In India, this week, headlines capture the outrage.
"Cough Syrup Horror" reads India Today. New Delhi Television Ltd or NDTV declares: "Toxic Cough Syrup Scare: What Went Wrong And Why All Syrups Aren't Unsafe"
More than 20 children in India are dead. The cause: Cough syrup contaminated with industrial chemicals.
For many, it feels like deja vu.
"This is an issue which has been going on for 90 years or more," says Naseem Hudroge, an analyst at the World Health Organization's team on substandard and falsified medical products.
In that time, more than 1,300 people — many children under 5 — have died of this type of contamination. And it's happened all over the world, including in the U.S. in 1937 when over 100 people died from an antibiotic that had been formulated as a liquid syrup and contaminated. Today, most cases happen in low- and middle-income countries.
For a long time each incident was thought of as an isolated tragedy. "They were all treated as one-offs," says Hudroge.
But that's changing.
Alarm bells
For Hudroge, his fascination with this issue — and determination to do something — started at 10 o'clock one night in the summer of 2022.
He was heading back to his hotel during a work trip when he saw a message about children dying in The Gambia in West Africa.
"I had a feeling this was something quite serious, but the scale of the problem was not clear from that email — that came out over the next few days," Hudroge recalls.
Children were arriving at the hospital with acute kidney injury. The most glaring symptom: "They have an inability to actually pee," he says. "This is quite a very, very serious condition." In The Gambia, at least 66 children died as a result, according to WHO.
A few months later, Indonesia dealt with a similar situation. Then, before 2022 was over, it was happening in Uzbekistan too. The year's death toll due to contaminated cough syrup rose by an additional 268 people, according to WHO.
"We then had three different manufacturers, so it wasn't the same product, and it wasn't the same country," says Hudroge. "This was too much of a coincidence."
And so WHO officials teamed up with experts from the United Nations Office on Drugs and Crime [UNODC] to undertake a multi-year investigation. It's the first time they've collaborated on this issue. The picture that's emerged is ominous.
Their report, published in July, pointed to a clear culprit: criminal activity that crisscrosses the globe. "We have seen evidence of corruption, negligence, intentional or unintentional efforts to enter [toxins] into the [medical] supply chain. We also see a number of falsified documentation being used," says Murat Yildiz, research assistant at UNODC.
"[These deaths are] not some sort of accident," says Dr. Saifuddin Ahmed, a professor at the Johns Hopkins Bloomberg School of Public Health. "This is intentionally done to reduce the cost of the drug and to pocket more money."
What's in the syrup?
The report lays out what's behind the decades of deaths: Shortcuts and cost-cutting measures in the production of inexpensive oral liquid medicines. Often these medications are marketed for kids and available without a prescription.
What should happen in the manufacturing process is that an active ingredient — in these cases, a cough suppressant — is put into a pharmaceutical-grade liquid that is safe for consumption. Often the liquid solvent used is propylene glycol — a viscous, colorless liquid with a slightly sweet flavor. But in some facilities, a much cheaper liquid is used to dilute it or substitute for it.
Sometimes the contaminant is an industrial-grade version of propylene glycol, says Ahmed, other times it's a toxic liquid, called either diethylene glycol or ethylene glycol. These liquids look just like the safe-to-consume propylene glycol but they are poisonous industrial chemicals used to manufacture engine coolant, brake fluids and anti-freeze.
"Your kidneys are trying to remove these toxins from your body. We have to remember that these are very young children and their kidneys are simply overwhelmed by the toxins," Hudroge explains.
"They get a slap on the wrist"
What Yildiz and his team at WHO and UNODC pieced together by studying eight distinct incidences is just how systematically and internationally this dangerous substitution has occurred.
Their report listed a litany of problems.
One issue, says Yildiz, is that there's no easy and cheap way for a manufacturer to dispose of the big plastic or steel drums the safe liquid is sold in. So those drums can fall into the hands of criminals who then refill them with the cheaper, toxic liquids and pass them off as the pharmaceutical-grade product, selling them to drug manufacturers who are looking to save money on ingredients.
