Pharmacy Law & Ethics Sample Papers

Sample Paper 1. Pharmacy Law & Ethics ER20-26T Time: 3 Hrs. M.M.: 80 2nd Year / Pharmacy.

SECTION-A

One-word / Multiple choice question. All questions are compulsory (20x1=20)

• Q.1 Drug Import Bill was passed in the year a) 1935 b) 1937 c) 1939 d) 1941

• Q.2 Write the full form of the IPR

• Q.3 PCI was constituted in a) 1919 b) 1948 c) 1949 d) 1942

• Q.4 The instruments of legislation are a) Act b) Section c) Orders d) All of the above

• Q.5 PCI is reconstituted at every a) 1 year b) 2 years c) 4 years d) 5 years

• Q.6 The schedule for the life period of the drug is

  a) Schedule Q b) Schedule P c) Schedule R d) Schedule S

• Q.7 Examples of Narcotic drugs a) Opium b) Coca c) Hemp d) All of the above

• Q.8 Advertisement of drugs claiming cure of disease mentioned in Schedule-j is

  a) Granted b) Prohibited c) Exempted d) None of the above

• Q.9 Display signboard or notices by a registered medical practitioner on his premises fall under

  a) Regular advertisement b) Permitted advertisement

  c) Exempted advertisement d) Prohibited advertisement

• Q.10 According to the Prevention of Cruelty to Animals Act,1960, the word ‘animal’ means any living creature except.

  a) Birds b) Animals c) Human Beings d) None of the above

• Q.11 Biomedical waste Management, Rules came into existence in the year _______

• Q.12 The Poison Act came into existence in the year __________.

• Q.13 What is the meaning of ED in the calculation of the retail price of drugs?

  a) Excise duty b) Exempted duty c) Extra duty d) Emergency Duty

• Q.14 The drug prices Control Order applies to

• a) Ayurveda medicines b) Unani Medicines

• c) Homoeopathic medicines d) Allopathic Medicines

• Q.15 The code of ethics of pharmacy is developed by a) PCI b) SPC c) MCI d) DCGI

• Q.16 What is the full form of ICMR?

• Q.17 The Medical Termination of Pregnancy Act was passed in years

  a) 1965 b) 1971 c) 1947 d) 1945

• Q.18 Where is the headquarters of CDSCO located? a) Mumbai b) Kolkata c) Chennai d) Delhi

• Q.19 How many Zonal offices of CDSCO are there? a) 6 b) 2 c) 4 d) 8

• Q.20 The Drug Regulatory body of India is __________.

SECTION-B Note: Attempt any ten questions out of Eleven questions. (10x3=30)

• Q.21 What are the functions of the Animal Welfare Board of India?

• Q.22 Describe the role of Schedules. C, G and H as per Drugs and Cosmetic Act 1948

• Q.23 Explain the principles of bioethics.

• Q.24 Explain the classes of Drugs & Cosmetics prohibited from import.

• Q.25 Write a short note on the Licensing Authority Q.26 Explain the role and responsibilities of Government Analysts

• Q.27 Write a short note on Penalties under the Poisons Act, 1919

• Q.28 Elaborate on the functions of FSSAI Q.29 Define Ceiling price and Market Price.

• Q.30 Explain about the basic concept of clinical trials.

• Q.31 Write a short note on the Consumer Protection Act.

SECTION-C

Long answer type question. Attempt any six questions. Out of seven questions. (6x5=30)

• Q.32 Elaborate on the objectives of the Drugs and Magic Remedies (Objectionable Advertisements) Act, of 1954

• Q.33 What are the duties and functions of the Drug Technical Advisory Board?

• Q.34 Elaborate on the functions and composition of the state and joint state pharmacy councils.

• Q.35 Write a short note on the Termination of pregnancy by registered medical practitioners.

• Q.36 Explain briefly the steps involved in the Drug Development Process.

• Q.37 Describe the Offences & penalties as per the Narcotics & Psychotropic Substances Act.

• Q.38 Write short notes on any two:

  a) Restricted License b) National list of essential medicines c) Biomedical Waste

Alok Bains

Sample Paper 2. Pharmacy Law and Ethics ER20-26T 2nd Year / Time: 3Hrs. M.M.: 80

SECTION-A Note: Multiple choice questions. All questions are compulsory (20x1=20)

• Q.1 Drug import bill was passed in the year a) 1935 b) 1945 c) 1940 d) 1937

• Q.2 Poisons Act was passed in a) 1923 b) 1919 c) 1920 d) 1918

• Q.3 Central Registered maintained by a) AICTE b) MCI c) PCI d) State Council

• Q.4 An act regulates the profession of Pharmacy.

  a) Patent Act b) Cosmetic Act c) MTP Act d) Pharmacy Act

• Q.5 Grant of license to manufacture a drug requires

• a) Form 24 b) Form 25 c) Form 26 d) Form 27

• Q.6 As per D & C Act Schedule W.

