New Delhi: The World Health Organization (WHO) has issued a global alert warning against three substandard oral cough syrups circulating in India Coldrif, Respifresh TR, and ReLife urging regulatory authorities worldwide to take immediate action if these products are found in their jurisdictions. The alert follows reports of multiple child fatalities, predominantly among children under five, linked to suspected kidney failure after consuming these medications.
According to the WHO notice, at least 22 children in Madhya Pradesh have died after being administered Coldrif, while three additional deaths have been reported in different districts of Rajasthan following the use of cough syrup. The agency emphasized the urgent need for healthcare professionals to report the detection of these substandard products, as well as any adverse events or lack of expected therapeutic effects, to National Regulatory Authorities (NRAs) or National Pharmacovigilance Centres.
The affected syrups were produced by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, with specific batches found to contain Diethylene Glycol (DEG), a toxic compound known to cause severe kidney damage and potentially fatal outcomes when ingested. WHO described these products as failing to meet quality standards, rendering them unsafe for human consumption, particularly for children. Symptoms of DEG poisoning can include abdominal pain, vomiting, diarrhea, reduced urine output, altered mental state, acute kidney injury, and in severe cases, death.
The alert noted that the Central Drugs Standard Control Organization (CDSCO) of India identified the contaminated batches on October 8, following WHO’s detection of localized clusters of acute illness and fatalities reported on September 30. State authorities in India have halted production at the implicated facilities, suspended product authorizations, and initiated product recalls to prevent further harm. At present, WHO confirmed there is no evidence of these contaminated products being exported internationally, though authorities have been urged to maintain vigilance, particularly in informal or unregulated markets.
The WHO alert further recommended that NRAs conduct targeted market surveillance, with special attention to oral liquid medicines produced at the same manufacturing sites since December 2024, and to ensure all substandard products are removed from circulation. The agency also stressed the importance of public awareness, advising individuals not to use these products and to seek immediate medical attention if they or someone they know may have ingested the contaminated syrups.
The alert concludes with a stark warning: the unsafe products pose severe risks to patients, especially children, and highlight the critical importance of vigilance, regulatory oversight, and swift action in protecting public health. WHO continues to monitor the situation closely and encourages international collaboration to prevent further tragedies.