Cough syrup deaths: The World Health Organization has asked Indian authorities to clarify whether Coldrif, the cough syrup linked to multiple child deaths, was exported to other countries, sources said.
WHO will decide on issuing a Global Medical Products Alert for the product once it receives formal confirmation. Such alerts flag substandard or contaminated medicines worldwide.
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The inquiry follows reports from Madhya Pradesh, where 20 children have died and five remain critical, with officials linking the cases to suspected diethylene glycol (DEG) and ethylene glycol (EG) contamination. At least three additional deaths have been reported in Rajasthan, allegedly after the consumption of cough syrup in separate districts.
Amid mounting concerns, the Drugs Controller General of India (DCGI) has directed all state and Union Territory drug regulators to verify testing of raw materials and finished formulations before market release. In an October 7 advisory, the DCGI cited inspection findings that some manufacturers failed to test each batch of excipients and active pharmaceutical ingredients, as well as finished products, against prescribed standards.
Regulators have been told to step up on-site monitoring, sensitise manufacturers via circulars, and ensure firms maintain robust vendor qualification systems, sourcing excipients and APIs only from approved suppliers. The advisory also notes recent quality concerns tied to cough syrups in Chhindwara (MP).
Separately, the Centre in 2023 mandated label and package-insert warnings that the FDC chlorpheniramine maleate IP 2 mg + phenylephrine HCl IP 5 mg per ml must not be used in children under four years.
Authorities said investigations are ongoing, and further steps, possible recalls and international alerts will depend on laboratory confirmation and traceability of distribution.
