The Central Government has imposed restrictions on the use of a commonly used cold and cough medicine combination in children below four years, citing concerns over potential health risks.
The Union Health Ministry has prohibited the manufacture, sale and distribution of fixed-dose combination (FDC) medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children under four.
Pharmaceutical companies have also been instructed to display a clear warning on all such products stating: “Not for use in children below the age of 4 years.”
Warning to Appear on All Relevant Material
The mandatory warning must be printed on the packaging, labels, package inserts and promotional material associated with the affected medicines.
The order covers the different formulations of the combination, including syrups, drops and other products intended to contain the two drugs. The latest decision places the relevant FDC medicines under a uniform restriction for children below four years.
Safety Review Led to Restriction
Chlorpheniramine Maleate and Phenylephrine Hydrochloride are used to manage symptoms such as a blocked or runny nose, sneezing and allergy-related discomfort.
The combination was reviewed by an expert committee and the Drugs Technical Advisory Board (DTAB) following concerns about its safety in young children.
The authorities concluded that the combination could result in serious adverse effects in children below four years. The review also considered the availability of safer alternatives for treating symptoms in this age group.
Nationwide Order Takes Immediate Effect
The government has issued the restriction under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers it to prohibit or regulate drugs when such action is considered necessary in the public interest. The order took effect immediately after being published in the Official Gazette and applies throughout the country.
Manufacturers, distributors and retailers dealing with the affected medicines have been directed to comply with the order and the mandatory labelling requirement. Non-compliance may result in action under the Drugs and Cosmetics Act and applicable rules.