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23 August 2026

Restrictions on cold medicines for children

This is a specific regulatory intervention by the Union Health Ministry under the Drugs and Cosmetics Act, 1940, which directly relates to public health policy and the protection of vulnerable sections.

2 min read 2 questions 2 prelims

Notes

  • The Union Health Ministry has restricted the manufacture, sale, and distribution of all Fixed-Dose Combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride for children under four years of age.
  • Manufacturers are mandated to display the warning: 'Fixed Dose Combination shall not be used in children below four years of age' on labels, package inserts, and promotional literature.
  • The decision is based on recommendations from an expert committee and the Drugs Technical Advisory Board.
  • Chlorpheniramine maleate is an antihistamine for runny nose and sneezing; phenylephrine hydrochloride is a decongestant for nasal blockage.
  • Health risks for children include dosing errors, drowsiness, excitability, and adverse effects on heart rate and blood pressure.
  • The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940.
  • Evidence suggests limited efficacy of these combinations in treating uncomplicated colds in children, with safer alternatives available.
  • International precedents for age-based restrictions on pediatric cold medicines exist in countries like the US and Australia.

Questions

  1. Discuss the significance of the Drugs and Cosmetics Act, 1940, in ensuring public health safety, particularly in the context of regulating pediatric pharmaceutical formulations. 150 words
    Attempt this — 150 words in 8 min
    0 / 150 words 8:00
  2. The regulation of Fixed-Dose Combinations (FDCs) is critical for rational drug use in India. Analyze the challenges in balancing pharmaceutical innovation with patient safety, especially for vulnerable populations like children. 250 words
    Attempt this — 250 words in 11 min
    0 / 250 words 11:00

Prelims

  1. Under which section of the Drugs and Cosmetics Act, 1940, does the Union Health Ministry have the authority to restrict the manufacture and sale of specific drug formulations in the interest of public health?

  2. Which of the following ingredients are part of the FDCs recently restricted by the Indian government for use in children under four years of age?

Syllabus

Topics

Sources

250words.in · https://250words.in/daily/2026-08-23/restrictions-on-cold-medicines-for-children