National 22 August 2026
Government Bans Cold & Cough FDC Medicines for Children Under 4 Years
Why in the News?
The Central Government has prohibited the use of Fixed-Dose Combination (FDC) cold and cough medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under 4 years of age.
Key Features / Major Points:
Scope of Ban: Applies to all cough syrups, drops, and liquid formulations that combine these two specific active drug ingredients.
Reason for Ban: Imposed on the recommendations of the expert committee and the Drugs Technical Advisory Board (DTAB), which noted potential health risks for infants and young children when safe alternatives are available.
Mandatory Warning Label: Pharmaceutical companies must prominently display a clear warning on packaging, package inserts, and promotional material stating: "Not to be used in children below 4 years of age."
Statutory Authority: Issued in the public interest under Section 26A of the Drugs and Cosmetics Act, 1940.
Understanding FDC: A Fixed-Dose Combination (FDC) medicine contains two or more active pharmaceutical ingredients combined in a fixed ratio into a single dosage form.
Static GK Facts:
Drugs and Cosmetics Act, 1940:
Enacted: 1940
Purpose: Regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India.
Section 26A: Empowers the Central Government to prohibit or regulate the manufacture, sale, or distribution of drugs in the public interest.
DTAB (Drugs Technical Advisory Board): Statutory body that advises the Central and State governments on technical matters arising out of the administration of the Act.
One-Liner Quiz (All Competitive Exams):
Under which section of the Drugs and Cosmetics Act, 1940 did the Centre issue the prohibition order on FDC cold medicines for children under 4?
Answer: Section 26A
Which two active drug salts combined in FDCs were banned for children under 4 years of age?
Answer: Chlorpheniramine Maleate and Phenylephrine Hydrochloride