Download RGUHS B.Pharm Question Bank Pharmaceutical Jurisprudence and Ethics QP Bank

Pharmaceutical Jurisprudence and Ethics

Short Answers - 02 Marks:

1. Add a note on Drugs Enquiry Committee.
2. What is Hathi Committee?

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3. What is Mudaliar Committee?
4. Explain role of pharmacist in relation to his trade.
5. Explain role of pharmacist in relation to his job.
6. Explain role of pharmacist in relation to his profession.
7. Define the term Drug under D & C Act.

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8. Define the term Adulterated drug under D & C Act.
9. Define the term Spurious drug under D & C Act.
10. Define the term Misbranded drug under D & C Act.
11. Define Schedule X and give 2 examples of drugs.
12. Define Schedule H and give 2 examples of drugs.

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13. Write the objectives of Medicinal and Toilet Preparations Act.
14. Define i.) Spirit ii.) Denatured Alcohol under M & TP Act.
15. Define i.) Lunatic; ii.) RMP under MTP Act.
16. Write the conditions for termination of Pregnancy.
17. Write the objectives of pharmaceutical policy 2002.

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18. Define the term MAPE.
19. Write the formula for calculating retail price of a formulation.
20. Add a note on NLEM.
21. Write the salient features of Hatch Waxman Act 1984.
22. Write a note on generic drugs with use examples.

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23. Write the constitution of IAEC.
24. Write the functions of IAEC.
25. List the conditions required for breeding animals for experimentation.
26. Add a note on NDA.
27. Add a note on ANDA

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28. Revocation of Patents
29. Write about the recommendations of DEC.
30. Write a note on Joint State Pharmacy Council.
31. Reproduce Pharmacist's Oath.
32. What are the labeling requirements for i) Colored Preparations ii.) Medicine for External use

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Short Essay - 05 Marks:

1. Write about the constitution and functions of PCI
2. Explain about ER. Write the salient features of ER 91.
3. Write the constitution and functions of state pharmacy council.
4. How is the first register prepared and maintained?

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5. Explain in brief about registration of pharmacist.
6. Write in brief about the layout of a bonded laboratory.
7. Write a note on warehousing of alcoholic preparations.
8. Discuss the provisions relating to manufacture of ayurvedic and homeopathic medicines containing alcohol
9. Explain in brief about manufacturing alcoholic preparations under M & TP Act.

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10. Write the operations controlled by Central and State Government under NDPS Act.
11. Discuss about cultivation of opium under NDPS Act.
12. Explain in brief about offences and penalties under NDPS Act.
13. Explain in brief about import and export of Narcotic drugs and Psychotropic substances under NDPS Act.
14. Discuss the advertisements exempted under Drugs and Magic Remedies Act.

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15. Discuss the advertisements prohibited under Drugs and Magic Remedies Act.
16. Write the general procedures with time lines for obtaining a patent.
17. What are the qualifications required for appointing a Government Analyst? What are the functions of the Government Analyst?
18. Write the labeling requirements of medicines for internal use with a model label.
19. Explain in detail about Schedule N.

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20. Write a note on loan license and repackaging license.
21. What is subsequent register and how is it prepared?
22. What are the grounds on which the name of a pharmacist can be removed from the Central Register? Write about the rights of pharmacist and procedure to appeal against it?
23. Write about Central Drugs Laboratory and its role.
24. Write about the power of entry, search and seizure without warrant under NDPS Act.

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Long Essay - 10 Marks:

1. Describe the constitution and functions of a) DTAB b) DCC
2. What are the conditions for the grant of a license to manufacture drugs other than those specified in Schedule C and C1 of D and C Rules 1945?
3. Explain the different licenses issued for the sale of drugs. Describe the general procedure for a license stating the conditions to be satisfied.
4. Explain in detail about Schedule M (GMP) under D & C Act.

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5. Explain in detail about Schedule Y under D & C Act.
6. What are the qualifications for appointment as a drugs inspector? Describe the powers and duties of drugs inspector appointed under D & C Act?
7. Enumerate in detail classes of drugs totally prohibited and permitted to be imported under license or permission under D & C Act.
8. Discuss the penalty for manufacturing and sale of drugs in contravention of the D & C Act 1940.
9. Explain in detail about manufacturing, import and sale of ayurvedic / homoeopathic medicines.

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