CDSCO recommends widely used anti-cold syrup not to be used in children below 4 years of age, after recommendation from SEC.
The FDC of Chlorpheniramine Maleate and Phenylephrine HCl 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 plus Phenylephrine HCL IP 5mg drop/ml was discussed before the committee.
Chlorpheniramine Maleate is an antiallergic which relieves allergy symptoms like runny nose, watery eyes and sneezing. Phenylephrine is a decongestant which narrows the small blood vessels providing relief from congestion or stuffiness in the nose.
The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warnings in this regard on label and package insert.
