D.Pharm 2nd Year Pharmacy Law and Ethics Important Question

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Table of Contents

Developing of the Pharmacy Profession in India

Multiple Choice Questions

  1. The Pharmaceutical Society of India was established in:
    a. 1923
    b. 1925
    c. 1944
    d. 1947
  2. Who is the father of medicine?
    a. None
    b. Galen
    c. Hippocrates
    d. None
  3. Which company was founded by Dr. Khwaja Abdul Hamied in:
    a. Cipla, 1935
    b. Ranbaxy Industries, 1966
    c. Lupin, 1968
    d. Aurobindo Pharma, 1966
  4. In developed countries, the qualification of a pharmacist includes pharmaceutical jurisprudence. Discuss in brief the importance of pharmaceutical jurisprudence.
  5. Discuss in brief the present pharmacy education in India.

Short Answer Questions

  1. Write a note on pharmacy education abroad.
  2. Write a note on the history of pharmacy.
  3. Define jurisprudence. Discuss in brief the importance of pharmaceutical jurisprudence.
  4. Discuss in brief the present pharmacy education in India.

Long Answer Questions

  1. Describe in brief the historical development of the pharmacy profession in India.
  2. Compare the pharmacy education in India with pharmacy education abroad.
  3. Discuss the Indian Pharmaceutical Industries.

Pharmacy Act – 1948 and Rules

Short Answer Questions

  1. What are the objectives of the Pharmacy Act, 1948?
  2. Give the functions and constitution of the Pharmacy Council of India.
  3. Define the following:
    a) Registered pharmacist
    b) Repatriates
    c) State Council
    d) Registered Medical Practitioner
    e) Displaced Person
  4. Write a note on the Central Register.
  5. Give the constitution of the Joint State Pharmacy Council.

Long Answer Questions

  1. Give the offences and penalties under the Pharmacy Act, 1948.
  2. What are the special provisions for displaced persons, repatriates, and other persons?
  3. Under what conditions can the names of certain persons be registration of their name in the register?

Drugs and Cosmetics Act 1940 and Rules 1945, and new Amendments

Short Answer Questions

1. What are the objectives of the Drugs and Cosmetics Act, 1940?

2. Define the following:

   a. Adulterated drug

   b. Spurious drug

   c. Misbranded drug

   d. Cosmetics

   e. Drug

   f. Manufacture

   g. Ayurvedic, Siddha, and Unani drugs

   h. Loan license

   i. Repacking of drugs

   j. Drug Inspector

   k. Qualified person

   l. Government Analyst

   m. Standards of quality

   n. Patent and proprietary medicine

3. Cite the constitution and function of the Drugs Technical Advisory Board.

4. Give the functions of the Central Drugs Laboratory.

5. How are the samples for test or analysis dispatched to the Central Drugs Laboratory?

6. What qualifications will entitle a person to be appointed as a Government Analyst?

7. Give the duties of a Government Analyst.

8. What procedure should be followed by a Government Analyst on the receipt of a sample from a Drug Inspector?

9. What qualifications are required for a person to be appointed as a Drug Inspector?

10. What are the powers of Drug Inspectors?

Long Answer Questions

1. What procedure should be followed by Drug Inspectors while sending the samples for test or analysis?

2. What do you mean by a restricted license? Describe the conditions of it and the conditions to be fulfilled by the licensee.

3. In which forms shall the application be made for the grant of a license? Mention different forms in which licenses are to be issued.

4. What qualifications are required for a person to be appointed as a licensing authority and appointing authority?

5. Give the constitution of the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board.

6. Discuss the conditions for the manufacture of Ayurvedic, Siddha, and Unani drugs.

7. Describe the conditions for the manufacture of Homoeopathic medicines.

8. Discuss in brief the sale of Schedule H and Schedule X drugs.

9. Discuss in brief the conditions for the manufacture of drugs other than those specified in Schedule C, C(1), and X.

10. Describe the general condition of a License.

Narcotic Drugs and Psychotropic Substances Act 1985 and Rules

Short Answer Questions

1. What are the objectives of the Narcotic Drugs and Psychotropic Substances Act, 1985?

2. Write a note on the National Fund for Control of Drug Abuse.

3. Define the following:
a) Narcotic drugs
b) Medicinal Cannabis
c) Medicinal opium
d) Coca derivatives
e) Opium poppy
f) Alcohol
g) Addict
h) Poppy straw

4. Explain the procedure to issue a warrant to a person punishable under this Act.

Long Answer Questions

1. Discuss the powers of the Central Government to control various operations.

2. Describe in brief the administrative agencies under this Act.

3. Describe the offences and penalties under this Act.

Drugs and Magic Remedy

Short Answer Questions

  1. What are the objectives of the Drugs and Magic Remedies Act, 1954?
  2. Give the offences and penalties under this Act.
  3. Define the following:
    a) Magic remedy
    b) R.M.P.
    c) Advertisement
    d) Drug

Long Answer Questions

  1. Give the classes of advertisements of drugs to which the DMR Act, 1954, is made applicable.
  2. Give the classes of advertisements of drugs to which the DMR Act, 1954, is not made applicable.

