Centre cites safety concerns and availability of safer alternatives
The Union government has tightened restrictions on all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, directing that these medicines must not be used in children below four years of age.
The Health Ministry said the restriction covers the manufacture, sale and distribution of all formulations containing the two ingredients. Manufacturers have been directed to prominently display an age-specific warning on medicine labels, package inserts and promotional material.
The notification follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). The government said the combination could pose risks to children below four and noted that safer alternatives are available.
What are these medicines used for?
Chlorpheniramine is an antihistamine commonly used to relieve allergy-related symptoms such as a runny nose and sneezing. Phenylephrine is a decongestant used to temporarily relieve nasal congestion associated with colds and allergies.
The latest move extends an earlier restriction on certain FDCs containing the two ingredients to all formulations containing them.
The government has directed manufacturers to carry the clear warning: “Fixed Dose Combination shall not be used in children below four years of age.” The restriction takes effect from the date of publication in the Official Gazette.
The move comes amid wider scrutiny of fixed-dose combinations in India. In June, the Health Ministry prohibited the manufacture, sale and distribution of 16 FDC medicines following concerns over their safety and rationality.
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