More than 20 kids in India have died from contaminated cough syrup. Who's to blame?

A authorities wellness charismatic sticks a announcement extracurricular nan Sresan Pharmaceutical factory, whose Coldrif cough syrup contained has been linked to nan decease of children successful India. Praveen Paramasivam/Reuters hide caption

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Praveen Paramasivam/Reuters

In India, this week, headlines seizure nan outrage.

"Cough Syrup Horror" sounds India Today. New Delhi Television Ltd aliases NDTV declares: "Toxic Cough Syrup Scare: What Went Wrong And Why All Syrups Aren't Unsafe"

More than 20 children successful India are dead. The cause: Cough syrup contaminated pinch business chemicals.

For many, it feels for illustration deja vu.

"This is an rumor which has been going connected for 90 years aliases more," says Naseem Hudroge, an expert astatine nan World Health Organization's squad connected substandard and falsified aesculapian products.

In that time, much than 1,300 group — galore children nether 5 — person died of this type of contamination. And it's happened each complete nan world, including successful nan U.S. successful 1937 erstwhile complete 100 group died from an antibiotic that had been formulated arsenic a liquid syrup and contaminated. Today, astir cases hap successful low- and middle-income countries.

For a agelong clip each incident was thought of arsenic an isolated tragedy. "They were each treated arsenic one-offs," says Hudroge.

But that's changing.

Alarm bells

For Hudroge, his fascination pinch this rumor — and determination to do thing — started astatine 10 o'clock 1 nighttime successful nan summertime of 2022.

He was heading backmost to his edifice during a activity travel erstwhile he saw a connection astir children dying successful The Gambia successful West Africa.

"I had a emotion this was thing rather serious, but nan standard of nan problem was not clear from that email — that came retired complete nan adjacent fewer days," Hudroge recalls.

Children were arriving astatine nan infirmary pinch acute kidney injury. The astir glaring symptom: "They person an inability to really pee," he says. "This is rather a very, very superior condition." In The Gambia, astatine slightest 66 children died arsenic a result, according to WHO.

A fewer months later, Indonesia dealt pinch a akin situation. Then, earlier 2022 was over, it was happening successful Uzbekistan too. The year's decease toll owed to contaminated cough syrup roseate by an further 268 people, according to WHO.

"We past had 3 different manufacturers, truthful it wasn't nan aforesaid product, and it wasn't nan aforesaid country," says Hudroge. "This was excessively overmuch of a coincidence."

And truthful WHO officials teamed up pinch experts from nan United Nations Office connected Drugs and Crime [UNODC] to undertake a multi-year investigation. It's nan first clip they've collaborated connected this issue. The image that's emerged is ominous.

Their report, published successful July, pointed to a clear culprit: criminal activity that crisscrosses nan globe. "We person seen grounds of corruption, negligence, intentional aliases unintentional efforts to participate [toxins] into nan [medical] proviso chain. We besides spot a number of falsified archiving being used," says Murat Yildiz, investigation adjunct astatine UNODC.

"[These deaths are] not immoderate benignant of accident," says Dr. Saifuddin Ahmed, a professor astatine nan Johns Hopkins Bloomberg School of Public Health. "This is intentionally done to trim nan costs of nan supplier and to pouch much money."

What's successful nan syrup?

The study lays retired what's down nan decades of deaths: Shortcuts and cost-cutting measures successful nan accumulation of inexpensive oral liquid medicines. Often these medications are marketed for kids and disposable without a prescription.

What should hap successful nan manufacturing process is that an progressive constituent — successful these cases, a cough suppressant — is put into a pharmaceutical-grade liquid that is safe for consumption. Often nan liquid solvent utilized is propylene glycol — a viscous, colorless liquid pinch a somewhat saccharine flavor. But successful immoderate facilities, a overmuch cheaper liquid is utilized to dilute it aliases substitute for it.

Sometimes nan contaminant is an industrial-grade type of propylene glycol, says Ahmed, different times it's a toxic liquid, called either diethylene glycol aliases ethylene glycol. These liquids look conscionable for illustration nan safe-to-consume propylene glycol but they are venomous business chemicals utilized to manufacture motor coolant, brake fluids and anti-freeze.

"Your kidneys are trying to region these toxins from your body. We person to retrieve that these are very young children and their kidneys are simply overwhelmed by nan toxins," Hudroge explains.

"They get a slap connected nan wrist"

What Yildiz and his squad astatine WHO and UNODC pieced together by studying 8 chopped incidences is conscionable really systematically and internationally this vulnerable substitution has occurred.

