Government bans anti-cold drug combination for kids aged under four
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, cautioning against the use of the combination in children below four years of age. "FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCI IP 5mg drop/ml was declared as rational by Prof.
Kokate committee and based on the recommendation of the committee, this office has issued NOC for continued manufacturing and marketing of subject FDC on July 17, 2015, under the 18 months policy decision", ANI reported quoting the letter. The letter further stated, "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, wherein, In light of the issue regarding the use of the FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCL IP 5mg drop/ml was discussed before the committee. "The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warning in this regard on label and package insert," the letter read.
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