India’s drug regulator bans anti-cold syrup for under-4 children

New Delhi, December 21

India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has banned the use of a popular anti-cold medicine combination among children below four years of age.

Fatal combination of drugs

• CDSCO bans fixed drug combination of chlorpheniramine maleate IP 2mg and phenylephrine HCI IP 5mg
• Formulation an unapproved one for infants, says the regulator
• Move in wake of 141 deaths of kids globally linked to cough syrups

The decision comes in the wake of the deaths of at least 141 children globally linked to cough syrups. In a letter to states and union territories, the CDSCO said concerns had been raised over the use of a fixed drug combination (FDC) of chlorpheniramine maleate IP 2mg and phenylephrine HCI IP 5mg drops. The formulation, the regulator said, was an unapproved one for infants.

The issue was taken up with the subject expert committee (SEC) on June 6, 2023, which recommended that the FDC should not be used for children below four years of age and accordingly, firms should mention warnings in this regard on labels and package insert.

“The recommendation of the SEC has been considered by this office. Accordingly, you are requested to direct all the manufacturers of the said FDC under your jurisdiction to mention warning ‘FDC should not be used in children below 4 years of age’ on label and package/insert literature of the drug,” said Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India.

The combination of drugs is used to treat cold and flu-like symptoms, which include coughing, sneezing and watery eyes.