The World Health Organization (WHO) has issued its first-ever guidelines on managing antibiotic pollution to address the issue of pharmaceutical waste and effluents from antibiotic manufacturing companies, which has increased the risk of antimicrobial resistance (AMR) or superbugs.
The guidance sets targets to mitigate risks of AMR and protect aquatic life from antibiotic contamination, addressing a largely unregulated issue where environmental emissions from pharmaceutical production often go unchecked.
The framing of guidelines is crucial in the context of India too, where active pharmaceutical ingredient (API) manufacturing poses significant environmental challenges. Wastewater from these plants frequently contains harmful byproducts that contaminate local water sources.
This pollution affects ecosystems and public health by potentially spreading antibiotic resistance, which, according to the WHO, is a top 10 global public health threat. A study last year found that, in 2019, it was responsible for 1.27 million deaths.
Studies reveal that the most common antibiotics found in water sources include Sulfamethoxazole which has been detected in 96 per cent of analyzed samples; Trimethoprim, frequently found in water sources and often present alongside sulfamethoxazole while Ciprofloxacin is another commonly detected antibiotic.
Additionally, various other antibiotics have been identified in water sources, including tetracyclines, macrolides, fluoroquinolones, and beta-lactams.
“Pharmaceutical waste from antibiotic manufacturing can facilitate the emergence of new superbugs, which can spread globally and threaten our health. Controlling pollution from antibiotic production contributes to keeping these life-saving medicines effective for everyone,” said Dr Yukiko Nakatani, WHO Assistant Director-General for AMR ad interim.
Globally, there is a lack of accessible information on the environmental damage caused by manufacturing of medicines. “The guidance provides an independent and impartial scientific basis for regulators, procurers, inspectors, and industry themselves to include robust antibiotic pollution control in their standards,” added Dr Maria Neira, Director, Department of Environment, Climate Change and Health, WHO.
Welcoming the move, Professor and Dr Sangeeta Sharma, from the Institute of Human Behaviour and Allied Sciences (IHBAS) and President of the Delhi Society for Promotion of Rational Use of Drugs (DSPRUD), highlighted that antibiotics and resistance genes loaded pharmaceutical wastewater poses a significant environmental threat. “This risk is exacerbated by inadequate treatment processes and irresponsible disposal practices,” she added.
The guidance sets health-focused goals to minimize the risk of AMR emergence and spread and also outlines objectives to mitigate risks to aquatic life from antibiotics used in humans, animals, or plants.
It covers all steps from manufacturing active pharmaceutical ingredients (APIs) and formulation into finished products, including primary packaging. Efforts to tackle this problem could also involve international collaboration and support, as the impact of such pollution can extend beyond national borders, as per the WHO document.
"Yes, The WHO guidelines provide a framework for minimizing environmental contamination through best practices in wastewater management, but their effectiveness relies on adoption by national governments. There is a need for countries to establish enforceable regulations, strengthen monitoring, and promote education on proper disposal," Dr. Sharma emphasised.
