Cold and Flu Syrups Banned for Children Under 4 Years of Age in India

New delhi: the medicine preferred controller (India) wrote a letter on december 18, to all states and requested states and union territories to update the bundle insert of merchandise made using a cocktail of two medicines chlorpheniramine maleate and phenylephrine.

According to the letter, fdc of chlorpheniramine maleate ip 2mg + phenylephrine hci ip 5mg drop/ml become declared as rational by way of prof. Kokate committee and based on the recommendation of the committee, this workplace has issued noc for persisted production and advertising of difficulty fdc on july 17, 2015, under the 18 months policy choice.

The letter further said that the priority has been coming to the awareness after the merchandising of unapproved anti-bloodless drug components for babies, œfinally concerns have been raised regarding promotion of unapproved anti-bloodless drug components for toddlers. The problem become deliberated within the challenge professional committee (sec- pulmonary) assembly hung on june 6, 2023, in which, in light of the issue concerning the usage of the fdc of chlorpheniramine maleate ip 2mg + phenylephrine hcl ip 5mg drop/ml turned into discussed before the committee.

the committee advocated that the fdc should no longer be utilized in children below 4 years of age and consequently the firms should point out warning on this regard on label and package insert, the letter examine.

Talking on the problem, dr dhiren gupta, sr pediatrician from delhi sir gangaram clinic advised ani, chlorpheniramine maleate+phenylephrine hydrochloride is not encouraged for youngsters under 1 year age . 2 to four year cautious use. Even if prescribed have to be for minimum period and minimum dose. Cautious about sedation as facet outcomes

The decision has been taken after the recommendation of the sec and it's been directed to all of the manufacturers to mention the warnings, fdc should now not be used in kids below 4 years of age on the label and package insert/promotional literature of the drug.