The Ministry of Health and Family Welfare has imposed significant restrictions on the manufacture, sale, and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride specifically for use in children below four years of age. This regulatory action mandates that all such formulations must carry a clear warning stating 'Fixed Dose Combination shall not be used in children below four years of age' on their labels, package inserts, and promotional literature.
This latest notification, dated 22 August 2026, extends previous restrictions imposed via notification S.O. 1717(E) dated 15 April 2025, which had applied to certain FDCs containing these ingredients with the same age-specific warning. The decision was taken based on recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB), which identified potential risks to children below four years and noted the availability of safer alternatives.
The regulatory action has been implemented under Section 26A of the Drugs and Cosmetics Act, 1940, citing public health interests as the primary justification. The restrictions became effective from the date of publication in the Official Gazette, which can be accessed through the provided link: https://egazette.gov.in/WriteReadData/2026/275640.pdf.