UPSC Prelims Practice Questions — Govt. amends rules to regulate drugs containing alcohol

Q1. Schedule K of the Drugs Rules, 1945 grants exemptions from the licensing requirements of one particular Chapter of the Drugs and Cosmetics Act, 1940. Which Chapter is that principal chapter dealing with the manufacture, sale and distribution of drugs?

  • A. Chapter II
  • B. Chapter III
  • C. Chapter IV
  • D. Chapter V

Q2. How many Schedules are appended to the Drugs and Cosmetics Rules, 1945, the subordinate legislation under which Schedules K and H1 are framed?

  • A. 2
  • B. 5
  • C. 12
  • D. 20

Q3. The exemptions enumerated in Schedule K of the Drugs Rules, 1945 derive from the rule-making authority conferred by which of the following statutes?

  • A. The Drugs and Cosmetics Act, 1940
  • B. The Pharmacy Act, 1948
  • C. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
  • D. The Narcotic Drugs and Psychotropic Substances Act, 1985

Q4. Under the revised Schedule K exemption, an oral high-alcohol formulation loses its licensing exemption once it is packed and sold in bottles exceeding how many millilitres?

  • A. 10 ml
  • B. 30 ml
  • C. 50 ml
  • D. 100 ml

Q5. With reference to how Schedule H1 differs from the broader Schedule H of the Drugs Rules, 1945, consider the following statements: 1. Schedule H1 was introduced later than Schedule H, through gazette notification GSR 588(E) of 2013. 2. Unlike ordinary Schedule H drugs, a Schedule H1 drug requires the seller to maintain a separate register recording the prescriber, patient and quantity, retained for three years. 3. Unlike Schedule H drugs, Schedule H1 drugs may be sold over the counter without any prescription. Which of the statements given above is/are correct?

  1. Schedule H1 was introduced later than Schedule H, through gazette notification GSR 588(E) of 2013.
  2. Unlike ordinary Schedule H drugs, a Schedule H1 drug requires the seller to maintain a separate register recording the prescriber, patient and quantity, retained for three years.
  3. Unlike Schedule H drugs, Schedule H1 drugs may be sold over the counter without any prescription.
  • A. 1 and 2 only
  • B. 2 and 3 only
  • C. 1 and 3 only
  • D. 1, 2 and 3

Q6. The classification of drugs into Schedule H1 under the Drugs Rules, 1945, and the recent amendment adding high-alcohol formulations to it, are administered by which Union Ministry?

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

Q7. Under the 2026 amendment, an oral formulation is brought under the stricter Schedule H1 regime if its ethyl alcohol content exceeds how many per cent v/v?

  • A. 5 per cent
  • B. 10 per cent
  • C. 12 per cent
  • D. 20 per cent

Q8. With reference to the 2026 amendment tightening regulation of high-alcohol drug formulations, consider the following statements: 1. It removes such formulations from the Schedule K licensing exemption and brings them under Schedule H1. 2. It applies to oral formulations containing more than 12% v/v ethyl alcohol packed in bottles exceeding 30 ml. 3. Affected products will require a registered medical practitioner's prescription for sale. 4. The amended rules took effect immediately on the date of their publication in the Gazette. Which of the statements given above is/are NOT correct?

  1. It removes such formulations from the Schedule K licensing exemption and brings them under Schedule H1.
  2. It applies to oral formulations containing more than 12% v/v ethyl alcohol packed in bottles exceeding 30 ml.
  3. Affected products will require a registered medical practitioner's prescription for sale.
  4. The amended rules took effect immediately on the date of their publication in the Gazette.
  • A. 1 and 3
  • B. 2 only
  • C. 4 only
  • D. 2 and 4

Q9. In the architecture of the Drugs and Cosmetics Act, 1940, the Drugs Technical Advisory Board (DTAB) is best described as which of the following?

  • A. The highest statutory body advising the central and state governments on technical matters arising out of the administration of the Act
  • B. The appellate tribunal that hears appeals against cancellation of drug manufacturing licences
  • C. The central laboratory that tests and certifies the quality of drug samples
  • D. The authority that directly grants marketing approval for every new drug

Q10. Who is the ex-officio Chairman of the Drugs Technical Advisory Board (DTAB) constituted under Section 5 of the Drugs and Cosmetics Act, 1940?

  • A. The Director General of Health Services
  • B. The Drugs Controller General of India
  • C. The Union Health Secretary
  • D. The Director of the Central Drugs Laboratory, Kolkata

Q11. The Central Drugs Standard Control Organisation (CDSCO) operates how many zonal offices across the country?

  • A. Four
  • B. Six
  • C. Seven
  • D. Thirteen

Q12. In the context of the amendment on high-alcohol formulations, the expression 'v/v' applied to a preparation's ethyl-alcohol content denotes which of the following?

  • A. The volume of ethyl alcohol per unit volume of the total preparation
  • B. The weight of ethyl alcohol per unit volume of the preparation
  • C. The volume of ethyl alcohol per unit weight of the preparation
  • D. The weight of alcohol per unit weight, a metric introduced only under the 2013 Schedule H1 notification