FDCs of chlorpheniramine + phenylephrine restricted for children under 4

The restriction on cold-medicine FDCs for young children: what happened?

A fixed dose combination puts two or more drugs in one pill or syrup. This pair is often found in cold and cough medicines. The Government found it may pose risks to very young children, and that safer options exist.

• The April 2025 restriction covered only certain FDCs of these two drugs.
• The new notification extends the warning to all formulations with both ingredients.
• The warning must appear on the label, package insert and promotional literature.
• It takes effect from the date of publication in the Official Gazette.

Which law was used?

• The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health.
• The Government noted that safer alternatives are available for young children.

Why does the restriction on cold-medicine FDCs for young children matter?

• Child health: Protects children under four from risky combinations.
• Regulation: Shows the role of DTAB and expert review in drug safety.

What can Prelims ask on the restriction on cold-medicine FDCs for young children?

• Chlorpheniramine maleate + phenylephrine FDCs: not for children below four (Aug 2026).
• Notified under Section 26A, Drugs and Cosmetics Act, 1940.
• DTAB: Drugs Technical Advisory Board.