Delhi, 21 December (H.S) :On December 18th, the Drugs Controller General of India sent a letter to all states and union Territories regarding the use of a cocktail of two medicines, chlorpheniramine maleate and phenylephrine. The FDC (Fixed Dose Combination) of Chlorpheniramine Maleate IP 2mg Phenylephrine HCI IP 5mg drop/ml was declared rational by Prof. Kokate’s committee and approved for manufacturing and marketing in July 2015.
However, concerns were raised about the promotion of unapproved anti-cold drug formulations for infants. In response, a Subject Expert Committee meeting was held on June 6th, 2023, where it was recommended that the FDC should not be used in children below 4 years of age.
This decision was made after careful consideration of potential side effects such as sedation. Dr. Dhiren Gupta, a senior pediatrician from Delhi’s Sir Gangaram Hospital, also emphasized caution in using this FDC for children below 1 year old and recommended minimal duration and dosage if prescribed.
As a result, the Drugs Controller General has directed all manufacturers to update the package insert and label with warnings about the age restriction and potential side effects in children below 4 years of age. This decision was made to ensure the safety and well-being of young children and to promote responsible use of this FDC.
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