Govt Bans Some Cold & Flu Syrups For Infants, Kids Below 4 Years; Asks Pharma Firms To Insert Warning

While the combination, called fixed-dose combination, was already under scanner for being “irrational”, the government committee had approved it after finding reasonable evidence.

“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,” said the letter, seen by News18, according to the report.

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 committee 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 report quoted paediatricians as saying that developed nations such as the United States and the European Union banned such products for infants and kids almost a decade ago.