NEW DELHI, Aug 22: The government has tightened safety regulations on fixed dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride, restricting their manufacture, sale and distribution for use in children below four years of age.
Under the latest notification, manufacturers of all formulations containing the two ingredients must prominently display an age-specific warning stating that the combination should not be used in children under four.
The move expands an earlier government order issued on April 15, 2025, which had imposed similar restrictions on certain FDCs containing the two chemical compounds. The latest decision extends the warning requirement to all formulations containing the ingredients.
The government said the measure was taken after considering recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB).
Authorities noted that the use of these combinations could pose health risks to children younger than four, while safer treatment alternatives are available for managing relevant symptoms.
Mandatory warning on packaging
Drug manufacturers have been instructed to clearly print the prescribed warning on product labels, package inserts and promotional material associated with the formulations.
The mandatory statement reads: “Fixed Dose Combination shall not be used in children below four years of age.”
The requirement is intended to ensure that parents, caregivers and healthcare professionals are clearly informed about the age restriction before the medicines are administered.
Order issued under Drugs and Cosmetics Act
The latest notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the government to restrict or prohibit the manufacture, sale or distribution of certain drugs when their use is considered to pose a risk to public health.
The restrictions take effect from the date of publication in the official Gazette.
The government’s decision is aimed at strengthening medicine safety for young children and ensuring that potentially unsuitable drug combinations are not used in this age group when safer alternatives are available.
