New Delhi, August 22, 2026: The Government has expanded restrictions on the manufacture, sale and distribution of Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, making it mandatory for manufacturers to warn that these medicines must not be used in children below four years of age.
The move extends an earlier government order issued on April 15, 2025, which had imposed the same age-related restriction on specified FDC formulations containing the two ingredients. The latest notification brings all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride within the scope of the requirement.
The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB). The Government has cited concerns regarding the potential risks associated with the use of these drug combinations in children under four, while noting that safer therapeutic alternatives are available for this age group.
Under the new requirement, manufacturers must prominently carry the warning: “Fixed Dose Combination shall not be used in children below four years of age.” The warning is required to appear on the medicine’s label and packaging, as well as in the package insert and promotional material relating to the formulation.
The restriction has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the Government to regulate or prohibit the manufacture, sale or distribution of certain drugs when considered necessary in the public interest. The latest notification takes effect from the date of its publication in the Official Gazette.
The measure is part of the Government’s continuing efforts to strengthen medicine safety and ensure that pharmaceutical products used by young children carry appropriate safeguards. By extending the restriction to all relevant FDCs, the Government has sought to establish a uniform age-specific warning across formulations containing the two ingredients.