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Govt Restricts FDCs with Chlorpheniramine & Phenylephrine for Children Below 4 Years under Section 26A

Target:UPSCMPSCSSC GATeachingPrelims HighMains MediumStatic GK Link
22 Aug 2026
~2 min
Source: The Hindu
Key Data:Section 26ADrugs and Cosmetics Act, 1940Children below 4 yearsChlorpheniramine MaleatePhenylephrine HydrochlorideApril 15, 2025
Bodies:Drugs Technical Advisory Board (DTAB)
Practice MCQs from today's news ▸
What This Article Covers

1.The government issued a notification on August 22, 2026, restricting manufacture, sale, and distribution of all FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below 4 years.

2.This extends a previous restriction from April 15, 2025, which covered certain FDCs; now all formulations with these two ingredients are included.

3.The move is based on recommendations by an expert committee and the Drugs Technical Advisory Board (DTAB), citing safer alternatives and risks to young children.

The Big Picture
Prelims · HighMains · Medium

The government has extended restrictions on all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a warning that these medicines shall not be used in children below four years. This decision under Section 26A of the Drugs and Cosmetics Act, 1940, follows expert committee and DTAB recommendations to safeguard young children from potential risks.

Exam Lens

Quick Exam Facts From News

Date of NotificationAugust 22, 2026
Prohibited Age GroupChildren below 4 years
Legal ProvisionSection 26A, Drugs and Cosmetics Act, 1940
Drugs RestrictedChlorpheniramine Maleate + Phenylephrine Hydrochloride FDCs
Previous NotificationApril 15, 2025

1-Minute Revision

  • ›Date of Notification: August 22, 2026
  • ›Prohibited Age Group: Children below 4 years
  • ›Target this Data: Children below 4 years (age restriction)
  • ›Target this Nodal Body: Drugs Technical Advisory Board (DTAB)
  • ›Target this Legal Point: Section 26A of the Drugs and Cosmetics Act, 1940

Mastered this topic? Test your knowledge with a full MCQ quiz.

Practice exam-style questions, track your score, and strengthen your recall.

Q1Static LinkageEasy

Which Act empowers the central government to prohibit the manufacture, sale, or distribution of drugs that are likely to involve risk to human beings?

Q2Statement-basedHard

Consider the following statements regarding the government's restriction on fixed dose combinations (FDCs):

1. The restriction applies to FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below 4 years.

2. The restriction applies to all formulations containing either Chlorpheniramine Maleate or Phenylephrine Hydrochloride alone.

3. The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940.

Which of the statements given above is/are correct?

Q3Data-centricMedium

What was the date of the earlier notification that restricted certain FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride?

Q4Application/ImpactMedium

What is the primary objective of the government's restriction on FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below 4 years?

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