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Contaminated medicines pose global threat; as Indian syrups linked to deaths of 134 children: WHO-UNODC

Islamabad: Contaminated medicines are killing hundreds—mostly children—globally due to toxic adulteration and regulatory failures, a new WHO-UNODC report warns, adding that India, one of the world’s top drug exporters, is directly linked to two of the deadliest incidents in recent years, where tainted cough syrups killed 134 children in The Gambia and Uzbekistan.

The landmark report, released in July 2025 and titled “Contaminated Medicines and Integrity of the Pharmaceutical Excipients Supply Chain,” details how the deliberate substitution of pharmaceutical excipients—non-active ingredients like glycerine and propylene glycol—with cheaper, industrial-grade solvents such as diethylene glycol (DEG) and ethylene glycol (EG), has led to mass poisonings.

These toxic chemicals, commonly used in antifreeze and brake fluid, are lethal when ingested, especially by children. Yet they have repeatedly ended up in pediatric medicines due to falsified labeling, criminal fraud, and regulatory breakdowns.

The WHO-UNODC report identifies India as the origin of two of the most fatal contamination events in recent years. In 2022, 66 children died in The Gambia after consuming Indian-made cough syrups containing dangerously high levels of DEG and EG. The products were manufactured by Maiden Pharmaceuticals, a company based in Haryana, and exported without adequate safety testing or quality assurance.

A few months later, another tragedy unfolded in Uzbekistan, where 68 children died after taking syrups produced by Marion Biotech, based in Uttar Pradesh. These syrups also contained the same toxic substances and caused acute kidney injuries—hallmark effects of DEG/EG poisoning.

In both cases, WHO issued global Medical Product Alerts, and laboratory analysis confirmed that the industrial solvents were present at levels far above the WHO-recommended impurity threshold of 0.10% (1,000 parts per million).

These were not isolated episodes as the report notes that more than 1,300 people—mostly children—have died worldwide over the past four decades due to contaminated medicines involving DEG and EG.

The first major incident was recorded in the United States in 1937, when 107 deaths led to the passage of the U.S. Federal Food, Drug, and Cosmetic Act. Yet, such fatal incidents continue to surface across Latin America, Africa, and Asia, mostly in countries with weak regulatory frameworks and poorly monitored pharmaceutical supply chains.

Despite its reputation as the world’s largest producer of generic medicines, India has failed repeatedly to guarantee the safety of its pharmaceutical exports. The report criticizes India’s regulatory bodies for not adequately overseeing the sourcing, verification, and testing of excipients.

In both The Gambia and Uzbekistan cases, the excipients were either not tested or were sourced from unverifiable suppliers, with criminal practices such as falsified documents and relabeled industrial-grade chemicals playing a central role.

Even after international outrage and the loss of young lives, India’s official response was slow and lacking in transparency. Regulatory actions were delayed, public warnings were limited, and WHO was not informed in time to prevent the deaths.

The report underscores that although Indian medicines have helped millions, these grave lapses have eroded global trust in the country’s pharmaceutical exports.

The report calls for urgent reforms in India and other major exporting countries: excipient traceability must be mandated, routine testing for DEG and EG must be enforced, those involved in fraudulent practices must face prosecution, and governments must invest in affordable detection technologies like Thin Layer Chromatography (TLC) to catch contamination at the source.

It also warns that other countries remain highly vulnerable as Pakistan is cited in the report as another at-risk nation where five contaminated syrups were recalled from export markets in 2023, and WHO issued two alerts in 2024 about toxic propylene glycol originating from Pakistan. Although no fatalities occurred in those cases, the same weaknesses in oversight, testing, and traceability are evident.

The WHO-UNODC report maintains that these deaths were not the result of medical error, but of systemic negligence, corruption, and regulatory failure. As long as excipients—the building blocks of liquid medicines—remain untested, untraceable, and unregulated, such tragedies will continue.

The onus now lies on pharmaceutical giants like India to act decisively, put safety before profit, and restore confidence in global medicine supply chains.

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