In a major step towards pediatric drug safety, the Union Health Ministry has limited the use of the popular common cold medication combination — Chlorpheniramine Maleate and Phenylephrine Hydrochloride — in children under four years of age. The manufacturers will now have to include a compulsory warning label on all packaging and promotional materials.

Key Highlights

Restriction Placed on FDC Medicine Combination

• The Health Ministry made a notification to place restrictions on the production, sale, and distribution of Chlorpheniramine Maleate + Phenylephrine Hydrochloride preparations in children below the age of 4.

• All the packs should prominently mention: "Fixed dose combination shall not be used in children below four years of age."

Backed by Expert Recommendations

• The move was made based on recommendations from the Drugs Technical Advisory Board (DTAB) and a Subject Expert Committee (SEC).

• The SEC, after consultation with pediatric experts, recommended against using this FDC in children because of safety issues and the presence of safer options.

Legal Enforcement Under Section 26A

• The ban has been put into force under Section 26A of the Drugs and Cosmetics Act, 1940, authorizing the government to implement a regulatory measure in the public interest.

• The regulation took effect immediately upon publication in the Official Gazette.

Previous Measures and Timeline

• The Drug Controller General of India (DCGI) had already instructed manufacturers to provide warning labels for this combination in 2023.

• The FDC had previously been classified as rational by the Prof. Kokate Committee in 2015, but there were concerns once again due to its promotion for infants, and so there were new reviews.

The Health Ministry's action reflects the increasing emphasis on drug safety in pediatric treatment. Based on newer evidence and consultation with experts, the ban on Chlorpheniramine Maleate + Phenylephrine Hydrochloride for children below four is intended to avoid misuse and harm. Manufacturers and healthcare professionals are now required to strictly adhere to the labeling requirement to provide clear comm