Centre restricts cold-medicine FDCs for children below four
The Union Health Ministry on 22 August 2026 restricted all fixed dose combinations of chlorpheniramine maleate and phenylephrine hydrochloride, requiring a warning that they must not be used in children below four years.
Summary
The Union Ministry of Health and Family Welfare announced on 22 August 2026 restrictions on the manufacture, sale and distribution of all fixed dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride, a common cold-medicine pairing. Labels, package inserts and promotional literature must now carry the warning: 'Fixed Dose Combination shall not be used in children below four years of age.' A notification of 15 April 2025 had applied the same warning to certain such FDCs; the new notification extends it to all formulations with the two ingredients. The decision follows recommendations of an Expert Committee and the Drugs Technical Advisory Board (DTAB), and the notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940.
Key facts
- Date
- 22 Aug 2026
- Drugs
- FDCs of chlorpheniramine maleate + phenylephrine hydrochloride
- Warning
- Not to be used in children below four years
- Earlier step
- 15 April 2025 notification for certain FDCs
- Advised by
- Expert Committee and DTAB
- Law
- Section 26A, Drugs and Cosmetics Act, 1940
Practice MCQs 3 questions
The August 2026 restriction covers all fixed dose combinations of chlorpheniramine maleate with which other drug?
Show answer
Correct answer: C — Phenylephrine hydrochloride
The restriction applies to all FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride.
Below what age must the restricted chlorpheniramine–phenylephrine FDCs not be used, as per the mandatory warning?
Show answer
Correct answer: A — 4 years
The label must say: 'Fixed Dose Combination shall not be used in children below four years of age.'
Consider the following statements about the August 2026 FDC restriction: 1. The notification was issued under the Epidemic Diseases Act, 1897. 2. The decision followed recommendations of an Expert Committee and the Drugs Technical Advisory Board. Which of the above is/are correct?
Show answer
Correct answer: B — 2 only
Only statement 2 is correct. The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940.