UPSC Prelims Practice Questions — Govt. seeks to cut access to substandard medicines

Q1. With reference to the World Health Organization's classification of poor-quality medical products, consider the following statements: Which of the statements given above is/are correct?

  1. Deliberate misrepresentation, not the degree of failure in laboratory tests, is what separates a falsified product from a substandard one.
  2. A product containing the correct active ingredient in the correct strength cannot be classed as falsified.
  3. An unauthorised product of unknown origin that fails its specifications would be classed as substandard.
  • A. 1 only
  • B. 1, 2 and 3
  • C. 1 and 2 only
  • D. 2 and 3 only

Q2. The Union Health Ministry has proposed immediate suspension of manufacturing licences for drugs declared Not of Standard Quality by amending the Drugs Rules, 1945 through a draft notification open for public objections. In this context, consider the following statements: Which of the statements given above is/are correct?

  1. Because the change is made to the Rules rather than the parent Act, it can take effect by executive notification without Parliament passing an amending Bill.
  2. Objections and suggestions received during the consultation period are binding on the Government when it finalises the rule.
  3. Prior publication of the draft is meant to let persons likely to be affected place their objections before the Government before the rule is finalised.
  • A. 1 only
  • B. 1 and 3 only
  • C. 1, 2 and 3
  • D. 2 and 3 only

Q3. Consider the following statements: Which of the following is correct in respect of the above statements?

  1. The proposed immediate-suspension provision for drugs declared Not of Standard Quality is being introduced by amending the Drugs Rules, 1945 rather than the Drugs and Cosmetics Act, 1940.
  2. Subordinate legislation in India comes into force only after it has been approved by resolutions of both Houses of Parliament.
  • A. Both Statement-I and Statement-II are correct and Statement-II explains Statement-I
  • B. Both Statement-I and Statement-II are correct, but Statement-II does not explain Statement-I
  • C. Statement-I is correct, but Statement-II is incorrect
  • D. Statement-I is incorrect, but Statement-II is correct

Q4. Suppose that, under a rule like the proposed draft, a licensing authority suspends a firm's manufacturing licence on the day its drug is declared Not of Standard Quality on a critical quality parameter, without issuing a prior show-cause notice. In this context, consider the following statements: Which of the statements given above is/are correct?

  1. The rule of audi alteram partem would additionally require that the authority suspending the licence have no personal interest in the outcome.
  2. The action can remain consistent with natural justice if the firm is heard after the suspension, since urgency to protect public health may justify postponing the hearing.
  3. Confining no-notice suspension to failures on specified critical parameters keeps the departure from a prior hearing proportionate to the risk.
  • A. 1 and 2 only
  • B. 1, 2 and 3
  • C. 1 only
  • D. 2 and 3 only

Q5. With reference to the constitutional distribution of legislative power over drugs in India, consider the following statements: Which of the statements given above is/are correct?

  1. Both Parliament and State Legislatures can make laws on drugs.
  2. Where a State law on drugs is repugnant to a Central law on the same matter, the Central law ordinarily prevails to the extent of the repugnancy.
  3. The Concurrent List entry on drugs is made subject to the Union List only in respect of opium.
  • A. 2 and 3 only
  • B. 1 only
  • C. 1, 2 and 3
  • D. 1 and 2 only