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Second Year Pharmacy
PHARMACY LAW AND ETHICS
(ER20-26T)
Time: Three Hours
Maximum Marks: 80
Note: i) Attempt any five questions
ii) Each question carry equal marks.
1. a)
Explain the role of Pharmacist in Health Care System.5
b)
Why should pharmacist study law?5
c)
Describe the functions of Pharmacy Council of India.6
2. a)
Give qualifications for appointment as Drug Inspector? Explain their powers and procedures.8
b)
State the offences and penalties relating to sale of drugs.4
c)
Define the following terms:4
- New Drug
- Spurious drugs
- Ethics
- Clinical trial
3. a)
Explain the objectives of Narcotic Drugs and Psychotropic Substance Act.6
b)
Compare the advertisements which are6
- Prohibits
- Exempted
c)
Describe the layout and construction of bonded laboratory.4
4. a)
Describe constitution and functions of Institutional Animal Ethics Committee.6
b)
What is meant by specified poisons? How are the import, possession and sale of poisons regulated under the Act?6
5. a)
Explain the procedure for FSSAI registration.4
b)
How are the prices of formulations to the whole sales and retailers calculate?6
c)
Who can terminate a pregnancy and what experience or training etc should be passes?6
d)
Define Registered Pharmacist and give the qualification for registration.4
6. a)
Explain the vision, mission and functions of Indian Pharmacopoeia Commission.6
b)
Discuss the key components of Good Regulatory Practices.6
c)
Explain the terms:4
- Genetic drugs
- NDA
- Patent
- PPE
7. a)
Discuss the functions of hospital blood bank.6
b)
Discuss the functions of Clinical Establishment Act.6
c)
Explain the General Guidelines for Clinical trial.4
8.
Write notes on the following (any four):16
- Consumer rights
- National Disaster Management Authority
- Medical and Non-medical Devices
- Importance of Pharmacist and Oath
- Drug Enquiry Committee