The Ministry of Health and Family Welfare (MoHFW) on August 19, 2026, issued Restriction on Manufacture, Sale and Distribution of FDCs Containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The Central Government has, under Section 26A of the Drugs and Cosmetics Act, 1940, restricted the manufacture, sale and distribution of all formulations of fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for human use in India. The restriction follows recommendations of the Expert Committee and the Drugs Technical Advisory Board, which identified a potential risk to children below four years of age and noted the availability of safer alternatives.
Manufacturers of such FDCs must prominently carry the warning “fixed dose combination shall not be used in children below four years of age” on the drug label, package insert and promotional literature. The notification is effective from the date of its publication in the Official Gazette.
[Notification No. S.O. 4595(E)]
