Government Restricts Fixed Dose Combinations Containing 2 Chemical Compounds for Young Children
The notification extends the ban to all formulations and requires labels warning they should not be used in children under 4.
- On August 22, 2026, the Indian government restricted all FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age, banning their manufacture, sale, and distribution.
- Indian authorities based the decision on recommendations from an expert committee and the Drugs Technical Advisory Board , noting that safer alternatives are available for young children.
- Manufacturers must display the warning 'Fixed Dose Combination shall not be used in children below four years of age' on labels, package inserts, and promotional literature associated with these formulations.
- Earlier, a government notification dated April 15, 2025, restricted certain FDCs containing these two chemical compounds, subject to the same age-specific warning requirement.
- Issued under Section 26A of the Drugs and Cosmetics Act, the notification is effective from its publication in the official gazette, providing legal foundation for the pediatric protection measure.
16 Articles
16 Articles
Centre Prohibits Cold Medicine Combinations Containing Chlorpheniramine and Phenylephrine for Children Under 4 | 📰 LatestLY
The Union Ministry of Health and Family Welfare has prohibited the manufacture, sale, and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under four years of age. Manufacturers are required to prominently display the warning on medicine labels, package inserts, and promotional material. 📰 Centre Prohibits Cold Medicine Combinations Containing Chlorpheniramine an…
Govt restricts fixed dose combinations containing 2 chemical compounds for young children
New Delhi, Aug 22 (PTI) In a significant step to safeguard the health and safety of young children, the government has imposed restrictions on the manufacture, sale and distribution of all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a clear warning that these medicines shall not be used in children below four […]
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