World Health Organization (WHO) has issued a global medical product alert for three contaminated cough and cold syrups manufactured in India, warning of severe health risks and urging national regulators to intensify surveillance, especially in informal supply chains.
The affected products—Coldrif (Sresan Pharmaceutical), Respifresh TR (Rednex Pharmaceuticals), and ReLife (Shape Pharma)—were found to contain diethylene glycol (DEG) at levels nearly 500 times the permissible limit, according to India’s Central Drugs Standard Control Organization (CDSCO).
The CDSCO informed WHO on October 8 that the syrups were reportedly consumed by children under five who recently died in Chhindwara, Madhya Pradesh. DEG is a toxic solvent known to cause acute kidney injury, neurological damage, and death when ingested.
In its alert, WHO stated: “The contaminated products pose significant risks to patients and can cause severe and potentially life-threatening illness. Diethylene glycol is toxic to humans when consumed and can prove fatal.”
The agency classified the syrups as substandard, noting they fail to meet quality standards and specifications. It warned that use, particularly in children, “may result in serious injury or death.”
Indian authorities have since halted production at the implicated manufacturing sites, suspended product authorisations, and initiated recalls.
CDSCO also confirmed that there is no evidence of illegal export, though WHO has urged global regulators to remain vigilant and conduct targeted market surveillance for any oral liquid medicines from the same manufacturers dating back to December 2024.
WHO outlined symptoms of DEG poisoning, including:
– Abdominal pain
– Vomiting and diarrhoea
– Inability to pass urine
– Headache and altered mental state
– Acute kidney injury, which may be fatal
The agency called on healthcare workers to report any detections or adverse events to their national pharmacovigilance systems and advised the public to avoid using the listed products.
“If you are in possession of any of these products, WHO recommends that you do not use them,” the alert stated. “Seek immediate medical advice if you or someone you know has used these products or experienced unexpected side effects.”
Consumers are reminded to obtain medicines only from authorised or licensed suppliers, and anyone with information on the manufacture or distribution of the contaminated syrups is urged to contact WHO at [email protected].
