India’s drug regulator has assured the World Health Organisation (WHO) that three cough syrups recently linked to child deaths have been recalled and their production halted, while confirming that none of the products were exported.
The Central Drugs Standard Control Organisation (CDSCO) informed the WHO on Wednesday that the syrups, Coldrif, RespifreshTR and ReLife, were withdrawn from the market following reports of paediatric deaths in Madhya Pradesh and Rajasthan.
Official sources said the WHO had sought details from Indian authorities after media reports suggested a possible connection between the deaths and the use of contaminated cough syrups. The global health agency is “closely monitoring” the situation, noting that several cases of acute renal failure and acute encephalitis syndrome have been reported in the affected regions since September 29.
According to sources, “The WHO has not received any official information as to the source of the DEG contamination or if contaminated pharmaceutical material has been identified.” The agency has expressed concern about the possibility of contaminated products entering other markets through unregulated channels and cited gaps in India’s screening for diethylene glycol (DEG) and ethylene glycol (EG) in domestically sold medicines.
It has also urged the identification and removal of any contaminated pharmaceutical materials that may still be in circulation.
Also read: WHO asks India if Coldrif cough syrup was exported abroad
In response, the Drugs Controller General of India (DCGI) has issued an advisory to state and Union Territory drug controllers, directing them to ensure mandatory testing of raw materials and finished formulations before releasing them in the market. The advisory follows reports that several manufacturers were failing to test each batch of excipients and active ingredients for compliance with prescribed standards.
“During the inspections carried out at the manufacturing facilities and in the investigations of the drugs declared as not of standard quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manufacture of formulations and also in the finished products,” the advisory dated October 7 stated.
“All the state/UT drug controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc. Further, it shall also be ensured that the manufacturers have robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only,” the advisory said.
The Centre had earlier directed pharmaceutical companies to include clear warnings on cough syrup labels and package inserts. An order issued on December 18, 2023, specified that the fixed-dose combination of chlorpheniramine maleate IP 2mg and phenylephrine HCl IP 5mg per ml “should not be used in children below four years of age.”
Officials said the recall of the three syrups and the suspension of their production were precautionary measures while investigations continue into the cause of the paediatric fatalities.
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