A new certification scheme to promote responsible antibiotics manufacturing was launched in India on June 26, 2023, by British Standards Institute (BSI) and AMR Industry Alliance.
AMR Industry Alliance, one of the largest private sector coalitions that provide long-term solutions to antimicrobial resistance, engaged BSI, a business improvement and standards company, to provide expert services for the development of this standard.
The online event followed the footsteps of a similar global certification launch held on June 5, 2023.
Courtney Soulsby, director of Global Healthcare and Lifesciences, BSI; Steve Brooks of AMR Industry Alliance; Vasudeva Murthy, head of healthcare, BSI India; Ashok Kumar Madan, executive director, Indian Drug Manufacturers’ Association etc, spoke during the online launch on June 26.
Responsible antibiotic production is critical to encouraging sustainable drug production. This also addresses growing environmental concerns about antimicrobial resistance (AMR) by limiting the release of antibiotic residues into waterways through industrial waste, which contributes significantly to AMR, particularly the environmental aspect of it.
Antibiotic residues enter waterways from various sources, including hospital wastewater, farms, sewage systems and others. While antibiotic overuse in humans and animals is considered the primary cause of AMR, the environmental aspect of AMR is gaining global attention.
The certification is the first of its kind, with a third-party validation process, to monitor environmental concerns in the antibiotic manufacturing process. The certification helps in determining whether environmental and waste control procedures are in place throughout the manufacturing process.
This intends to ensure that the concentration of antibiotics in waste streams is below a threshold that does not result in the emergence of AMR in the environment. During the development of this certification, several manufacturers have expressed their willingness to self-regulate the processes.
A manufacturer should provide effective environmental management and a wastewater treatment system that minimises the discharges of active pharmaceutical ingredients to obtain certification. The certificate, once issued, is valid for three years. Annual surveillance is carried out to ensure ongoing maintenance.
Antibiotic concentration at the release point must be less than the predicted no-effect concentration — the level at which the chemical has no toxic effect and will not promote AMR — to meet the certification standard.
“Waste should be minimised and strictly controlled every time production is run, so we want to create a robust environmental management system,” said Steve Brooks, an advisor to the AMR Industry Alliance.
In 2022, The AMR Industry Alliance and BSI came up with a set of Antibiotic Manufacturing Standards and launched the certification to ensure their implementation.
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