UPSC Prelims Practice Questions — A dangerous dose of deception
Q1. Under the Drugs and Cosmetics Act, 1940 and the Rules made thereunder, permission to conduct clinical trials and approval for the import of new drugs into India are granted by which one of the following?
- A. The Drugs Technical Advisory Board, the statutory technical body constituted under the Act
- B. Licensing authorities appointed by the respective State Governments under the Rules
- C. The Drugs Controller General of India, the central licensing authority under the Rules
- D. The Indian Pharmacopoeia Commission, Ghaziabad, an autonomous body under the Ministry
Q2. Consider the following statements regarding provisions of the Drugs and Cosmetics Act, 1940:
1. Section 17A deems a drug to be adulterated if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated.
2. Section 17B treats as spurious a drug which purports to be the product of a manufacturer of whom it is not truly a product.
3. Section 18 prohibits the manufacture for sale, sale or distribution of any drug which is not of standard quality, or is misbranded, adulterated or spurious.
4. The provisions of Sections 5 and 7 of the Act apply equally to Ayurvedic, Siddha and Unani drugs.
Which of the above is/are correctly identified?
- Section 17A deems a drug to be adulterated if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated.
- Section 17B treats as spurious a drug which purports to be the product of a manufacturer of whom it is not truly a product.
- Section 18 prohibits the manufacture for sale, sale or distribution of any drug which is not of standard quality, or is misbranded, adulterated or spurious.
- The provisions of Sections 5 and 7 of the Act apply equally to Ayurvedic, Siddha and Unani drugs.
- A. 1 and 4
- B. 2, 3 and 4
- C. 1, 2 and 3
- D. 3 and 4 only
Q3. The statutory advisory body that advises the Central Government, the State Governments and the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout India in the administration of the drug law is constituted under which one of the following provisions?
- A. Section 5 of the Drugs and Cosmetics Act, 1940
- B. Section 7 of the Drugs and Cosmetics Act, 1940
- C. Section 17B of the Drugs and Cosmetics Act, 1940
- D. Section 27 of the Drugs and Cosmetics Act, 1940
Q4. Which one of the following officers is the ex officio Chairman of the Drugs Technical Advisory Board?
- A. The Drugs Controller General of India
- B. The Director, Central Drugs Laboratory, Kolkata
- C. The President of the Pharmacy Council of India
- D. The Director General of Health Services
Q5. The August 2026 raid on a farmhouse in the Bidadi–Dodderi area of Bengaluru South, which uncovered a counterfeit medicines repackaging operation, was carried out by officials of which one of the following?
- A. The Central Drugs Standard Control Organisation acting with the Narcotics Control Bureau
- B. The Central Bureau of Investigation acting on a reference from the Union Health Ministry
- C. The Directorate of Revenue Intelligence with the Karnataka Commercial Taxes Department
- D. The State Health and Family Welfare Department with the Food Safety and Drugs Administration
Q6. Monthly lists of drug samples declared Not of Standard Quality, spurious, misbranded or adulterated are compiled and placed in the public domain as 'Drug Alerts' by which one of the following?
- A. The Central Drugs Standard Control Organisation, on reports forwarded by State Drugs Controllers
- B. The Indian Pharmacopoeia Commission, which publishes the official compendium of drug standards
- C. The National Pharmaceutical Pricing Authority, which monitors compliance under the DPCO, 2013
- D. The Drugs Technical Advisory Board, which advises governments on technical matters under the Act
Q7. Under Section 27 of the Drugs and Cosmetics Act, 1940, where the manufacture or sale of a spurious drug has not resulted in death or grievous hurt, the minimum term of imprisonment prescribed is how many years?
- A. Three years
- B. Five years
- C. Seven years
- D. Ten years
Q8. Which one of the following best describes the function of the National Coordination Centre of the Pharmacovigilance Programme of India?
- A. It fixes and revises the ceiling prices of scheduled formulations and monitors manufacturers' compliance
- B. It monitors adverse drug reactions among Indians and assists CDSCO in decisions on the safe use of medicines
- C. It monitors the quality of imported consignments of drugs at ports and clears them for domestic distribution
- D. It publishes and periodically revises monographs prescribing standards of purity and strength for medicines
Q9. Consider the following statements comparing India's pharmaceutical regulatory bodies:
1. The National Pharmaceutical Pricing Authority fixes and revises the prices of scheduled drugs under the Drugs (Prices Control) Order, 2013, whereas the Indian Pharmacopoeia Commission prescribes standards of identity, purity and strength for medicines.
2. The Indian Pharmacopoeia is the official compendium of drug standards recognised under the Drugs and Cosmetics Act, 1940.
3. The National Pharmaceutical Pricing Authority is empowered to act only on drugs scheduled under the Drugs (Prices Control) Order, 2013, and has no power whatsoever over non-scheduled medicines.
Which of the statements given above is/are correct?
- The National Pharmaceutical Pricing Authority fixes and revises the prices of scheduled drugs under the Drugs (Prices Control) Order, 2013, whereas the Indian Pharmacopoeia Commission prescribes standards of identity, purity and strength for medicines.
- The Indian Pharmacopoeia is the official compendium of drug standards recognised under the Drugs and Cosmetics Act, 1940.
- The National Pharmaceutical Pricing Authority is empowered to act only on drugs scheduled under the Drugs (Prices Control) Order, 2013, and has no power whatsoever over non-scheduled medicines.
- A. 1 only
- B. 1 and 2 only
- C. 2 and 3 only
- D. 1, 2 and 3
Q10. The requirement that specified drug products carry a bar code or Quick Response code on their packaging to enable authentication and traceability across the supply chain has been introduced and subsequently widened by amending the Drugs Rules, 1945 by which one of the following?
- A. The Ministry of Health and Family Welfare
- B. The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers
- C. The Ministry of Consumer Affairs, Food and Public Distribution
- D. The National Pharmaceutical Pricing Authority
Q11. Consider the following statements regarding the legal handling of inter-State spurious drug networks in India:
1. Once the Central Government issues a notification extending the jurisdiction of the Central Bureau of Investigation to a State, the consent of that State Government is not required for the CBI to investigate an offence there.
2. Under Section 111 of the Bharatiya Nyaya Sanhita, 2023, organised crime resulting in the death of a person is punishable with death or imprisonment for life and a fine of not less than ten lakh rupees, while in other cases the punishment is imprisonment of not less than five years extending to imprisonment for life with a fine of not less than five lakh rupees.
3. Offences relating to spurious drugs under the Drugs and Cosmetics Act, 1940 are cognizable and non-bailable.
Which of the statements given above is/are correct?
- Once the Central Government issues a notification extending the jurisdiction of the Central Bureau of Investigation to a State, the consent of that State Government is not required for the CBI to investigate an offence there.
- Under Section 111 of the Bharatiya Nyaya Sanhita, 2023, organised crime resulting in the death of a person is punishable with death or imprisonment for life and a fine of not less than ten lakh rupees, while in other cases the punishment is imprisonment of not less than five years extending to imprisonment for life with a fine of not less than five lakh rupees.
- Offences relating to spurious drugs under the Drugs and Cosmetics Act, 1940 are cognizable and non-bailable.
- A. 1 only
- B. 1 and 2 only
- C. 2 and 3 only
- D. 1, 2 and 3