Pharmaceutical Jurisprudence MCQs

Pharmaceutical Jurisprudence Important MCQs for Nepal Pharmacy Council License Exam & Pharmacy Loksewa.

1. When was Drug Act, 2035(1978) promulgated?
(a) 2035/07/10
(b) 2035/07/08
(c) 2035/08/14
(d) 2035/08/24

2. Drug Act, 2035(1978) was promulgated as the act number ___ of the year 2035(1978).
(a) 40
(b) 7
(c) 2
(d) 21

3. How many times has Drug Act, 2035(1978) been amended till now?
(a) 7
(b) 3
(c) 2
(d) 4

4. The first amendment of Drug Act, 2035(1978) was made in ___.
(a) 2045/07/10
(b) 2035/07/08
(c) 2057/08/14
(d) 2067/11/19

5. When was Drug Act, 2035(1978) amended for the second time?
(a) 2067/02/14
(b) 2045/07/10
(c) 2035/07/08
(d) 2057/08/14

6. When was Drug Act, 2035(1978) amended for the third time?
(a) 2045/07/10
(b) 2067/02/14
(c) 2057/08/14
(d) None

7. Drug Act, 2035(1978) consists of ___ chapters in total.
(a) 20
(b) 40
(c) 7
(d) 21

8. How many sections does Drug Act, 2035(1978) have?
(a) 40
(b) 7
(c) 21
(d) 14

9. The preamble of Drug Act, 2035(1978) does not speak on ___.
(a) storage of drugs
(b) consumption of drugs
(c) clinical trial of drugs
(d) quality of drugs

10. Except which of the following are objectives of Drug Act, 2035(1978)?
(a) To prohibit misuse or abuse of drugs
(b) To ensure safety, quality and efficacy of drugs
(c) To prevent false or misleading advertisement of drugs
(d) To ensure GMP of pharmaceutical companies

11. As per Drug Act, 2035(1978), Drug is meant for ___.
(a) human being
(b) animal and bird
(c) vermin and insect
(d) all of them

12. As per Drug Act, 2035(1978), Drug is used for ___.
(a) diagnosis, cure, mitigation treatment or prevention of disease
(b) affecting the structure or any organic functions of human body, animal or bird
(c) preparing pharmaceutical products
(d) all of them

13. As per Drug Act, 2035(1978), the definition of Manufacturing covers all of them except ___.
(a) preparing
(b) packing
(c) refining
d) dispensing

14. As per Drug Act, 2035(1978), consumption means giving or administering a drug ___ to a patient.
(a) a doctor
(b) patient himself/herself
(c) a person authorized by a doctor
(d) all of them

15. The section 3 of Drug Act, 2035(1978) has got the provision of ___.
(a) Drug Consultative Council
(b) Drug Advisory Committee
(c) Department of Drug Administration
(d) National Medicine Laboratory

16. Drug Consultative Council has been constituted under ___ of Drug Act, 2035(1978).
(a) Section 6
(b) Section 5
(c) Section 4
(d) Section 3

17. ___ advises Government of Nepal on theoretical and administrative matter relating to drugs.
(a) Drug Advisory Committee
(b) Drug Consultative Council
(c) National Medicine Laboratory
(d) Department of Drug Administration

18. The section 4 of Drug Act, 2035(1978) contains the provision of ___.
(a) Department of Drug Administration
(b) National Medicine Laboratory
(c) Drug Consultative Council
(d) Drug Advisory Committee

19. Under which section of Drug Act, 2035(1978) has Drug Advisory Committee been constituted?
(a) Section 6
(b) Section 4
(c) Section 3
(d) Section 5

20. Which advises Department of Drug Administration on technical matters related with the research, development and control of drugs?
(a) National Medicine Laboratory
(b) Drug Consultative Council
(c) Drug Advisory Committee
(d) All of them

21. The chapter 3 of Drug Act, 2035(1978) is related with ___.
(a) Quality Standard of Drugs
(b) Inquiry and Inspection
(c) Research and Control of Drugs
(d) Miscellaneous

