In a recent development, the Central Drugs Standard Control Organisation (CDSCO) of India has taken a decisive step by banning a widely used anti-cold cocktail medicine combination designed for infants and children under the age of four. This prohibition is accompanied by a mandate requiring appropriate labeling of the medication.

The regulatory action comes in the wake of recommendations from a Subject Expert Committee (SEC), which strongly advised against the administration of a specific medicine combination to children below four years of age. The cocktail in question comprises chlorpheniramine maleate and phenylephrine, two commonly used ingredients in cold medications,  reported Livemint.

Following the SEC’s counsel on June 6, 2023, Rajeev Singh Raghuvanshi, the chief of the Drug Controller General of India (DCGI), issued a directive on December 18. This directive instructed all manufacturers producing the common cold fixed-dose combination (FDC) containing chlorpheniramine maleate IP 2mg with phenylephrine HCL IP 5 mg per ml drops to include a warning on the label and package insert. The warning explicitly cautions against the use of the combination in children below four years of age.

Incorporate Warning On Label

The decision to ban this particular combination stems from concerns raised about the promotion of an unapproved anti-cold drug formulation for infants. According to information released, the committee responsible for declaring the FDC as rational was the Prof. Kokate committee. The NOC (No Objection Certificate) for continued manufacturing and marketing of the subject FDC was issued on July 17, 2015, under the 18-month policy decision.

The letter issued by DCGI chief Rajeev Singh Raghuvanshi also clarified the background, stating, “Subsequently, concerns have been raised regarding the promotion of unapproved anti-cold drug formulation for infants.” The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on June 6, 2023, where the committee recommended that the FDC should not be used in children below four years of age. The firms were directed to incorporate a warning to this effect on the label and package insert.

Chlorpheniramine Maleate, one of the components of the banned combination, is recognized as an antiallergic drug, while Phenylephrine is known for its decongestant properties.

With the recent ban on the anti-cold drug combination for children under the age of four, the Indian drug regulatory body is taking proactive measures to safeguard the health and well-being of the youngest members of society. This decision underscores the importance of stringent regulations and thorough evaluations of medications targeted at vulnerable populations, especially children. Manufacturers and healthcare providers are urged to adhere to the stipulations outlined by the CDSCO to ensure the safety of young patients.

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