Site in India Receives Responsible Antibiotic Manufacturing Certification

Pharmaceutical company Viatris announced today that its manufacturing site in India has received Minimized Risk of Antimicrobial Resistance (AMR) certification.

The certification, developed by the British Standards Institution (BSI) in collaboration with the AMR Industry Alliance, provides third-party, independent verification that the antibiotic waste released into the environment by antibiotic manufacturing sites is below a threshold that could promote AMR in the environment. That threshold was established in responsible manufacturing guidelines developed by BSI and the AMR Industry Alliance in 2022 to encourage sustainable production of antibiotics.

The certification scheme is targeting key antibiotic supply chain markets like India and China. According to a CIDRAP-ASP report, approximately 20,000 tons of pharmaceuticals, including antibiotics, are produced at active pharmaceutical manufacturing sites in India, which are largely unregulated. Researchers have found high levels of antibiotics and multidrug-resistant bacteria in waters near some of those sites, raising concern about the environmental risks posed by antibiotic manufacturing.

The Viatris facility is in Aurangabad, India.

“We are proud to be the first pharmaceutical site in India to achieve this important Minimized Risk of Antimicrobial Resistance certification from BSI, demonstrating our commitment to controlling antibiotic discharge,” Viatris Chief Operations Officer Sanjeev Sethi said in a company press release.

date 28/02/2024
source CIDRAP, University of Minnesota
Author Chris Dall, MA