Deadly consequences of US reliance on Indian-made drugs


Deadly consequences of US reliance on Indian-made drugs

WASHINGTON -- Our investigation, Tainted Trust: Inside the Global Medicine Pipeline, reveals how the drugs taken by millions of Americans trace back to factories in India, a system plagued by weak oversight and fake data. Now, we're following the trail to its deadliest consequences: toxic medicine, children dying and a system that still supplies American pharmacies.

It's a backstory most Americans don't know. India is one of the world's largest suppliers of generic drugs, on which America is heavily dependent. Some plants meet high standards. Others are filthy, fraudulent and impossible to trust. And there's no way for consumers to know which is which, and that can have deadly consequences.

During his years as an FDA inspector covering India, Peter Baker knew something was off. He recalled fresh paint, manicured landscaping, and elaborate welcomes when he went to inspect drug manufacturing plants.

He told us it took sifting through trash, booking secret travel and working undercover to find what was, by his own admission, "terrifying."

He discovered that some Indian drug-making facilities were using falsified data and operating in filthy, sometimes hidden sites.

"This is called a shadow facility," Peter Baker said. "They'll make the products over there and then they'll ship them to what they call a show facility, and on paper, it looks like the product was manufactured there and meets a high standard for quality, but in fact, the quality of the product is unknown."

What we found goes deeper. New, secret locations that locked out FDA regulators, deaths tied to negligence, and the first proof that Indian-made generic drugs pose a greater risk to patients.

"The most vulnerable in society taking these drugs have no idea of the games being played and certainly no idea that the game, as designed today, can never be won," said Baker as he testified before US Congress.

Years after Baker first exposed India's unregistered "shadow" facilities, we found they are still operating.

We obtained an FDA inspection report from September 2025 of Hetero, a major maker of HIV, cancer, and neurological drugs. The FDA cited the company for running an unregistered testing lab, and somewhere in a rural Indian village, storing critical ingredients in an unregistered warehouse, unknown to the FDA.

When FDA inspectors went to that warehouse, workers ran and locked the gates, refusing entry to FDA inspectors for two hours.

We asked Baker what might prompt that kind of response. He told us it's likely they were hustling to move unapproved products bound for export to the U.S.

"During those two hours, what they'll do is they'll try their best to get those out through the back door and so that the investigators can't understand or document the true scope of the problem of which they are uncovering," he said.

Once they were eventually allowed inside, inspectors found bird droppings on storage units and cats and lizards crawling among active pharmaceutical ingredients.

Hundreds of miles away, our crew tried to film another Hetero facility, previously cited for razors and screws in packaging. Security forced our cameras off.

Hetero told us it is working with the FDA to resolve any issues. You can read the company's full response at the bottom of this article.

While anecdotes painted a picture of potential harm for patients, Ohio State University Professor John Gray was piecing together hard evidence.

He spent years unearthing what's been kept secret: where generic drugs are made and what happens when they fail.

"The FDA will not release where a drug is made to the public, even through request," he said, adding that the work of his team was "extremely challenging."

Gray connected the dots to something groundbreaking. He found a 54% higher likelihood of "severe adverse events," including hospitalization, disability, and death, tied to generic drugs made in India versus in the U.S.

"What we found is large scale careful empirical evidence that for the same exact generic drug, there were many more severe adverse events linked to the Indian drugs than to the domestic drugs," Gray said.

Gray told us that many drugs made in India are safe, but the system needs a major turn toward transparency for consumers to understand not only where the drugs are coming from, but the track record of their makers.

Even, he suggested, a QR code that would give the consumer a quality code and help them make an informed choice.

"I think there's a substantial public health impact that outweighs the costs of putting some things in place to try to remedy this problem and fix this market," he said.

In the past three years, more than 300 children in Africa, Indonesia, Uzbekistan and India have died from cough syrup tainted with antifreeze made by Indian companies.

Criminals passed off the poison as a pharmaceutical ingredient, and factories turned it into medicine multiple times, as recently as this past October, when the owner of an Indian pharmaceutical company was arrested in connection with the deaths of at least 21 children in India, most under the age of 5.

This summer, the World Health Organization and the UN issued a landmark, 120-page report on this, saying, "What has become clear during this research is that intentional criminal behaviours, including the falsification of excipients, accentuated by poor compliance with regulatory requirements, is a persistent and pervasive threat to public health."

U.S. regulators are on high alert.

We found FDA warning letters from 2023 to Indian manufacturers, including Global Pharma, noting the company planned to export children's medications "with a high risk of contamination" from the very same deadly chemicals.

The FDA was there not because of the cough syrup, but because of another deadly crisis unfolding in America, from a different product made in the very same building.

In 2023, four people died, four had to have their eyes removed, 14 lost their vision, and 114 suffered infections from contaminated eye drops made in India, blindsiding Renee Martray, who developed an ulcer that threatened her sight, and destroyed her trust in the US regulatory system.

"I would think I could trust them to make sure I'm not gonna be hurt from something they bring in from overseas," she told Spotlight on America.

We examined the FDA's history of inspections at Global Pharma and found it had never been inspected until March of 2023, nearly a year after the CDC launched its investigation into contaminated eyedrops.

It's not just one company.

Last year, Glenmark issued a major recall of its blood pressure pills that were supposed to be extended-release but released the dose too quickly.

According to our review of the FDA's Adverse Event Reporting database, at least eight deaths have been reported to the FDA citing those pills, including Mary Louise Cormier of Maine, who suffered cardiac arrest and died.

A subsequent warning letter found the company's investigation into those pills "was not sufficient to adequately determine root cause(s) of your repeated dissolution failures during long-term stability testing."

Months after the recall, inspectors flagged "contamination" risks at the very same plant, in addition to major production equipment "not decontaminated," lack of proper testing procedures, and "inadequate" investigations of complaints.

Only after those deaths and an FDA inspection did the company recall 39 more drugs from U.S. shelves, from acetaminophen to seizure and blood pressure medication, all from the same facility.

Baker believes that for every violation an FDA inspector catches, hundreds go unaddressed.

"The investigator may just see what is the tip of the iceberg," he said. "What's under the water is unknown."

It's a risk tied to a system that was built for cheap medicine, but costing far more than we might imagine.

--

Glenmark and Global did not respond to our requests for comment. In court documents, however, Glenmark has denied responsibility for any deaths.

Hetero Labs issued this statement:

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