DCGI bans this popular anti-cold FDC for children under 4
New Delhi: The Drug Controller General of India (DCGI) has banned use of popular anti-cold cocktail medicine combination for children under four years of age, and ordered that drugs should mention warning in this regard on label and package insert.
The decision comes after the Drugs Technical Advisory Board (DTAB), in its 91st meeting, addressed concerns regarding the use of the fixed-dose combination (FDC) of Chlorpheniramine Maleate IP and Phenylephrine Hydrochloride IP in children under 4 years of age.
This FDC is being sold under various brand names including T-Minic (Glaxo SmithKline Pharmaceuticals Ltd.), Wikoryl AF (Alembic Pharmaceuticals Ltd.), Solvin Cold AF (Ipca Laboratories Ltd.), Delcon (Veritaz Healthcare Ltd.), and Coriminic (Wanbury Ltd.).
Initially, the Subject Expert Committee (SEC) on Pulmonary diseases reviewed the FDC containing Chlorpheniramine Maleate IP 2mg + Phenylephrine Hydrochloride IP 5mg drop/ml and recommended that the FDC should not be used in children below 4 years of age and accordingly manufacture should mention warning in this regard on label and package insert.
However, manufacturers sought clarification on whether this warning applied to all formulations containing Chlorpheniramine and Phenylephrine or only the specific strength of Chlorpheniramine Maleate IP 2mg + Phenylephrine Hydrochloride IP 5mg drop/ml should be labelled.
In response, the SEC re-examined the matter on January 4th, 2024, with additional input from pediatricians. Following this detailed deliberation, the committee recommended that all formulations of FDC of Chlorpheniramine Maleate IP + Phenylephrine Hydrochloride should not be used in children below 4 years of age and accordingly manufacturers should mention warning “FDC should not be used in children below 4 years of age" on label and package insert/promotional literature of the drug.
The DTAB, after deliberation, concurred with the SEC's recommendation, ultimately prohibiting the manufacture, sale, or distribution of any product containing the FDC of Chlorpheniramine Maleate + Phenylephrine Hydrochloride for children under 4 years old.
Medical Dialogues team had earlier reported that more than 36 percent of 400 manufacturing units inspected since last year had been directed to close. This action had followed heightened scrutiny prompted by deaths associated with sub- standard cough syrup.
Also Read: Over 36 percent of inspected drug-manufacturing units had to be shut: CDSCO Official
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