WHO raises alert over DEG-contaminated cough syrups in India
The World Health Organization (WHO) issued an alert on Monday identifying oral cough syrups manufactured in India that contain diethylene glycol (DEG), a substance typically used as an industrial solvent and in antifreeze. According to the BBC, at least 20 children in India have died after ingesting these cough syrups.WHO said it received a notice from India’s Central Drugs Standard Control Organization (CDSCO) on 8 October alerting it to the presence of DEG in at least three oral liquid drugs. WHO said it first identified “localized clusters of acute illness and child fatalities” on 30 September 2025.
The affected products include specific batches of cough syrups marketed as Coldrif, made by Sresan Pharmaceutical; Respifresh TR, made by Rednex Pharmaceuticals; and ReLife, made by Shape Pharma.
CDSCO has confirmed to WHO that state authorities ordered an immediate halt to production at the implicated manufacturing sites and suspended product authorizations. The affected products have since been recalled by state authorities.
CDSCO also informed WHO that none of the contaminated medicines have been exported from India and there is no evidence of illegal export of the drugs. WHO “encourages National Regulatory Authorities (NRAs) to consider targeted market surveillance, with particular attention to informal and unregulated supply chains where products may circulate undetected. NRAs are also advised to carefully evaluate the risks associated with any oral liquid medicines originating from the same manufacturing sites—particularly those produced since December 2024.”
WHO said it is working closely with Indian health authorities to monitor the situation, identify the source of contamination, and mitigate potential public health risks.
The US Food and Drug Administration (FDA) also issued a warning addressing the contaminated cough syrups, noting that the drugs have not been shipped to the US.
FDA said there are reports of a fourth cough medicine has been linked to adverse events in children in India, dextromethorphan hydrobromide syrup manufactured by Kaysons Pharma Ltd, which has also been recalled by Indian authorities. However, testing of that drug in India has not detected DEG or ethylene glycol (EG) contamination. FDA said it is in contact with CDSCO and is coordinating its response efforts with WHO.
According to the BBC, most of the deaths have occurred in the India state of Madhya Pradesh in children under five and are linked to Coldrif syrup, and that that police arrested G. Ranganathan, the owner of Sresan Pharmaceuticals last week in connection to the deaths. The outlet reports that Praveen Soni, a doctor who prescribed the syrup, has been arrested for negligence, though Indian medical groups blame regulators for inadequate testing and oversight.
According to the Business Standard, Sresan was licensed in 2011 by the Tamil Nadu Food and Drug Administration (TNFDA), and continued operations unchecked for over a decade “despite its dismal infrastructure and multiple violations of national drug safety rules,” according to CDSCO sources.
DEG-tainted cough syrups have been a global problem in recent years. In 2022, contaminated cough syrups from India were tied to 70 child deaths in Gambia and 18 in Uzbekistan.
According to WHO’s health alert issued in January 2023, reports of contaminated cough syrups containing DEG and EG were linked to 300 deaths in three countries in 2022, with most of the fatalities occurring in children. (RELATED: WHO proposes updated excipient GMPs in wake of contaminated cough syrup, Regulatory Focus 10 April 2023)
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