SWITZERLAND – A coalition of companies representing the pharmaceutical, biotech, and diagnostics industries have 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 collaboration with the British Standards Institute (BSI), provides guidance to antibiotic manufacturers to help ensure that their products are made responsibly and don’t contribute to the risk of antimicrobial resistance (AMR) in the environment.

The standard formalizes the Alliance’s Common Antibiotic Manufacturing Framework, which described a risk-based approach to assessing and controlling antibiotic manufacturing waste streams in 2018.

“Antimicrobial resistance is one of the biggest public health challenges of our time. Our Alliance’s Standard launches the next chapter of responsible manufacturing throughout the global antibiotic value chain,” Thomas Cueni, Chair of the AMR Industry Alliance and Director General of the International Federation of Pharmaceutical Manufacturers and Associations, said in a press release.

In 2019, antimicrobial resistant bacteria accounted for 1.27 million deaths and contributed to another nearly five million deaths.

Antibiotics are critical innovations that have transformed modern healthcare, but the rise of AMR is jeopardizing their efficacy.

According to a study published in The Lancet, AMR is currently one of the World Health Organization’s (WHO) top ten global public health threats.

In 2019, antimicrobial resistant bacteria accounted for 1.27 million deaths and contributed to another nearly five million deaths.

Deemed the ‘Silent Pandemic’ by some in recent years, the scale of the issue is expected to continue to rise.

According to the Alliance, if AMR is left unchecked it could “undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective, making mainstream medical advances like chemotherapy, hip replacements, caesarean sections and root canals, risky and even deadly.”

Growing concern over environmental antibiotic pollution

The guidelines were developed because of growing concerns that the release of antibiotic-laced wastewater into the environment from manufacturing sites is contributing to the emergence of AMR in environmental bacteria.

Direct links between AMR in the environment and drug-resistant infections in humans have yet to be established, and healthcare settings are also known to be a significant source of environmental antibiotic pollution.

Consequently, the AMR Industry Alliance and other groups have been pushing for more regulation of API emissions to address the role of antibiotic manufacturing.

Major focus in India

A major focus of these efforts is in India, which, according to a recent report from the Center for Infectious Disease Research and Policy’s Antimicrobial Stewardship Project (CIDRAP-ASP), is home to at least 40 API manufacturing plants.

These plants produce APIs in bulk and release the unnecessary byproducts as wastewater into local rivers and streams.

The CIDRAP-ASP report highlights research by Indian environmental groups that has found strains of multidrug-resistant bacteria and high levels of antibiotics in waters near antibiotic manufacturing sites, which are clustered in hubs around 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 bolster these efforts and establish a general set of principles around the issue, the Antibiotic Manufacturing Standard requires that antibiotic manufacturers have an effective environmental management and wastewater treatment system that minimizes API discharges in wastewater.

It also calls for the antibiotic concentration in manufacturing wastewater to be less than the predicted no-effect concentration, which is defined as the level below which adverse environmental effects are not expected to occur.

To provide additional guidance and quality assurance, the Alliance and BSI will also develop a certification scheme that will allow antibiotic manufacturers to demonstrate compliance with the standard through independent third-party evaluation.

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