Centre expands curbs on cold medicines for children under 4, Pg1

Key Highlights:

• The Union Health Ministry has expanded restrictions on all Fixed-Dose Combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride.
• These medicines are now mandated to carry a clear warning against their use for children below four years of age.
• The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board.
• The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940, prioritizing public health.

Detailed Insights:

• The latest directive extends previous restrictions from 2023 and 2025 to cover all formulations of these specific FDCs.
• Chlorpheniramine maleate is an antihistamine, while phenylephrine hydrochloride acts as a decongestant, commonly used for cold symptoms.
• Young children are particularly vulnerable to adverse effects such as drowsiness, excitability, and impacts on heart rate and blood pressure.
• Evidence supporting the substantial improvement of uncomplicated colds in children using these combinations is limited.
• Manufacturers are required to prominently display the warning on labels, package inserts, and promotional materials.
• Countries like the US and Australia have also implemented age restrictions or safeguards for pediatric cough-and-cold medicines.

Key Concepts Involved:

• Fixed-Dose Combinations (FDCs): Pharmaceutical products combining two or more active ingredients in a single dosage form.
• Chlorpheniramine maleate: An antihistamine used to alleviate symptoms like runny nose and sneezing.
• Phenylephrine hydrochloride: A decongestant used to relieve nasal congestion and blockage.
• Drugs and Cosmetics Act, 1940: The central legislation governing the manufacture, sale, and distribution of drugs and cosmetics in India.
• Drugs Technical Advisory Board (DTAB): The highest technical body advising the central and state governments on matters related to the Drugs and Cosmetics Act, 1940.