  a) List of the minimum equipment required for the running of the Pharmacy

  b) Life Period of the Drugs c) Standard for disinfectant fluids

  d) None of the above

• Q.7 Examples of Narcotic Drugs a) Charas b) Morphine c) Ganja d) All the above

• Q.8 What is the meaning of ED in the calculation of the retail price of the drug?

  a) Directorate of Enforcement b) Exempted duty c) Excise duty d) Emergency Duty

• Q.9 Medical termination of pregnancy is safe up to

  a) 12 Weeks b) 18 Weeks c) 26 Weeks d) 10 Weeks

• Q.10 Which of the following areas has the lowest chance of producing biomedical waste?

  a) Hospitals b) Clinical c) Laboratories d) Agricultural lands

• Q.11 Regulatory body of USA ___________

• Q.12 Schedule M is related to ___________

• Q.13 What is the composition of the District Forum?

• Q.14 Government Opium Factory is located at _________

• Q.15 FSSAI means ___________

• Q.16 Ethics means ___________

• Q.17 How many patients are involved in clinical trial phase 2?

• Q.18 NDA means ___________

• Q.19 Medical Devices rules were established in the year ________

• Q.20 The State Disaster Management Authority is headed by ___________

SECTION-B

Short answer type questions. Attempt any ten questions out of eleven questions. (10x3=30)

• Q.21 What is the power of a drug inspector?

• Q.22 What are the standards of quality of misbranded drugs and adulterated drugs?

• Q.23 What are the conditions of import licenses?

• Q.24 Write a short note on Education Regulation.

• Q.25 Give general responsibility under the Food Safety and Standard Act.

• Q.26 Write a short note Indian Pharmacopoeia Commission (IPC).

• Q.27 Explain brand name versus generic name with example.

• Q.28 Write a short note on compulsory license in Intellectual Property Rights.

• Q.29 Write a short note on Registered Pharmacy.

• Q.30 Mention the treatment and disposal for the biomedical management rules 2016.

• Q.31 What are the functions of state authority of Disaster Management Act 2005?

SECTION-C

Long answer type questions. Attempt any six questions out of seven questions. (6x5=30)

• Q.32 What are the duties of Govt. Analyst?

• Q.33 Write a note on Drug & Magic Remedies.

• Q.34 Write a note on the objective and types of Clinical Trials.

• Q.35 Write a note on the e-governance of drug manufacturing.

• Q.36 What are the duties and functions of FSSAI?

• Q.37 Discuss in detail the requirements for the manufacture of blood products.

• Q.38 What is the procedure for granting a Patent in India?

Alok Bains

Sample Paper 3. Pharmacy Law & Ethics ER20-26T Time: 3 Hrs. M.M.: 80 2nd Year / Pharmacy

SECTION-A. Note: Multiple choice questions. All questions are compulsory (20x1=20)

Q.1 For the first time in India, a chemist shop was opened in about 1811 by

a) Mr. Bathgate b) Mr. Gajjar c) R.N. Chopra d) Mr. Gosh

Q.2 The Pharmacy Council reconstituted every a) 10 years b) 15 years c) 5 years d) 6 years

Q.3 Schedule "X" of the Drug & Cosmetics Act Comprises

a) List of incurable diseases b) Guideline for clinical trials

c) List of generic drugs d) None of the above

Q.4 AS per Drug & Cosmetics Act Schedule "FF" is related with

a) Paranteral Preparation b) Ointment Formulation

c) Skin Cosmetics Preparation d) Ophthalmic Preparation

Q.5 In 1985 one of the following acts was passed

a) Drug & magic remedies b) Poisonous Act

c) Narcotic & Psychotropic Substances Act d) Drug & Cosmetics Act

Q.6 Talisman, mantra & Kanawha come under

a) Misbranded Drugs b) Spurious Drugs c) Magic Remedies d) None of the above

Q.7 Animal welfare board is established by

a) the Central Government b) the State Government c) the Central Council d) the State Council

Q.8 The latest Drug Price Control Order was passed by a) 2012 b) 2013 c) 2015 d) 2014

Q.9 It means a science of morals or a code of moral principles

a) Ethics b) Morality c) Law d) Pharmaceuticals ethics

Q.10 Indian Pharmacopoeia Commission headquarters is located at

a) Delhi b) Hyderabad c) Mumbai d) Ghaziabad

Q.11 CDSCO means____________

Q.12 Write the regulatory body of Australia.

Q.13 IPR mean_____________

Q.14 How many phases are involved in a clinical trial?

Q.15 License for blood storage Centre is valid for________

Q.16 Human anatomical wastes are categorized into which category of biomedical waste_________

Q.17 The Disaster Management Act was made in___________

Q.18 The national Disaster management is headed by__________

Q.19 ICH means _____________

Q.20 DTAB means ____________

SECTION-B

Short answer type questions. Attempt any ten questions out of eleven questions. (10x3=30)

• Q.21 Write the classification of medical devices with an example.

