B.Pharm - Pharmaceutical Jurisprudence - Question Bank - Unit 1, 2 & 3 - The Drugs and Cosmetics Act & The Pharmacy Act

1. FIFTH SEMESTER B.PHARM – PHARMACEUTICAL JURISPRUDENCE – QUESTION BANK
DR. A. SUMATHI, PROFESSOR, DEPARTMENT OF PHARMACEUTICS 1
UNIT 1 & 2 - Drugs and Cosmetics Act, 1940 and its rules 1945
> Objectives, Definitions, Legal definitions of schedules to the Act and Rules
> Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
> Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
> Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
> Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA)
> Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties.
> Labeling & Packing of drugs- General labeling requirements and specimen labels for
drugs and cosmetics, List of permitted colors. Offences and penalties.
> Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs
Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing
authorities, controlling authorities, Drugs Inspectors
Essay Questions (10 marks)
1. Explain the qualifications and duties of drugs inspector as per drugs and cosmetics Act
2. Give an account on qualification and duties of government analyst
3. Discuss about the conditions of license for manufacture of drugs for test, examination and
analysis
4. Explain the constitution and functions of Drugs Technical Advisory Board
5. Explain the principles of good manufacturing practices under D& C Act
6. Discuss on loan license and repacking license
7. Explain the qualifications and functions of government analyst
8. Explain the constitution and functions of drugs technical advisory board
9. Explain the conditions of import licence & classes of drugs that prohibited to be imported into
India
10. Discuss the rule belong to sale of drugs as per drugs and cosmetic act
Short Notes (5 marks)
1. Labeling and packaging guidelines as per Drugs and Cosmetics Act
2. Write all the cautionary label requirements for schedule G drugs as per drugs and cosmetics Act
3. Explain the labelling requirements for schedule G drugs
4. Draw a neat label for Schedule G drug
5. Draw a neat label of schedule H drug
6. Mention the special requirements for manufacture of Schedule H drugs
7. Mention the special requirements for manufacture of schedule X drugs
8. Explain schedule Y
9. Functions of a drugs inspector
10. Qualifications and functions of drugs inspector
11. Provisions related to import of drugs into India
12. Qualifications and functions of a government analyst
13. Functions of drugs consultative committee*

2. FIFTH SEMESTER B.PHARM – PHARMACEUTICAL JURISPRUDENCE – QUESTION BANK
DR. A. SUMATHI, PROFESSOR, DEPARTMENT OF PHARMACEUTICS 2
14. Constitution of Drug Technical Advisory Board (DTAB)
15. Approved colours used in drugs and cosmetics
16. Provisions related to sale of drugs in India
17. Discuss the rule relating to import of drugs as per drugs and cosmetics Act
18. Conditions for grant of license for wholesale of schedule C and C1 drugs
19. Provisions related to manufacturing of homeopathic medicines
20. Discuss the provisions for manufacture of ayurvedic preparations
21. Loan license*
22. Discuss about the loan and repacking license
23. Discuss about the Drugs Technical Advisory Board
24. Write a note on Schedule M
25. Write the duties of public authorities
26. Members and duties of drugs technical advisory board (DTAB) (or)
Discuss about the compositions of Drugs Technical Advisory Board (or)
Explain about Drugs Technical Advisory Board (DTAB)
27. Qualifications and duties of drugs inspector
28. Explain the conditions for grant of licence for retail sale of drugs
29. Describe the procedure and conditions for obtaining a licence for the manufacture of drugs
specified in schedule C, C1 and X
30. Write a note on Schedule N
31. Explain the conditions for grant of license for retail sale of drugs
32. Briefly describe the schedule Y requirements for conducting clinical trials in India
33. Repacking Licence
34. Labelling and packing of Schedule X drugs
35. Repacking Licences and their conditions
36. Classes of drugs prohibited to sale
37. What are the conditions for the issue of import license
Short Answers (2 marks)
1. Define spurious drug
2. Explain Schedule N
3. Explain the minimum qualification required for the registration of a pharmacist as per ER 2020
4. Education regulation under Pharmacy Act 1948
5. Explain the list of permitted colours
6. Name the Central Drug Laboratories
7. Explain Schedule F
8. Give the specimen label for Schedule X
9. Conditions for removal names from the first register
10. Define the following • Schedule T • Schedule M2 • Schedule J • Schedule H
11. Explain the duties of Govt. Analyst
12. Define Repacking Licence
13. Define misbranded, adulterated and spurious drugs under D & C Act and Rules, 1940
14. Give the specimen label for ophthalmic preparation
15. Storage conditions for Schedule X and Veterinary drugs
16. Functions of Drugs Consultative Committee
17. Schedule H
18. Adulterated drugs
19. Labelling condition for ophthalmic preparations

3. FIFTH SEMESTER B.PHARM – PHARMACEUTICAL JURISPRUDENCE – QUESTION BANK
DR. A. SUMATHI, PROFESSOR, DEPARTMENT OF PHARMACEUTICS 3
20. State the advisory agency as per drugs and cosmetics Act
21. Qualification of Drug Inspectors
22. Misbranded cosmetics
23. Define Ayurvedic and Unani drugs
24. Registered Medical Practitioner
25. Schedule ‘X’ Drugs
26. Schedule C and C1
27. Spurious drug
28. Labeling condition for Schedule G
29. State the administrative agencies as per Drugs and Cosmetics Act
30. Schedule J
31. Chemists and Druggists
32. Define Manufacture of drugs
33. Define the term misbranded and adulterated drug
34. What are functions of drugs consultative committee?
35. What is third party license?
36. Define the term misbranded and adulterated drugs
37. What are controlling authorities?
38. Define Schedule C
UNIT 3 - Pharmacy Act – 1948
> Objectives, Definitions, Pharmacy Council of India; its constitution and functions,
Education Regulations, State and Joint state pharmacy councils; constitution and
functions, Registration of Pharmacists, Offences and Penalties.
Essay Questions (10 marks)
1. Explain the constitution and functions of Pharmacy Council of India
2. Explain the objectives of Pharmacy Act; constitutions & functions of pharmacy council of India
3. Write in detail about the constitution and functions of the state and joint state pharmacy council
4. Explain in detail about the constitution and function of state pharmacy council
5. Explain in detail about the Constitutions and functions of Joint State Pharmacy Council
6. Explain the constitutions and functions of state pharmacy council
Short Notes (5 marks)
1. Members and functions of state pharmacy council
2. Constitution of state pharmacy council
3. Explain the procedure for registration of pharmacist in State Pharmacy Council (or)
Registration procedure for Pharmacist after formation of state pharmacy council (or)
Registration of Pharmacist
4. Education regulation
5. Explain the functions of state and joint state pharmacy council
6. Write a brief review on Hathi committee
Short Answers (2 marks)
1. Central register*
2. Subsequent registers
3. Define registered as medical practitioner?