This article is an exam oriented Pharmacy Law and Ethics question paper for D. Pharmacy students. It is useful for board exam preparation, revision, and practice for MSBTE, AKTU, BTEUP, RUHS and other state boards.
Pharmacy Law and Ethics Practice Question Paper
Course: Diploma in Pharmacy
Time: 3 Hours
Maximum Marks: 80
Section 1: Long Answer Questions
Attempt any SIX of the following:
(6 × 5 = 30 Marks)
- Write the constitution and functions of the State Pharmacy Council.
- Discuss the code of ethics of a pharmacist in relation to his trade as per the code of ethics.
- Explain Schedule N under the Drugs and Cosmetics Act, 1940 in detail.
- What are clinical trials? Discuss briefly the phases of clinical trials.
- Write the qualifications and powers of a Drug Inspector under the Drugs and Cosmetics Act, 1940.
- Write the constitution and functions of the Drugs Technical Advisory Board.
- State any two objectives of DPCO, 1995. Describe the formula for calculating the retail price of a formulation.
Section 2: Short Answer Questions
Attempt any TEN of the following:
(10 × 3 = 30 Marks)
- Give the important recommendations of the Drug Enquiry Committee and explain their significance.
- Discuss any three functions of the Central Drugs Laboratory.
- Describe the labelling requirements of ophthalmic preparations under the Drugs and Cosmetics Act, 1940.
- Explain briefly the provisions related to import of drugs under the Drugs and Cosmetics Act, 1940.
- Write any three offences and penalties under the NDPS Act, 1985.
- Give bona fide reasons for termination of pregnancy as per the MTP Act, 1971.
- What are Good Regulatory Practices? Write about documentation and licences in a community pharmacy.
- Define patent. Enlist the various types of Intellectual Property Rights (IPR).
- Explain the registration of clinical establishments as per the Act.
- State the classes of exempted advertisements as per the Drugs and Magic Remedies Act, 1954.
- Define poison. Give the objectives of the Poisons Act, 1919 with two examples.
Section 3: Very Short Answer / Objective Type
Attempt ALL of the following:
(20 × 1 = 20 Marks)
- Define Chemist and Druggist under the Drugs and Cosmetics Act, 1940.
- As per the Drugs and Cosmetics Act, Schedule O is related to __________.
- The list of drugs used by a patient under medical supervision is covered under __________.
i) Schedule G ii) Schedule H iii) Schedule I iv) Schedule J - CPCSEA has its headquarters at __________.
- A price fixed by the Government for scheduled formulations according to the provisions of DPCO is called:
i) Ceiling price ii) Retail price iii) Buying price iv) Maximum retail price - Post-tax return on net worth under DPCO, 1995 is __________.
- Hawking of drugs is a part of the ethics of a pharmacist in relation to which code of ethics?
- Define lunatic under the MTP Act, 1971.
- Registration of breeders requires permission from:
i) Central Government ii) IAEC iii) CPCSEA iv) No permission required - IPC stands for:
i) Indian Pharmaceutical Congress
ii) International Pharmacy Council
iii) Indian Pharmaceutical Council
iv) Indian Pharmacopoeia Commission - The principle of bioethics is essentially derived from religious books. State True or False.
- What is the SUGAM portal?
- Enlist the steps involved in a biomedical waste treatment method.
- How often can blood be donated?
- The core principles of bioethics include the following except:
i) Justice ii) Autonomy iii) Beneficence iv) Maleficence - Enlist any two rights of consumers as per the Consumer Protection Act, 2019.
- Write the full form of NDRF.
- High-risk medical devices are classified under which class?
- Headquarters of FSSAI is located in __________.
- State any one guideline of ICMR.
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