India's drug regulator Central Drugs Standard Control Organization (CDSCO) has banned a commonly used combination of anti-cold cocktails for infants and children under four years of age and ordered that medicines be labeled accordingly, Reuters news agency reported on Wednesday.
The drug regulator's decision followed the recommendations of a Subject Expert Committee (SEC) which stressed that the specified combination – a cocktail of the two drugs chlorpheniramine maleate and phenylephrine – should not be administered to children under the age of four.
Following the SEC's recommendation on June 6, 2023, Rajeev Singh Raghuvanshi, chief drug controller general of India (DCGI) issued a letter on December 18 asking all manufacturers of the fixed-dose cold combination (FDC) containing chlorpheniramine maleate IP 2 mg contains with phenylephrine HCL IP 5 mg per ml drops, to include a warning on the label and package leaflet, warning against the use of the combination in children under four years of age.
“FDC of Chlorpheniramine Maleate IP 2 mg Phenylephrine HCI IP 5 mg drop/ml was declared rational by the committee of Prof. Kokate and based on the recommendation of the committee, this agency issued NOC on July 17, 2015 for continued production and marketing of the concerned FDC. , under the policy decision of 18 months,” ANI reported quoting the letter.
The letter continued: “Concerns have subsequently been raised about the promotion of unapproved cold medicines for infants. The issue was discussed at the meeting of the Subject Expert Committee (SEC-Pulmonary) on June 6, 2023, wherein, in light of the issue regarding the use of the FDC of chlorpheniramine maleate IP 2 mg phenylephrine HCL IP 5 mg drop/ ml was discussed before the committee.
“The committee recommended that the FDC should not be used in children under the age of four years and therefore the companies should include a warning in this regard on the label and package leaflet,” the letter said.
Although chlorpheniramine maleate is an antiallergic drug, phenylephrine is known to be a decongestant.
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Published: Dec 21, 2023 12:35 PM IST