What Happened
The Government of India has imposed expanded restrictions on the manufacture, sale, and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. These medications are now mandated to carry a clear warning that they shall not be used in children below four years of age. This directive follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB).
Key Facts
- The Ministry of Health and Family Welfare issued the notification on August 22, 2026.
- The restrictions apply to all FDCs that include Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
- Manufacturers are required to display the warning, “Fixed Dose Combination shall not be used in children below four years of age,” on labels, package inserts, and promotional materials.
- This decision was made under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health.
- An earlier notification on April 15, 2025, had restricted certain FDCs with these ingredients, also subject to age-specific warnings. The latest notification extends this requirement to all such formulations.
Why It Matters
This action is a significant step to safeguard the health and safety of young children by addressing potential risks associated with these drug combinations. The government noted the availability of safer alternatives for this age group.
What To Watch
The directive is effective from its publication date in the Official Gazette, which can be accessed online.