UPSC Prelims Practice Questions — Government amends Drugs Rules, 1945 to Strengthen Regulation of High Alcohol-Containing Drug Formulations

Q1. The category of prescription-only drugs designated as 'Schedule H1' under the Drugs Rules, 1945 was created through a Gazette notification issued in which year?

  • A. 2005
  • B. 2011
  • C. 2013
  • D. 2019

Q2. With reference to the 2026 amendment to the Drugs Rules, 1945 concerning high alcohol-containing formulations, consider the following statements. Which of the statements given above is NOT correct?

  1. Formulations containing more than 12% v/v ethyl alcohol are covered by the tightened regime.
  2. The trigger applies to such formulations supplied in quantities exceeding 30 mL.
  3. The affected formulations are brought under Schedule H1, requiring prescription-based sale.
  4. The amendment was made under the Narcotic Drugs and Psychotropic Substances Act, 1985.
  • A. 1 only
  • B. 4 only
  • C. 2 and 3
  • D. 3 and 4

Q3. Following the 2026 amendment, high-alcohol tinctures such as those of cardamom and ginger are primarily brought under which single Schedule of the Drugs Rules, 1945?

  • A. Schedule H
  • B. Schedule H1
  • C. Schedule K
  • D. Schedule X

Q4. The Drugs and Cosmetics Act, 1940 provides for the regulation of drugs and cosmetics with respect to how many of the following broad activities: import, manufacture, distribution, and sale?

  • A. Two
  • B. Three
  • C. Four
  • D. Five

Q5. The Central Drugs Standard Control Organisation (CDSCO), which enforces the Drugs and Cosmetics Act, 1940, functions under which one of the following Union Ministries?

  • A. Ministry of Health and Family Welfare
  • B. Ministry of Chemicals and Fertilizers
  • C. Ministry of Consumer Affairs, Food and Public Distribution
  • D. Ministry of AYUSH

Q6. Under the December 2025 amendment (G.S.R. 927(E)), the Schedule K exemption for sale of cough syrups was withdrawn for villages having a population of less than how many persons?

  • A. 500
  • B. 1,000
  • C. 2,000
  • D. 5,000

Q7. Regarding the December 2025 notification withdrawing the Schedule K cough-syrup exemption, the following particulars are listed. Which of the above is/are correctly identified?

  1. Notification number — G.S.R. 927(E).
  2. Date of notification — 29 December 2025.
  3. Schedule amended — Schedule K of the Drugs Rules, 1945.
  4. Word omitted from the entry — 'Tincture'.
  • A. 1, 2 and 3
  • B. 1 and 4
  • C. 2, 3 and 4
  • D. 1, 2, 3 and 4

Q8. Some aromatic preparations that enjoyed the Schedule K exemption reportedly contained ethyl alcohol up to approximately what level (v/v), a key concern prompting the reform?

  • A. 25%
  • B. 40%
  • C. 60%
  • D. 80%

Q9. At the national level, the approval of new drugs and the framing of standards under the Drugs and Cosmetics Act, 1940 is headed by which one of the following?

  • A. Drugs Controller General of India
  • B. State Drugs Controller
  • C. National Pharmaceutical Pricing Authority
  • D. Central Drugs Laboratory

Q10. The record of each supply of a Schedule H1 drug must be maintained in a separate register and kept open for inspection for how many years?

  • A. One year
  • B. Two years
  • C. Three years
  • D. Five years