Govt Restricts Cold-Medicine FDCs for Children Under Four
Chlorpheniramine-phenylephrine combinations must carry mandatory warning following expert safety recommendations
- All FDCs containing the two ingredients are covered by the new restriction.
- Manufacturers must display a clear warning against use in children below four.
- The move follows recommendations of the Expert Committee and DTAB.
- The notification has been issued under Section 26A of the Drugs and Cosmetics Act.
GG News Bureau
New Delhi, 22nd Aug: The Government has restricted the manufacture, sale and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, with mandatory instructions that these medicines must not be used in children below four years of age.
The decision follows recommendations of an Expert Committee and the Drugs Technical Advisory Board (DTAB). The Government said the use of such combinations may pose risks to children below four and noted that safer alternatives are available.
Under the notification, manufacturers have been directed to prominently display the warning: “Fixed Dose Combination shall not be used in children below four years of age.” The warning must appear on the product label, package insert and promotional literature.
The latest decision expands an earlier notification issued on April 15, 2025, which restricted certain FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride with the same age-specific warning.
The Government has now extended the requirement to all formulations containing the two ingredients.
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health. The restrictions are effective from the date of publication in the Official Gazette.
