WAAW 2024: India can play a pivotal role in global response to AMR by balancing regulatory compliance with economic viability

Antimicrobial Resistance (AMR), one of the most urgent health threats facing the world, can jeopardise human health, agricultural productivity, and the environment. Declared by the World Health Organization (WHO) as one of the top 10 global public health threats, AMR could lead to 10 million deaths annually and economic losses of around $100 trillion by 2050 if not addressed.

India, along with China, contributes 80-90 per cent of the world’s antibiotic production, positioning itself at the forefront of the global AMR response. However, India’s strict adherence to environmental regulations has sometimes put manufacturers at a competitive disadvantage, particularly compared to countries like China, resulting in the Indian Active Pharmaceutical Ingredient (API) industry losing ground to Chinese competitors since the 1990s. Establishing a level playing field through fair regulations is essential for India’s competitiveness while safeguarding the environment. Integrating a One Health approach — recognising the interconnected health of humans, animals, and the environment — is crucial for effective AMR containment.

The G20, under India’s presidency in 2023, declared AMR a priority area, urging collaborative action among member nations. This commitment, echoed in the 2024 United Nations General Assembly (UNGA) Political Declaration and the latest WHO report on AMR, emphasises the urgent need for global cooperation, regulatory insight, and action.

The One Health approach, endorsed in the UNGA 2024 Declaration, is vital for addressing AMR effectively, particularly in API manufacturing. By minimising environmental pollutants and practicing responsible antibiotic manufacturing, API facilities can help prevent the spread of AMR and protect ecosystems. The recent declarations call for comprehensive national action plans to enhance surveillance, reduce unnecessary antibiotic use, and increase research funding.

The 2024 WHO AMR Report highlights the necessity for regulatory vigilance concerning pharmaceutical pollutants. The WHO’s AWARE classification (Access, Watch, and Reserve antibiotics) provides a framework for prioritising effective antibiotics while protecting those reserved for last-line treatments. For API manufacturers, this means monitoring production practices closely, especially for antibiotics in the Watch and Reserve categories, which have a higher resistance potential. Implementing advanced wastewater treatment technologies can significantly reduce AMR spread.

High capital expenditure and PNEC compliance

Compliance with Predicted No Effect Concentrations (PNEC) —environmental concentration limits for antibiotics — poses a financial challenge for API manufacturers. Establishing PNEC compliance can require substantial investments, estimated to be Rs 60-120 crore ($7-15 million) for initial setup and Rs 5-20 crore ($600,000–2.4 million) annually for maintenance. Additionally, individual AMR testing can cost between Rs 15,000-35,000 ($180-420), placing significant financial strain on manufacturing operations, particularly for small and medium enterprises. There is a need for India-specific studies to address antimicrobial residues in effluents under tropical conditions.

Both the G20 and UNGA declarations, along with the WHO report, advocate for financial incentives, such as subsidies and tax breaks, to offset high costs. Government-backed funding to establish advanced wastewater treatment and residue testing facilities is critical for ensuring compliance and maintaining India’s competitive edge in the global pharmaceutical market.

Implementing Zero Liquid Discharge (ZLD)

Implementing ZLD technology is crucial for managing antibiotic residues in wastewater from API facilities. However, the substantial capital and recurring expenses associated with ZLD can be prohibitive for smaller manufacturers. Despite the high costs, ZLD systems align with international environmental targets by reducing the environmental burden and conserving water resources.

Policies like the United Nations Environment Programme’s Responsible Antibiotics Manufacturing Programme suggest that ZLD facilities be exempt from bio-assay tests due to their advanced standards. To promote ZLD adoption, government incentives and clear regulatory guidelines distinguishing ZLD from non-ZLD facilities are necessary to ensure compliance without jeopardizing economic viability.

Aligning with Global Standards

Recognising the unique scale of API manufacturing in countries like India, the G20, UNGA 2024, and WHO reports highlight the need for tailored standards. Regulatory standards should differentiate between high-output API production and formulation manufacturing to avoid unnecessary financial burdens on smaller facilities. This approach will enable India to lead in AMR containment while preserving its API sector’s global standing.

Incentivising R&D and National AMR Alliances

The global antibiotic pipeline has thinned, with only 34 new antibiotics in development—a crisis underscored by the 2024 WHO report. In response, the pharmaceutical industry is creating initiatives like the AMR Action Fund to support new antibiotics. For India’s API industry, establishing a national AMR alliance could facilitate pooled resources for R&D and advance research in priority areas.

Funding R&D aligned with the WHO’s 40 research areas on AMR can foster innovation and expand treatment options. Developing partnerships for early-stage research into resistant bacteria, fungi, and Mycobacterium tuberculosis would position India as a pivotal player in the global AMR response.

Implementing responsible use and green procurement standards

Countries like Norway are adopting green procurement policies that prioritise environmental performance over cost. By embracing green standards, Indian manufacturers can attract international clients while minimising AMR spread. These standards include rational antibiotic use and effective residue monitoring, promoting a sustainable pharmaceutical industry in India.

India’s National AMR Response

India’s National Guidelines for Infection Prevention and Control and its AMR containment program across 38 state medical colleges support WHO recommendations. As a significant player in antibiotic production, India is well-positioned to combat AMR while ensuring the sustainability of its pharmaceutical sector. By aligning with the G20’s AMR prioritization, the UNGA 2024 Political Declaration, and the latest WHO AMR report, Indian API manufacturers can contribute meaningfully to global AMR goals.

A collaborative environment where regulatory standards are effective and practical is essential. This includes supporting sustainable manufacturing practices, adopting advanced waste management solutions, and encouraging research into antibiotic alternatives. By balancing regulatory compliance with economic viability, India can enhance its competitive edge and play a pivotal role in the global response to AMR.

Ashok K Madan is Executive Director of Indian Drug Manufacturers' Association, Delhi

The author has written the article in his individual capacity. Views expressed are the author’s own and don’t necessarily reflect those of Down To Earth.