Antimicrobial Sales Growth Under Pressure in 2026

Q: What is Antimicrobial Resistance (AMR) and why is it a significant concern for public health in India?

Definition: Antimicrobial Resistance (AMR) occurs when microorganisms—including bacteria, viruses, fungi, and parasites—evolve mechanisms to resist the drugs designed to kill them, rendering standard treatments ineffective. Significance in India: AMR is projected to cause around 2 million deaths in India by 2050, representing a substantial public health challenge. High rates of antibiotic misuse, over-the-counter sales without prescriptions, and unregulated healthcare practices have accelerated resistance. For example, common antibiotics like azithromycin and amoxicillin were frequently dispensed informally, increasing the prevalence of resistant strains. Broader implications: AMR undermines the effectiveness of essential treatments, increases healthcare costs, and risks reversing decades of medical progress. Infections that were once easily treatable may require longer hospital stays, stronger medications, and may result in higher morbidity and mortality.

Q: Why has the Indian government introduced regulatory measures such as blue vertical chips on antimicrobial packaging?

Objective: The introduction of blue vertical chips on all antimicrobial packaging is part of the government’s strategy to combat AMR by promoting responsible use of antibiotics. It ensures that healthcare providers and consumers can easily identify regulated antimicrobials, reducing misuse and over-the-counter sales without prescription. Enforcement mechanism: Alongside labeling, the Central Drugs Standard Control Organisation (CDSCO) may implement stricter sales monitoring, prescription stamping, and state-specific software to track antimicrobial consumption in real time. Implications: These measures aim to shift the market from informal, self-medication-driven usage towards evidence-based, prescription-led consumption. By doing so, the government seeks to protect public health, reduce resistance development, and ensure the long-term sustainability of critical antimicrobial drugs.

Q: How will stricter enforcement of prescription-only antibiotic sales impact the Indian pharmaceutical market?

Market impact: Stricter enforcement may temporarily constrain sales of antibiotics that previously relied on over-the-counter access. Analysts expect short-term volume reduction, especially for segments driven by self-medication and informal distribution channels. Shift towards prescription-led demand: Legitimate clinical demand, which is prescription-based, is expected to remain stable or grow over time. The market will gradually transition to evidence-based prescribing practices, with hospitals and formal healthcare providers driving consumption rather than informal retail. Long-term benefits: While initial growth may be tempered, this transition promotes rational use of antimicrobials, reduces the risk of resistance, and creates sustainable market growth. Companies such as Mankind Pharma and Orchid are already aligning antibiotic portfolios with national guidelines, emphasizing quality and compliance.

Q: What are the reasons for slower projected growth in the anti-infectives segment in India?

Regulatory factors: Planned restrictions on antimicrobial overuse and prescription-only mandates are expected to constrain sales growth, particularly in informal and retail channels. Market maturation and seasonality: Anti-infectives, which form the third largest therapy segment in India, are witnessing steady but moderate growth (5.2% in 2025) due to market saturation and seasonal fluctuations in infection prevalence. Shift in consumption patterns: There is a growing focus on targeted therapy, diagnostics, and hospital-based anti-infectives, reducing the reliance on broad-spectrum, over-the-counter drugs. This demand re-routing supports evidence-based medicine but limits unchecked sales expansion, explaining the projected tempered growth of 4–5% in 2026.

Q: What are the challenges and opportunities presented by India’s approach to combating AMR?

Challenges: India faces several hurdles in controlling AMR, including widespread informal sales of antibiotics, lack of public awareness, and inconsistent compliance across regions. Enforcing prescription-only regulations across a vast and fragmented retail pharmacy sector is a significant operational challenge. Opportunities: Regulatory interventions, such as blue vertical chip labeling, real-time monitoring software, and alignment with national treatment guidelines, present opportunities to professionalize antimicrobial use. Pharmaceutical companies can leverage this environment to promote rational prescribing, improve manufacturing standards, and strengthen hospital-centric sales channels. Strategic significance: Addressing AMR proactively positions India as a leader in responsible antimicrobial stewardship. Over time, these measures could reduce resistance prevalence, improve patient outcomes, and sustain the efficacy of essential drugs, ultimately safeguarding public health and economic productivity.

