Drug bans: nimesulide and fixed-dose combinations

1. Question 1Answer A

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

   • ACorrect answer: 16
   • B18
   • C12
   • D26

   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

2. Question 2Answer D

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

   • AParacetamol with caffeine
   • BMetformin with glimepiride
   • CAmoxicillin with clavulanic acid
   • DCorrect answer: Amoxicillin with serratiopeptidase

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

3. Question 3Answer B

   Which body issued the notifications after expert review?

   • ADepartment of Pharmaceuticals
   • BCorrect answer: Ministry of Health and Family Welfare
   • CNITI Aayog
   • DMinistry of Chemicals and Fertilizers

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

4. Question 4Answer D

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

   • A150 mg
   • B50 mg
   • C200 mg
   • DCorrect answer: 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

5. Question 5Answer B

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

   • A2024
   • BCorrect answer: 2016
   • C2012
   • D2018

   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

6. Question 6Answer A

   Why did ICMR recommend the nimesulide ban?

   • ACorrect answer: Liver toxicity
   • BKidney failure
   • CHeart rhythm disorder
   • DAntibiotic resistance

   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

7. Question 7Answer D

   Who chairs the Drugs Technical Advisory Board?

   • AThe Drugs Controller General
   • BThe Health Minister
   • CThe Union Health Secretary
   • DCorrect answer: 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

8. Question 8Answer C

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

   • A26 January 1940
   • B15 August 1940
   • CCorrect answer: 10 April 1940
   • D23 March 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

9. Question 9Answer A

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

   • ACorrect answer: 1 February 1983
   • B1 January 1982
   • C1 February 1985
   • D10 April 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

10. Question 10Answer A

    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?

    • ACorrect answer: Only 1
    • BOnly 2
    • CBoth 1 and 2
    • DNeither

    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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