Central Drugs Standard Control Organization advisory on cough syrup

The 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 17.07.2015 under the 18 months policy decision.

Subsequently concerns have been raised regarding promotion of unapproved anti-cold drug formulation for infants. The matter was deliberated in Subject Expert Committee (SEC- Pulmonary) meeting held on 06.06.2023 wherein, In light of the issue regarding 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 recommendation of the SEC has been considered by this office. Accordingly, all the manufacturers of said FDC are to be directed 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. 

Source : CDSCO