20226
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03 Hours / 80 Marks Seat No.
Instructions
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% +r@eJr*4 $?, (2) Answer each next main Question
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814
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(3) Mobile Phone, Pager
810 and any other Electronic Communication devices
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are not permissible in Examination Hall.
(4) Incase student has attempted sub-question of question no. 3 more than
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once, only first B^^^BP C B^^^B
attempt should be considered for assessment.
# 7?+ 8P&FK)" 1 7+!n?CyT(09-!: Marks
0224 20115
1. Attempt any SIX of the following: 30
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a) List ex-officio members and describe the functions of the Pharmacy Council of
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2
0113
India.
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b) Give objective of D&C Act 1940 and Give constitution of DTAB.
c) Define:
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i) Misbranded drug and
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ii) Adulterated drug as per D&C Act, 1940
d) What does following schedule contains as per Drugs and cosmetic Act 1940:
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i) Schedule A
ii) Schedule G
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iii) Schedule H
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202
iv) Schedule N
v) Schedule R
e) Define ‘Bulk drug’ as per DPCO and how the retail price of a formulation is
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calculated?
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815 f) Explain the code of ethics by the PCI for the pharmacist in relation to his Job.
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g) Describe the phases of clinical trials.
2. Attempt any TEN of the following:
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30
a) Describe
' 7%!+964; 8 76"" the recommendations of the drug enquiry committee.
0225 b) State the classes of drugs prohibited to import as per D&C Act, 1940.
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c) Give functions of CDL as per D&C Act, 1940 (Any 6)
d) Write the qualification required to appoint a government analyst as per D&C Act,
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e) Define opium. Addict and coca leaf as per NDPS Act, 1985.
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809 f) Define Magic Remedies? State the objectives of drugs and magic remedies Act,
1954.
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g) State the various rules prescribed by State Government for possession, possession
for sale and for sale of poisonous substances under Poison Act, 1919.
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h) Write any three bonafied reasons for termination of pregnancy under MTP Act,
1971.
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0114
i) Discuss the documentation and License required for community pharmacy as per
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good regulatory practices.
j) Give difference between Brand name drug and Generic drug.
k) Explain the constitution of the national council for clinical establishments.
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1 /3+$9;%8?
P.T.O.
816
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20226
811
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20112
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[2] 20226
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Marks
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3. Attempt ALL of the following:
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a) DTAB has __________ Ex-officio members.
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b) Examples of schedule
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i) Analgin ii) Amobarbital
26
iii) Pentobarbital
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iv) Cyclobarbital
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c)
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Indian veterinary research
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institute is situated at __________ .
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20115
1 7+!n?CyT(09-!:
d) CPCSEA stands for __________ .
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e) According to ‘Prevention of cruelty to Animal Act’, ‘Animal’ means any living
creature other than __________ .
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f) State any two important things should appear on the label of Food Supplements
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812 808
as per FSSAI.
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g) What does schedule I prescribe as per DPCO.
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h) State any two examples of drug added to the list of NLEM 2021.
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i) Hawking of drugs is
20222
a part of ethics related to __________
20113
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i) Pharmacist in relation to his job
ii) Pharmacist in relation to his trade
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iii) Pharmacist in relation to medical profession
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806 815
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iv) Pharmacist in relation to his own profession
j) MTP Act was passed in year __________ .
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k) Role of CDSCO except __________
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20111 20225
i) Responsible for approval of new drug
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ii) Conduct of clinical trials
202
iii) Amendments of D&C Act and rules
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813 iv) Publish Indian 809
Pharmacopoieu
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l) Write the full form of CDER with respect to pharmacy profession.
m) State the function of blood bank.
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n) Human Anatomical 20114
20223
Waste is discarded in which category as per biomedical waste
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management schedule.
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o) What is the long form of ICMR.
p) What are the common bioethical issues?
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i) Eugenics
807 816
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ii) Euthanasia
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iii) Organ donation iv) All of these
q) State the name of bioethical principle. 18 / 1
r) The consumer protection act was initiated in India in year __________ .
s) National Institute of Disaster Management authority comes under __________
i) Ministry of Home Affairs ii) Ministry of Environment
iii) Ministry of Pollution iv) Ministry of Foreign Affairs
t) Give two example of medical device.
