Child Safety First: Delhi High Court and Central Government Tighten Rules on Cough Syrup and Cold Medicines for Children Below 4 Years

The Delhi High Court has directed cough syrup manufacturers to issue warnings against the use of their products in children under 4 years of age.

Manufacturers must update product labels to reflect the new warning.

Public notices must be issued within 7 days in widely circulated newspapers.

The Court’s order was prompted by concerns over safety risks and potential adverse effects in young children.

The case arose from a petition highlighting inadequate labeling and the need for stronger regulatory action.

The directive aims to increase consumer awareness and enhance child safety.

The Central Government has imposed restrictions on the manufacture, sale, and distribution of fixed-dose combination (FDC) formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under four years.

This decision was made under Section 26A of the Drugs and Cosmetics Act, 1940, and takes effect from April 15, 2025.

The move addresses concerns about potential risks to young children, with safer alternatives available.

A Subject Expert Committee reviewed the matter and recommended a mandatory warning on the drug’s label, package insert, and promotional materials.

The Drugs Technical Advisory Board (DTAB) supported prohibiting the use in children under four years and emphasized the need for prominent display of warnings.

The Central Government concluded that regulation was necessary for child safety.

Manufacturers must clearly display the warning:
“Fixed dose combination shall not be used in children below four years of age” on all labels, inserts, and promotional materials.