The Union Health Ministry has issued a fresh notification restricting the manufacture, sale and distribution of all Fixed Dose Combination (FDC) that contain chlorpheniramine maleate and phenylephrine hydrochloride. The label must carry a clear warning: “Fixed Dose Combination shall not be used in children below four years of age.”
Key Developments
- Extension of the 2025 restriction to **all** formulations containing the two ingredients.
- Mandatory display of the age‑specific warning on the label, package insert and promotional material.
- Notification issued under Section 26A of the Drugs and Cosmetics Act.
- Effective from the date of publication in the Official Gazette (2026).
Important Facts
The decision follows recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB). The government highlighted two concerns:
- Children under four are prone to dosing errors and adverse reactions from multi‑ingredient medicines.
- Evidence of significant benefit of these combinations in uncomplicated colds is limited.
Adverse effects noted include marked drowsiness or paradoxical excitability from chlorpheniramine, and altered heart rate or blood pressure from phenylephrine.