales data, as Farooqui et al. (2020) documented. Community-level pharmacy behaviour has been slower to follow. Non-prescription dispensing persists in large numbers of pharmacies, according to simulated client studies, suggesting that monitoring mechanisms are either absent or insufficiently resourced to maintain compliance. The regulation is structurally reasonable. The enforcement architecture around it is not.

What these findings point to is not a failure of policy design. The frameworks exist and are broadly appropriate. The gap lies between what the frameworks specify and what the healthcare system — with its existing staffing constraints, infrastructure deficits, and governance fragmentation — is currently capable of delivering.

2.  Institutional Barriers to Hospital-Level AMR Control and Stewardship

Stewardship data from India consistently return the same finding. Despite NAP-AMR 2.0 identifying antimicrobial stewardship as a central strategy, the conditions that make stewardship work — trained clinical staff, functional microbiology, reliable diagnostic capacity, and active prescribing oversight — are absent or insufficient in a large proportion of facilities.

NACNET and SACNET data from 2024 show Watch-category antibiotics significantly over-represented in prescribing patterns relative to national guidance. This is a documented marker of stewardship failure: hospitals are reaching for last-resort drugs when first-line options would be clinically appropriate, which accelerates resistance in exactly the antibiotics

that matter most when everything else fails. Rajendran et al. (2025) identified the underlying causes — shortages of infectious disease specialists, clinical pharmacologists, and microbiology infrastructure, with the worst gaps in primary and secondary care. These are not resource problems that better guidelines alone can solve.

Surveillance in hospitals reflects the same geographic concentration seen nationally. The NCDC NARS-Net Annual Report (2024) and the ICMR AMR Surveillance Network Report (2024) both suggest that limited participation from community hospitals and rural facilities skews national data toward the patient populations and pathogen profiles found in large teaching hospitals. For AMR planning purposes, this creates meaningful blind spots around regional resistance variation and limits the ability to allocate resources and interventions to where they are most needed.

The Schedule H1 enforcement gap creates a further complication for hospital stewardship. When restricted antibiotics remain accessible over the counter, patients can arrive at hospital having already self-medicated — sometimes with the very drugs that hospital stewardship programmes are trying to conserve. Stewardship cannot fully correct for what happens before admission. Regulatory enforcement and antimicrobial stewardship are not parallel tracks running independently; they need to be treated as part of the same system.

Real and sustainable improvements in stewardship will require capital investment in laboratory infrastructure, targeted workforce development, and regulatory enforcement that functions consistently at community level — not just in well-resourced hospitals.

3.  Socioeconomic Implications of National AMR Control Policies

 The economic story of AMR in India is most visible in treatment cost and household spending data. Resistant infections are expensive. Kadam et al. (2024) found that hospitalised patients with resistant bloodstream infections faced substantially higher treatment expenditure than those with susceptible infections, with drug costs as one of the largest contributors across both public and private settings. In a country where most patients pay directly for their care, this is not an abstraction — it is the difference between financial recovery and financial crisis for many families.

Schedule H1’s initial impact on antibiotic sales was genuine — Farooqui et al. (2020) established that through interrupted time series analysis. The problem is that the effect has not held consistently. Uneven state-level enforcement, continuing non-prescription dispensing, and the administrative demands the regulation places on smaller pharmacies have all limited its long-term reach. Compliance requires record maintenance, product relabelling, and — increasingly — digital systems. For large pharmacy chains, this is manageable. For smaller independent pharmacies, the operational burden is significant, and compliance slips where oversight is weak.

 At household level, the full cost of a drug-resistant infection goes well beyond the hospital bill. Prolonged treatment, repeat consultations, and expensive antimicrobials combine with indirect losses — income foregone during recovery, transport to specialist facilities, the cost of repeat testing — to create a total burden that pushes some families toward debt or asset sales. For those with no savings buffer, the decision to cut treatment short becomes a financial survival strategy with serious clinical consequences. The existing healthcare financing architecture does not protect these households adequately; PM-JAY’s orientation toward inpatient costs leaves much of the AMR-related outpatient burden uncovered.

Healthcare institutions face their own version of this pressure. Extended admissions constrain bed capacity. Rising demand for culture and sensitivity testing, specialist input, and repeat investigations strains laboratory services that are already running close to capacity in many settings. These institutional costs are real even when they don’t appear in a patient’s bill.

