The Central Drugs Standard Control Organisation (CDSCO) is set to implement a ban on a widely used anti-cold cocktail medicine combination for infants and children under four years of age.

This decision stems from the recommendations of a Subject Expert Committee (SEC), which provides guidance to drug regulators on matters concerning drug approvals and trials in the pulmonary segment, Financial Express reported. The SEC emphasised that the specified combination should not be administered to children below four years of age.

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

In addition to this directive, the DCGI has issued a letter to all State and Union Territory drug controllers, urging them to instruct manufacturers under their jurisdiction to prominently display the warning “FDC should not be used in children below 4 years of age” on not just the label and package insert but all promotional literature of the drug.

The letter, viewed by Financial Express, read that manufacturers should “mention warning ‘FDC should not be used in children below 4 years age’ on label and package insert/promotional literature of the drug”.

The DCGI, in addressing concerns raised about the promotion of unapproved anti-cold drug formulations for infants, underscored the importance of notifying the regulatory office about any actions taken in this regard.

The combination in question is typically taken to alleviate symptoms associated with cold and flu, such as watery eyes, runny nose, sneezing, and nasal or throat itching.

The letter read, “The 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.”

While Chlorpheniramine Maleate is an antiallergic drug, Phenylephrine is known to be a decongestant.

As per Financial Express, this combination is manufactured by several companies including Glaxo SmithKline Pharmaceuticals Ltd’s T-Minic, Glenmark Pharmaceuticals Ltd’s Ascoril Flu, Alembic Pharmaceuticals Ltd’s Wikoryl AF, Wanbury Ltd Coriminic, Wanbury Ltd Coriminic QR and Ipca Laboratories Ltd’s Solvin Cold AF.