Last Updated on April 27, 2025 by The Health Master
Cold Medicine
The Indian government’s Union Health Ministry has issued a significant restriction on the use of the common cold medicine combination Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under the age of four vide notification No. S.O 1717(E) dated 15-04-2025.
This decision mandates that all manufacturers clearly state a warning on packaging and promotional materials of the said cold medicine, explicitly advising against its use in this young age group.
Expert Recommendations
A Subject Expert Committee (SEC) had recommended this restriction, highlighting the need for a clear warning on the packaging of the drug.
The Drugs Technical Advisory Board (DTAB) had also examined the matter and recommended prohibiting the use of this particular drug combination for children under the age of four years.
Government initiative
The Central Government has issued a notification No. S.O 1717(E) dated 15-04-2025 and restricted the manufacture, sale, and distribution of the fixed-dose combination (FDC) of Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below the age of four years.
Notification states as under:
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby restricts the manufacture, sale or distribution of all formulations of fixed dose combination of Chlorpheniramine Maleate + Phenylephrine Hydrochloride subject to the following condition, that the manufacturers shall mention the warning “fixed dose combination shall not be used in children below four years of age” on the label and package insert or the promotional literature of the drug.
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