Cold Medicines With Two-Drug Combination Restricted for Children Below 4

The government has imposed restrictions on the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, citing potential health risks to young children.

Under the latest notification, manufacturers of formulations containing the two ingredients must prominently display a warning stating that the FDC must not be used in children below four years of age. The warning is required on the product label, package insert and promotional literature associated with the medicines.

The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), which examined the safety concerns associated with the use of these combinations in children. The government said such medicines could pose risks to children below four and noted that safer alternatives are available for treating relevant symptoms.

The move expands restrictions introduced earlier by the government. In a notification issued on April 15, 2025, certain FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride were restricted, with manufacturers required to carry the same age-specific warning.

The latest order extends the requirement to all formulations containing the two chemical compounds, bringing a wider range of medicines under the safety provision.

The government has issued the notification under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers authorities to regulate or prohibit the manufacture, sale or distribution of drugs in the public interest.

The restrictions will come into effect from the date of publication in the Official Gazette. Manufacturers will therefore be required to ensure that affected products and their accompanying promotional and informational material carry the prescribed warning.

The measure is aimed at strengthening safeguards around medicines used for children, particularly those below four years of age, and ensuring that parents, caregivers and healthcare providers are clearly informed about the potential risks associated with these formulations.