Table of Contents
Pharmaceutical jurisprudence question bank B pharmacy semester 5
Pharmaceutical jurisprudence question bank released by rguhs Bangalore. It contains all the important questions according to PCI syllabus, also contains all the questions in 10, 5, and 2 marks format.
UNIT-I Pharmaceutical jurisprudence question bank
Drugs and Cosmetics Act, 1940 and its rules 1945 π 10+5+2)
Long essays (10 marks)
- Explain the conditions to grant license for manufacture of drugs specified in schedule C, C1 and X.
- Explain the conditions to grant license for manufacture of drugs specified other than schedule H and X.
- What are the proceedents and subsequent conditions for grant of license to manufacture of drugs and cosmetics specified in schedule C, C1 and X?
- Write the conditions to grant license for manufacture of: a). Drugs for purpose of examination, test and analysis. b). Loan licenses
- Explain in detail about manufacture of new drug, loan license and repacking license.
- Explain the various licenses issued under Drug and Cosmetics Act 1940.
- Describe the classes of drugs and cosmetics which are prohibited from import and import under License.
- Explain in detail about schedule M.
- Discuss the penalties for manufacturing and sale of drugs in contravention of Drugs AndCosmetics Act 1940.
- Explain in detail about prohibition of manufacture and sale of certain drugs under Drugs and Cosmetics Act 1940.
Short essays (5 marks):
- What are the classes of drugs prohibited to import into India?
- Discuss in detail about loan licenses.
- Discuss in detail about repacking licenses.
- Describe the classes of drugs to import under license or permit
- Write a note on list of permitted colors as per Drugs and Cosmetics Act 1940.
Short answers (2 marks):
- Give offences and penalties about import of drugs.
- Write about import of drugs for personal use.
- Write about import of new drugs.
- Give two examples of permitted colors as per Drugs and Cosmetics Act 1940.
- Write places from which drugs are imported in India.
- Define drugs and cosmetics as per Drugs and Cosmetics Act
- Write about manufacturing of new drugs.
- Define spurious drugs as under Drugs and Cosmetics Act
- Define misbranded and adulterated drugs
- Mention the rules for drugs and cosmetics.
UNIT β II Pharmaceutical jurisprudence question bank
Drugs and Cosmetics Act, 1940 and its rules 1945 π 10+5+2)
Long essays (10 marks):
- Explain briefly about schedule Y.
- Explain in detail about schedule M.
- Discuss briefly about clinical trials as per schedule Y.
- Write the constitution and functions of Drug Technical Advisory Board (DTAB).
Short essays (5 marks):
- Write a note on retail sale.
- Write a note on schedule M.
- Write a note on Central Drug Laboratory (CDL).
- Define and write the qualifications and duties of government analyst.
- Write a note on general labelling requirements and give the specimen labels for schedule X drugs.
- Describe about restricted license.
- What are qualifications and duties of Drug Inspector?
- Describe the general requirements of labelling under Drugs and Cosmetics Act 1940.
- Describe schedule P, U & V under Drugs and Cosmetics Act 1940.
- Explain in brief about wholesale and retail sale under D&C Act
- Give the specimen label for schedule H with suitable example.
- Explain in brief about controlling authority as per D&C Act.
- Write a short note on schedule F.
- Write the labelling requirements of medicines for internal use with a model labelling.
Short answers (2 marks):
- Write any two offences and penalties for sale of drugs.
- Enumerate two functions of PCI Inspector.
- Give the labelling requirements and write specimen label for schedule G.
- What is Drug Consultative Committee (DCC)?
- Write a note on repacking license.
- Enumerate schedule B.
- Write the types of retail sale of drugs. Give two examples of schedule J.
- Write a short note on Drug Control Laboratory.
- What is schedule G & N.?
- Write the labelling requirements for ophthalmic preparation.
UNIT β III Pharmaceutical jurisprudence question bank
Pharmacy Act β 1948 π 10+5+2)
Long essays (10 marks):
- Write the constitution and functions of PCI.
- Explain in detail about Education Regulation (ER) 1991.
- Write in detail about Education Regulation of State and Joint State Pharmacy Councils.
- Define Education Regulation. Mention the standards, regulations prescribed for Education Regulation.
- What are subsequent registers? Mention the qualifications required for entry into first and subsequent registers.
Short essays (5 marks):
- Write in detail on first register, subsequent register and removal of name from register as per Pharmacy Act.
Short answers (2 marks):
- Write about preparation of first register.
- Mention the offences and penalties in contravention of Pharmacy Act.
- Differentiate between State and Joint State Pharmacy Council.
- Define Education Regulation.
- Mention the ex-officio members of PCI.
Medicinal and Toilet Preparation Act β 1995 π 5+2)
Long essays (10 marks):
- Give the design of bonded laboratory. Discuss in detail about manufacturing of alcoholic preparations in bonded laboratory.
- Give the design of non-bonded laboratory. Discuss in detail about manufacturing of alcoholic preparations under non-bonded laboratory.
- Define Drug Inspector. Mention the qualifications, degrees and powers of Drug Inspector.
Short essays (5 marks):
- Discuss in detail about manufacture in bonded laboratory.
- Write a short note on non-bonded laboratory.
- Explain about ware-housing of alcoholic preparations as per M&TP Act 1995.
- What are requirements of bonded laboratory?
- Explain in brief about alcoholic preparations.
- Write a note on patent and proprietary preparations.
- Explain in brief about manufacturing of Ayurveda preparations under M&TP Act.
- Write in brief about manufacturing in non-bonded laboratories.
