The Centre has imposed restrictions on the manufacture, sale and distribution of all fixed dose combinations containing chlorpheniramine maleate and phenylephrine hydrochloride. The mandate is issued in regard to the prescribing of these medicines in children below four years of age.
The notification is being issued under Section 26A of the Drugs and Cosmetics Act, 1940, and is effective from its publication in the Official Gazette.
Earlier, as per a notification dated April 15, 2025, the government had restricted certain fixed-dose combinations containing two chemical compounds, subject to the same age-specific warning. The latest notification covers this requirement to all formulations containing these two ingredients, according to a government press release.
The mandate, according to sources, was issued on the recommendations of a committee and the Drugs Technical Advisory Board.
In the notification, the government noted that such combinations may pose risks to children below four years of age. It reportedly said that safer alternatives are available.
Manufacturers have been directed to clearly display the warning, “Fixed dose combination shall not be used for children below four years of age,” on the package insert and promotional literature associated with these formulations.
The two drugs join the already issued list of formulations banned in June this year. These include acetylsalicylic acid with etyoheptazine, dicyclomine, paracetamol and clidinium bromide, dicyclomine, paracetamol, clidinium bromide and chlordiazepoxide, glimepiride with chromium picolinate, and paracetamol with lignocaine.
Antibiotic-based combinations were also prohibited, including amoxicillin with serratiopeptidase, amoxicillin with serratiopeptidase and Lactobacillus sporogenes, amoxicillin with cloxacillin, lactic acid bacillus and serratiopeptidase, cefadroxyl with probenecid, and cefuroxime with serratiopeptidase.
The Union Health Ministry earlier this year in June banned the manufacture, sale and distribution of 16 fixed-dose combination drugs, stating they lacked sufficient therapeutic justification and that the potential risks associated with their use did not yield any benefits.
It added that these combination drugs were found to lack therapeutic justification and were not considered beneficial with respect to the risks involved.