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Responsible antibiotic production Certificate

Facts for Prelims (FFP)

Source: DTE

Context: A new certification scheme has been launched in India to promote responsible antibiotic manufacturing (first of its kind)


About the Scheme:

  • Developed by: the British Standards Institute (BSI) (a business improvement and standards company) and the AMR Industry Alliance (one of the largest private sector coalitions that provide long-term solutions to antimicrobial resistance)
  • Aim: To address environmental concerns related to antimicrobial resistance (AMR) by limiting the release of antibiotic residues into waterways through industrial waste.
  • Process:
    • The certification process involves third-party validation to monitor environmental practices throughout the manufacturing process.
    • Manufacturers must demonstrate effective environmental management and wastewater treatment systems to obtain certification.
    • The concentration of antibiotics in waste streams must be below a specified threshold to prevent the emergence of AMR in the environment.
  • Time: The certification is valid for three years, with annual surveillance to ensure ongoing compliance.

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. The initiative is part of efforts to promote sustainable and responsible drug production while mitigating the environmental impact of antibiotic manufacturing.

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