UPSC Prelims Practice Questions — Union Health Ministry Notifies Key Amendments to NDCT Rules, 2019 to Reduce Regulatory Burden and Promote Ease of Doing Business

Q1. Under the New Drugs and Clinical Trials Rules, 2019, the term "new drug" is most precisely defined as which one of the following?

  • A. A drug, including its active pharmaceutical ingredient or new drug substance, that has not been used in the country to any significant extent and has not been approved as safe and efficacious by the Central Licensing Authority
  • B. Any drug that is being manufactured for the first time by a particular pharmaceutical company
  • C. Any drug that is imported into India, irrespective of whether it has prior domestic approval
  • D. A drug whose patent has expired and which is being manufactured as a generic

Q2. The January 2026 amendments to the NDCT Rules, 2019 were notified as part of a deregulation drive undertaken pursuant to which one of the following?

  • A. Directions of the Prime Minister to reduce the regulatory compliance burden and promote ease of doing business
  • B. An order of the Supreme Court on clinical-trial safety
  • C. A binding directive of CDSCO's Drugs Technical Advisory Board
  • D. Recommendations of the NITI Aayog Governing Council

Q3. Under the amended Rules, certain low-risk BA/BE studies may now be initiated on the basis of a simple online intimation submitted to which authority?

  • A. Central Drugs Standard Control Organisation (CDSCO)
  • B. Indian Council of Medical Research (ICMR)
  • C. National Pharmaceutical Pricing Authority (NPPA)
  • D. The State Drugs Controller of the concerned State

Q4. In the context of the amended NDCT Rules, a "bioequivalence study" is best described as one that establishes which one of the following?

  • A. That a test drug product delivers its active ingredient into the bloodstream at a comparable rate and extent as a designated reference product
  • B. That a drug is effective against all known strains of a target pathogen
  • C. That a drug produces no adverse effects in any patient population
  • D. That every batch of a drug has an identical chemical composition

Q5. The single most significant regulatory change introduced by the 2026 amendment for the non-commercial (research-purpose) manufacture of drugs is best described as which one of the following?

  • A. The licensing requirement was replaced with a prior-intimation mechanism
  • B. It was brought entirely under the licensing authority of the States
  • C. It was made subject to a fresh mandatory ethics committee clearance
  • D. It was prohibited except under a compulsory licence

Q6. The NDCT Rules, 2019 provide a predictable approval window for clinical trials of new drugs discovered and to be manufactured in India, beyond which an application is deemed approved if no query is raised. This window is of how many days?

  • A. 30 days
  • B. 45 days
  • C. 90 days
  • D. 180 days

Q7. With reference to Ethics Committees and compensation under the NDCT Rules, 2019, which one of the following statements is NOT correct?

  1. An Ethics Committee must have a minimum of seven members drawn from medical, non-medical, scientific and non-scientific areas.
  2. At least fifty percent of the Ethics Committee's members must not be affiliated with the institute where it is constituted.
  3. The Ethics Committee undertakes causality assessment of serious adverse events to help decide the quantum of compensation.
  4. Compensation for a clinical-trial-related death is fixed solely by the trial sponsor, with no Ethics Committee involvement.
  • A. 1 only
  • B. 2 and 3
  • C. 1 and 4
  • D. 4 only

Q8. The digitisation of CDSCO's approval intimations under the reform is aligned with which one of the following single-window investor-facilitation platforms?

  • A. National Single Window System (NSWS)
  • B. Government e-Marketplace (GeM)
  • C. PARIVESH portal
  • D. e-Sanjeevani platform

Q9. The Union Health Ministry first publicly announced its intent to amend the NDCT Rules, 2019 for streamlining test licence and BA/BE study applications in which of the following?

  • A. March 2025
  • B. January 2026
  • C. March 2019
  • D. August 2024