• Q.22 Write the names of consumer protection councils

• Q.23 Explain the principles of bioethics.

• Q.24 Define biomedical waste and enlist the categories of biomedical waste.

• Q.25 Write the objective of the Clinical Establishment Act.

• Q.26 Write a short note on NDA. Q.27 Write a short note on the Loan License.

• Q.28 Write the qualifications of a Drug Inspector.

• Q.29 Write a short note on the Licensing Authority.

• Q.30 Mention the ex-officio member of PCI.

• Q.31 Write a short note on Clinical trial phase IV

SECTION-C

Long answer type questions. Attempt any six questions out of seven questions. (6x5=30)

• Q.32 Write the offence & penalties as per the Narcotic Drugs & Psychotropic Substances Act.

• Q.33 Write the function of the Animal Welfare Board of India.

• Q.34 What are the duties & functions of FSSAI?

• Q.35 Write a note on the retail Price of a schedule formation calculation.

• Q.36 Write a note on the Medical Termination of Pregnancy Act.

• Q.37 Explain in brief the new drug development process.

• Q.38 Write a note on the e-governance of drug manufacture.

Sample Paper 4. Pharmacy Law & Ethics ER-20-26T Time : 3 Hrs. M.M.: 80 2nd Year/ Pharmacy

SECTION-A Note: Multiple choice questions. All questions are compulsory (20x1=20)

• Q.1 OPIUM ACT was passed in the year. a) 1919 b) 1878 c) 1896 d) 1857

• Q.2 When did The Pharmacy Act 1948, come into force?

  a) 1 April 1949 b) 24 April 1948 c) 01 May 1949 d) 04 March 1948

• Q.3 The State Pharmacy Council Haryana is situated

  a) Chandigarh b) Faridabad c) Panchkula d) Rohtak

• Q.4 Schedule C is related to

  a) List of biological & immunological products b) List of Homeopathy Products

  c) List of Ayurvedic Products d) List of Allopathic Products

• Q.5 Cocaine is obtained from a) Opium b) Hemp c) Coca d) None of the above

• Q.6 As per D&C Act Schedule O.

  a) List of the minimum equipment required for the running of the Pharmacy

  b) Life Period of the Drugs c) Standard for disinfectant fluids d) None of the above

• Q.7 Advertising the report of Government Analyst is a) Exempted b) Permitted c) Prohibited d) None of the above

• Q.8 Code of Pharmaceutical Ethics is developed by

  a) PCI b) D & C Act c) Both of them d) None of the above

• Q.9 The main object of the Poison Act

  a) Control the import of the Poison b) Control the possession of the poison

  c) Control the sale of poison d) None of the above

• Q.10 Which authority issues the drug manufacturing license

  a) CDSCO b) IPC c) AICTE d) UGC

• Q.11 Regulatory body of Europe ....................

• Q.12 Schedule R is related to ....................

• Q.13 How many elected members are in the Joint State Pharmacy Council?

• Q.14 Headquarters of ICH ....................

• Q.15 ANDA means ....................

• Q.16 Ethics means ....................

• Q.17 How many patients were involved in clinical trial phase 3?

• Q.18 BCS means ....................

• Q.19 PAHO means ....................

• Q.20 The Disaster Management Authority is headed by ....................

SECTION-B

Short answer type questions. Attempt any ten questions out of eleven questions. (10x3=30)

• Q.21 What are the Qualifications of a drug inspector?

• Q.22 Write the composition of DTAB. Q.23 Write a short note on Registered Pharmacists.

• Q.24 Describe in brief the offences & penalties of the Medical Termination of Pregnancy Act.

• Q.25 List key functions of CDSCO. Q.26 Define trademarks and copyrights as per IPR.

• Q.27 Define Magic Remedy, Advertisement and Opium.

• Q.28 What are the classes of drugs prohibited to import into India?

• Q.29 Discuss theories of Bio-ethics.

• Q.30 Discuss about the regulatory aspects of the Medical Devices.

• Q.31 What are the functions of state authority of Disaster Management Act 2005?

SECTION-C

Long answer type questions. Attempt any six questions out of seven questions. (6x5=30)

• Q.32 Define PCI and Illustrate the functions of PCI.

• Q.33 Write a note on the Poison Act.

• Q.34 Explain the redressal mechanism available to consumers under the Consumer Protection Act 1986 in brief.

• Q.35 Write a note on Pharmacists in relation to the medical profession.

• Q.36 Write the difference between Branded and Generic drugs.

• Q.37 Write a note on the standard operating procedures of the blood bank.

• Q.38 Write a note on Indian Pharmacopoeia Commission (IPC).

Alok Bains