A coalition of companies representing the pharmaceutical, biotechnology and diagnostics industries today released new guidelines to help antibiotic manufacturers limit the release of antibiotic manufacturing waste into the environment.
The Antibiotic Manufacturing Standard, developed by the AMR Industry Alliance in conjunction with the British Standards Institute (BSI), provides guidance to antibiotic manufacturers to help them ensure that their products are produced responsibly and do not contribute not at risk of antimicrobial resistance (AMR). in the environment. The document marks the formalization of a framework the Alliance developed in 2018 to establish industry standards for the release of active pharmaceutical ingredients (APIs) from antibiotic manufacturing sites.
“Antimicrobial resistance is one of the greatest public health challenges of our time. Our Alliance standard opens the next chapter in responsible manufacturing along the global antibiotic value chain,” said Thomas Cueni, Chairman of the AMR Industry Alliance and Chief Executive of the International Federation of Pharmaceutical Manufacturers and Associations. , said in a press release.
Growing concern over environmental pollution from antibiotics
The guidelines were developed in response to growing concerns that the release of wastewater containing antibiotics into the environment from manufacturing sites is contributing to the emergence of antimicrobial resistance in environmental bacteria.
Although direct links between antimicrobial resistance in the environment and drug-resistant infections in humans have yet to be established, and healthcare facilities are also known to be a significant source of environmental pollution by antibiotics, the AMR Industry Alliance and other groups have pushed for more regulation. API shows to address the role of antibiotic manufacturing.
A major focus of these efforts is India, which according to a recent report by the Center for Infectious Disease Research and Policy’s Antimicrobial Stewardship Project (CIDRAP-ASP), is home to at least 40 API manufacturing plants. . These factories produce APIs in bulk and discharge unnecessary by-products as wastewater into local rivers and streams.
The CIDRAP-ASP report highlights research by Indian environmental groups that found multi-resistant strains of bacteria and high levels of antibiotics in waters near antibiotic manufacturing sites, which are clustered in centers around from India. In response, several pharmaceutical companies with manufacturing plants in India that belong to the AMR Industry Alliance have committed to a “zero liquid discharge” practice that aims to minimize pollutants discharged into waterways.
To reinforce these efforts and establish a general set of principles around the issue, the Antibiotic Manufacturing Standard requires antibiotic manufacturers to have an effective environmental management and wastewater treatment system that minimizes releases of APIs to wastewater. It also calls for the concentration of antibiotics in manufacturing wastewater to be below the predicted no-effect concentration, which is defined as the level below which adverse environmental effects are not expected to occur.
The AMR Industry Alliance and BSI say they also plan to develop and launch a certification system in which an independent third party will determine that manufacturing plants meet the requirements of the standard.
The standard and resulting certification program will “build much-needed global awareness, encourage decisive action, and provide an external and independent assurance mechanism, leading to a new model of transparency for the industry,” Courtney said. Soulsby, BSI’s Global Head of Healthcare and Life Sciences. said.