Union Health Ministry restricts FDCs with chlorpheniramine and phenylephrine for children below four

Key facts

• The Union Health Ministry has imposed restrictions on the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride.
• The restriction mandates a warning that these medicines shall not be used in children below four years of age.
• The notification extends the requirement to all formulations containing these two ingredients, following a previous restriction on certain FDCs.
• The decision follows recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB).
• The Government noted that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available.
• Manufacturers have been directed to prominently display the warning on the label, package insert and promotional literature.
• The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, and is effective from the date of publication in the Official Gazette.