The Central Drugs Standard Control Organization (CDSCO) has issued a notice mandating a warning to be included in the labels of Fixed Dose Combination (FDC) of Chlorpheniramine Maleate IP 2mg And Phenylephrine HCI IP 5mg drop/ml. This notice was published on December 18, 2023.
The CDSCO had granted NOC for continued manufacture and marketing of FDC of Chlorpheniramine Maleate IP 2mg And Phenylephrine HCI IP 5mg drop/ml on July 17, 2015. This was granted under an 18-month policy decision. This decision was taken on the basis of the FDC being declared as rational by the Prof. Kokate Committee.
Subsequently, concerns were raised on promotion of unapproved anti-cold drug for infants. Hence, this matter was considered by the Subject Expert Committee (SEC- Pulmonary) in a meeting held on June 6, 2023.
This Committee recommended that the FDC should not be used for children less than 4 years of age. The label and package insert of the FDC should also mention a warning in this regard.
Therefore, the CDSCO has emphasised that all manufacturers of this FDC should mention a warning that, ‘FDC should not be used in children below 4 years of age‘. This should be included in the label and the package insert/ promotional literature of the drug.
