UPSC Prelims Practice Questions — 10 new import hubs for drugs, medical devices proposed

Q1. With reference to the legal regime governing the import of drugs and medical devices into India, consider the following statements: Which of the statements given above is/are correct?

  1. Customs authorities can, on their own, designate a new port of entry for drug imports by administrative order, because border clearance of goods is a customs function.
  2. Drugs imported into India are regulated by the central drug regulator irrespective of whether the drug is under patent.
  3. Licensing procedures under the Medical Devices Rules, 2017 can be changed by the Union Health Ministry amending the Rules, without a fresh Act of Parliament.
  • A. 2 and 3 only
  • B. 3 only
  • C. 1 and 2 only
  • D. 1, 2 and 3

Q2. A pharmaceutical firm in Hyderabad holds a State-issued drug manufacturing licence. It plans to make a formulation containing an active ingredient never before approved in India, using that ingredient imported through a newly notified Inland Container Depot. In this context, consider the following statements: Which of the statements given above is/are correct?

  1. The firm needs new-drug permission from the central regulator before the State authority can license manufacture of this formulation.
  2. The import of the active ingredient falls under the Central Government's regulatory control, not the State's.
  3. Once the formulation is approved and manufactured, licensing its retail sale within Telangana is a State function.
  • A. 1 and 3 only
  • B. 1 and 2 only
  • C. 2 and 3 only
  • D. 1, 2 and 3

Q3. A unit in SEZ Bommasandra, Karnataka assembles a medical device from components imported duty-free and sells the finished device to a hospital in Bengaluru. In this context, consider the following statements: Which of the statements given above is/are correct?

  1. For authorised operations, the SEZ is treated as territory outside India's customs territory, which is why the components could enter duty-free.
  2. Because the device was assembled within India's geographical boundaries, its sale to the hospital attracts no customs duty.
  3. On removal to the hospital, the device is chargeable to customs duty, including anti-dumping duty where applicable, as if it were imported.
  • A. 1 only
  • B. 2 and 3 only
  • C. 1 and 3 only
  • D. 1, 2 and 3