WHO Warns of Regulatory Gaps After Fatal Cough Syrup Contamination in India

Coldrif cough syrup was identified as the cause of children's deaths in Madhya Pradesh

Following the nationwide outrage regarding children's deaths from contaminated cough syrups in Madhya Pradesh and Rajasthan, the World Health Organization (WHO) has voiced serious concerns about the "regulatory gap" in India's screening processes for diethylene glycol and ethylene glycol in domestically marketed medicines. The organization has also highlighted the potential danger of such tainted products reaching other countries, especially through unregulated distribution channels.

The statement comes after approximately 20 children, primarily under 5 years of age, died from kidney failure after being given adulterated cough syrup for cold and cough symptoms. Many victims had received Coldrif cough syrup, which testing revealed contained 48.6 percent diethylene glycol, a hazardous industrial chemical not meant for consumption.

In an official release, the WHO expressed being "deeply saddened" by these fatalities and offered condolences to the bereaved families. The organization disclosed that it had contacted the Central Drugs Standard Control Organisation (CDSCO) seeking information about the contaminated medications and whether they had been exported. CDSCO informed WHO that diethylene glycol was found in at least three products: Coldrif, Respifresh TR, and ReLife. The Indian regulator confirmed that these products have been recalled from the market, and the manufacturers were instructed to cease production of all medical items. CDSCO also assured WHO that none of these products were exported from India.

"WHO expresses deep concern over these developments and emphasises the following: The potential risk of contaminated products being exported to other countries, particularly via unregulated channels. The regulatory gap in DEG/EG screening for domestically marketed medicines in India. Identifying the source of the contamination and identifying and removing any contaminated pharmaceutical material which may be in circulation," the statement detailed.

The global health authority affirmed its readiness to assist national authorities in investigating and addressing these tragic incidents.