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DP206TT

This document outlines the examination details for the Diploma Pharmacy Year-2 at Gujarat Technological University, specifically for the subject 'Pharmacy Law and Ethics' scheduled for December 16, 2023. It includes instructions for the exam, a compulsory question section, and a variety of topics covering drug definitions, pharmaceutical legislation, clinical trials, and ethical codes. The exam consists of multiple questions from which students must attempt a selection, with a total of 80 marks available.

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nabakrushnachoudhury2005
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60 views2 pages

DP206TT

This document outlines the examination details for the Diploma Pharmacy Year-2 at Gujarat Technological University, specifically for the subject 'Pharmacy Law and Ethics' scheduled for December 16, 2023. It includes instructions for the exam, a compulsory question section, and a variety of topics covering drug definitions, pharmaceutical legislation, clinical trials, and ethical codes. The exam consists of multiple questions from which students must attempt a selection, with a total of 80 marks available.

Uploaded by

nabakrushnachoudhury2005
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Seat No.: _____ Enrolment No.

_____________

GUJARAT TECHNOLOGICAL UNIVERSITY


DIPLOMA PHARMACY YEAR- 2 • EXAMINATION – WINTER - 2023

Subject Code: DP206TT Date: 16/12/2023


Subject Name: Pharmacy Law and Ethics
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Question -1 is compulsory to attempt.
2. Attempt any 04 questions from Question 2 to 7.
3. Make suitable assumptions wherever necessary.
4. Figures to the right indicate full marks.

Q.1 Answer the following questions. (Attempt Any 16) (1 mark each) 16

1) Define Drug
2) Mention the contents of schedule X with one example
3) Define Cosmetics
4) Mention the contents of schedule J with one example
5) Define Spurious drugs
6) Give two examples of copyright
7) Give two examples of Trade Marks
8) Write Full Form of CDL
9) Give the full form of DTAB
10) Where central drug laboratory is situated in India?
11) What do you mean by BMW in reference to Blood Bank?
12) Give two examples of Geographical indication
13) Write Full Form of IND
14) Write full form of FSSAI
15) Write full form of IPC
16) Define Disaster
17) Define Addict
18) Write full form of CPCSEA
19) What do you mean by BCS Class II drug?
20) Write full form of CDSCO
Q.2 (a) Write Constitution of Central Pharmacy Council 06
(b) Describe History of pharmaceutical legislation in detail. 05
(c) Write a detailed note on General labelling requirements for drugs 05
Q.3 (a) Describe at length Powers and Procedure for Drug Inspector. 06
(b) Write note on Retail sale of schedule X and H drugs 05
(c) Discuss Subsequent registration of pharmacists in detail 05
Q.4 (a) Discuss various phases of Clinical Trials in detail 06
(b) Write a note on Provisions of Medical Termination of Pregnancy Act 05
(c) Write Short note on Abbreviated New Drug Application (ANDA) 05

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Q.5 (a) Write in brief about Institutional Animal Ethics Committee (IAEC) 06
(b) Discuss provisions of Drugs and Magic Remedies act’ 1954 05
(c) Define Code of Pharmaceutical Ethics. Discuss it in relation to pharmacist’s 05
Job.
Q. 6 (a) Write short note on Patent and Copyright 06
(b) Write a note about Emergency Use Authorization (EUA) 05
(c) Write a note on Documentation required for Community pharmacy (Retail sale) 05

Q.7 (a) Write about Consumer protection Act OR Education Regulation 06


(b) Documentation required for Export of drugs and medical devices 05
(c) Write a note on Good Manufacturing Practice OR Requirements of Blood Bank 05

***************

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