Government Restricts Manufacture, Sale and Distribution of Fixed Dose Combinations Containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for Use in Children Below Four Years

Executive Summary The Ministry of Health and Family Welfare has restricted the manufacture, sale, and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children under four years of age. This directive, issued on August 22, 2026, under Section 26A of the Drugs and Cosmetics Act, 1940, mandates specific warning labels on all formulations to mitigate health risks. The notification is effective immediately from its date of publication in the Official Gazette.

Key Points / Main Content

Scope of Restrictions

• The restriction applies to all FDCs containing the ingredients Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
• This latest notification extends previous restrictions (dated April 15, 2025) to cover all formulations containing these two specific ingredients.

Labeling and Packaging Requirements

• Manufacturers are strictly directed to display a mandatory warning on all associated materials.
• The warning must state: “Fixed Dose Combination shall not be used in children below four years of age.”
• This text must be clearly visible on the product label, the package insert, and all promotional literature.

Regulatory Justification

• The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB).
• The government concluded that these combinations pose health risks to children under four and noted that safer alternatives are currently available.

Legal and Administrative Details

• The order was issued in the interest of public health under Section 26A of the Drugs and Cosmetics Act, 1940.
• The full notification is accessible via the Official Gazette link provided in the document.

Impact Analysis

Manufacturers Impact Manufacturers of FDCs containing these ingredients are now prohibited from marketing these products for children under four and must comply with new labeling standards for all such formulations. Action Required Update all labels, package inserts, and promotional literature to include the mandatory age-restriction warning.

Retailers and Distributors Impact The sale and distribution of these specific FDCs are now legally restricted regarding the target demographic (children under four). Action Required Ensure that the distribution and sale of these medicines comply with the new safety warnings and that promotional materials are updated or removed as per the directive.

Healthcare Providers and Consumers Impact These stakeholders are informed that these specific medicine combinations are no longer considered safe for very young children and that safer alternatives should be used instead. Action Required Healthcare providers must cease prescribing these FDCs for children under four, and consumers must check labels for the mandatory warning before administration.