To mitigate the cost burden on industry, the government could always make effluent treatment deliverables a part of its PLI scheme for pharma; summary scrapping of effluent caps is certainly not a wise move.
The environment ministry’s decision to drop antibiotic effluent limits for pharma manufacturing bodes ill for a country that faces a serious antimicrobial resistance (AMR) challenge. The Union government, in January 2020, had specified caps for antibiotic residue in pharmaceutical effluents for 121 types of antibiotics in paragraph D of the draft Environmental (Protection) Amendment Rules 2019. This, according to some industry experts, made India one of the first jurisdictions to propose such limits.
Indeed, when the Rules were notified earlier this month, that none of the developed nations have such limits, The Economic Times reports, seems to have been a factor behind the decision to drop paragraph D. The new Rules, instead, provide for all antibiotic effluent to be classified as hazardous waste without any explicit capping.
It is true that the limits would have called for pharma companies to invest large sums in treating effluent, and these costs would have significantly affected the industry’s competitiveness. At a time when the government is keen on pushing bulk drug development in India and end reliance on China for key ingredients, as also bolstering India’s position as the supplier of inexpensive drugs to the world at large, the pharma industry has successfully persuaded the government to give in.
But, the government ought to have taken a long-term view. The WHO, which considers AMR as a global health emergency, had come up with the AWARe (Access, Watch, Reserve) system of classification of antibiotics, based on resistance potential with ‘Watch’ being high potential and Reserve being ‘last-resort, restricted use’ antibiotics. India, the largest consumer of antibiotics globally at 7.9 billion daily defined doses (DDDs) in 2020 (this was 5.4 billion in 2010), has seen a large increase in consumption of Watch antibiotics; as per a study published in Lancet Infectious Diseases, while India’s relative consumption of Access antibiotics (in the overall pool of antibiotics consumed) fell from 56.8% to 27.2% between 2000 and 2015, together with China, it accounted for 6.6 billion DDDs of 15.2 billion of Watch antibiotics consumed in 2015.
The relative consumption of Watch antibiotics in India is nowhere close to Japan’s 83%, the highest clocked, but India’s 65% showing earned it the second spot in terms of indiscriminate consumption of these antibiotics. No wonder, India reports one of the highest rates of resistance for certain common pathogens—70% of the Staphylococcus aureus isolates in the country are methicillin-resistant and a whopping 90% of the Escherichia coli isolatesare third-generation cephalosporin resistant. And high direct-human consumption is not the only problem; the staggering level of farm-use has its own ramifications.
The government must keep in mind that, every year, 60,000 newborns in the country die because of sepsis caused by microbes resistant to first-line antibiotics. The twin-problem of antibiotic overuse and lack of access already poses a tough challenge. To that end, India has taken some commendable steps: a National Action Plan on AMR, an AMR surveillance network of 30 tertiary hospitals and at least three state-level action plans. To mitigate the cost burden on industry, the government could always make effluent treatment deliverables a part of its PLI scheme for pharma; summary scrapping of effluent caps is certainly not a wise move.