Government bans anti-cold drug combination for kids aged under four
Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) has banned a widely used anti-cold cocktail medicine combination for infants and children under four years of age, and ordered that drugs should be labelled accordingly, news agency Reuters reported on Wednesday.
The drug regulator decision followed the recommendations of a Subject Expert Committee (SEC) which emphasised that the specified combination— a cocktail of two medicines chlorpheniramine maleate and phenylephrine—should not be administered to children below four years of age.
Following the SEC’s recommendation on June 6, 2023, the Drug Controller General of India (DCGI) chief Rajeev Singh Raghuvanshi issued a letter on December 18, asking all manufacturers of the common cold fixed-dose combination (FDC) containing chlorpheniramine maleate IP 2mg with phenylephrine HCL IP 5 mg per ml drops, to include a warning on the label and package insert, cautioning against the use of the combination in children below four years of age.
“FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCI IP 5mg drop/ml was declared as rational by Prof. Kokate committee and based on the recommendation of the committee, this office has issued NOC for continued manufacturing and marketing of subject FDC on July 17, 2015, under the 18 months policy decision”, ANI reported quoting the letter.
The letter further stated, “Subsequently concerns have been raised regarding the promotion of unapproved anti-cold drug formulation for infants. The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on June 6, 2023, wherein, In light of the issue regarding the use of the FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCL IP 5mg drop/ml was discussed before the committee.
“The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warning in this regard on label and package insert,” the letter read.
While Chlorpheniramine Maleate is an antiallergic drug, Phenylephrine is known to be a decongestant.
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Published: 21 Dec 2023, 12:35 AM IST
Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) has banned a widely used anti-cold cocktail medicine combination for infants and children under four years of age, and ordered that drugs should be labelled accordingly, news agency Reuters reported on Wednesday.
The drug regulator decision followed the recommendations of a Subject Expert Committee (SEC) which emphasised that the specified combination— a cocktail of two medicines chlorpheniramine maleate and phenylephrine—should not be administered to children below four years of age.
Following the SEC’s recommendation on June 6, 2023, the Drug Controller General of India (DCGI) chief Rajeev Singh Raghuvanshi issued a letter on December 18, asking all manufacturers of the common cold fixed-dose combination (FDC) containing chlorpheniramine maleate IP 2mg with phenylephrine HCL IP 5 mg per ml drops, to include a warning on the label and package insert, cautioning against the use of the combination in children below four years of age.
“FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCI IP 5mg drop/ml was declared as rational by Prof. Kokate committee and based on the recommendation of the committee, this office has issued NOC for continued manufacturing and marketing of subject FDC on July 17, 2015, under the 18 months policy decision”, ANI reported quoting the letter.
The letter further stated, “Subsequently concerns have been raised regarding the promotion of unapproved anti-cold drug formulation for infants. The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on June 6, 2023, wherein, In light of the issue regarding the use of the FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCL IP 5mg drop/ml was discussed before the committee.
“The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warning in this regard on label and package insert,” the letter read.
While Chlorpheniramine Maleate is an antiallergic drug, Phenylephrine is known to be a decongestant.
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Published: 21 Dec 2023, 12:35 AM IST
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