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The World Health Organization (WHO) on Monday issued a health advisory against the use and distribution of three types of cough syrup believed to be responsible for the deaths of several children in India last month.
The WHO statement said the drugs were identified as specific batches of Coldrif, RespiFresh TR and Relife manufactured by three Indian companies: Suresan Pharmaceuticals, Rednex Pharmaceuticals and Shape Pharma.
The agency said oral liquid medications were found to contain high concentrations of diethylene glycol (DEG), a toxic ingredient that can lead to serious injury or death, especially in children.
This is not the first time dangerous levels of toxic chemicals have been found in cough medicines made in India, the world’s largest exporter of generic drugs. In 2023, cough syrup exported from Uzbekistan and Gambia was linked to the deaths of dozens of children.
WHO said in a statement that Indian state authorities have ordered three companies to immediately stop manufacturing the drug and suspended product approvals. The contaminated products have also been recalled and are no longer being exported from India.
The WHO said there was “no evidence of illegal export at this time” and called on global regulators to be wary of unregulated supply chains and other oral liquid medicines produced by the three companies from December 2024 onwards.
CNN has reached out to Suresan Pharmaceuticals, Rednex Pharmaceuticals and Shape Pharma for comment.
Authorities in the southern state of Tamil Nadu, where Sresan Pharmaceuticals is headquartered, said on Monday they had suspended the manufacturer’s license and shut down the company after an investigation found that at least 19 children in the central state of Madhya Pradesh died after ingesting Coldrif syrup, Reuters reported.
“At first, the patient had cough and cold symptoms, then kidney failure symptoms developed, which led to his death,” Ajau Pandey, the superintendent of education in Madhya Pradesh’s Chhindwara district, said at a press conference on October 5.
A subsequent investigation determined that DEG “exceeding permissible limits” was the cause of the death, Pandey added.
Police in Tamil Nadu last week arrested the manager of Suresan Pharmaceuticals, and two senior narcotics detectives in Kancheepuram have also had their licenses revoked and are expected to face disciplinary action for failing to carry out mandatory site inspections, the state government said on Monday.
Superintendent Pandey said a case has also been filed against the Tamil Nadu-based doctor who prescribed the drug.
The WHO warning came after the agency identified outbreaks of acute illness and child deaths across India in late September. Days later, India’s Central Drug Standards Control Organization informed WHO that DEGs had been detected in at least three types of cough syrup consumed by the affected children.
In 2022, Indian health authorities suspended production of Maiden Pharmaceuticals’ cough syrup after several brands of oral liquid medicines were found to contain “unacceptable amounts” of chemicals that can damage the brain, lungs, liver and kidneys of users.
Health authorities believe the drug may have been linked to the deaths of more than 60 children in Gambia and 20 children in Indonesia.
