Sunday, March 3, 2024

Anti-cold fixed drug combination banned for under-four children

The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of anti-cold fixed drug combination in children below four years of age, PTI reported.

The Fixed Dose Combination (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop/ml has come under scrutiny following concerns about its promotion as an anti-cold drug for infants.

Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has asked the drug regulators of all states and Union territories to instruct the manufacturers to insert a warning that “FDC should not be used in children below 4 years of age” on label and package insert/promotional literature of the drug.

In the letter, the DCGI stated that the FDC was declared as rational by the Professor Kokate Committee and based on its recommendation, this office had issued NOC for continued manufacturing and marketing of the FDC on July 17, 2015, under the 18-month policy decision.


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