22. The chapter 3 of Drug Act, 2035(1978) is related with ___.
(a) Quality Standard of Drugs
(b) Inquiry and Inspection
(c) Research and Control of Drugs
(d) Miscellaneous

23. Under which section of Drug Act, 2035(1978) has Department of Drug Administration been established?
(a) Section 3
(b) Section 4
(c) Section 5
(d) Section 6

24. The section 5 of Drug Act, 2035(1978) has the provision of ___.
(a) National Medicine Laboratory
(b) Department of Drug Administration
(c) Drug Advisory Committee
(d) Drug Consultative Council

25. Which one of the following has been constituted/established for the implementation of objectives of Drug Act, 2035(1978)?
(a) National Medicine Laboratory
(b) Drug Consultative Council
(c) Drug Advisory Committee
(d) Department of Drug Administration

26. The section 6 of Drug Act, 2035(1978) has got the provision of ___.
(a) Drug Consultative Council
(b) Drug Advisory Committee
(c) National Medicine Laboratory
(d) Department of Drug Administration

27. National Medicine Laboratory has been established under ___ of Drug Act, 2035(1978).
(a) Section 3
(b) Section 4
(c) Section 5
(d) Section 6

28. Which one of the following is the principal body of Government of Nepal to perform scientific research, testing and analysis of drugs?
(a) Drug Advisory Committee
(b) Drug Consultative Council
(c) National Medicine Laboratory
(d) Department of Drug Administration

29. With approval of which of the following can a research center or laboratory for scientific research and development of drugs be established?
(a) Ministry of Health
(b) National Medicine Laboratory
(c) Department of Drug Administration
(d) All of them

30. Which section of Drug Act, 2035(1978) is related with the provision of obtaining a recommendation letter from Department of Drug Act for establishment of drug industry?
(a) Section 7
(b) Section 27
(c) Section 21
(d) Section 9

31. The section 7 of Drug Act, 2035(1978) is related with the provision of ___.
(a) product license
(b) registration of drugs
(c) name registration certificate
(d) recommendation letter for establishment of drug industry

32. The section 8 of Drug Act, 2035(1978) contains the provision of ___.
(a) registration of drugs
(b) product license
(c) name registration certificate
(d) recommendation letter for establishment of drug industry

33. Under which section of Drug Act, 2035(1978) is product license to be obtained?
(a) Section 10
(b) Section 16
(c) Section 8
(d) Section 21

34. The section 8A of Drug Act, 2035(1978) has the provision of ____.
(a) product license
(b) registration of drugs
(c) name registration certificate
(d) recommendation letter for establishment of drug industry

35. Under which section of Drug Act, 2035(1978) does a drug manufacturer or importer/exporter have to register a drug with Department of Drug Administration?
(a) Section 7
(b) Section 8
(c) Section 9
(d) Section 8A

36. Under which section of Drug Act, 2035(1978) has a drug exporter or importer to be obtained a recommendation letter for exportation or importation of drugs?
(a) Section 7
(b) Section 9
(c) Section 31
(d) Section 11

37. The section 9 of Drug Act, 2035(1978) has got the provision of ___.
(a) product license to be obtained
(b) registration of name for sale and distribution of drugs
(c) recommendation letter for establishment of drug industry
(d) recommendation letter to be obtained for exportation or importation of drugs

38. The section 9A of Drug Act, 2035(1978) is concerned with ___.
(a) power to frame rules
(b) emergency use of drug or vaccine
(c) narcotics and poisonous drug to be kept safely
(d) none of the above

39. In which section of Drug Act, 2035(1978) is there the provision of Emergency Use of Drug or Vaccine?
(a) Section 10A
(b) Section 9A
(c) Section 8A
(d) Section 8

40. Who applies for registration of drugs for import in Nepal?
(a) Drug Manufacturer
(b) Authorized Importer
(c) Hospital
(d) Drug Retailer

41. Under which section of Drug Act, 2035(1978) is Name and Pharmacy to be registered with Department of Drug Administration for sale and distribution of drugs?
(a) Section 10
(b) Section 34
(d) Section 18
(d) Section 8A

