Health Ministry Restricts Use Of Chlorpheniramine And Phenylephrine Combo In Children Below 4 Years

The Ministry of Health and Family Welfare has officially banned the use of the widely available fixed dose combination (FDC) of Chloropheniramine Maleate and Phenylephrine Hydrochloride for children under the age of four years.

According to recent news reports, the Ministry of Health and Family Welfare has officially banned the use of the widely available fixed dose combination (FDC) of Chloropheniramine Maleate and Phenylephrine Hydrochloride for children under the age of four years. They have strictly directed the manufacturers to display a warning or disclaimer on the drug's label and package stating that it is not meant for use for children under age four.

Many over-the-counter drugs that are used for allergies, cold and cough contain this FDC formulation and it is very common. However, according to the new directive mandates, the pharmaceutical manufacturers are obliged to update packaging and marketing materials to include the prescribed warning on the bottles. If they fail to comply with the following regulations, it will lead to regulatory action which includes the prohibition of sale of the particular drug.

This decision was taken and published in the Gazette of India on April 15. It was followed by a detailed evaluation by two expert panels, the Subject Expert Committee and the Drugs Technical Advisory Board (DTAB). Both panels unanimously concluded that the combination drug poses high risk to very young children especially under age four and that it should carry mandatory warning labels on the bottle.