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The government on Saturday restricted the manufacture, sale and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age.
The Health Ministry issued a notification requiring manufacturers to display a clear warning on these medicines.
The label, package insert and promotional material must carry the statement:
Fixed Dose Combination shall not be used in children below four years of age.
The Ministry issued the notification under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health.
The restriction took effect from the date of its publication in the Official Gazette.
The government had previously restricted certain FDCs containing these two ingredients with the same age-specific warning.
The latest order extends the requirement to every formulation containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB).
The government said these combinations could pose risks to children under four years. It further noted that safer alternatives are available.
Earlier in June, the Health Ministry prohibited the manufacture, sale and distribution of 16 FDC medicines for human use nationwide.
The medicines covered several therapeutic categories, including dermatological products, pain-relief medicines, antispasmodics and antibiotic-based formulations.
The Ministry said those combinations were irrational and lacked adequate scientific evidence.
The government imposed that prohibition under Section 26A of the Drugs and Cosmetics Act, 1940.
The move followed Supreme Court directions seeking a comprehensive review of FDCs available in India.
Following those directions, the DTAB formed an expert committee to examine various FDCs and assess their safety, efficacy and therapeutic value.
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