The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of anti-cold fixed drug combinations in children below four years of age.
Drugs Controller General of India (DCGI) Rajeev Raghuvanshi asked the drug regulators of all states and Union territories to instruct the manufacturers of fixed drug combination (FDC) of Chlorpheniramine Maleate IP 2mg Phenylephrine HCL IP 5mg drop/ml to insert warning that "FDC should not be used in children below four years of age" on label and package insert/promotional literature of the drug.
In the letter, the DCGI stated that the FDC was declared as rational by the Professor Kokate Committee, and based on its recommendation, this office had issued NOC for continued manufacturing and marketing of the FDC on July 17, 2015, under the 18-month policy decision.
"Subsequently concerns have been raised regarding the promotion of unapproved anti-cold drug formulation for infants," he said.
The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting 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 stated.
"Accordingly, you are requested to direct all the manufacturers of said FDC under your jurisdiction to mention the warning 'FDC should not be used in children below 4 years of age' on the label and package insert/promotional literature of the drug," according to the DCGI's letter dated December 18.
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