The government has imposed restrictions on the manufacturing, sale and distribution of all fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age.
The Ministry of Health and Family Welfare has directed manufacturers to prominently display a clear warning on products containing these combinations.
Editorial Insight
Key Highlights
Important points readers should notice.
Restrictions apply to specified FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The restriction concerns children below four years of age.
Manufacturers must display a mandatory warning. The warning must appear on the label and package insert.
Promotional literature must also carry the warning. The government cited safety concerns and availability of safer alternatives.
The move follows broader scrutiny of fixed-dose combination medicines.
The mandatory warning states:
“Fixed Dose Combination shall not be used in children below four years of age.”
The warning is required to appear on the label, package insert and promotional literature associated with the formulations.
Editorial Analysis
Why This Matters
The notification directly concerns medicines intended for young children and requires manufacturers to clearly communicate the age restriction. The measure is intended to ensure that parents, caregivers and healthcare professionals are made aware that these specified combinations should not be used in children below four years.
According to the government notification, the restriction has been introduced because the use of such combinations may pose risks to children below four years of age, while safer alternatives are available.
The move is part of the government's broader regulatory approach towards the safety and appropriate use of medicines.
The latest notification specifically requires manufacturers to ensure that the age-related warning is clearly communicated wherever the affected formulations are marketed or supplied.
The government had also taken wider action on fixed-dose combination medicines earlier this year.
In June, the Ministry of Health and Family Welfare prohibited the manufacturing, sale and distribution of 16 fixed-dose combination drugs for human use across the country.
That decision followed recommendations from an Expert Committee and the Drug Technical Advisory Board.
