Consider the following statements about the August 2026 order on chlorpheniramine and phenylephrine medicines:

1. All fixed-dose combinations of the two drugs must carry a warning against use in children below four years.

2. Medicines containing only phenylephrine are also covered by the order.

3. The warning must appear on the label, package insert and promotional material.

Which of the statements given above is/are correct?A.1 onlyB.1 and 3 onlyC.2 and 3 onlyD.1, 2 and 3

Question

Consider the following statements about the August 2026 order on chlorpheniramine and phenylephrine medicines: 1. All fixed-dose combinations of the two drugs must carry a warning against use in children below four years. 2. Medicines containing only phenylephrine are also covered by the order. 3. The warning must appear on the label, package insert and promotional material. Which of the statements given above is/are correct?

Accepted Answer

1 and 3 only. Statements 1 and 3 are correct. The order covers only medicines that mix both drugs. Single-drug medicines, like those with only phenylephrine, are not covered. The warning must be on the label, the leaflet and adverts. Read more: GenSci0060 — Fixed-Dose Combinations: How India Regulates Medicines.

Assertion (A): The Central Government can prohibit the manufacture and sale of a fixed-dose combination medicine. Reason (R): Section 26A of the Drugs and Cosmetics Act, 1940 empowers the Centre to prohibit drugs that may involve risk or lack therapeutic justification.

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