30/08/2026
The Union Health Ministry has issued a fresh notification expanding curbs on Fixed Dose Combinations (FDCs) containing Chlorpheniramine maleate and Phenylephrine hydrochloride.
Following warnings issued in 2023 and a formal restriction in 2025, the latest notification extends the restriction to ALL such FDC formulations for children below four years of age.
Why has this decision been made?
The government highlighted that these combinations pose risks to young children and that there is very limited scientific evidence showing they substantially improve uncomplicated colds. Furthermore, safer alternatives are readily available.
What manufacturers must now do:
Under Section 26A of the Drugs and Cosmetics Act, 1940, manufacturers are legally required to prominently display the warning: “Fixed Dose Combination shall not be used in children below four years of age.” This warning must appear on the label, package insert, and promotional literature.
This announcement aligns India with international health standards, as countries including the US and Australia have already adopted strict age restrictions or safeguards for pediatric cough-and-cold medicines.
💡 What should you do?
Please check your home medicine cabinets and safely dispose of any cold syrups containing these ingredients if you have children under 4. Always consult a licensed pediatrician for safe alternatives to treat colds.
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(Note: Informational post based on news reports, not a substitute for professional medical advice.)