Prevention of Cruelty to Animals Act, 1960

Short Answer Questions

1. What are the objectives of the Prevention of Cruelty to Animals Act, 1960?

2. Give the constitution and functions of the Animal Welfare Board.

3. Write a note on experimentation on animals.

4. Define the following:
a) Cruelty
b) Animal
c) Phokka or Doom Dev

Long Answer Questions

1. Describe the rules made by the Committee while performing experimentation on animals.

2. Give the offences and penalties under this Act.

3. Under what conditions will the Committee prohibit the experimentation of animals?

The Poison Act, 1919

Multiple Choice Questions

1. Import of poison is regulated by:
a) State Government
b) Central Government
c) State Council
d) Central Council

2. Possession and possession for sale of poison is regulated by:
a) State Government
b) Central Government
c) State Council
d) Central Council

Short Answer Questions

1. What is the objective of the Poisons Act, 1930?

2. Define ‘poison’ under the Poisons Act, 1930.

3. What implications are regulated by the State Government for possession for sale of any specified poison?

4. How is the import of poisonous substances regulated by the Central Government?

5. Give the offences and penalties under this Act.

6. Enlist List A and List B poisonous substances.

FSSAI (Food Safety Standards Authority of India) Act and Rules

Multiple Choice Questions

1. As per the FSS Act, the sale of certain mixtures is prohibited. Which of the following is included in this?
a. Condensed milk
b. Water-mixed milk
c. Curd made from pasteurized milk
d. Coffee and chicory blend

2. Which of the following is not true about FSSAI?

a. Head office situated in Delhi.
b. It is a single reference point for all matters relating to FSSAI.
c. FSSAI has been established under the Food Safety and Standards Act, 2006
d. FSSAI has not established the ‘Food Safety and Standards Act 2006’.

3. Which of the following is not a food item?
a. Dried meat
b. Flesh and other edible parts of a carcass
c. Cured meat
d. Vegetable oil

Short Answer Questions

1. What are the objectives of the FSSAI (Food Safety and Standards Authority of India) Act and Rules?

2. Give the composition and functions of the FSSAI Act.

3. What are the challenges of the FSSAI Act?

4. What is the FSSAI Act 2006?

National Pharmaceutical Pricing Authority

Multiple Choice Questions

1. DPCO 1987 was replaced by:
a. 1990
b. 1995
c. 1997
d. 2000

2. The Drug Price Control Order was passed with the aim to:
a. Achieve adequate production
b. Secure or regulate equitable distribution
c. Make these available at fair prices
d. All of the above

Short Answer Questions

1. What are the objectives of the National Pharmaceutical Pricing Authority?

2. What are the quality aspects of this Act?

3. What are the criteria for deletion of a medicine from NLEM 2015?

4. What is the purpose of the National List of Essential Medicines?

5. Explain the National List of Essential Medicines (NLEM).

Code of Pharmaceutical Ethics

Short Answer Questions

  1. What is an apprentice pharmacist as per the code of pharmaceutical ethics?
  2. Enlist the code of pharmaceutical ethics in relation to the medical profession.
  3. How should a pharmacist follow fair trade practices as per the code of pharmaceutical ethics?
  4. Describe professional vigilance as a code of pharmaceutical ethics.
  5. Define pharmaceutical ethics.
  6. Reproduce the pharmacist’s oath.
  7. Write a brief note on the code of pharmaceutical ethics.
  8. Differentiate between ethics and laws.
  9. Write about the role of a pharmacist in the health care system.

Long Answer Questions

  1. Define the code of ethics. Explain the receiving and handling of prescriptions by a pharmacist.
  2. Discuss the code of ethics for a pharmacist in relation to their trade.
  3. Discuss the code of ethics for a pharmacist in relation to their job.
  4. Mention the role of a pharmacist in relation to their medical profession.
  5. Describe the role of a pharmacist in relation to their profession.

