The CDSCO confirmed DEG contamination in three cough syrup products following a cluster of paediatric deaths reported in Madhya Pradesh and Rajasthan over the past month.
Published Oct 09, 2025 | 11:33 PM ⚊ Updated Oct 09, 2025 | 11:33 PM
Cough syrup (Representational image. Credit: iStock)
Synopsis: While the CDSCO informed the WHO that the contaminated products have been recalled and manufacturers ordered to stop all production, the UN health agency said it “has not received any official information as to the source of the DEG contamination or if contaminated pharmaceutical material has been identified.”
The World Health Organization has flagged a critical “regulatory gap” in India’s drug safety system after confirming that contaminated cough syrups containing deadly levels of toxic chemicals have claimed the lives of 17 children under the age of five.
The UN health agency issued the stark warning on Wednesday, 8 October, following confirmation from India’s Central Drugs Standard Control Organisation that diethylene glycol (DEG) — a toxic industrial solvent used in antifreeze — had been detected in three cough syrup brands at levels up to nearly 500 times the permissible limit.
The WHO expressed serious concern over “the regulatory gap in DEG/EG screening for domestically marketed medicines in India” and warned of “the potential risk of contaminated products being exported to other countries, particularly via unregulated channels.”
The CDSCO confirmed DEG contamination in three cough syrup products following a cluster of paediatric deaths reported in Madhya Pradesh and Rajasthan over the past month:
All three products have been recalled and manufacturers ordered to cease all medical product manufacturing. The CDSCO confirmed to the WHO that “none of the products were exported from India.”
“The symptoms described were consistent with acute renal failure and acute encephalitis syndrome, with suspected links to the use of oral syrup medicines,” the WHO said, adding that it contacted Indian authorities on 1 October seeking clarification.
While the CDSCO informed the WHO that the contaminated products have been recalled and manufacturers ordered to stop all production, the UN health agency said it “has not received any official information as to the source of the DEG contamination or if contaminated pharmaceutical material has been identified.”
“WHO expresses deep concern over these developments,” the organization stated, emphasizing three critical areas:
“WHO recognizes the gravity of these incidents and stands ready to support national authorities in investigating and responding to these tragic events,” the agency said, adding “WHO remains committed to supporting India in safeguarding public health and ensuring the safety of medical products.”
The WHO noted that since 2002, multiple global outbreaks of DEG and ethylene glycol contamination in oral syrup medicines have occurred across several countries, claiming many lives and severely affecting countless patients, mostly children.
Since October 2022 alone, the WHO has issued seven Medical Product Alerts concerning contaminated liquid oral medicines, many marketed for paediatric use and exported to low and middle-income countries. The agency also issued two alerts about falsified bulk chemicals masquerading as pharmaceutical-quality ingredients.
DEG and EG can be fatal even in small amounts, especially for children, the WHO warned.
India’s top drug regulator issued a damning advisory on 7 October admitting that pharmaceutical companies were systematically failing to test raw materials before manufacturing medicines — a mandatory requirement under Indian law.
Inspections revealed that manufacturers were not testing each batch of raw materials and finished products for quality compliance, violating Rules 74(c) and 78(c)(ii) of the Drugs Rules.
At Sresan Pharmaceuticals’ Tamil Nadu facility, inspectors found rusted machinery, open heating of chemicals, and inadequate protective measures. Paradoxically, samples collected in Madhya Pradesh tested negative for DEG, highlighting inconsistencies in quality control across different states and deepening the mystery.
This marks the third major contamination scandal involving Indian-made syrups in recent years. In 2022, similar products were implicated in child deaths in The Gambia and Uzbekistan, triggering international outrage and forcing India to mandate pre-export testing of cough syrups.
However, domestic enforcement appears to have lagged behind.
(Edited by Sumavarsha)
