Alert: CDSCO Bans Common Cold Medicine for Kids Under 4!

The Central Drugs Standard Control Organisation (CDSCO) in India has prohibited the use of a common cold medication combination for infants and children under four years old.

The Drug Controller General of India (DCGI) issued a letter on December 18, 2023, following the SEC’s recommendation on June 6, instructing manufacturers to include a warning on the label and package insert, advising against the use of the fixed-dose combination containing chlorpheniramine maleate and phenylephrine HCL in children below four years of age.

The SEC raised concerns about the promotion of this unapproved anti-cold drug formulation for infants during their meeting. The combination includes an antiallergic drug, Chlorpheniramine Maleate, and a decongestant, Phenylephrine.