Industrial pollution from Indian pharmaceutical companies making medicines for nearly all the world’s major drug companies is fuelling the creation of deadly superbugs, suggests new research. Global health authorities have no regulations in place to stop this happening.
A major study published on May 6 in the prestigious scientific journal Infection found “excessively high” levels of antibiotic and antifungal drug residue in water sources in and around a major drug production hub in the Indian city of Hyderabad, as well as high levels of bacteria and fungi resistant to those drugs. Scientists told the Bureau the quantities found meant they believe the drug residues must have originated from pharmaceutical factories.
The presence of drug residues in the natural environment allows the microbes living there to build up resistance to the ingredients in the medicines that are supposed to kill them, turning them into what we call superbugs. The resistant microbes travel easily and have multiplied in huge numbers all over the world, creating a grave public health emergency that is already thought to kill hundreds of thousands of people a year.
When antimicrobial drugs stop working common infections can become fatal, and scientists and public health leaders say the worsening problem of antibiotic resistance (also known as AMR) could reverse half a century of medical progress if the world does not act fast. Yet while policies are being put into place to counter the overuse and misuse of drugs which has propelled the crisis, international regulators are allowing dirty drug production methods to continue unchecked.
Global authorities like the Food and Drug Administration and the European Medicines Agency strictly regulate drug supply chains in terms of drug safety – but environmental standards do not feature in their rulebook. Drug producers must adhere to Good Manufacturing Practices (GMP) guidelines – but those guidelines do not cover pollution.
Even the World Health Organisation (WHO) – a global public health body which has repeatedly called for concerted international action to tackle the dangerous threat of antibiotic resistance – buys antibiotics from companies whose drug ingredients are made in Hyderabad without carrying out environmental checks.
The international bodies say the governments of the countries where the drugs are made are the ones responsible for stopping pollution – but domestic legislation is having little impact on the ground, say the study’s authors. The lack of international regulation must be addressed, they argue, highlighting the grave public health threat faced by antibiotic resistance as well as the rampant global spread of superbugs from India, which has become an epicentre of the crisis.
“Unprecedented antimicrobial drug contamination”
A group of scientists based at the University of Leipzig worked with German journalists to take an in-depth look at pharmaceutical pollution in Hyderabad, where 50% of India’s drug exports are produced. A fifth of the world’s generic drugs are produced in India, with factories based in Hyderabad supplying Big Pharma and public health authorities like World Health Organisation with millions of tons of antibiotics and antifungals each year.
The researchers tested 28 water samples in and around the Patancheru-Bollaram Industrial zone on the outskirts of the city, where more than than 30 drug manufacturing companies supplying nearly all the world’s major drug companies are based. Thousands of tons of pharmaceutical waste are produced by the factories each day, the paper says.
Almost all the samples contained bacteria and fungi resistant to multiple drugs (known as MDR pathogens, the technical name for superbugs). Researchers then tested 16 of the samples for drug residues and found 13 of them were contaminated with antibiotics and antifungals. Previous studies have shown how exposure to antibiotics and antifungals in the environment causes bacteria and fungi to develop immunity to those drugs.
Environmental pollution and poor management of wastewater in Hyderabad is causing “unprecedented antimicrobial drug contamination” of surrounding water sources, conclude the researchers – contamination which appears to be driving the creation and spread of dangerous superbugs which have spread across the world. Combined with the mass misuse of antibiotics and poor sanitation, superbugs are already having severe consequences in India – an estimated 56,000 newborn babies die from resistant infections there each year.
German broadcaster NDR, which contributed to the study, identified 19 companies operating inside the area tested as suppliers of antibiotics to the European market. Of those 19, the Bureau has identified at least four companies which supply the UK and five which supply the US.
The companies in question strongly deny that their factories pollute the environment, and the sheer number of factories operating in Hyderabad means it is impossible to identify exactly which companies are responsible for the contamination found in the samples tested.
What is clear is one of the world’s biggest drug production hubs is producing dangerous levels of pharmaceutical pollution, and the international bodies tasked with ensuring drug safety are doing little to address it.
Health regulators have to take action, said professor Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics & Policy and a leading voice on antibiotic resistance. “We need to take environmental contamination from bulk manufacturing facilities seriously and put an immediate end to the practice,” he said. “This should be a part of GMP without question and pharmaceutical companies throughout the world should be subject to an audit to ensure that they are compliant with what the industry has promised to do.”
This article was originally published by The Bureau of Investigative Journalism.