AMR Industry Alliance underscores need for antibiotic manufacturers to prevent aquatic eco-toxicity

Bengaluru, June 27, 2022:

The new Antibiotic Manufacturing Standard (AMS) developed by the AMR Industry Alliance is a critical step to implement responsible production practices to mitigate the impact of antimicrobial resistance (AMR) in the environment. Antibiotics are essential innovations saving lives. In the production of these medicines, emissions in manufacturing waste streams can lead to AMR.

In the absence of a national and international standard for antimicrobial manufacturing emissions, the need of the hour is to put in place an environmental management system and risk-based approach to assess and control its effluents into the water.

Adherence to Predicted No-Effect Concentrations (PNEC), are unlikely to result in increased risk of resistance.  It is here the AMR Industry Alliance is playing a key role to prevent emissions to surface water and the environment through control of antibiotic residue in wastewater and solid waste to safe levels.

However establishing the Antibiotic Manufacturing Standard is a critical step toward awareness raising and more widespread adoption of responsible practices. Further, adoption of the standard if included in procurement tenders would help influence necessary change across the global antibiotic value chain.

Through a process that was facilitated by the British Standards Institution (BSI), the AMR Industry Alliance has now advanced its work on the Common Antibiotic Manufacturing Framework and PNECs to be adopted.

As of January 2, 2023, the AMS will replace the Common Antibiotic Manufacturing Framework as the guiding documentation for antibiotic manufacturers. As a further step, AMR Industry Alliance is working with BSI to develop a certification scheme.

By taking adequate steps, 98% of the AMR Industry Alliance manufacturing companies are meeting framework requirements either fully or partially, with more work to be done at supplier sites.  Further, 87% of products manufactured are meeting the PNECs.

The Alliance’s coordinated approach to date has driven a significant part of the industry forward in the absence of other controls such as regulation. Introduction a certification scheme which is expected to stimulate widespread adoption of controls to minimize emissions of antibiotics, minimize AMR risk that may otherwise arise from manufacturing emissions.

 Further, adherence to the AMS can help antibiotic manufacturing companies achieve their sustainability goals. The financial investment community’s guidance on ESG (Environmental, Social, Governance) has identified AMR and pharmaceuticals in the environment as key initiatives for the biopharmaceutical sector, calling on for action both internally and across the supply chain.

According to the WHO, AMR is among the top 10 global public health threats. Antimicrobial resistant bacteria accounted for 1.27 million fatalities in 2019 and another nearly 5 million succumbed during the same year, as per Institute for Health Metrics and Evaluation, published in The Lancet.

Unchecked, AMR threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective, making chemotherapy, hip replacements, caesarian sections, and root canals, risky and even deadly. The inaction could risk 1.3 million otherwise preventable annual fatalities globally. The public health response to Covid-19 delayed the progress to combat AMR but showed how powerful a coordinated global effort can allow responsible manufacturing, stated the Alliance.

According to Centrient Pharmaceuticals, “As a founding member of the AMR Industry Alliance, our company appreciates the standards being put in place. We are the first company to publicly announce 100% PNEC compliance for our entire oral antibiotics product range, we will seek certification once this is available.” PharmaBiz