Pharmacy Law And Ethics

Course: D.Pharmacy Code: 8111 Branch: UNKNOWN Date: Unknown 2024

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F/2024/8111
[2]
Total Pages : 2
Second Year Pharmacy
PHARMACY LAW AND ETHICS
(ER20-26T)
Time: Three Hours
Maximum Marks : 80
Note :
  1. Attempt any five questions out of eight.
  2. Each question carry equal marks.
1.
a) Discuss the background of Chopra committee and Bhore committee and their recommendations in shaping the drug legislation in India.
6
b) Compare the constitution and functions of State pharmacy councils and joint State pharmacy councils.
6
c) Define the terms
  1. Registered pharmacist
  2. Central register
  3. Clinical pharmacists
  4. Misbranded drugs
4
2.
a) How many types of licences can be issued for the sale of drugs? Describe the general procedure for obtaining a sale licence stating the condition to be satisfied.
8
b) Describe the constitution and functions of Drug Technical Advisory Board (DTAB).
4
c) Describe the labelling requirement for ophthalmic products.
4
3.
a) What is meant by manufacture in bond? Outline the procedure that should be followed in obtaining a licence for manufacture in bond including the conditions that are to be filled.
8
b) Discuss the advertisements whose import and export is prohibited.
4
c) Define the terms.
  1. Narcotic drug
  2. Psychotropic substance
  3. Opium
  4. Opium derivatives
4
4.
a) State the objectives of prevention of cruelty to Animal Act. Explain its provisions relating to experimentation on animals.
8
b) Describe the penalties under the poisons Act.
4
c) Describe aims and objectives of FSSAI Act.
4
5.
a) Explain the core ethical principles in pharmacy practice and healthcare.
6
b) Give the objectives of drug (price control) order.
6
c) Write the full form of following abbreviates.
  1. CPCSEA
  2. CDSCO
  3. BMW rules
  4. GMP
4
6.
a) Discuss briefly the major regulatory bodies relating to drugs and pharmaceuticals in India.
6
b) Give the objectives and benefits of e-Governance.
6
c) Define the following terms.
  1. Guardian
  2. Lunatic
  3. Minor
  4. Registered medical Practitioner
4
7.
a) What is New Drug Development? Explain its importance.
6
b) Discuss in requirements for the functioning and operation of a Blood Bank.
5
c) Discuss the functions of National Council of Clinical establishments.
5
8.
Write note any four of the following.
  1. Schedules for BMW management
  2. Functions of Ethics committee
  3. Consumer Disputes Redressal Commission
  4. National Policy on Disaster Management, 2009
  5. Sale of medical devices
16
F/2024/8111
P.T.O.