Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has requested the drug regulators of all states and Union territories to instruct the producers of mounted drug mixture (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg drop/ml to insert warning that “FDC should not be used in children below 4 years of age” on label and package deal insert/promotional literature of the drug.

In the letter, the DCGI acknowledged that the FDC was declared as rational by the Professor Kokate Committee and based mostly on its advice, this workplace had issued NOC for continued manufacturing and advertising of the FDC on July 17, 2015 beneath the 18-month coverage resolution.

“Subsequently concerns have been raised regarding promotion of unapproved anti-cold drug formulation for infants,” he stated.

The matter was deliberated within the Subject Expert Committee (SEC- Pulmonary) assembly held on June 6.

“The committee recommended that the FDC should not be used in children below four years of age and accordingly the firms should mention warnings in this regard on label and package insert. The recommendation of the SEC has been considered by this office,” the letter acknowledged.

“Accordingly, you are requested to direct all the manufacturers of 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/promotional literature of the drug,” in response to the DCGI’s letter dated December 18.