Govt restricts sale of anti-cold drug combination for children under 4 yrs

The Centre has formally restricted the manufacture and sale of fixed drug combinations (FDCs) of chlorpheniramine maleate and phenylephrine hydrochloride for use in children under four years of age.

 

The combination is primarily used in cough syrups for children and is present in several popular brands, including GSK’s T-Minic syrup, Glenmark’s Ascoril Flu Drops and Alembic’s Wikoryl AF, along with many other cold and flu preparations.

 

In a gazette notification, the health ministry contended that the FDC is likely to involve risk to children below four years of age, with safer alternatives to the said drug combination being available.

 

The FDC is also effective in treating symptoms like watery eyes, runny nose, sneezing and other discomforts.

 

While chlorpheniramine maleate is an antiallergic that relieves allergy symptoms, phenylephrine is a decongestant that narrows small blood vessels, providing relief from congestion or stuffiness in the nose.

 

The move comes after the matter was examined by a Subject Expert Committee (SEC) constituted by the central government and the Drug Technical Advisory Board (DTAB), with both recommending banning the use of the FDC in children.

 

The SEC had also advised manufacturers to include the warning that the FDC shall not be used in children below four years of age on the product label, package insert and any promotional literature.

 

In December 2023, the Drug Controller General of India (DCGI) had written to all states and union territories (UTs), asking them to ensure that manufacturers of the FDC put a warning on the product labels.