Their study listed a litany of problems.

One issue, says Yildiz, is that there's nary easy and inexpensive measurement for a shaper to dispose of nan large integrative aliases alloy drums nan safe liquid is sold in. So those drums tin autumn into nan hands of criminals who past refill them pinch nan cheaper, toxic liquids and walk them disconnected arsenic nan pharmaceutical-grade product, trading them to supplier manufacturers who are looking to prevention money connected ingredients.

"We person seen that location is an online marketplace for second-hand drums," Yildiz says. "And immoderate of nan drums person nan authentic labels connected still which fundamentally enhances nan assurance of nan purchaser [the pharmaceutical manufactures]."

Another large challenge: The manufacturing of aesculapian products is global. For example, nan inactive constituent mightiness beryllium made successful South Korea. The progressive constituent successful China. The manufacturing works successful India. The products mightiness extremity up each complete East Africa.

"There are — for deficiency of a amended connection — bad guys who utilization this world nature," says Hudroge. "They utilization regulatory gaps, because astatine immoderate constituent betwixt Country A and Country B location is simply a spread and that's wherever they tin insert drums of these substances and past coming them [to cough syrup makers] arsenic perfectly safe."

Dinesh Thakur says these world borders not only thief criminals get their materials into nan proviso chain, it besides helps them debar ineligible repercussions. "There is nary world model that enables nan grieving parties successful The Gambia to clasp nan shaper successful India accountable," says Thakur, a chemic technologist and writer of The Truth Pill: The Myth of Drug Regulation successful India. 

The number of group to blasted tin beryllium agelong — from those who capable nan drums pinch toxic liquids to manufacturers that neglect to do nan due testing to customs officials who are being paid off. But erstwhile prosecutions are brought, often wrong an individual country, nan laws are often rather lenient connected this type of crime and "the punishments are really, really, really low," says Hudroge. "So nan bad guys are alert that they tin get distant pinch it because nan investigative powers are not location or, if they're caught, they get a slap connected nan wrist and there's nary financial deterrent."

"The full world is astatine risk"

Ahmed says nan world should return statement of what's unfolding successful India because nan state is 1 of nan world's largest manufacturers of medications. For example, nan contaminated cough syrups successful The Gambia, Indonesia and Uzbekistan were manufactured successful India.

"Whenever this happens successful India, it is not nan rumor of only India. The full world is astatine risk. This is nan astir alarming part," he says. "India wholly grounded successful this peculiar respect because it is many times happening."

He worries that pinch nan online waste of medications and nan progressively world quality of supplier manufacturing, this problem of contaminated medications will only get worse.

WHO told NPR that it has contacted Indian authorities telling them it "stood fresh to support nationalist authorities successful investigating and responding to these tragic events." WHO added that it was told by India that 1 of nan cough syrups tested contained 48.6% of nan toxic constituent and that nary of nan contaminated products successful this lawsuit were exported from India.

There are systems successful spot to thief reside nan rumor of contaminated medications. In 2021 India group up nan Online National Drug Licensing System — and, aft nan 2022 tragedy, required an other level of screening for exported cough syrups. The WHO besides a elemental methodology for testing ingredients and its ain certification strategy for pharmaceutical products. But according to a study retired this twelvemonth successful PLOS Global Public Health, India has not "fully implemented" nan WHO certification system.

On Wednesday, Indian constabulary did arrested nan proprietor of nan cough syrup maker, Sresan Pharmaceutical Manufacturer. NPR reached retired to nan institution for remark but has not yet heard back.

Ahmed says much is needed to bolster India's regulatory standards. He says that's what happened successful nan U.S. aft nan 1937 tragedy. The outcry accelerated nan enactment successful 1938 of nan Federal Food, Drug, and Cosmetic Act, which underpins nan Food and Drug Administration's existent regularisation of medicines.

NPR reached retired to some nan Drugs Controller General of India and nan Indian Pharmacopoeia Commission wrong nan 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 amended nan information of pharmaceuticals manufactured successful India, including inspections of manufacturing accommodation and "rigorous value power checks of medicinal products intended for export." However, earlier this week, nan country's Drug Controller General acknowledged successful a memo that Sresan Pharmaceutical Manufacturer had not been decently testing its products for safety.

This doesn't astonishment Thakur, who doubts that this admittance — aliases moreover nan owner's apprehension — will lead to semipermanent reforms. His worry is that arsenic soon arsenic nan children's deaths slice from nan headlines "then group don't really salary attraction to it until nan adjacent 1 happens."

Freelance journalist Kamala Thiagarajan contributed reporting to this story.