UPSC Prelims Practice Questions — Union Ministry of Health and Family Welfare Amends Drugs Rules, 1945; Exemption for Sale of Cough Syrups in Small Villages Withdrawn

Q1. With reference to the schedules of the Drugs Rules, 1945, consider the following statements: 1. Schedule H specifies drugs that may be sold by retail only on the prescription of a Registered Medical Practitioner. 2. Schedule J contains a list of diseases and ailments which a drug may not purport to prevent or cure. 3. Schedule K is a list of cosmetic ingredients whose import into India is prohibited. Which of the statements given above are correct?

  1. Schedule H specifies drugs that may be sold by retail only on the prescription of a Registered Medical Practitioner.
  2. Schedule J contains a list of diseases and ailments which a drug may not purport to prevent or cure.
  3. Schedule K is a list of cosmetic ingredients whose import into India is prohibited.
  • A. 1 and 2 only
  • B. 2 and 3 only
  • C. 1 and 3 only
  • D. 1, 2 and 3

Q2. Under the Drugs and Cosmetics Act, 1940, which one of the following is the National Regulatory Authority of India for approval of new drugs, conduct of clinical trials, laying down standards for drugs and control over the quality of imported drugs?

  • A. National Pharmaceutical Pricing Authority (NPPA)
  • B. Central Drugs Standard Control Organisation (CDSCO)
  • C. Indian Pharmacopoeia Commission (IPC)
  • D. Food Safety and Standards Authority of India (FSSAI)

Q3. With reference to Schedule K of the Drugs and Cosmetics Rules, 1945, consider the following: Which of the above is/are correctly identified as falling within the exemptions granted by Schedule K (prior to the December 2025 amendment)?

  1. Drugs supplied by a registered medical practitioner to his own patient, where the practitioner does not keep an open shop.
  2. Specified household remedies sold in a village with a population not exceeding 1,000, where no licensed dealer is located.
  3. Drugs supplied by Government-maintained hospitals and dispensaries to their patients, subject to conditions of supervision and record keeping.
  4. Narcotic drugs sold by retail pharmacies in metropolitan cities under a special quota.
  • A. 1 and 2 only
  • B. 1, 2 and 3
  • C. 2 and 4 only
  • D. 1, 3 and 4

Q4. Schedule K of the Drugs and Cosmetics Rules, 1945, which lists drugs exempted from certain licensing provisions, derives its statutory force exclusively from which one of the following parent enactments?

  • A. The Drugs and Cosmetics Act, 1940
  • B. The Pharmacy Act, 1948
  • C. The Drugs (Control) Act, 1950
  • D. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

Q5. Which one of the following national regulatory bodies under the Union Ministry of Health and Family Welfare formally reported the presence of Diethylene Glycol (DEG) in Indian-made oral liquid medicines to the WHO in October 2025, triggering Medical Product Alert N°5/2025?

  • A. Central Drugs Standard Control Organisation (CDSCO)
  • B. National Pharmaceutical Pricing Authority (NPPA)
  • C. Indian Council of Medical Research (ICMR)
  • D. National Institute of Pharmaceutical Education and Research (NIPER)

Q6. In the context of the 2025 cough syrup contamination crisis, which one of the following best describes Diethylene Glycol (DEG)?

  • A. An industrial solvent and antifreeze agent illicitly substituted for pharmaceutical-grade propylene glycol or glycerol in liquid medicines, toxic even in small doses
  • B. A pharmaceutical-grade sweetening excipient routinely added to paediatric syrups to mask bitterness
  • C. An active antitussive ingredient that suppresses the cough reflex by acting on the medullary cough centre
  • D. An antimicrobial preservative permitted in oral liquid formulations to prevent microbial spoilage

Q7. With reference to the regulatory architecture under the Drugs and Cosmetics Act, 1940, consider the following statements: Which of the statements given above is/are correct?

  1. Approval of new drugs and oversight of clinical trials in India fall within the regulatory remit of the Central Government, exercised through the Central Drugs Standard Control Organisation (CDSCO).
  2. The licensing of retail sale and the regulation of manufacture of drugs at the establishment level is primarily a function of State Drug Control Authorities, not of CDSCO headquarters.
  3. The Drugs Technical Advisory Board (DTAB), the highest statutory technical body under the Act, is chaired ex officio by the Drug Controller General of India (DCGI).
  • A. 1 and 2 only
  • B. 2 and 3 only
  • C. 1 and 3 only
  • D. 1, 2 and 3

Q8. The Central Drugs Standard Control Organisation (CDSCO), India's National Regulatory Authority for drugs and medical devices, functions under which one of the following?

  • A. Directorate General of Health Services, Ministry of Health and Family Welfare
  • B. Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers
  • C. Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare
  • D. National Pharmaceutical Pricing Authority, Department of Pharmaceuticals

Q9. In October 2025, which Indian agency formally reported to the World Health Organization the presence of Diethylene Glycol contamination in oral liquid medicines, triggering WHO Medical Product Alert N°5/2025?

  • A. National Pharmaceutical Pricing Authority (NPPA)
  • B. Central Drugs Standard Control Organisation (CDSCO)
  • C. Indian Council of Medical Research (ICMR)
  • D. Food Safety and Standards Authority of India (FSSAI)

Q10. Which one of the following is India's National Regulatory Authority for drugs, responsible for approval of new drugs, laying down standards and coordinating enforcement of the Drugs and Cosmetics Act, 1940?

  • A. Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare
  • B. National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers
  • C. Indian Council of Medical Research (ICMR) under the Department of Health Research, Ministry of Health and Family Welfare
  • D. Pharmacy Council of India (PCI) under the Ministry of Health and Family Welfare

Q11. Under the Drugs and Cosmetics Rules, 1945, for what minimum period is a retail pharmacist required to maintain the separate register recording the supply of a drug specified in Schedule H1?

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

Q12. With reference to the schedules under the Drugs and Cosmetics Rules, 1945, consider the following statements: 1. Schedule H1 includes certain third- and fourth-generation antibiotics, anti-TB drugs and select habit-forming drugs whose sale must be recorded in a separate register. 2. For drugs specified in Schedule X, the retailer is required to preserve the prescription for a period of three years. 3. Schedule K is a list of drugs whose manufacture and sale are wholly prohibited within the territory of India. Which of the statements given above is/are correct?

  1. Schedule H1 includes certain third- and fourth-generation antibiotics, anti-TB drugs and select habit-forming drugs whose sale must be recorded in a separate register.
  2. For drugs specified in Schedule X, the retailer is required to preserve the prescription for a period of three years.
  3. Schedule K is a list of drugs whose manufacture and sale are wholly prohibited within the territory of India.
  • A. 1 only
  • B. 1 and 2 only
  • C. 2 and 3 only
  • D. 1, 2 and 3