CDSCO bans use of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg drop/ml FDC in kids below 4 years
New Delhi: To ensure the safety of infants and young children in the country, the Central Drugs Standard Control Organization (CDSCO) has recently banned the use of anti-cold fixed drug combination (FDC) of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg drop/ml in kids below 4 years of age.
With this, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has asked the state and UT drug controllers to direct all the manufacturers of the fixed-dose combination (FDC) of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg drop/ml under their jurisdiction to add warning that FDC should not be used in children below 4 years of age on label and package insert/ promotional literature of the drug.
This follows an expert committee's recommendation concerning the usage of the said FDC, particularly in the pediatric population.
"Subsequently concerns have been raised regarding promotion of unapproved anti-cold drug formulations for infants," the letter read. The advisory comes after the Subject Expert Committee (SEC-Pulmonary) discussed the concerns on June 6, 2023, and concluded that the drug should not be used in children below the age of 4.
"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 label and package inserts or promotional literature of the drug," the letter added.
The fixed dose combination is avaiable in India under various brands including T-minic by GSK, Ascoril Flu Srup by Glenmark Pharma, Wikoryl AF Syrup by Alembic Pharma, Solvin Cold AF Syrup by IPCA pharma to name a few
To view the official letter, click on the link below:
https://medicaldialogues.in/pdf_upload/fdcpublic18dec23-228406.pdf
