New Delhi, August 22: The central government has made a significant decision regarding the health and safety of young children. It has imposed a complete ban on the manufacture, sale, and distribution of fixed-dose combination (FDC) drugs containing chlorpheniramine maleate and phenylephrine hydrochloride for children under four years of age.
The Ministry of Health issued a notification stating that no formulations containing these two ingredients can be produced or sold. Additionally, companies are now required to include a clear warning on the labels of these medications, indicating that they should not be used for children under four.
The government cited child safety as the primary reason for this decision. This move follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). Experts found that the combination of chlorpheniramine maleate and phenylephrine poses risks for children in this age group, with potential side effects being more pronounced, despite safer alternatives being available in the market.
Previously, on April 15, 2025, the government had issued a notification restricting certain FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride, which included age-related warnings. However, the latest notification broadens this regulation. Now, the ban applies to all formulations containing these ingredients, regardless of brand or dosage.
According to the new notification, all manufacturers are instructed to prominently display the warning on labels, package inserts, and promotional materials: “The use of fixed-dose combinations is not recommended for children under four years of age.”
This notification has been issued in the public interest under Section 26A of the Drugs and Cosmetics Act, 1940, and will take effect from the date of its publication in the official gazette.
As a result of this decision, many popular cold and cough syrups and medications previously used for young children may be affected in the market.
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