Responsible antibiotic manufacturing: Future of pharma sustainability

Antimicrobial Resistance (AMR) continues to impact the efficacy of antibiotics – resulting in a serious potential threat to global population health. According to the UN, “AMR could push 28.3 million people into extreme poverty by 2050 due to high treatment costs and chronic infections.” That means there is a clear opportunity for collaboration to address this challenge and enhance pharmaceutical sustainability, benefiting people and the planet.

The World Health Organization has declared AMR a top 10 global public health threat and expects it to get worse unless action is taken, particularly across India and Asia where AMR resistance rates are some of the highest globally. This could threaten to undermine the basis of modern medicine by rendering antibiotics used to treat and prevent infections ineffective.

Emissions in antibiotic manufacturing waste streams, especially wastewater, have the potential to contribute to the development of AMR in the environment unless effectively controlled. The potential ramifications are significant. If the water supply includes a higher concentration of resistant bacteria due to antibiotic waste, the bacteria within may be more likely to be resistant to treatment in the long term. There are other sources of antibiotics in the environment, including waste from human and animal use, and agricultural applications, which also require consideration. 

In India specifically, a lack of enforced pollution regulation, limited expertise for the measurement for safe concentrations of discharge, assessment and remediation of AMR and an often-complex wastewater process are some of the unique challenges manufacturers have encountered in addressing AMR in the environment. Pharmaceutical plants can act as hotspots releasing significant amounts of antibiotics into the environment. This is particularly concerning in regions with inadequate monitoring and wastewater management capacity.

Wastewater discharge measurement is essential for designing production facility-specific interventions and assessing the success of reduction and wastewater treatment efforts. Likewise, rigorous environmental control measures are essential at every stage of manufacturing to ensure that wastewater from antibiotics meet established discharge concentration standards. A comparative risk assessment framework can be adapted to evaluate the risk of environmental issues posed by individual antibiotics. This approach considers severity and probability factors.

To support manufacturers with this challenge, in 2022 BSI facilitated the development of a globally applicable industry standard setting out how to measure and monitor the environmental impact of waste discharge. Following this, a certification program was developed to certify antibiotics. Viatris was amongst the first organisations and the first pharmaceutical company in India to undergo an independent assessment of their compliance to the Antibiotic Manufacturing Standard for a selection of their antibiotics. 

Environmental standards and independent assessment, particularly the AMRIA Manufacturing standard and BSI’s Kitemark, can fill the void of regulation, provide guidance and evidence of best practice by manufacturers to help counter the environmental and public health threat of AMR. Certification to the standard offers a clear sign that manufacturers are taking necessary steps to ensure antibiotics are made responsibly, helping to minimise the risk of releasing antibiotic waste emissions into the environment. This certification program takes into account and has a mechanism to review the unique discharge control methods by the Indian manufacturing community – the Zero Liquid Discharge guidelines. Indian manufacturers can use this to prove to external stakeholders that the circularity of their model, which takes wastewater discharge and uses it in cooling and energy systems for production facilities, does mitigate the threat of pollution to the environment.

A unique opportunity lies before pharmaceutical leaders in India: Stepping up against AMR could potentially save lives across the globe. And though recent research suggests mitigating AMR may require a more comprehensive strategy, including looking at the waste controls in the manufacturing process, pharmaceutical companies are well-positioned to make a direct impact on the issue.

Pharmaceutical leaders in India can seize the moment to consider how they can both become more sustainable and benefit society at the same time. In taking a critical step forward to address the growing threat from AMR and reduce discharge from the manufacturing process into the environment, India’s pharmaceutical sector can work collaboratively to accelerate progress to a more sustainable world.