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Topic 297 · Society, Health, Education & Schemes

Drug bans: nimesulide and fixed-dose combinations

10 MCQs · tap an option to check it · All answers

Revise the 12 points first Book 1 RATNA

Core Trigger: Notifications dated 11 June 2026 banned 16 fixed-dose combinations under section 26A of the Drugs and Cosmetics Act, 1940.
Examples: Banned combinations include amoxicillin with serratiopeptidase and paracetamol with lignocaine.
Issuing Body: The Ministry of Health and Family Welfare issued the notifications after expert review.
Earlier Ban: A gazette notification of 29 December 2025 prohibited oral immediate-release nimesulide above 100 mg.
Data Point: The FDC clean-up banned 344 FDCs in 2016, 328 in 2018 and 156 in 2024.
Stakeholders: ICMR recommended the nimesulide ban over liver toxicity; a DTAB sub-committee found the FDCs lacked therapeutic justification.
India Link: The Government found the 16 FDCs risky, with safer alternatives available.
Advisory Body: The Drugs Technical Advisory Board, under section 5, advises Centre and States; the DGHS chairs it.
Founded: The Drugs and Cosmetics Act, 1940 (Act 23 of 1940) is dated 10 April 1940.
Landmark: Section 26A was inserted by Act 68 of 1982, effective 1 February 1983; 'regulate, restrict or' was added in 2008.
Statute: Section 26A lets the Centre prohibit a drug by Gazette notification if it is risky or its ingredients lack justification.
Definition: A fixed-dose combination joins two or more active drugs in a fixed ratio; an irrational FDC lacks therapeutic justification.

Question 1 of 10

The notifications dated 11 June 2026 banned how many fixed-dose combinations?

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Answer: (A) 16

Core Trigger: Notifications dated 11 June 2026 banned 16 fixed-dose combinations under section 26A of the Drugs and Cosmetics Act, 1940.From Book 1 RATNA, topic 297, point 1

Question 2 of 10

Which combination is among those banned in the 11 June 2026 notifications?

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Answer: (D) Amoxicillin with serratiopeptidase

Examples: Banned combinations include amoxicillin with serratiopeptidase and paracetamol with lignocaine.From Book 1 RATNA, topic 297, point 2

Question 3 of 10

Which body issued the notifications after expert review?

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Answer: (B) Ministry of Health and Family Welfare

Issuing Body: The Ministry of Health and Family Welfare issued the notifications after expert review.From Book 1 RATNA, topic 297, point 3

Question 4 of 10

The 29 December 2025 notification prohibited oral immediate-release nimesulide above what dose?

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Answer: (D) 100 mg

Earlier Ban: A gazette notification of 29 December 2025 prohibited oral immediate-release nimesulide above 100 mg.From Book 1 RATNA, topic 297, point 4

Question 5 of 10

In which year did the FDC clean-up ban 344 combinations?

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Answer: (B) 2016

Data Point: The FDC clean-up banned 344 FDCs in 2016, 328 in 2018 and 156 in 2024.From Book 1 RATNA, topic 297, point 5

Question 6 of 10

Why did ICMR recommend the nimesulide ban?

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Answer: (A) Liver toxicity

Stakeholders: ICMR recommended the nimesulide ban over liver toxicity; a DTAB sub-committee found the FDCs lacked therapeutic justification.From Book 1 RATNA, topic 297, point 6

Question 7 of 10

Who chairs the Drugs Technical Advisory Board?

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Answer: (D) The DGHS

Advisory Body: The Drugs Technical Advisory Board, under section 5, advises Centre and States; the DGHS chairs it.From Book 1 RATNA, topic 297, point 8

Question 8 of 10

The Drugs and Cosmetics Act, 1940 is dated which day?

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Answer: (C) 10 April 1940

Founded: The Drugs and Cosmetics Act, 1940 (Act 23 of 1940) is dated 10 April 1940.From Book 1 RATNA, topic 297, point 9

Question 9 of 10

Section 26A was inserted by Act 68 of 1982, effective from which date?

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Answer: (A) 1 February 1983

Landmark: Section 26A was inserted by Act 68 of 1982, effective 1 February 1983; 'regulate, restrict or' was added in 2008.From Book 1 RATNA, topic 297, point 10

Question 10 of 10

Consider the statements: 1. Section 26A lets the Centre prohibit a drug by Gazette notification. 2. A drug can be prohibited only after a court order. Which is/are correct?

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Answer: (A) Only 1

Statute: Section 26A lets the Centre prohibit a drug by Gazette notification if it is risky or its ingredients lack justification.From Book 1 RATNA, topic 297, point 11

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