File image of a bottle of Colddrif cough syrup | Photo credit: Reuters
The World Health Organization (WHO) has sought clarity from India on whether cough medicine linked to the deaths of more than 15 children in the country was exported to other countries, a senior official of the organization said on Wednesday (Oct 8, 2025).
WHO has not yet issued a global medical product warning for Coldrif syrup, a cough syrup that is believed to have caused deaths in children in Madhya Pradesh and Rajasthan. The official added that the need for an alert would be looked into only after receiving a response from Indian health authorities.
So far, at least 17 children under the age of five have reportedly died in India after consuming cough syrup containing the toxic compound diethylene glycol (DEG). Coldrif is manufactured by Tamil Nadu-based Sresan Pharmaceuticals. The company is currently investigating.
Exports of cough syrup from India will be required to pass additional tests at government-mandated laboratories from 2023, following the deaths of more than 140 children in Gambia, Uzbekistan and Cameroon. The deaths were linked to syrup manufactured in India.
The central government, in an order dated December 18, 2023, said that the fixed dose combination (FDC) of chlorpheniramine maleate IP 2 mg and phenylephrine HCl IP 5 mg drops/ml “should not be used in children below 4 years of age.” Coldrif, prescribed to treat cold and cough symptoms including runny nose, sneezing, sore throat and watery eyes, contains chlorpheniramine maleate, paracetamol and phenylephrine.
The order, issued by the Central Drugs Standard Control Organization and signed by Rajeev Singh Raghuvanshi, Director-General of the Drug Controller General of India, requires companies to issue “warnings” in this regard on their labels and package inserts. Ordered to mention.
Trade organization advisory
On Wednesday (October 8, 2025), the All India Organization of Chemists and Pharmacists (AIOCD) wrote to pharmaceutical manufacturers and marketing companies against the guidelines issued by the Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organization (CDSCO). This guidance mandates that the labeling of all cough and cold products clearly indicate a restriction for use in children under 4 years of age.
“It has been observed that this information is missing or not prominently displayed in some inventory on the market, which may lead to non-compliance or potential misuse. As this is an issue directly related to patient safety and compliance, all manufacturing and marketing authority owners should review immediately to ensure that all products comply with these statutory labeling standards,” the group noted.
It urged stakeholders to advise and guide stockists, distributors and field staff accordingly to ensure that proper communication and compliance is maintained throughout the supply chain while fully complying with government notifications and circulars.
Posted – October 8, 2025 9:25 PM IST