Medical Termination of Pregnancy Act, 1971 and Rules

Multiple Choice Questions

1. MTP is an acronym for:

   a) Menstrual Termination of Pregnancy

   b) Medical Test for Pregnancy

   c) Medical Termination of Pregnancy

   d) Menstrual Test for Pregnancy

 2. Which of the following is not a reason for the debate of legalizing MTP in many countries?

   a) Emotional issues

   b) Ethical issues

   c) Religious issues

   d) Economic issues

3. What restriction has been posed by the Government of India on the use of MTP?

   a) Illegal female foeticide

   b) Illegal use of narcotics

   c) Illegal drug smuggling

   d) Illegal sale of narcotics

4. What period of pregnancy are the MTPs safest?

   a) First trimester

   b) Second trimester

   c) Third trimester

   d) Fourth trimester

5. Recent amendment of MTPs is:

   a) 2021

   b) 2010

   c) 2018

   d) 2014

Short Answer Questions

1. Write a short note on termination of pregnancy as per the MTP Act.

2. Describe the places where pregnancy may be terminated as per the MTP Act.

3. Write a short note on the role of Chief Medical Officer (CMO).

4. Mention the objectives of the MTP Act.

5. Mention the circumstances under which pregnancy can be terminated.

6. Mention the offences and penalties of MTP.

Long Answer Questions

1. Define the following terms as per MTP Act, 1971:

   a. Guardian

   b. Minor

   c. Restricted preparation

   d. Unrestricted preparations

2. Give the bona fide reasons for termination of pregnancy under the Medical Termination of Pregnancy Act, 1971.

3. Give the procedure to be followed for the movement of goods from one warehouse to another under the MTP Act, 1955.

4. Give three offences and penalties for the same under the MTP Act, 1971.

5. What are the approved places for MTP under MTP Act, 1971? Give the conditions for approval of places for termination of pregnancies.

6. Mention whether termination of pregnancies at residence will be legal or illegal. State the places where it will be legal with facilities as per MTP Act, 1971.

Role of Government Pharma Regulator Bodies

Multiple Choice Questions

1. The drug regulatory authority in India is:

   a) USFDA

   b) CDSCO

   c) TGA

   d) MHRA

2. CDSCO is:

   a) Central Drug Standard Control Organization

   b) Central Development Standard Control Organization

   c) Center for Drug and Standard Control Organization

   d) Centers of Dose Stability Control Organization

3. CDSCO is located in:

   a) Mumbai

   b) New Delhi

   c) Bhopal

   d) Pune

4. Major vision of CDSCO is:

   a) Safety of public health

   b) Efficacy of drugs

   c) Quality of drugs

   d) Remove impurities

5. Who is head of CDSCO?

   a) Dr. V.G. Somani

   b) Dr. V.V. Chandankhar

   c) Dr. Ritu Saha

   d) Dr. Gaurav Kumar

Short Answer Questions

1. What is CDSCO and its major functions?

2. What are the vision and duties of CDSCO?

3. What are Indian Pharma and co-patented Commission?

4. What is CDSCO and its duties?

5. What are the vision and mission of CDSCO?

Good Regulatory Practices

Short Answer Questions

1. What are Good Regulatory Practices?

2. Give the scope of Good Regulatory Practices?

3. Define Community Pharmacy.

4. Define Hospital Pharmacy.

Long Answer Questions:

1. Write a note on the amendment of the policies made by CDSCO & DCGI.

2. Write a note on the pharma manufacturing and wholesale business of pharmaceutical products.

BCS System & New Drug Discovery and Development

Short Answer Questions

1. Define Biopharmaceutics and protein binding.

2. Define absolute and relative bioavailability.

3. What is NDA and ANDA?

4. Differentiate between branded and generic drugs.

5. What is the BCS system and its classes?

Long Answer Questions

1. Write in detail about NDA.

2. What is bioavailability? Discuss the different methods for measurement of bioavailability.

3. Explain branded drugs and generic drugs with examples.

4. What is the BCS system and its classification of drugs?

5. Explain ANDA.

Blood Bank – Basic Requirements and Functions

Short Answer Questions

1. Define blood and its functions.

2. What is a blood bank?

3. What is a blood bank and its objectives?

4. What are antibodies?

5. What is clotting time?

Long Answer Questions

1. What is a blood bank, its scope, and objectives?

2. What is blood and its functions?

3. What are blood bank tests?

4. What is blood, and explain the different blood groups?

Clinical Establishment Act and Rules

Multiple Choice Questions

1. The Clinical Establishments Act was passed by the Parliament of India on:
a) 17th August 2010
b) 17th July 2010
c) 17th August 2012
d) 17th August 2014

2. The number of members required for the establishment of the National Council of Clinical Establishments is:
a) 25
b) 20
c) 30
d) 25

