Nearly half of Americans took at least one prescription drug in the past 30 days,¹ but chances are most of them did not give much thought to where those drugs came from. Unbeknownst to many, most drugs taken by Americans are not made in the U.S. but, rather, come from bulk drug manufacturing facilities in places like China and India.

Hyderabad, India, is one particularly prolific city for these bulk drug manufacturers, producing 50 percent of India’s drug exports.² The U.S. Food and Drug Administration (FDA) and other international regulatory bodies like the European Medicines Agency require such manufacturers to follow Good Manufacturing Practices (GMP) to ensure drug safety, but there is a glaring omission from these guidelines: They do not consider the environment.

As such, massive amounts of pharmaceutical waste — perhaps thousands of tons a day — are entering waterways near the facilities and, according to new research published in the journal Infection, resulting in the development of multidrug-resistant pathogens.³

High Concentrations of Antimicrobials Detected Near Drug Manufacturing Facilities

In November 2016, researchers from Germany’s University of Leipzig collected water samples from “the direct environment of bulk drug manufacturing facilities, the vicinity of two sewage treatment plants, the Musi River and habitats in Hyderabad and nearby villages.”⁴ Twenty-eight sampling sites were surveyed, and the water samples were analyzed for 25 anti-infective pharmaceuticals as well as multidrug-resistant pathogens and certain resistance genes.⁵

All of the samples were contaminated with antimicrobials, including high concentrations of moxifloxacin, voriconazole, and fluconazole as well as increased concentrations of eight other antibiotics in area sewers. Some of the samples contained antimicrobials at levels up to 5,500 times higher than the environmental regulation limit. What’s more, more than 95 percent of the samples also contained multidrug-resistant bacteria and fungi.

The researchers called this contamination with antimicrobial pharmaceuticals “unprecedented” and blamed it on “insufficient wastewater management by bulk drug manufacturing facilities, which seems to be associated with the selection and dissemination of carbapenemase-producing pathogens.”⁶

India Has Become a ‘Hot Spot’ of Antimicrobial Resistance

Large environmental contaminations, including those leading to resistant organisms, have repeatedly been identified around bulk drug manufacturing plants in India and China. The study explained:⁷

“Particular bulk drug manufacturing plants in Hyderabad, South India, have been shown to dump waste into their surroundings or fail to treat manufacturing discharges appropriately, resulting in the contamination of rivers and lakes.

The substantial quantities of antibiotic pollution, combined with runoff from agriculture and human waste, facilitate the growth of MDR [multidrug-resistant] bacteria in water bodies and sewage treatment plants. Consequently, India has become a hot spot of drug resistance, with drastic clinical consequences.”

They note that more than 56,000 newborn babies die in India each year due to drug-resistant infections. This is not a problem contained to India, of course, since “multidrug-resistance can move around the world within a flight time of only a few hours.” They even stated that if you visit India or another country with a high prevalence of antibiotic resistance, you’ll likely return home colonized by resistant bacteria which may be transmitted to others, including those in your household.⁸