"We have seen that there is an online market for second-hand drums," Yildiz says. "And some of the drums have the authentic labels on still which basically enhances the confidence of the buyer [the pharmaceutical manufactures]."
Another big challenge: The manufacturing of medical products is global. For example, the inactive ingredient might be made in South Korea. The active ingredient in China. The manufacturing plant in India. The products might end up all over East Africa.
"There are — for lack of a better word — bad guys who exploit this global nature," says Hudroge. "They exploit regulatory gaps, because at some point between Country A and Country B there is a gap and that's where they can insert drums of these substances and then present them [to cough syrup makers] as perfectly safe."
Dinesh Thakur says these international borders not only help criminals get their materials into the supply chain, it also helps them avoid legal repercussions. "There is no international framework that enables the grieving parties in The Gambia to hold the manufacturer in India accountable," says Thakur, a chemical engineer and author of The Truth Pill: The Myth of Drug Regulation in India.
The number of people to blame can be long — from those who fill the drums with toxic liquids to manufacturers that fail to do the proper testing to customs officials who are being paid off. But when prosecutions are brought, often within an individual country, the laws are often quite lenient on this type of crime and "the punishments are really, really, really low," says Hudroge. "So the bad guys are aware that they can get away with it because the investigative powers are not there or, if they're caught, they get a slap on the wrist and there's no financial deterrent."
"The whole world is at risk"
Ahmed says the world should take note of what's unfolding in India because the country is one of the world's largest manufacturers of medications. For example, the contaminated cough syrups in The Gambia, Indonesia and Uzbekistan were manufactured in India.
"Whenever this happens in India, it is not the issue of only India. The whole world is at risk. This is the most alarming part," he says. "India completely failed in this particular respect because it is repeatedly happening."
He worries that with the online sale of medications and the increasingly global nature of drug manufacturing, this problem of contaminated medications will only get worse.
WHO told NPR that it has contacted Indian authorities telling them it "stood ready to support national authorities in investigating and responding to these tragic events." WHO added that it was told by India that one of the cough syrups tested contained 48.6% of the toxic substance and that none of the contaminated products in this instance were exported from India.
There are systems in place to help address the issue of contaminated medications. In 2021 India set up the Online National Drug Licensing System — and, after the 2022 tragedy, required an extra level of screening for exported cough syrups. The WHO also a simple methodology for testing ingredients and its own certification system for pharmaceutical products. But according to a report out this year in PLOS Global Public Health, India has not "fully implemented" the WHO certification system.
On Wednesday, Indian police did arrested the owner of the cough syrup maker, Sresan Pharmaceutical Manufacturer. NPR reached out to the company for comment but has not yet heard back.
Ahmed says more is needed to bolster India's regulatory standards. He says that's what happened in the U.S. after the 1937 tragedy. The outcry accelerated the enactment in 1938 of the Federal Food, Drug, and Cosmetic Act, which underpins the Food and Drug Administration's current regulation of medicines.
NPR reached out to both the Drugs Controller General of India and the Indian Pharmacopoeia Commission within the Ministry of Health and Family Welfare. Neither replied to emails requesting interviews.
In an article published earlier this year, Indian authorities wrote that they'd taken steps to improve the safety of pharmaceuticals manufactured in India, including inspections of manufacturing facilities and "rigorous quality control checks of medicinal products intended for export." However, earlier this week, the country's Drug Controller General acknowledged in a memo that Sresan Pharmaceutical Manufacturer had not been properly testing its products for safety.
This doesn't surprise Thakur, who doubts that this admission — or even the owner's arrest — will lead to long-term reforms. His worry is that as soon as the children's deaths fade from the headlines "then people don't really pay attention to it until the next one happens."
Freelance journalist Kamala Thiagarajan contributed reporting to this story.
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