WHO Inquires About Export of Indian Cough Syrup Linked to Child Deaths

New Delhi, Oct 9 (PTI) The World Health Organisation (WHO) has inquired with Indian authorities about the potential exportation of the cough syrup implicated in child deaths within the country. The query was made on Thursday, sources reported.

The WHO will await official confirmation from Indian authorities before deciding whether to issue a 'Global Medical Products Alert' regarding the cough syrup, known as Coldrif. Such alerts are typically released for medicines that are found to be substandard or contaminated.

The incident has seen five children in Madhya Pradesh in critical condition and 20 others having died due to kidney infections. The infections are linked to the consumption of the "contaminated" cough syrup, which contains Diethylene Glycol (DEG) and Ethylene Glycol (EG).

Additionally, at least three children have reportedly succumbed in Rajasthan after consuming the cough syrup across different districts.

Sources stated, "The World Health Organisation (WHO) on Wednesday asked for clarification on whether the cough syrup linked to children's deaths was distributed internationally."

Reacting to the deaths, the Drugs Controller General of India (DCGI) on Wednesday instructed all state and UT drug controllers to ensure rigorous testing of both raw materials and final pharmaceutical products before their release in the market.

The advisory from DCGI noted that recent inspections exposed lapses among manufacturers, who often failed to test each batch of excipients and active ingredients for compliance with standards before use.

Recent fatalities in Chhindwara, Madhya Pradesh, associated with the cough syrups, accentuated concerns about their quality, the advisory highlighted.

The document dated October 7 observed, "Inspections revealed that manufacturers were not conducting necessary testing of each batch of excipients and active pharmaceutical ingredients to verify compliance with standards before use in formulations and finished products."

The advisory urged all State/UT drug controllers to enforce stringent measures to act before manufacturing and market release, emphasising inspections and sensitization of manufacturers through circulars. It also advised that manufacturers maintain a robust vendor qualification system, sourcing raw materials and excipients from approved, trustworthy vendors.

For added safety, the Centre in 2023 mandated that pharma companies indicate a warning on the label and package insert for a fixed-dose combination (FDC) containing chlorpheniramine maleate IP 2mg and phenylephrine HCl IP 5mg drop/ml, cautioning against use in children under four years.

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