New Delhi: The Central authorities has prohibited the sale and use of the fixed-dose combination (FDC) of “Chlorpheniramine Maleate and Phenylephrine Hydrochloride in youngsters beneath 4 years of age”, citing potential well being dangers.
In a gazette notification, the Union Well being Ministry directed producers of the involved FDCs to hold a warning stating, “The drug shall not be utilized in youngsters beneath 4 years of age.”
The ministry mentioned the usage of these medicines in youngsters beneath 4 years may pose well being dangers, whereas their safer alternate options can be found out there.
Phenylephrine hydrochloride and chlorpheniramine maleate mixture is used to deal with signs of the frequent chilly, flu, and allergy symptoms, resembling a stuffy nostril, sneezing, and watery eyes.
Nevertheless, an professional committee constituted by the Ministry examined the matter, reviewed the FDC and flagged potential well being dangers for youngsters. It advisable {that a} warning label be positioned on all medication containing the 2 salts which are manufactured and bought throughout the nation.
Later, the Medicine Technical Advisory Board (DTAB) additionally endorsed the proposal at its assembly held on February 16, 2026.
Notably, the newest transfer is available in a sequence of crackdowns over the previous 12 months, throughout which the ministry has imposed a whole ban or restricted sale of greater than 50 irrational mixtures. Most not too long ago, 16 FDCs had been banned in June this 12 months.
In response to a number of experiences, the central regulator –CDSCO– is endeavor a assessment of legacy merchandise and older FDCs, notably these with incomplete or outdated data, to strengthen regulatory oversight and implement high quality and security norms.
In the meantime, the scrutiny of common-cold therapies has intensified following the deaths of not less than 24 youngsters in Madhya Pradesh final 12 months and a number of other state businesses have additionally imposed related restrictions on use of such drug mixtures in youngsters.