Q: Can you provide examples of initiatives by Indian pharmaceutical companies to support rational antimicrobial use?

Portfolio alignment: Companies such as Mankind Pharma and Orchid are restructuring antibiotic portfolios to align with national treatment guidelines, ensuring drugs are prescribed appropriately. Manufacturing and quality improvement: These firms are investing in enhanced manufacturing practices to maintain drug quality and consistency, critical for combating resistance. Awareness and engagement: Collaborating with healthcare professionals, these companies promote rational prescribing and patient awareness programs, emphasizing adherence to correct dosages and treatment durations. Such initiatives exemplify how industry-led measures complement government regulations in tackling AMR.

Q: How can India’s regulatory and industry initiatives together mitigate the risk of AMR in the long term?

Integrated approach: By combining government regulations (prescription-only sales, blue vertical chips, real-time tracking) with proactive industry measures, India can create a comprehensive ecosystem for antimicrobial stewardship. Expected outcomes: This synergy ensures that antibiotics are used responsibly, resistance patterns are closely monitored, and healthcare providers are guided by evidence-based protocols. Hospital-centric growth of anti-infectives ensures that patient care is prioritized over informal market expansion. Long-term significance: Sustained enforcement, combined with public and professional education, can slow the spread of resistant microorganisms, reduce preventable deaths, and maintain the efficacy of critical drugs. This case illustrates the importance of collaborative action between regulatory authorities and the pharmaceutical industry in addressing major public health threats.

Government initiatives to combat antimicrobial resistance may significantly impact the growth of antibiotic sales in India by 2026.

Surya

•January 27, 2026•5 mins read

India clamps down on antibiotic misuse to fight antimicrobial resistance (AMR)

Not Started

1. Context: Antimicrobial Resistance (AMR) as a Public Health and Governance Challenge

Antimicrobial resistance (AMR) refers to the ability of microorganisms such as bacteria, viruses, fungi and parasites to withstand medicines designed to eliminate them. This makes common infections harder, costlier, or sometimes impossible to treat, directly threatening public health systems.

Globally, AMR has moved from a technical health concern to a development and governance issue, as it undermines disease control, increases healthcare costs, and reduces productivity. For countries like India, with a high infectious disease burden and large population, the risks are amplified.

According to the World Health Organisation (WHO), around 10 million deaths globally by 2050 are projected due to AMR, with India accounting for nearly 2 million of these deaths. This places AMR alongside climate change and pandemics as a long-term existential risk.

If unchecked, AMR can reverse decades of health gains, weaken trust in healthcare systems, and impose severe fiscal stress on governments due to longer hospital stays and expensive second-line treatments.

"Antimicrobial resistance is one of the top 10 global public health threats facing humanity." — World Health Organisation (WHO)

From a governance perspective, AMR highlights the limits of market-driven medicine use and the need for regulatory stewardship. Ignoring it risks systemic healthcare failure and unsustainable public expenditure.

2. India’s Anti-Infective Market: Scale, Composition, and Growth Trends

Anti-infectives form the third-largest therapy segment in the Indian Pharmaceutical Market (IPM), indicating their centrality to India’s healthcare delivery. In CY 2025, the segment recorded sales of ₹27,534 crore, growing 5.2% from ₹26,167 crore in CY 2024.

Within this segment, antibacterials dominate with 86% share (₹23,806 crore), followed by antifungals (7%) and antivirals (4%). This reflects India’s continued dependence on antibiotics for routine infection management.

However, growth momentum is expected to moderate. Market estimates suggest tempered growth of 4–5% in 2026, primarily due to regulatory tightening, seasonality, and a push for rational antibiotic use.

This shift signals a structural transition rather than a demand collapse, where volume-driven growth gives way to prescription-led, evidence-based consumption.

"Restrictions on antimicrobial overuse, combined with seasonality, may constrain category growth." — Sheetal Sapale, Pharmarack

Economically, this transition exposes how earlier growth was partly supported by informal and irrational usage. Governance-led correction aims to align market incentives with public health outcomes.

3. Regulatory Response: Government Measures to Contain AMR

Recognising AMR as a national priority, the Central government has intensified regulatory oversight over antimicrobial use. The Union Health Ministry has proposed a draft amendment to Drug Rules, mandating a blue vertical strip on all antimicrobial labels to clearly distinguish them.

