New Delhi, August 22: The Centre has restricted the manufacture, sale and distribution of certain fixed dose combination medicines for children under four.
The restriction covers medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The Centre has directed manufacturers to print clear warnings on labels, package inserts and advertisements.
Centre Expands Restrictions On Child Medicines
The warning must state that these medicines should not be used by children below four years.
The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board.
According to the Centre, these combinations may cause health risks in young children. Safer alternatives are also available.
The government had earlier restricted some medicines containing the same ingredients through a notification issued on April 15, 2025.
However, the latest order extends the restriction to all formulations containing both ingredients.
The Centre issued the notification under Section 26A of the Drugs and Cosmetics Act, 1940.
The new provision will take effect from the date of its publication in the official Gazette.
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