The Ministry of Health and Family Welfare (MoH&FW) on August 22, 2026, issued a notification regarding restrictions on FDCs for Children below 4 Years.
The following has been stated: -
•The Government has restricted the manufacture, sale and distribution of all FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years.
•Manufacturers must prominently display the warning: “Fixed Dose Combination shall not be used in children below four years of age.”
•The requirement applies to labels, package inserts and promotional literature of such formulations.
•The restriction follows recommendations of the Expert Committee and DTAB, considering potential risks and availability of safer alternatives.
•The notification is issued under Section 26A of the Drugs and Cosmetics Act, 1940 and is effective from August 22, 2026.
The detailed notification is given in the document below.
[Notification No.:2302237]