The Central Drugs Standard Control Organisation (CDSCO) is also considering an overhauled policy for antibiotic sale and monitoring. This follows recommendations submitted by a high-level subcommittee to the Drugs Consultative Committee (DCC) as part of the National Action Plan on AMR.

Earlier, the Directorate General of Health Services (DGHS) explicitly directed pharmacies not to dispense antibiotics without a valid prescription, targeting widespread over-the-counter (OTC) misuse of drugs such as azithromycin and amoxicillin.

These measures reflect a shift from advisory guidelines to enforceable regulatory mechanisms.

Policy measures highlighted:

Mandatory blue strip labelling for antimicrobials
Stricter enforcement against OTC antibiotic sales
Proposed real-time tracking software for antimicrobial sales
Prescription stamping to prevent reuse

Regulatory intervention seeks to correct market failure where individual incentives to self-medicate conflict with collective health outcomes. Weak enforcement would perpetuate resistance and negate policy intent.

4. Impact on Industry, Pharmacies, and Prescribing Practices

Stricter regulation is expected to have differentiated impacts across the pharmaceutical value chain. Products reliant on informal access and self-medication are likely to face short-term volume pressures, particularly in retail trade channels.

However, experts note that prescription-based and hospital-led demand remains resilient. Hospital anti-infectives are already showing stronger growth than trade anti-infectives, indicating a gradual curbing of irrational use.

Industry voices emphasise that the policy shift addresses misuse rather than genuine medical need. Over time, demand is expected to re-route toward rational prescribing, diagnostics, and targeted therapies.

"This is less about demand destruction and more about demand re-routing." — Nirali Shah, Ashika Group
"Legitimate, prescription-based demand will continue." — Rishi Agrawal, TeamLease Regtech

From a development lens, short-term commercial adjustments are a necessary trade-off for long-term health security. Failure to adapt could leave both industry and healthcare systems vulnerable.

5. Role of Pharmaceutical Companies and Systemic Adaptation

Pharmaceutical companies are increasingly aligning their strategies with national AMR objectives. Firms such as Mankind Pharma and Orchid are strengthening AMR-focused initiatives, including compliance with national treatment guidelines and improved manufacturing standards.

There is also greater collaboration with healthcare professionals to promote rational prescribing and patient awareness. Additionally, the shift towards diagnostics-led and targeted therapy has increased scrutiny of irrational fixed-dose combinations.

Industry leaders argue that India’s antibiotic demand is largely driven by genuine clinical need, and that regulation-led rationalisation will support sustainable growth rather than suppress innovation.

"Doctor-prescription-led usage would bring sustainable growth for the category over time." — Sheetal Arora, Mankind Pharma

Systemic adaptation shows that AMR containment is not anti-industry but pro-sustainability. Ignoring this alignment risks regulatory backlash and reputational costs.

Conclusion

India’s tightening regulatory approach to antimicrobials reflects a necessary recalibration between public health priorities and pharmaceutical market dynamics. By curbing misuse while preserving legitimate demand, the policy framework aims to address AMR without undermining healthcare access. Over the long term, effective enforcement, industry alignment, and evidence-based prescribing will be critical to safeguarding health security and sustainable development.

Quick Q&A

Everything you need to know

Definition: Antimicrobial Resistance (AMR) occurs when microorganisms—including bacteria, viruses, fungi, and parasites—evolve mechanisms to resist the drugs designed to kill them, rendering standard treatments ineffective.

Significance in India: AMR is projected to cause around 2 million deaths in India by 2050, representing a substantial public health challenge. High rates of antibiotic misuse, over-the-counter sales without prescriptions, and unregulated healthcare practices have accelerated resistance. For example, common antibiotics like azithromycin and amoxicillin were frequently dispensed informally, increasing the prevalence of resistant strains.

Broader implications: AMR undermines the effectiveness of essential treatments, increases healthcare costs, and risks reversing decades of medical progress. Infections that were once easily treatable may require longer hospital stays, stronger medications, and may result in higher morbidity and mortality.

