"Union Health Ministry restricts cough-cold FDC medicines for children under four"
Fixed-Dose Combination (FDC)
a medicine combining two or more active ingredients in one dosage form at fixed doses.
Section 26A (Drugs and Cosmetics Act, 1940)
provision empowering the Centre to restrict or ban any drug in public interest.
India regulates drugs through the Drugs and Cosmetics Act, 1940, one of the oldest and most comprehensive pieces of pharmaceutical legislation in the country. The Act governs the import, manufacture, distribution, and sale of drugs and cosmetics. A key provision, Section 26A, empowers the Central Government to prohibit or restrict the manufacture, sale, or distribution of any drug in the public interest, without requiring a full legislative amendment. This makes it a flexible tool for rapid regulatory action when safety concerns emerge.
Fixed-dose combinations (FDCs) are medicines that combine two or more active pharmaceutical ingredients in a single dosage form. FDCs can improve patient compliance and simplify treatment, but they also carry risks. When ingredients are combined, dosing becomes less flexible, and adverse effects from one component cannot be separated from the other. India has a large and largely unregulated FDC market. The Drugs Technical Advisory Board (DTAB) is the apex statutory body under the Drugs and Cosmetics Act that advises the government on technical matters related to drug standards and safety. Expert committee recommendations routed through DTAB form the standard basis for regulatory action under Section 26A.
Concerns about paediatric cough-and-cold medicines are not new. The World Health Organization (WHO) and several national regulators have flagged multi-ingredient cold preparations for young children as offering limited benefit while carrying real risks of adverse effects. India had already required warnings on certain FDC formulations containing chlorpheniramine and phenylephrine in earlier years, and the latest notification extends that restriction to all such formulations.
Chloropheniramine maleate is a first-generation antihistamine. It reduces symptoms like runny nose and sneezing by blocking histamine receptors. However, it also crosses the blood-brain barrier, which can cause marked sedation or, paradoxically, excitability in young children. Phenylephrine hydrochloride is a sympathomimetic decongestant. It works by constricting blood vessels in the nasal passages to relieve congestion, but it can also affect heart rate and blood pressure, making it particularly risky in small children where dosing margins are narrow.
The core regulatory concern is that young children are especially vulnerable to dosing errors with multi-ingredient medicines. A single FDC tablet or syrup delivers a fixed ratio of both drugs, leaving no room to adjust one ingredient independently. …
'Triclosan', considered harmful when exposed to high levels for a long time, is most likely present in which of the following?
With reference to Section 26A of the Drugs and Cosmetics Act, 1940, consider the following statements:
1.It empowers the Central Government to prohibit or restrict the manufacture, sale, or distribution of any drug in the public interest.
2.Action under Section 26A requires a full amendment to the Drugs and Cosmetics Act.
3.Notifications under Section 26A take legal effect from the date of publication in the Official Gazette.
Which of the statements given above is/are correct?
Which of the following best describes the Drugs Technical Advisory Board (DTAB)?
Consider the following statements about Fixed-Dose Combinations (FDCs):
1.An FDC combines two or more active pharmaceutical ingredients in a single dosage form at fixed doses.
2.FDCs always improve patient outcomes compared to individual drugs administered separately.
3.India's regulatory framework allows the Central Government to restrict FDCs under Section 26A of the Drugs and Cosmetics Act, 1940.
Which of the statements given above is/are correct?
The Union Health Ministry's restriction on FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride for children below four years is primarily justified on which of the following grounds?
1.These ingredients have no therapeutic use in any age group.
2.Young children are particularly vulnerable to dosing errors and adverse effects from multi-ingredient medicines.
3.Evidence that such combinations substantially improve uncomplicated colds in young children is limited.
Select the correct answer using the codes below:
Want the full note, Prelims Facts & MCQ answers?
Create a free account — takes less than a minute.
Create free account