Govt bans fixed-dose combo drugs with chlorpheniramine, phenylephrine for under 4yrs

The Union ministry of health and family welfare on Saturday announced that it has banned Fixed Dose Combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride for use in children below four years of age.

“In a significant step to safeguard the health and safety of young children, the government has imposed restrictions on the manufacture, sale and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a clear warning that these medicines shall not be used in children below four years of age,” the health ministry said in a statement on Saturday.

The modification in rules has been notified in the Gazette.

Chlorpheniramine is a histamine-H1 receptor antagonist indicated for the management of symptoms associated with upper respiratory allergies.

Also read: Centre bans 16 fixed-dose drug combinations citing public health concerns

Phenylephrine is used as a nasal decongestant to temporarily unblock a nose or relieve sinus pressure in people with nasal and sinus congestion caused by colds or allergies.

Earlier, the Centre had restricted certain FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride, subject to the same age-specific warning. The latest notification extends this requirement to all formulations containing these two ingredients.

The decision has been taken following the recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB).

According to the statement, experts in the department noted that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available.

“Manufacturers have been directed to clearly display the warning, “Fixed Dose Combination shall not be used in children below four years of age,” on the label, package insert and promotional literature associated with these formulations,” read the health ministry statement.

“The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and is effective from the date of its publication in the Official Gazette,” it added.

In June, the government banned 16 fixed-dose combinations, including skin medications, painkillers and muscle relaxants, that it felt had limited therapeutic use.

FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as “cocktail” drugs.

Also Read: Painkillers, muscle relaxants among 16 more FDCs banned

The health ministry has been trying to phase out from the market those fixed-dose combinations that pose a risk to human beings and for which better and safer alternatives are available in the market.

The Drugs Technical Advisory Board (DTAB), which advises the ministry’s drugs regulatory authority—the Central Drugs Standard Control Organisation (CDSCO)—constitutes an expert committee to examine various FDCs and identify those that are “irrational, lack therapeutic justification or may pose risks to human health.”

Based on the scientific assessment and recommendations of the expert committee, the government then takes action.

The government in 2016 announced a ban on 344 FDCs following recommendations from an expert panel.

Between 2023 and 2025, a total of 205 FDCs were banned as part of the exercise to phase out unapproved fixed-dose combination drugs from the Indian market. Many of the FDCs banned over the years were also among those 344 drug combinations.