Objective: The introduction of blue vertical chips on all antimicrobial packaging is part of the government’s strategy to combat AMR by promoting responsible use of antibiotics. It ensures that healthcare providers and consumers can easily identify regulated antimicrobials, reducing misuse and over-the-counter sales without prescription.

Enforcement mechanism: Alongside labeling, the Central Drugs Standard Control Organisation (CDSCO) may implement stricter sales monitoring, prescription stamping, and state-specific software to track antimicrobial consumption in real time.

Implications: These measures aim to shift the market from informal, self-medication-driven usage towards evidence-based, prescription-led consumption. By doing so, the government seeks to protect public health, reduce resistance development, and ensure the long-term sustainability of critical antimicrobial drugs.

Market impact: Stricter enforcement may temporarily constrain sales of antibiotics that previously relied on over-the-counter access. Analysts expect short-term volume reduction, especially for segments driven by self-medication and informal distribution channels.

Shift towards prescription-led demand: Legitimate clinical demand, which is prescription-based, is expected to remain stable or grow over time. The market will gradually transition to evidence-based prescribing practices, with hospitals and formal healthcare providers driving consumption rather than informal retail.

Long-term benefits: While initial growth may be tempered, this transition promotes rational use of antimicrobials, reduces the risk of resistance, and creates sustainable market growth. Companies such as Mankind Pharma and Orchid are already aligning antibiotic portfolios with national guidelines, emphasizing quality and compliance.

Regulatory factors: Planned restrictions on antimicrobial overuse and prescription-only mandates are expected to constrain sales growth, particularly in informal and retail channels.

Market maturation and seasonality: Anti-infectives, which form the third largest therapy segment in India, are witnessing steady but moderate growth (5.2% in 2025) due to market saturation and seasonal fluctuations in infection prevalence.

Shift in consumption patterns: There is a growing focus on targeted therapy, diagnostics, and hospital-based anti-infectives, reducing the reliance on broad-spectrum, over-the-counter drugs. This demand re-routing supports evidence-based medicine but limits unchecked sales expansion, explaining the projected tempered growth of 4–5% in 2026.

Challenges: India faces several hurdles in controlling AMR, including widespread informal sales of antibiotics, lack of public awareness, and inconsistent compliance across regions. Enforcing prescription-only regulations across a vast and fragmented retail pharmacy sector is a significant operational challenge.

Opportunities: Regulatory interventions, such as blue vertical chip labeling, real-time monitoring software, and alignment with national treatment guidelines, present opportunities to professionalize antimicrobial use. Pharmaceutical companies can leverage this environment to promote rational prescribing, improve manufacturing standards, and strengthen hospital-centric sales channels.

Strategic significance: Addressing AMR proactively positions India as a leader in responsible antimicrobial stewardship. Over time, these measures could reduce resistance prevalence, improve patient outcomes, and sustain the efficacy of essential drugs, ultimately safeguarding public health and economic productivity.

Portfolio alignment: Companies such as Mankind Pharma and Orchid are restructuring antibiotic portfolios to align with national treatment guidelines, ensuring drugs are prescribed appropriately.

Manufacturing and quality improvement: These firms are investing in enhanced manufacturing practices to maintain drug quality and consistency, critical for combating resistance.

Awareness and engagement: Collaborating with healthcare professionals, these companies promote rational prescribing and patient awareness programs, emphasizing adherence to correct dosages and treatment durations. Such initiatives exemplify how industry-led measures complement government regulations in tackling AMR.

Integrated approach: By combining government regulations (prescription-only sales, blue vertical chips, real-time tracking) with proactive industry measures, India can create a comprehensive ecosystem for antimicrobial stewardship.

Expected outcomes: This synergy ensures that antibiotics are used responsibly, resistance patterns are closely monitored, and healthcare providers are guided by evidence-based protocols. Hospital-centric growth of anti-infectives ensures that patient care is prioritized over informal market expansion.

Long-term significance: Sustained enforcement, combined with public and professional education, can slow the spread of resistant microorganisms, reduce preventable deaths, and maintain the efficacy of critical drugs. This case illustrates the importance of collaborative action between regulatory authorities and the pharmaceutical industry in addressing major public health threats.

Attribution

Original content sources and authors

Sanket Koul

Business Standard

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