New Delhi: The Drugs general controller (India) wrote a letter on December 18, to all states and asked states and Union Territories to update the package insert of products 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 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.”
The letter further stated that the concern has been coming to the notice after the promotion of unapproved anti-cold drug formulation for infants, “Subsequently concerns have been raised regarding 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.
Speaking on the matter, Dr Dhiren Gupta, Sr Pediatrician from Delhi’s Sir Gangaram Hospital told ANI, “CHLORPHENIRAMINE MALEATE+PHENYLEPHRINE HYDROCHLORIDE is not recommended for children below 1 year age . 2 to 4 year cautious use. Even if prescribed should be for minimal duration and minimum dose. Careful about sedation as side effects.”
The decision has been taken after the recommendation of the SEC and it has been directed to all the manufacturers to mention the warnings, “FDC should not be used in children below 4 years of age” on the label and package insert/Promotional Literature of the drug.”
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