42. The section 10 of Drug Act, 2035(1978) has got the provision of ___.
(a) registration of drugs
(b) product license to be obtained
(c) sale and distribution of registered drugs only
(d) registration of name for sale and distribution of drugs

43. Under which section of Drug Act, 2035(1978) is there the provision of sale and distribution of registered drugs only?
(a) Section 27
(b) Section 34
(c) Section 10A
(d) Section 28

44. The section 10A of Drug Act, 2035(1978) has the provision of ___.
(a) registration of drugs
(b) product license to be obtained
(c) sale and distribution of registered drugs only
(d) registration of name for sale and distribution drugs

45. The validity period of product license, recommendation letter and certificate after issuance from Department of Drug Act for the first time is ___.
(a) 5 years
(b) 4 years
(c) 3 years
(d) 2 years

46. The product license, recommendation letter and certificate should be renewed each year after the expiration of validity period, without fine, within___.
(a) 90 days
(b) 35 days
(c) 2 years
(d) 5 years

47. How much additional fee is charged if renewed product license, recommendation letter and certificate within 3 months after expiration of validity period?
(a) 25% of renewal fee
(b) 1% of renewal fee
(c) 50% of renewal fee
(d) 75% of renewal fee

48. The product license, recommendation letter or certificate becomes void if not renewed within ___.
(a) 35 days of expiration of validity period
(b)
(c) 1 year of expiration of validity period
(d) 5 years of expiration of validity period

49. As per the section 12 of Drug Act, 2035(1978), drug should be ___ for maintaining its prescribed standard.
(a) safe for public consumption
(b) effective
(c) qualitative standard
(d) all of them

50. Under which section of Drug Act, 2035(1978) is there the provision of prohibition on manufacture, sale, distribution, export, import, storage or consumption of drugs not confirming the prescribed standard?
(a) Section 25
(b) Section 18
(c) Section 14
(d) Section 19

51. Under which section of Drug Act, 2035(1978) is a drug which is not safe for public consumption, efficacious and of quality standard returned from market?
(a) section 39
(b) Section 18
(c) Section 13
(d) Section 19

52. The section 15 of Drug Act, 2035(1978) has provision of ___.
(a) compensation
(b) prohibition on misuse or abuse of drugs
(c) prohibition on false or misleading advertisement of drugs
(d) none of the above

53. Who provides the compensation to the victim as the section 15 of Drug Act, 2035(1978)?
(a) Drug Manufacturer
(b) Department of Drug Administration
(c) Retailer
(d) None of them

54. As per the section 16 of Drug Act, 2035(1978), the drug manufacturer himself/herself or authorized agent or exporter or importer submits a letter of guarantee to Department of Drug Administration for all except ____.
(a) efficacy
(b) safety
(c) accessibility
(d) qualitative standard

55. Under which section of Drug Act, 2035(1978) are drugs categorized/classified?
(a) Section 34
(b) Section 17
(c) Section 20
(d) Section 40

56. The provision of ‘no person sells or distributes drugs without prescription of a doctor as categorized not to be sold or distributed without prescription is mentioned in the ___ of Drug Act, 2035(1978).
(a) sub- section 2 of section 17
(b) sub- section 2 of section 11
(c) sub- section 2 of section 34
(d) sub- section 2 of section 6

57. Which section of Drug Act, 2035(1978) is concerned with the provision of prohibition on misuse or abuse of drugs?
(a) Section 18
(b) Section 29
(c) Section 19
(d) Section 40

58. The ___ of Drug Act, 2035(1978) defines the misuse or abuse of drugs.
(a) sub- section 2 of section 18
(b) sub- section 2 of section 20
(c) sub- section 2 of section 19
(d) sub- section 2 of section 21

59. The sale and distribution of any drugs in contravention of provision mentioned in ___ of Drug Act, 2035(1978).
(a) sub- section 2 & 3 of section 11
(b) sub- section 2 & 3 of section 34
(c) sub- section 2 & 3 of section 17
(d) sub- section 2 & 3 of section 20

60. The provision of section 27 of drug act,2035 is…
(a) Trade mark
(b) Clinical trial
(c) Prescribing right
(d) Prohibition of drug