How India can nip the looming threat of antimicrobial resistance in the bud

Often hailed as the pharmacy of the world, the booming pharmaceutical sector of India has more than doubled its share in exports over the past decade. India accounts for 60% of vaccines and 20% of generic medicines globally. During the Covid-19 pandemic, the sector supported many countries with medication and vaccines. The industry has unlocked growth for the Indian economy, enabling better employment opportunities, improved health and quality of life. However, the looming threat of antimicrobial resistance (AMR) holds the potential to undo years of progress made by the pharma sector.

In 2019, AMR was directly responsible for over 1 million deaths, and an additional associated 5 million deaths. This was much more than the deaths caused by malaria and HIV collectively that year. Humans and animals do drive AMR in the environment from untreated wastewater in healthcare facilities, municipal wastewater and farms, and untreated effluents from pharmaceutical manufacturing may contribute to the spread of environmental AMR when discharged into the water streams.

Together, these drivers subsequently increase the build-up of AMR in humans and animals due to the interconnectivity between ecosystems. The spread of AMR not only has ramifications on health but also impacts economic and developmental goals, including those on sanitation, poverty and well-being.

Multilateral organisations like the World Health Organisation (WHO), United Nations Environment Programme (UNEP) and fora like G7 have emphasised curtailing the various drivers of AMR. With the inclusion of UNEP in the global quadripartite to curtail AMR, there has been a renewed emphasis on limiting it. In India, the Centre and some state governments like Andhra Pradesh, Kerala and Madhya Pradesh have also developed action plans to arrest AMR spread.

The National Action Plan on AMR and the Andhra Pradesh’s State Action Plan have also called for stringent limits for antibiotic residues from farms, healthcare facilities, factories and pharma manufacturing units. However, in the absence of strict limits for antibiotic residues, several cases of antibiotic pollution in rivers of pharma hubs like Telangana and Himachal Pradesh have been reported.

Since its inception, the AMR Industry Alliance (AMRIA) has been striving to develop safe discharge values for various antibiotics. Recently, with the help of the British Standards Institution (BSI), AMRIA formulated the Antibiotic Manufacturing Standards (AMS) to reduce the risk from antibiotic manufacturing effluents. AMS requires the manufacturer to develop an environmental management system and risk-based approach to assess and control effluents along with implementing predicted no-effect concentrations (PNEC) criteria.

With a certification scheme that will provide independent verification that an antibiotic is made in accordance with the requirements of the standard in the pipeline, widespread adoption of these standards can usher in a new era of environmental transparency, accountability and responsibility in antibiotic manufacturing. Sustainable manufacturing must be supplemented with sustainable procurement practices to help revamp the global pharma supply chain.

Countries like Norway, Sweden and Britain are providing market incentives to promote sustainable antibiotic manufacturing. While Norway’s antibiotic procurement policy offers 30% weightage to environment-friendly production, the Swedish government uses environmental criteria in pharma procurement. With countries providing first-mover benefits to manufacturers with greener practices, Indian manufacturers should ensure their competitive advantage by embracing them.

While some industry members can take the lead by self-regulating, a robust monitoring framework along the lines of the AMS and certification scheme anticipated in early 2023 that can be widely adopted is the need of the hour. Also, with SME manufacturers concentrating most of the pharma sector in India, GoI needs to step in to facilitate the adoption of risk assessment. That means manufacturers quantify antibiotic losses to the environment and understand where and how best to reduce such emissions.

Where necessary, low-cost technologies can significantly reduce the discharge from antibiotic manufacturing. Undertaking collaborative and cohesive measures for regulating the discharge of effluents from pharma manufacturing sites is a prerequisite in ensuring the elimination of AMR from the environment.