Center alerts regarding safety of children amid cough and cold season
New Delhi. Keeping in mind the safety of children, the Central Government has imposed new restrictions on the manufacture, sale and distribution of all Fixed Dose Combination (FDC) medicines containing chlorpheniramine maleate and phenylephrine hydrochloride for common cold. The government has clarified that these medicines will not be given to children below four years of age.
According to the notification issued on Saturday, it will be mandatory to write warnings on the labels, package inserts and promotional materials of these medicines. Earlier, this ban was imposed on some selected FDC medicines on 15 April 2025. Now the government has expanded its scope to include all FDC medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride under this rule.
The government has taken this decision on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board. The government says there may be a risk from using these medicines in children under four years of age, even though there are safer alternatives available to them. This order has been issued in the interest of public health under Section 26A of the Drug and Cosmetics Act 1940.