Government Restricts Manufacture and Sale of Chlorpheniramine-Phenylephrine FDCs for Children Below Four Years

In a PIB announcement dated August 22, 2026, the Government said it had restricted the manufacture, sale and distribution of FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years. 

The order applies to all formulations containing both ingredients and makes a warning against use in children under four mandatory. 

Mandatory Warning for Manufacturers 

Manufacturers have been asked to print a specific warning on the label and package insert of the medicines. The same warning must also appear in promotional material linked to the products. 

The notification states: “Fixed Dose Combination shall not be used in children below four years of age.” The requirement takes effect from the publication of the order in the Official Gazette. 

Earlier Order Issued in April 2025 

A similar restriction was introduced on 15 April 2025 through a notification. However, that order applied only to certain FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. 

The latest notification has widened its scope. Instead of covering selected combinations, the restriction now applies to all formulations containing the two ingredients. 

Expert Committee and DTAB Recommendations 

The Government took the decision after considering recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB). 

It noted that the use of these combinations may carry risks for children below four years of age. The availability of safer alternatives for this age group was also taken into account. 

Notification Issued Under Drugs and Cosmetics Act 

The restriction has been notified under Section 26A of the Drugs and Cosmetics Act, 1940, which gives the Government the power to regulate drugs in the interest of public health. 

The new rules came into effect with the publication of the notification in the Official Gazette. Affected manufacturers must update the information provided with these products. 

Read More: India Tightens Sugar Stock Limits to 15 Days Amid Record Prices Ahead of Festive Season! 

Conclusion 

All formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride now fall under the restriction for children below four years. The warning will be required on product information and promotional material. 

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