The economic implications reach beyond healthcare as well. Agricultural use of antimicrobials and the presence of residues in food products have attracted trade scrutiny in certain export markets. The argument for effective AMR policy is not only clinical — it extends to India’s agricultural competitiveness and its position in international commodity trade.

What this analysis makes clear is that the economic burden of resistance in India is being amplified by implementation failures, not solely by the biology of resistance. The treatment costs families are absorbing, the hospital resources being consumed, the export risks emerging — these are, in part, preventable. But preventing them requires enforcement, stewardship, and financial protection mechanisms that work in practice, not just in policy documents.

DISCUSSION: REFORMING INDIA’S AMR POLICY FRAMEWORK

Read through the lens of Public Policy Implementation Theory, the findings of this study tell a coherent story. NAP-AMR and Schedule H1 are not the problem. India has produced two broadly well-designed frameworks for managing antimicrobial resistance. The problem is execution — and the execution failures are structural, not incidental. Governance fragmentation, institutional capacity gaps, inconsistent enforcement, and inadequate inter-sector coordination have all prevented these policies from realising their potential.

Bridging the Centre-State Execution Gap

NAP-AMR 2.0 covers the scientific and strategic ground competently. Its structural weakness is the absence of any binding implementation mechanism between the Centre and the states. Because hospital prescribing, pharmacy regulation, and agricultural oversight all fall primarily within state jurisdiction, AMR policy in India is largely a matter of state discretion — and the results reflect that. Some states have moved meaningfully; many others have not. The policy exists at the national level; execution is patchwork.

The most direct fix is institutional: a permanent National-State AMR Council, chaired by the Union Health Minister and including representation from NITI Aayog and all state health secretaries. This body would establish AMR as a shared governance priority — a national security concern rather than a health department project. Conditional funding through NHM-linked grants, tied to measurable state-level indicators such as action plan notification and laboratory capacity development, would create the financial accountability that voluntary coordination has so far failed to produce.

 Digital Transformation and Supply Chain Oversight

Schedule H1 currently runs on paper registers. That is its central vulnerability. Three-year paper trails are straightforward to manipulate and nearly impossible for overstretched drug inspectors to verify systematically. A mandatory transition to electronic records is long overdue. Paired with a Patient Digital Health Card that consolidates antibiotic prescription and dispensing data across pharmacies, this would close the pharmacy-hopping loophole through which non-prescription sales currently operate. Digitisation also produces real-time surveillance data as a by-product — something the current manual system cannot generate. Retail pharmacies, which currently carry significant administrative costs under Schedule H1, would likely see those costs reduced.

Mitigating Financial Toxicity via PM-JAY

One of the clearest findings of this research is the degree of financial hardship that AMR generates at household level — a problem that is particularly acute given that approximately 70% of healthcare spending in India is out-of-pocket. PM-JAY, as currently structured, covers inpatient costs but leaves outpatient expenditure — including expensive last-resort antibiotics— largely to patients. Extending PM-JAY to cover drug-resistant infection treatment in the outpatient setting would address this gap directly. India’s DOTS-Plus model from the TB programme offers a practical template: restricted access to specialist drugs through accredited centres, combined with financial support for nutrition and treatment costs, designed to ensure patients complete their courses without the financial pressure that drives early dropout.

CONCLUSION

India’s AMR policies don’t fail because they are badly designed. They fail because the systems needed to implement them are inadequate, inconsistently resourced, and operating across governance structures that don’t reliably move in the same direction. That is the central finding of this study.

The consequences are not abstract. Families are paying more for healthcare than they should be. Hospitals are managing increasingly complex infections with increasingly expensive drugs. The antibiotics that still work are being consumed faster than they need to be. Surveillance systems are not yet capturing enough of the resistance picture to drive the targeted responses that would actually make a difference.

None of this is irreversible. Fixing the centre-state coordination problem, moving prescription records to digital systems, expanding surveillance beyond tertiary hospitals, and protecting lower-income households from catastrophic out-of-pocket costs are all achievable. The policy intent exists. What India needs now is the institutional infrastructure to match it.

Future research should move beyond secondary analysis. Qualitative fieldwork with pharmacists, primary care clinicians, and district health officials — the people who operate within these systems daily — would reveal implementation dynamics that published surveillance data cannot capture. That contextual evidence is what is needed to build policy solutions specific enough to actually work.

ACKNOWLEDGMENT 

We sincerely acknowledge the contributions of our fellow intern, Nandini Sharma, Amrita Mishra, S. Santhosh ,whose support and dedication greatly enriched this research project.

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