Model Paper
End Semester Examination, Dec - 2024
Program: B.Pharm
Semester: V
Course: Pharmaceutical Jurisprudence
Course code- BP505T
Course Descriptions
Outcomes
CO1 To acquire knowledge and concept of Drug and Cosmetic Act and License
of manufacturing drugs.
CO2 To develop concept of various schedule and selling of drugs.
CO3 To acquire knowledge, concept and objective of Pharmacy Act.
CO4 To acquire knowledge of magic remedies Act and CPCSEA guideline.
CO5 To develop concept of Pharmaceutical Ethics.
Section A (No. of Question x 5= Total Marks)
1. What are the objectives of Drug and Cosmetic Act-1940? [Unit-1,CO1, LOT,
Understanding]
2. Define drug and cosmetic as per D & C Act. [Unit-1,CO1, LOT, Remembering]
3. What are different categories of drugs to be imported? [Unit-1,CO1, LOT, Apply]
4. How control over import of drugs and cosmetics done in India? [Unit-1,CO1, HOT,
Analyse]
5. What are the offences and penalties for contravention of import of cosmetics under
section 10 & 10 A of D & C Act-1940? [Unit-1,CO1, LOT, Apply]
6. How many categories of licenses are granted for manufacture of drugs? [Unit-1,CO1,
HOT, Analyse]
7. What are the perspective needed for manufacture of drugs for examination, test and
analysis? [Unit-1,CO1, HOT, Apply]
8. Make a specimen label of schedule H drug.[Unit-2,CO2, LOT, Apply]
9. Enumerate the objective of Pharmacy Act. .[Unit-3,CO3, LOT, Understanding]
10. Define the following: .[Unit-3,CO3, LOT, Remembering]
a) Registered Pharmacist
b) Central Register
11. How the Pharmacy Council of India Constitute? .[Unit-3,CO3, HOT, Understanding]
12. Explain the composition of Executive Committee of PCI. .[Unit-3,CO3, LOT,
Remembering]
13. What are the role of Pharmacy Council of India? .[Unit-3,CO3, LOT, Understanding]
14. Explain the different steps involved for registration in State Pharmacy Council. .[Unit-
3,CO3, LOT, Apply]
15. Draw a diagram for area of bonded manufacturing. .[Unit-3,CO3, HOT, Apply]
16. How rectified spirit obtained from warehouse for manufacturing? .[Unit-3,CO3, HOT,
Apply]
17. Name different organizations which are exempted from duty as per Medicinal & Toilet
Preparation Act-1955.[Unit-3,CO3, LOT, Remembering]
18. Enumerate the power of excise officer. .[Unit-3,CO3, LOT, Remembering]
19. What is Illicit Traffic? .[Unit-3,CO3, LOT, Remembering]
20. Explain about manufacture in relation to Narcotic Drugs or Psychotropic Substance.
.[Unit-3,CO3, HOT, Remembering]
21. What are the different classes of exempted advertisement as per Drug & Magic Remedy
Act? .[Unit-4,CO4, LOT, Apply]
22. Explain Offences and Penalties under Drug & Magic Remedy Act. [Unit-4,CO4, LOT,
Remembering]
23. Why experimentation on animals are required? [Unit-4,CO4, HOT, Analyze]
24. What are the role of CPCSEA? [Unit-4,CO4, LOT, Understanding]
25. Explain the constitution of Committee for the purpose of control and supervision of
experiments on animals. [Unit-4,CO4, HOT, Apply]
26. What are the contents required to maintain a record for animal house? [Unit-4,CO4,
HOT, Understanding]
27. Write the role of Drug Enquiry Committee. [Unit-5,CO5, LOT, Understanding]
28. Explain the recommendation of Drug Enquiry Committee. [Unit-5,CO5, LOT,
Understanding]
29. Explain pharmacist in relation to his job. [Unit-5,CO5, LOT, Understanding]
30. What are the role of pharmacist in relation to his trade? [Unit-5,CO5, HOT, Apply]
Section B (No. of Question x 10= Total Marks)
31. What are the steps involved in process for manufacture of drugs? [Unit-1,CO1, LOT,
Understanding]
32. Enumerate about manufacture of drugs other than those specified in schedule C & C1.
[Unit-1,CO1, LOT, Apply]
33. What are the contents needed to keep in record for dispensing & compounding of drugs?
[Unit-1,CO1, HOT, Apply]
34. Explain about GMP as per schedule-M. [Unit-1,CO1, LOT, Remembering]
35. How Drug Technical Advisory Board is constituted? [Unit-2,CO2, HOT, Apply]
36. Write about the education regulation along with its role. [Unit-3,CO3, LOT,
Understanding]
37. Explain the formation of State Pharmacy Council with its function. [Unit-3,CO3, LOT,
Understanding]
38. Differentiate between State Pharmacy Council & Joint Pharmacy Council. [Unit-3,CO3,
LOT, Remembering]
39. What are the ideal requirements of bonded laboratory? [Unit-3,CO3, HOT, Apply]
40. Write in brief about NDPS Act-1985 and its Rules. [Unit-3,CO3, LOT, Understanding]
41. How retail price of drugs can be calculated? [Unit-4,CO4, HOT, Analyze]
42. Explain in brief about Drug & Magic Remedies Act-1954. [Unit-4,CO4, LOT,
Understanding]
43. Explain constitution and function of IAEC. [Unit-4,CO4, LOT, Understanding]
44. Explain Intellectual Property Rights in detail along with example. [Unit-5,CO5, LOT,
Remembering]
45. Enumerate Medical Termination of Pregnancy Act in brief. [Unit-5,CO5, LOT,
Understanding]
Summary Sheet:
CO Wise
CO Q. No Marks
CO1 1,2,3,4,5,6,7,31,32,33,34 75
CO2 8,35 15
CO3 9,10,11,12,13,14,15,16,17,18,19,20,36,37,38,39,40 100
CO4 21,22,23,24,25,26,41,42,43 60
CO5 27,28,29,30,44,45 40
Total 290
Unit Wise
Unit Q. No Marks
Unit 1 1,2,3,4,5,6,7,31,32,33,34 75
Unit 2 8,35 15
Unit 3 9,10,11,12,13,14,15,16,17,18,19,20,36,37,38,39,40 100
Unit 4 21,22,23,24,25,26,41,42,43 60
Unit 5 27,28,29,30,44,45 40
Total 290
Blooms Taxonomy Level (BTL) Wise
BTL Q. No Mark
s
LOT 1,2,3,5,8,9,10,12,13,14,17,18,19,21,22,24,27,28,29,31,32,34,36,37,38,40,42, 205
43,44,45
HOT 4,6,7,11,15,16,20,23,25,26,30,33,35,39 85
Total 290
Prepared By: Reviewed By:
Disclaimer:- This is a model Question Paper. The Question in End term examination will differ from
the model Question paper. This model paper is meant for practice only.