WHO seeks clarification from India if cough syrup linked to child deaths here have been exported

The World Health Organization (WHO) has sought clarification from India on whether the cough syrup linked to over 15 child deaths in the country have been exported to other countries, a senior official of the global health agency said on Wednesday (October 8, 2025).

The WHO is yet to issue a Global Medical Products Alert on Coldrif syrup, the cough syrup which has allegedly caused the child deaths in Madhya Pradesh and Rajasthan. The official added that the need for an alert will be investigated only after receiving a response from Indian health authorities.

So far at least 17 children aged below five have died in India allegedly after consuming cough syrup containing a toxic compound diethylene glycol (DEG). Coldrif was manufactured by Sresan Pharmaceuticals, based in Tamil Nadu. The company is currently under investigation.

Exports of cough syrups from India have been mandated to clear additional testing at government-mandated laboratories since 2023 following the deaths of over 140 children in the Gambia, Uzbekistan and Cameroon. The deaths were linked to syrups made in India.

The Central government, in an order dated December 18, 2023, had said that the fixed-dose combination (FDC) of chlorpheniramine maleate IP 2mg and phenylephrine HCl IP 5mg drop/ml “should not be used in children below four years of age.” Prescribed to treat symptoms of cold and cough, including runny nose, sneezing and sore throat and watery eyes, Coldrif contains chlorpheniramine maleate, paracetamol and phenylephrine.

The order, issued by the Central Drugs Standard Control Organisation, and signed by Rajeev Singh Raghuvanshi, Drugs Controller General of India, ordered firms to “mention warning” in this regard on the label and the package insert.

Trade body advisory

On Wednesday (October 8, 2025), the All India Organisation of Chemists and Druggists (AIOCD) wrote to pharmaceutical manufacturers and marketing companies on the directives issued by the Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organisation (CDSCO), which make it mandatory that the labelling of all cough and cold preparations clearly indicates the usage restriction for children below four years of age.

“It has been observed that in some stock in the market, this information is either missing or not prominently displayed, which may lead to non-compliance and potential misuse. The matter being directly related to patient safety and regulatory compliance, we urge all manufacturing and marketing authorities holders to immediately review and ensure that all products conform to these statutory labelling norms,’’ the group noted.

It urged stakeholders to advise and guide stockists, distributors, and field personnel accordingly, so that proper communication and compliance are maintained throughout the supply chain, in full conformity with the government’s notification and circulars.