UPSC Prelims Practice Questions — Centre Amends Drugs Rules, 1945 to Ensure Uniform Regulation of Advanced Cell and Gene Therapies

Q1. The following are cited as categories of drugs/biological products regulated through the Centrally Licence Approving Authority (CLAA) route. Which of the above is/are NOT correctly identified as a CLAA category?

  1. Vaccines
  2. Large volume parenterals exceeding 100 ml
  3. Xenografts
  4. Small volume parenterals of less than 100 ml
  • A. 1 and 2
  • B. 2 and 3
  • C. 4 only
  • D. 3 and 4

Q2. The 2026 amendment to the Drugs Rules, 1945 added how many new product categories to the Centrally Licence Approving Authority (CLAA) framework?

  • A. Two
  • B. Three
  • C. Four
  • D. Five

Q3. Which Union Ministry issued the 2026 amendment to the Drugs Rules, 1945 bringing cell and gene therapies under the CLAA?

  • A. Ministry of Health and Family Welfare
  • B. Ministry of Science and Technology
  • C. Ministry of Chemicals and Fertilizers
  • D. Ministry of AYUSH

Q4. The 2026 change bringing cell/stem cell-derived products, gene therapeutic products and xenografts under the CLAA was effected by amending which of the following instruments?

  • A. The Drugs Rules, 1945
  • B. The New Drugs and Clinical Trials Rules, 2019
  • C. The Drugs and Cosmetics Act, 1940
  • D. The Medical Devices Rules, 2017

Q5. With reference to India's drug regulatory architecture, consider the following statements. Which of the statements given above is/are correct?

  1. The Drugs and Cosmetics Act, 1940 is the parent statute under which the Drugs Rules, 1945 are framed.
  2. The New Drugs and Clinical Trials Rules, 2019 classify stem cell-derived and gene therapeutic products as 'new drugs'.
  3. The Central Drugs Standard Control Organisation functions under the Directorate General of Health Services in the Ministry of Health and Family Welfare.
  4. The Drugs Rules, 1945 are framed under the Medical Devices Rules, 2017.
  • A. 1, 2 and 3
  • B. 1 and 4 only
  • C. 2 and 3 only
  • D. 1, 2, 3 and 4

Q6. Under the New Drugs and Clinical Trials Rules, 2019, how many of the following categories — vaccines, r-DNA derived products, Living Modified Organisms, stem cell-derived products and gene therapeutic products — are 'always considered new drugs'?

  • A. Three
  • B. Four
  • C. Five
  • D. Two

Q7. For products in the CLAA category, the manufacturing licence is granted after joint evaluation and inspection by how many distinct licensing authorities?

  • A. One
  • B. Two
  • C. Three
  • D. Four

Q8. With reference to the role of CDSCO and the division of drug-regulatory powers in India, consider the following statements. Which of the statements given above is/are correct?

  1. CDSCO is the National Regulatory Authority of India for drugs.
  2. For CLAA-category products, the manufacturing licence is granted after joint evaluation by the concerned State Licensing Authority and CDSCO.
  3. r-DNA-based products are always treated as new drugs requiring central permission before a manufacturing licence is considered.
  4. Under the Drugs and Cosmetics Act, licensing for the manufacture of all ordinary (non-CLAA) drugs rests solely with the Central Government.
  • A. 1, 2 and 3
  • B. 1 and 4 only
  • C. 2, 3 and 4
  • D. 3 and 4 only

Q9. The following statements relate to India's indigenous cell and gene therapy achievements. Which of the above is/are NOT correctly identified?

  1. NexCAR19 is described as India's first indigenous CAR-T cell therapy.
  2. NexCAR19 was developed by ImmunoACT, a spin-off of IIT Bombay, with Tata Memorial Centre.
  3. India's indigenous CRISPR-based gene therapy for sickle cell disease was developed by CSIR-IGIB.
  4. NexCAR19 is a xenograft-derived heart-valve product used in cardiology.
  • A. 1 and 2
  • B. 4 only
  • C. 3 and 4
  • D. 2 only

Q10. With reference to the 2026 amendment to the Drugs Rules, 1945 concerning cough-syrup sales, consider the following statements. Which of the statements given above is/are correct?

  1. The amendment removed the word 'Syrup' from Schedule K of the Drugs Rules, 1945.
  2. The withdrawn exemption had applied to villages with a population of less than 1,000.
  3. Cough syrups in such villages may now be sold only through duly licensed pharmacies.
  4. The amendment was issued under the Medical Devices Rules, 2017.
  • A. 1, 2 and 3
  • B. 2 and 4 only
  • C. 1 and 3 only
  • D. 1, 3 and 4

Q11. Under which of the following are stem cell-derived products and gene therapeutic products classified as 'new drugs' requiring special central scrutiny?

  • A. The New Drugs and Clinical Trials Rules, 2019
  • B. The Drugs Rules, 1945
  • C. The Drugs and Cosmetics Act, 1940
  • D. The Biological Diversity Act, 2002