Health Ministry Restricts the Use of Common Cold Medicine in Children below Four Years

Introduction

the India's Health Ministry has imposed restrictions on the use of a widely prescribed common cold medication combination—Chlorpheniramine Maleate and Phenylephrine Hydrochloride—for children below four years of age to enhance pediatric drug safety point. This decision aims to mitigate potential health risks associated with this fixed-dose combination (FDC) in young children.

On April 15, 2025, the Ministry issued a notification under Section 26A of the Drugs and Cosmetics Act, 1940, restricting the manufacture, sale, and distribution of all formulations containing the FDC of Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under four years. Manufacturers are now mandated to include a clear warning on the label, package insert, and promotional materials stating:

This directive follows recommendations from the Drugs Technical Advisory Board (DTAB) and a Subject Expert Committee (SEC), which highlighted the potential risks of using this combination in young children and noted the availability of safer alternatives.

Understanding the Drug Combination

• Chlorpheniramine Maleate: An antihistamine used to relieve allergy symptoms such as runny nose and sneezing.
• Phenylephrine Hydrochloride: A decongestant that narrows blood vessels in the nasal passages, reducing nasal congestion.

This combination is commonly found in pediatric cold and flu medications, including popular brands like GSK’s T-Minic syrup, Glenmark’s Ascoril Flu Drops, and Alembic’s Wikoryl AF.

Reasons for the Restriction

The decision to restrict this FDC stems from concerns over its safety profile in children under four years. Potential adverse effects include increased heart rate, convulsions, and, in severe cases, life-threatening reactions. The Subject Expert Committee (SEC) and Drugs Technical Advisory Board (DTAB) concluded that the risks outweigh the benefits in this age group, especially when safer alternatives are available.

Global Context

This move aligns with global health recommendations. For instance, the U.S. Food and Drug Administration (FDA) advises against the use of over-the-counter cough and cold medications in children under two years due to serious and potentially life-threatening side effects.

Implications for Parents and Caregivers

• Consult Healthcare Professionals: Always seek medical advice before administering any medication to young children.
• Read Labels Carefully: Ensure that any cold or cough medication does not contain the restricted FDC.
• Explore Alternatives: Consider safer, age-appropriate remedies for managing cold symptoms in young children.

Conclusion

The Health Ministry's restriction on the use of Chlorpheniramine Maleate and Phenylephrine Hydrochloride in children under four underscores the importance of cautious medication use in pediatrics. This proactive measure aims to safeguard children's health by preventing potential adverse reactions associated with this drug combination.

References

• https://www.business-standard.com/health/govt-restricts-sale-of-anti-cold-drug-combination-for-children-under-4-yrs-125041701105_1.html
• https://www.fda.gov/consumers/consumer-updates/should-you-give-kids-medicine-coughs-and-colds?
• https://pharmacypro.io/news/health-ministry-restricts-use-of-common-cold-drug-in-children-below-4-years