DCGI directs popular combination drug for cold and flu to be not used in children under the age of 4

The drug makers have been directed to put the new warning on the label, package insert and promotional literature of the medicine

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The Drugs Controller General of India (DCGI) has directed manufacturers of common cold drug fixed dose combination (FDC) of chlorpheniramine maleate IP 2mg with phenylephrine HCL IP 5 mg per ml drops to carry a warning to not use the combination in children below the age of four years.

In its communication dated December 18, the DCGI said the decision comes following a recommendation by the Subject Expert Committee (SEC). The drug makers are now supposed to put the new warning on the label, package insert and promotional literature.

While chlorpheniramine maleate functions as an anti-allergic, phenylephrine acts as a decongestant narrowing small blood vessels to provide relief from nasal congestion or stuffiness.

“The Fixed Dose Combination (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop per ml was declared as rational by Prof. Kokate’s committee and based on the recommendation of the committee, this office has issued No Objection Certificate (NOC) for continued manufacturing and marketing of subject FDC on 17.07.2015 under the 18 months policy decision,” the letter said.

However, later, concerns were raised against the use of this combination among infants and children. “Subsequently, concerns have been raised regarding the promotion of unapproved anti-cold drug formulations for infants,” the letter said.

On June 6, the letter said the matter was deliberated in the Subject Expert Committee (Pulmonary).

The panel recommended that the FDC should not be used in children below four years of age and accordingly, the firms should mention a warning in this regard on label and package insert, the drug regulator stated.