UPSC Prelims Practice Questions — New Discovery Track for Startups and MSMEs with Financial Assistance upto ₹ 50 cr under PRIP Scheme announced

Q1. With reference to biosimilars and new biological entities, consider the following statements: Which of the statements given above is/are correct?

  1. A biosimilar is identical in molecular structure to its reference biologic, in the same way that a generic matches the active ingredient of its reference small-molecule drug.
  2. Approval of a biosimilar rests on a head-to-head comparability exercise against an already licensed reference product.
  3. A new biological entity has no licensed reference product against which similarity could be demonstrated.
  • A. 2 and 3 only
  • B. 1 and 2 only
  • C. 1 and 3 only
  • D. 3 only

Q2. A public funding window for startups is restricted to projects on new chemical or biological entities. Which one of the following projects would qualify for it?

  • A. An implantable glucose sensor, not yet marketed, that transmits readings to a smartphone
  • B. A biosimilar of an approved monoclonal antibody whose patent protection has recently expired
  • C. A monoclonal antibody against a disease target for which no antibody has been approved anywhere
  • D. An extended-release tablet of a widely used off-patent molecule, allowing once-daily dosing

Q3. A public risk-capital scheme for novel drug discovery requires that at least a quarter of each project's funding come from bona fide institutional investors. Which of the following are likely consequences of this condition?

  1. Investors' willingness to commit their own capital acts as a market test of a project's commercial promise.
  2. The public funding displaces private investors from early-stage projects, which is an instance of crowding out.
  3. The condition shifts the entire downside risk of failure onto the investors, so the public money is no longer at risk.
  4. The total investment mobilised for each rupee of public money increases.
  • A. 3 and 4 only
  • B. 1 and 4 only
  • C. 2, 3 and 4 only
  • D. 1 and 2 only

Q4. Consider the following assertion: 'Public risk capital for early-stage drug discovery can mobilise more private investment than it displaces.' Which of the following statements support the above assertion?

  1. Public funds that absorb early technical risk can make a project attractive to private investors at later stages.
  2. Knowledge generated at publicly funded research centres can spill over to firms and lower their cost of follow-on R&D.
  3. Private investors seldom fund projects at the lowest readiness levels, so public money there does not compete with private money for the same projects.
  4. Government borrowing to finance such grants can raise interest rates and reduce private investment elsewhere in the economy.
  • A. 1 and 3 only
  • B. 2 and 4 only
  • C. 1, 2, 3 and 4
  • D. 1, 2 and 3 only

Q5. Consider the following statements: Which of the following is correct in respect of the above statements?

  1. India's pharmaceutical sector has grown mainly on cost-competitive manufacturing rather than on original drug discovery.
  2. A production-linked incentive calculated on incremental sales over a base year rewards expansion of manufacturing output rather than the discovery of new molecules.
  • 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

Q6. With reference to output-linked and R&D-linked incentives in the pharmaceutical sector, consider the following statements: Which of the statements given above is/are correct?

  1. Under a production-linked incentive, the payout is computed on a firm's total sales, so an incumbent gains even without expanding output.
  2. A milestone-linked R&D grant can release funds before the resulting product earns any revenue.
  3. Production-linked incentives are designed primarily to finance the discovery of new molecules at low technology-readiness levels.
  • A. 1 and 3 only
  • B. 2 only
  • C. 2 and 3 only
  • D. 1 and 2 only

Q7. A startup's novel molecule, developed with grant support under an industrial-promotion scheme of the Department of Pharmaceuticals, reaches the stage where testing in humans is needed. In this context, consider the following statements: Which of the statements given above is/are correct?

  1. Receiving the scheme's funding does not by itself authorise the startup to begin clinical trials; that requires permission from the national drug regulator.
  2. Because NIPERs host the scheme's Centres of Excellence, a NIPER can grant the marketing licence for a drug developed under the scheme.
  3. As the funding department, the Department of Pharmaceuticals is also the authority that permits clinical trials of the molecule.
  • A. 1 and 2 only
  • B. 1, 2 and 3
  • C. 2 and 3 only
  • D. 1 only

Q8. Consider the following statements: Which of the following is correct in respect of the above statements?

  1. In India, a phytopharmaceutical drug may undergo clinical trials approved by the national drug regulator before it is marketed.
  2. Phytopharmaceuticals are regulated as traditional AYUSH formulations, whose approval rests on references to their use in classical texts.
  • 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