The ministry said the use of “Chlorpheniramine Maleate and Phenylephrine Hydrochloride” drug combination in children below four years could pose health risks, while their safer alternatives are available in the market.
New Delhi: The Central government has prohibited the sale and use of the fixed-dose combination (FDC) of “Chlorpheniramine Maleate and Phenylephrine Hydrochloride in children below four years of age”, citing potential health risks.
In a gazette notification, the Union Health Ministry directed manufacturers of the concerned FDCs to carry a warning stating, “The drug shall not be used in children below four years of age.”
The ministry said the use of these medicines in children below four years could pose health risks, while their safer alternatives are available in the market.
Phenylephrine hydrochloride and chlorpheniramine maleate combination is used to treat symptoms of the common cold, flu, and allergies, such as a stuffy nose, sneezing, and watery eyes.
However, an expert committee constituted by the Ministry examined the matter, reviewed the FDC and flagged potential health risks for children. It recommended that a warning label be placed on all drugs containing the two salts that are manufactured and sold across the country.
Later, the Drugs Technical Advisory Board (DTAB) also endorsed the proposal at its meeting held on February 16, 2026.
Notably, the latest move comes in a series of crackdowns over the past 12 months, during which the ministry has imposed a complete ban or restricted sale of more than 50 irrational combinations. Most recently, 16 FDCs were banned in June this year.
According to multiple reports, the central regulator –CDSCO– is undertaking a review of legacy products and older FDCs, particularly those with incomplete or outdated records, to strengthen regulatory oversight and enforce quality and safety norms.
Meanwhile, the scrutiny of common-cold therapies has intensified following the deaths of at least 24 children in Madhya Pradesh last year and several state agencies have also imposed similar restrictions on use of such drug combinations in children.