3. A multi-member authority at the district level is known as:
a) State
b) Central
c) District
d) None

Short Answer Questions

1. What is the Clinical Establishments (Registration & Regulation) Act, 2010?

2. What does ‘clinical establishments’ mean?

3. What are the salient features of the Act?

4. What is the objective of the Act?

5. What are the functions of the National Council for Clinical Establishments?

Biomedical Waste Management Rules 2016

Multiple Choice Questions

1. Which of the following areas has the lowest chance of producing biomedical waste?
a) Hospitals
b) Clinics
c) Laboratories
d) Agricultural lands

2. Which of the following is not a biomedical waste?
a) Animal waste
b) Microbiological waste
c) Chemical waste
d) Domestic waste

3. Which of the following should not be mixed with other waste to avoid contamination?
a) Tarry residue
b) Oily sludge
c) Animal waste
d) Vegetable oil

4. Which of the following is not a waste treatment method for biomedical waste?
a) Incineration
b) Chemical disinfecting
c) Autoclaving
d) Slewing

Short Answer Questions

1. Define biomedical waste.

2. What is the importance of managing biomedical waste?

3. What are the different types of biomedical waste?

4. What is containment?

5. How should biomedical waste be stored?

6. What methods of treatment technologies are available at the primary health center level to manage biomedical waste?

Bioethics

Multiple Choice Questions

1. The American biochemist ______ coined the term bioethics in 1970.

   a. Van Rensselaer Potter

   b. Tom Beauchamp

   c. James Franklin Childress

   d. None

2. The long form of IBC is ______.

   a. International Bioethics Council

   b. International Bioethics Committee

   c. International Biomedical Committee

   d. International Biomedical Council

Short Answer Questions

1. Define Bioethics?

2. Give purpose of Bioethics?

3. Give importance of Bioethics?

4. Who published Principles of Biomedical Ethics?

Long Answer Questions

1. Define bioethics? Give purpose, principle, and importance of bioethics?

2. Explain ICMR’s National Ethical Guidelines for Biomedical?

Introduction to The Consumer Protection Act

Multiple Choice Questions

1. Which of the following are consumer rights specified in the Consumer Protection Act?
a) Right to safety
b) Right to choose
c) Right to consumer education
d) All of the above

2. The Consumer Protection Act is significant to:
a) Immovable goods
b) Movable goods
c) Particular goods and services
d) All goods and services

3. How many rights does a consumer have under the Consumer Protection Act?
a) 8
b) 6
c) 1

4. Under the Consumer Protection Act, the rights of a consumer do not include the right to be:
a) Safe
b) Choose
c) Protected
d) None

5. In which forum is it compulsory to have a female member?
a) National Commission
b) State Commission
c) District Commission
d) All of the above

Short Answer Questions

1. What are the main features of the Consumer Protection Act 2019?

2. What consumer rights are guaranteed under the Consumer Protection Act, 2019?

3. What is an unfair contract?

4. What is a misleading advertisement?

5. What is the Consumer Protection Act?

6. What is the Consumer Protection Act, and what is its objective?

Page 20

Introduction to the Disaster Management Act

Multiple Choice Questions

1. The National Institute of Disaster Management was inaugurated on:
a) September 23, 2006
b) October 2006
c) August 2006
d) None

2. The head office of the National Institute of Disaster Management is situated in:
a) Kolkata
b) New Delhi
c) Hyderabad
d) Manipur

3. When do situations of hazard arise?
a) When there is a threat of natural consequences of the disaster
b) When there is a threat to the consequences of the disaster
c) When there is a threat to property and lives from calamities
d) All of the above

4. The National Disaster Management Authority comes under:
a) Ministry of Pollution
b) Ministry of Environment
c) Ministry of Home Affairs
d) Ministry of Foreign Affairs

5. Among which of the following are hazards and disasters classified?
a) Cultural and social
b) Natural and man-made
c) Chemical and physical
d) Human and physical

Short Answer Questions

1. What is disaster management?

2. Explain man-made disasters with examples.

3. What do you mean by hazards?

4. What is rehabilitation?

5. What are the psychological effects of a disaster?

Long Answer Questions

1. Explain the salient provisions of the National Disaster Management Act.

2. Define what you mean by disaster, hazard, and vulnerability.

3. Explain the importance and principles of disaster management policies.

4. Write a short note on:
a) Direct effects of disasters.
b) Indirect effects of disasters.

Page 21

Medical Devices – Categorization, basic aspects Related to Manufacture and Sale

Multiple Choice Questions

1. The classes of medical devices are:
a) Class I
b) Class II
c) Class III
d) All of the above

2. Class II medical devices are:
a) Lowest
b) Moderate
c) Highest
d) None

3. Class II medical devices are:
a) Lowest
b) Moderate
c) Highest
d) None

Short Answer Questions

1. What is a medical device?

2. How does the FDA classify medical devices?

3. What are the uses of medical devices?

4. What are the phases of medical devices?

5. What are the classes of medical devices?

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