Government Restricts Fixed Dose Combinations With Chlorpheniramine and Phenylephrine for Children Under Four
· India · The Hindu, Hindustan Times
The government has imposed restrictions on the manufacture, sale, and distribution of fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. These medicines must include a warning prohibiting their use in children below four years of age. The decision follows recommendations by an expert committee and the DTAB, citing potential risks to young children. Manufacturers are required to update labels, package inserts, and promotional materials with the specified warning. The restriction applies to all formulations containing these two chemical compounds, extending previous 2025 regulations. The move aims to enhance child safety through stricter pharmaceutical oversight.
Why it matters
Parents and healthcare providers must now avoid administering these FDCs to children under four, while manufacturers face mandatory labeling requirements to prevent misuse. This change ensures safer alternatives are prioritized for pediatric care across India.
Read the original report — The Hindu
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