The Indian government is to limit the amount of antibiotic residue permitted in wastewater released by drug factories, after a series of stories by the Bureau of Investigative Journalism.
A draft bill published on 23 January introduces limits on the concentrations of antibiotics found in the waste discharged by pharmaceutical factories into rivers and the surrounding environment. Experts believe anything above these limits fuels the creation of drug-resistant bacteria, or superbugs.
The growth in superbugs is one of the biggest public health crises facing the world today. Nearly 60,000 newborns a year die from superbug infections in India. If resistance keeps rising people could once again die from common infections, while procedures such as Caesareans, hip replacements and chemotherapy could become impossible to carry out.
Most of the world’s antibiotics are made in factories in India and China, but for over a decade studies have repeatedly shown that these facilities leak antibiotic waste, known as effluent, into the environment. Until now there have been no regulations to curb poor production methods.
Experts praised the Indian government for taking action. Professor Joakim Larsson, director of the Centre for Antibiotic Resistance research at the University of Gothenburg, called the bill “a great leap forward” and critically important, but warned that it could be challenging to enforce.
He added: “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.”
The Bureau published a series of stories on drug manufacturers releasing antibiotic wastewater into the environment in 2016 and 2017, published with the Wire in India and The Times and the i newspapers in the UK. We also showed that NHS trusts were buying drugs from factories leaking antibiotic effluent. Advocates said that the Bureau’s stories were widely shared in policy circles alongside the work of other organisations.
In one paper exclusively revealed by the Bureau and the German TV channel NDR, concentrations of the antibiotic moxifloxacin found outside factories were more than ten thousand times higher than the Indian government’s proposed new limit of 0.05 micrograms per litre.
None of the world’s 17 biggest antibiotic producers publish details of the levels of antibiotic residue discharged in wastewater, according to the 2020 AMR Benchmark report by the Access to Medicines Foundation, which monitors whether pharmaceutical companies are taking action to tackle superbugs.
In 2017 the industry created a voluntary coalition, the AMR Industry Alliance, to monitor companies’ progress in fighting antibiotic resistance, which published targets for antibiotic discharges in September 2018.
However, the Alliance measures antibiotic concentrations in the watercourse where the waste is released -– for example the river into which discharge is funnelled – rather than the actual effluent created by companies during the manufacturing process.
In contrast, the Indian Ministry of Environment, Forest and Climate Change’s limits apply to the wastewater itself, meaning much lower concentrations of antibiotics will eventually be released. The government’s limits will also be legally binding across all companies making drugs in the country.
The AMR Industry Alliance said that its companies took the nature of the watercourse – whether it is a fast-flowing river or a stagnant lake – into account alongside other factors when calculating the risk of drug resistance from manufacturing antibiotics. This “important step” is excluded in the proposed regulations, a spokesperson said, adding “we would hope to be able to share our knowledge and experience with the Indian authorities through the current consultative process.”
The draft bill, which sets out limits for 121 common antibiotics, will become legally binding after a 60-day consultation period.
Professor Larsson praised the Indian government for bringing in stronger regulations than the industry’s targets. He said: “While acknowledging the problem with industrial antibiotic pollution, industry themselves have not been able to provide any evidence that they have solved the emission problems, despite being aware of it for way over a decade.”
He said the planned legislation was ambitious: “Some of the proposed limits are really low, lower than concentrations found in regular treated human sewage not impacted by any antibiotic factories.”
Header image: Water pollution in Hyderabad, one of the centres of antibiotic manufacturing in India. Credit: Christian Baars/NDR