Short answers (2 marks):
- Define London proof spirit under M&TP Act.
- Define rectified spirit as per M&TP Act.
- Write a short note on Central Drugs Standard Control Organization (CDSCO).
Narcotic Drugs and Psychotropic substances Act β 1985 and Rules π 10+5+2)
Long essays (10 marks):
- Write the objectives of NDPS Act 1985. Discuss briefly about offences and penalties of NDPS Act 1985.
- What are the objectives of NDPS Act 1985? Give a detailed account on cultivation, production and sale of poppy straw.
Short essays (5 marks):
- Explain opium-poppy cultivation as per NDPS Act.
- Define manufactured drug and controlled substances as per NDPS Act
- Give the offences and penalties under NDPS Act.
- Write a short note on Narcotic and Psychotropic consultative committee.
- Describe the manufacture, sale and export of opium under NDPS Act.
- Define manufactured drugs.
- Write the operations controlled by central and state government under NDPS Act.
- Write a note on manufacture of cocaine and morphine.
Short answers (2 marks):
- What is the punishment specified for illegal cultivation of coca plant.
- What are objectives of NDPS Act?
- Define cannabis under NDPS Act.
- State clandestine arrangement.
UNIT-IV Pharmaceutical jurisprudence question bank
Study of Salient Features of Drugs and Magic Remedies Act and its rules π 5+2)
Short essays (5 marks):
- Define magic remedies. Write the classes of advertisements prohibited under D&MR Act.
- Define drugs, advertisements and magic remedies as per D&MR Act.
- Discuss the classes of advertisements exempted conditionally under D&MR Act.
- Define magic remedies. Give the classes of advertisements.
- Write the offences and penalties in contravention of D&MR Act.
- Define advertisement and mention the objectives of D&MR Act.
- Define magic remedies. Write a note on scrutiny of misguiding advertisements related to drugs.
- Write about salient features of D&MR Act.
Prevention of Cruelty to Animals Act-1960 π 5+2)
Short essays (5 marks):
- Give the constitution and functions of Institutional Animal Ethical Committee (IAEC).
- Write the objectives and prevention of cruelty to animals. What are the parts of CPCSEA guidelines?
- What are CPCSEA guidelines for breeding and stocking of animals?
- Write about transport and acquisition of animals for experiment.
- Write a note on power to suspend or revoke of registration as per Prevention of Cruelty to animals Act.
- Describe the facilities to be maintained for experimentation on animals under CPCSEA guidelines.
National Pharmaceutical Pricing Authorities π 5+2)
Short essays (5 marks):
- Write a short note on National List of Essential Medicines (NLEM).
- Explain Drugs Price Control Order (DPCO).
- Write a note on retail price and ceiling price of scheduled formulations.
- Write a short on DPCO.
- Write a short on sale price of bulk drugs and retail price of formulations.
- Who maximum allowable post manufacturing expenses (MAPE) is calculated as per DPCO.
UNIT-V Pharmaceutical jurisprudence question bank
Pharmaceutical Legislations π 5+2)
Short essays (5 marks):
- Write the contributions of Bohre committee to the pharmacy profession.
- Write a note on profession conduct of pharmacist.
Short answers (2 marks):
- Give two recommendations made by Bhatia committee.
- Give the significance of Drugs Enquiry Committee (DEC).
- Give any three recommendations of Hathi committee.
- Write about Mudaliar committee.
- What is Chopraβs committee?
- Mention the objectives of Pharmaceutical Legislations.
- What is Hathi committee?
- Write a note on health survey of Pharmaceutical Legislation.
- Define Pharmaceutical Legislation.
- Write a brief review on Pharmaceutical Legislation.
Code of Pharmaceutical Ethics π 5+2)
Short essays (5 marks):
- Define code of ethics. Explain receiving and handling of prescription of pharmacist.
- Discuss the code of ethics for pharmacist in relation to his trade.
- Discuss the code of ethics for pharmacist in relation to his job.
- Mention the role of pharmacist in relation to his medical profession.
- Describe the role of pharmacist in relation to his profession.
Short answers (2 marks):
- What is Apprentice Pharmacist as per the code of pharmaceutical ethics?
- Enlist the code of pharmaceutical ethics in relation to medical profession.
- How a pharmacist should follow fair trade practice as per code of pharmaceutical ethics.
- Describe professional vigilance as code of pharmaceutical ethics.
- Define Pharmaceutical Ethics.
- Reproduce pharmacistβs oath.
- Write a brief note on code of pharmaceutical ethics.
- Differentiate between ethics and laws.
- Write the role of pharmacist in health care system.
Medical Termination of Pregnancy Act π 5+2)
Short answers (2 marks):
- Write a short note on termination of pregnancy as per MTP Act.
- Describe the places where pregnancy may be terminated as per MTP Act.
- Write a short note on role of Chief Medical Officer (CMO).
- Mention the objectives of MTP Act.
- Mention the circumstances under which pregnancy can be terminated.
- Mention the offences and penalties of MTP.
Right to Information Act π 2)
Sort answers (2 marks):
- Write a note on Central Information Commission.
- Write a note on State Information Commission.
- Define Right to Information.
- What is Right to Information?
- What are the duties of Right to Information?
- Mention the functions of Right to Information Act.
- Mention the responsibilities of Right to Information Act.
- Enumerate the functions of Right to Information.
Introduction to Intellectual Property Rights (IPR) π 2)
Short answers (2 marks):
- Mention the type of patents.
- Define copyright.
- Write the types of patents.
- Define patents. Mention types of patents.
- Give the criteria for patenting of inventions.
- Define trademark as per IPR Act.