Govt extends child-use warning to all chlorpheniramine-phenylephrine drugs
Decision
The government has extended restrictions on all fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, saying they should not be used in children under four. Manufacturers must now put that warning on the label, package insert and promotional material.
Compliance Impact
The notification widens an earlier 2025 restriction and applies it to every formulation with those two ingredients, not just selected products. It was issued under Section 26A of the Drugs and Cosmetics Act, which allows the government to curb or ban drugs in the public interest.
Counterpoints
The government says expert committee and Drugs Technical Advisory Board recommendations supported the move, and that safer alternatives are available.
The source does not spell out the underlying clinical evidence, so the practical basis for extending the warning cannot be assessed from this report alone.