WHO releases global guidance to tackle antibiotic pollution from manufacturing processes

WHO releases global guidance to tackle antibiotic pollution from manufacturing processes

Sub :Sci

Sec: Health

Context:

• WHO released its first global guidance on managing antibiotic pollution from manufacturing on September 3, 2024, titled Guidance on wastewater and solid waste management for manufacturing of antibiotics.

Details:

• The document provides a scientific framework for regulators, industry players, and other stakeholders to control antibiotic pollution.
• Developed with international experts, the guidance seeks collective action to reduce the environmental impact of antibiotic manufacturing.

Key Elements of the Guidance:

• The guidance outlines three core elements:

1. Setting targets for resistance selection and ecological effects based on risk assessments.
2. Implementing risk management processes using hazard analysis and critical control points, along with audits and public communication.
3. Conducting independent audits to ensure targets are met.

• Two guiding principles are included:

1. A precautionary approach for target setting, and
2. Progressive improvement towards achieving these targets.

Comparison with AMR Industry Alliance Standards:

• The document shares similarities with the AMR Industry Alliance standard but exceeds its requirements in certain areas.
• It introduces a two-level approach (‘good’ and ‘stringent’) and specifies limitations on mass balance calculations.
• WHO hosted a webinar to discuss the guidance and its impact with global experts.

Focus on Transparency and Impact of Antibiotic Pollution:

• The guidance highlights public transparency, aiming to empower buyers, investors, and the public to make informed decisions about manufacturers’ pollution control efforts.
• It underscores the importance of ensuring affordable access to antibiotics, especially for vulnerable populations.
• While it lacks a detailed financial analysis, stakeholders are encouraged to conduct economic evaluations to assess feasibility.

Antibiotic Pollution and AMR Crisis:

• AMR, where pathogens become resistant to treatment, is worsened by antibiotic discharge from manufacturing processes.
• Antibiotic pollution from manufacturing sites remains largely unregulated, despite the detection of residual antibiotics in nearby waterbodies.
• Controlling pollution from antibiotic production is vital to preserving the effectiveness of these medicines.

The recent ban of Fixed-Dose Combinations (FDC) drugs in India:

• The government has banned 156 fixed-dose combinations (FDC) drugs, including popular medicines such as Cheston Cold and Foracet, used for cold, fever and pain respectively.
• The ban is the most sweeping crackdown on FDCs — which are combinations of two or more known drugs in single-dosage form — since 2018 when 328 such drugs were banned. A total of 499 FDCs have been banned since 2014.