Responsible manufacturing is critical to stop drug resistance from becoming uncontrollable, and to ensure a life-saving drug does not cause unintended harm to human health and environment, says a study by Netherlands-based Access to Medicine Foundation.

Anti-microbial resistance (AMR) is a global health threat and a key driver of this drug resistance is the release of antibiotic waste into the environment. “By responsibly managing and disposing of their antibiotic manufacturing waste, pharmaceutical companies can help combat AMR and limit their impact on the environment,” says the report.

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China and India have a large number of sites involved in antibacterial production, the non-profit group said. Marijn Verhoef, the Foundation’s Director of Operations and Research, said that companies with a presence in India (who were analysed) have been stepping up efforts to limit the risk of AMR from manufacturing. “In line with local policies, companies show a strong commitment to apply Zero Liquid Discharge (ZLD) at their owned and operated manufacturing sites, meaning that no antibiotic waste is released into local waterways…. it is encouraging to see that companies who apply ZLD in India, such as Aurobindo, Cipla, Viatris and Sun Pharma, report to stay away from reusing any recycled water from these manufacturing sites in gardening and horticulture,” he said.

“In the absence of regulation on antibiotic discharge limits, the critical challenge for companies is to work with their suppliers to ensure the risk of AMR from manufacturing is limited across the full supply chain,” he added.

Of the companies surveyed by the study, a handful are taking promising action the report said, mentioning Abbott, Centrient, Sandoz and Shionogi.

“Centrient, GSK, Pfizer and Shionogi report compliance with discharge limits at the majority of their upstream suppliers, showing how companies can transform the antibiotic supply chain.”

“During the manufacture of antibiotics, waste that is generated at a manufacturing site is typically released into rivers and waterways. If this wastewater contains high levels of active pharmaceutical ingredients

(APIs), it poses a serious risk to the spread of AMR,” the report explained.

Pharmaceutical companies that hold market authorisations for antibiotics, are uniquely positioned to drive change across the antibiotic supply chain, and can help transform the industry, the study said. “Not only can they prioritise responsible manufacturing at the manufacturing sites they own and operate, but they have the ability to influence the standards and practices of the various third-party suppliers they contract in the production of their lifesaving medicines.”

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“Responsible manufacturing is among the ways in which they can help prevent drug resistance from becoming uncontrollable – and can ensure that the production of their lifesaving antibiotics does not cause unintended harm to human health or the environment,” said Jayasree K. Iyer, Chief Executive with the Foundation.

Wastewater management

Companies need to prioritise effective wastewater management methods to establish, quantify and monitor discharge limits for ensuring wastewater safety at their own manufacturing sites, the study said.

By implementing wastewater treatment processes at their manufacturing sites, Centrient and Shionogi show that reaching compliance in wastewater before releasing it is feasible, the report said, citing the example of Centrient that has reportedly achieved this at its site in Tonsa, India. Other methods include, Sandoz, which uses a membrane filtration process at its main antibiotic manufacturing site in Kundl, Austria, to remove bacteria from its wastewater.

Ensuring transparency and accountability across the antibiotic supply chain is crucial, the study added. To date, overall transparency has been lacking, “while Centrient, GSK, Shionogi, Teva and Viatris publicly report specific details on their waste management practices, only Shionogi provides clarity on its antibacterial manufacturing supply chain. Critically, no company currently reports actual antibiotic discharge levels at its own sites or supplier sites,” the study said.

“Stakeholders – including procurers, investors and regulators – are already looking to pharmaceutical companies that demonstrate their commitment to limiting their impact on AMR and the environment,” said Verhoef. The study cited the examples of Fresenius Kabi, Sandoz and Viatris, who were awarded tenders as part of the Norwegian Hospital Procurement Agency’s 2019 sustainable pilot procurement programme.