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India fails to outline pharmaceutical standard despite new research underlining the environmental importance

A section of India’s Ganges river, pictured in Bihar. The river is bearing a burden of environmental pollution in the country.

India’s Ministry of Environment, Forests and Climate Change has failed to outline norms for discharge standards for effluents from bulk drugs and pharmaceutical industries, due to a lack of ‘necessary information’. 

Home to one of the world’s largest pharmaceutical industries, India has long faced calls for regulation on effluents and runoff which have both an environmental impact, and also a pressing effect on the prevalence of antimicrobial resistance. Yet the norms, which would have built on a draft notification on emission and discharge standards for Bulk Drugs and Formulations Industries released in January 2020, failed to materialise

“Necessary information and research is not available for prescribing the appropriate norms for limiting the concentration of antibiotics, monitoring, and compliance verification and testing protocols effluents discharged from [the] pharma industry,” the ministry explained.

Antimicrobial threat continues to grow

The draft notification from January 2020 had previously been lauded as ‘a great leap forward’ by Professor Joakim Larsson, director of the Centre for Antibiotic Resistance Research at the University of Gothenburg. 

He said, “antibiotic resistance is a global challenge that must be managed globally. Resistant bacteria fly within the gut flora of traveling humans from India to Europe in a few hours. Therefore, this is a step from the Indian government that in the long run could benefit everyone.”

Environmental effect of Indian pharmaceutical industries  

As Health Issues India previously reported, researchers detected evidence of ‘superbug’ in more than half of community water samples tested in Bareilly, and exacerbating cause for concern around antimicrobial resistance in India, a country now infamously regarded as the world’s capital for multi-drug resistant organisms.  

Alongside the ever-increasing threat from antimicrobial resistance, the importance of regulations on the environmental impact of pharmaceutical industries is underlined by the fact that several studies have found evidence of ciprofloxacin, enoxacin, cetirizine, terbinafine, and citalopram in several wells in villages in Hyderabad; just one example of pharmaceutical industries hidden footprint across India. 

More recent studies conducted by researchers from Doon University have highlighted that the Ganges River is showing evidence of harbouring pollutants, including caffeine, anti-inflammatory drugs, common antibiotics, beta-blockers, antibacterials, and insect repellents. The study examined findings in the waterway over three seasons, and analysed water at two particular entry points; Haridwar, and Rishikesh.  

The research, published in the same month as the failure to outline norm standards, could have been used to evaluate the efficiency of future anti-pollution measures, or as a baseline for further study into the effect of pollutants. 

The need for regulations remains 

Others had argued that if the new bill had been passed, it would have significantly contributed to ‘the development of environmentally-conscious manufacturing processes.’ With none of the world’s seventeen largest antibiotic producers publishing details of effluents and discharge in 2020, according to an AMR Benchmark report by the Access to Medicines Foundation, it is clear there is significant room for improvement. 

Yet the need for regulations remains. As antimicrobial resistance and environmental impacts intertwine, it must be up to governments, leading public health bodies, and researchers to outline limitations on the concentrations of effluents and residue subsiding into the surrounding environments. The consequences are too large for these industries to self-regulate, but as others have suggested they must collaborate to ensure safety standards are met. 

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