The decision follows an earlier notification which applied the same warning requirement to certain formulations of the combination
| Photo Credit:
Ramesh C
The Centre on Friday imposed restrictions on the manufacture, sale and distribution of fixed-dose combination (FDC) medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age.The notification states that the move has been taken in the public interest following recommendations from the Drugs Technical Advisory Board (DTAB).Under the new notification, manufacturers of these fixed-dose combination medicines must prominently carry the warning: “fixed dose combination shall not be used in children below four years of age” on the drug label, package insert or promotional literature.Safer AlternativesThe government said it was satisfied that the use of such combinations could pose risks to children below four years, while safer alternatives are available.The decision follows an earlier notification which applied the same warning requirement to certain formulations of the combination. An Expert Committee constituted by the Ministry of Health and Family Welfare examined other fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride and recommended that the warning be extended to all such formulations manufactured, imported or marketed in India.Published on August 21, 2026
