Seat No.: _____ Enrolment No.
_____________
GUJARAT TECHNOLOGICAL UNIVERSITY
DIPLOMA PHARMACY YEAR- 2 EXAMINATION – SUMMER - 2023
Subject Code: DP206TT Date: 26/06/2023
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) 1)
G Give a statement of Schedule N
2)i Write down the full form of DTAB
v
3) When the prevention of cruelty to animal act was passed
e
4)t Give a definition of cosmetic
5)h Give a statement of schedule Q
6)e Import of poison is controlled by________
7)s What is a full form of ANDA
8)t The prescribed registration fees should be paid before_______of every year
9)a Central drug laboratory is located at_______
t ________is local body which allows experiments on small animals
10)
e
11) In retail price calculation what is meaning of M.C
m
e According to BCS, class III drugs have_______
12)
n What is a full form CDSCO
13)
t A drug sample taken by drug inspector for analysis is sent to__________
14)
o The narcotic and psychotropic substance act was passed in_________
15)
f
16) Write down full form of FSSAI
17) Which type of research trials do not involve human beings
18) Full form of NDRF is________
19) Medical termination of pregnancy is safe upto_______weeks
20) The P.C.I was constituted in__________
Q.2 (a) Discuss constitution and function of PCI 06
(b) Discuss prohibited and exempted Advertisement under Drug and Magic 05
Remedies act
(c) Discuss the function of CPCSEA 05
Q.3 (a) Discuss objective, offences, penalties of narcotic Drugs and psychotropic 06
Substance act, 1985
(b) Discuss qualification and responsibilities of Drug Inspector 05
(c) Discuss silent feature of DPCO and how the MRP of drug is calculated 05
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Q.4 (a) Write a short note on Medical termination of pregnancy act 06
(b) Write a detailed short note on DTAB 05
(c) Explain Import of drug in detail 05
Q.5 (a) Discuss the code of pharmaceutical ethics drafted by PCI 06
(b) What is clinical trials and explain various phases of clinical trials 05
(c) Write a detailed note on food Analyst 05
Q.6 (a) What is BCS system of classification and explain various classes 06
in detail.
(b) Discuss loan license and repacking license in detail. 05
(c) Write a short note on Good Regulatory Practice 05
Q.7 (a) Write a detailed note on labeling and packing of drug. 06
(b) Discuss the blood bank in detail 05
(c) Explain poison act in detail 05
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