Government Takes Major Step to Protect Young Children, Bans Certain Cold-Medicine Combinations for Under-4s
New Delhi, August 22: In a major move to protect the health and safety of young children, the Central Government has banned the manufacture, sale and distribution of all fixed-dose combination (FDC) medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age.
The decision was taken following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). According to the government, the use of these drug combinations in children below four years may pose risks, while safer alternatives are available.
Earlier, on April 15, 2025, the government had introduced age-specific warnings for certain medicines containing these two ingredients. The latest notification extends the restriction to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
Drug manufacturers have been directed to clearly display a warning on medicine labels, package inserts and promotional material stating that these fixed-dose combinations should not be used in children below four years of age.
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the public interest. It will come into effect from the date of its publication in the Official Gazette.
