Question bank
III Pharm D
Pharmaceutical Jurisprudence
Chapter 1 – Pharmaceutical legislation
5 marks questions
- Give an account of pharmaceutical legislations in India.
- Describe the recommendations made by Chopra committee
- Write contributions of Joseph Bhore committee to pharmacy profession
- Write final recommendations of Drug Enquiry Committee.
- Discuss pre-independence pharmaceutical legislation of India
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2 marks questions
- Give the recommendations of 'Hathi Committee'
- Give future trends in pharmaceutical legislation
- What is CDSCO
- Give two recommendations made by Bhatia Committee
- List four key functions of CDSCO
- Give two recommendations made by Drug Enquiry Committee
- Give significance of Drug Enquiry committee.
- Justify repealing of the ‘dangerous drugs act' into Narcotics and Psychotropic substances act'.
- State importance of CDSCO.
- State Indian drug Policy
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Chapter 2 - principle & significance of professional ethics
5 marks questions
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- Discuss the code of ethics for pharmacists in relation to his trade.
- Discuss the code of ethics for pharmacists in relation to his job.
- Define Code of Ethics. Explain Receiving and Handling of prescription by pharmacist
- Discuss the code of ethics for pharmacists in relation to his medical profession.
- Briefly mention about the code of ethics for pharmacists framed by PCI.
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2 marks questions
- What are the limitations of professional activity for a pharmacist as per code of Pharmaceutical ethics
- State Clandestine Arrangement
- Describe Professional vigilance as Code of Pharmaceutical Ethics
- Enlist Code of Pharmaceutical Ethics in relation to his profession
- Enlist Code of Pharmaceutical Ethics in relation to medical profession.
- Justify pharmacist to be liaison with public as per code of pharmaceutical ethics.
- How should be 'conduct of pharmacy' as per code of pharmaceutical ethics.
- Brief about' Professional Vigilance' as stated under code of pharmaceutical ethics.
- How a pharmacist should follow' fair trade practice' as per code of pharmaceutical ethics.
- Brief 'Apprentice Pharmacist' as code of pharmaceutical ethics
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Chapter 3- Drugs & cosmetics Act & its rules
10 marks questions
- What are the precedents and subsequent conditions for grant of license to manufacture of drugs specified in schedule C, C1 and X.
- Write the qualifications, duties and responsibilities of drugs inspector. Explain the procedure for taking of samples by drugs inspector.
- Describe the good manufacturing practices to be followed as per schedule M specified under Drugs and Cosmetics Act 1940.
- Explain various provisions of Schedule Y as per Drugs and Cosmetics Act 1940.
- What are the precedents and subsequent conditions for grant of license to manufacture of drugs specified in schedule C, C1 and X.
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5 marks questions
- Give the labeling requirements and write the specimen label for ophthalmic preparation
- Mention the classes of Drugs Prohibited to be imported into India
- Give the qualification required for appointment of Government analyst. Add note on his duties.
- Name different types of licenses for the retail and whole sale of drugs
- Give the labeling requirements and write the specimen label for ophthalmic preparation.
- Give licensing conditions for import of drugs other than CC1 and X.
- Explain Central Drugs laboratory under D &C Act.
- Duties and responsibilities of drug inspector.
- Describe the procedure for import of drugs for examination, test, and analysis
- Write the Qualification and Duties of Government Analyst.
- Explain in detail about Schedule N as per the D&C Act.
- What are the conditions for General and restricted license for sale of drugs?
- Give labelling requirements and specimen label for schedule X drugs
- Define misbranded and adulterated drugs?
- What are loan license and repacking license as per D &C act. Explain their licensing conditions.
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2 marks questions
- Define Schedule J. Give two examples.
- Define Loan licenses.
- Define Schedule FF. Give two examples.
- Give labeling requirements for schedule H drugs.
- Define Schedule P. Give two examples.
- Give labeling requirements for schedule G drugs.
- Define Schedule X. Give two examples.
- Define Repacking licenses.
- Define Schedule J. Give two examples.
- Define Loan licenses.
- Define Schedule U& V.
- Give labeling requirements for Schedule H drugs.
- Define Schedule P& Jas per D &C act.
- Give two examples of permitted colors as per D &C act.
- Write specimen label of Schedule H drug for parenteral administration.
- Define cosmetics under D&C Act
- Define 'patent and proprietary medicines' as per D&C act.
- Give the functions of Drug Consultative Committee.
- Give labeling requirements of patent and proprietary medicines as per D&C Act.
- Define Schedule Y as per D&C act.
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Chapter 4- Pharmacy Act
10 marks questions
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- Describe in detail the constitution of Pharmacy Council of India. Discuss in detail education regulation.
- Write in detail about the constitution and functions of the state and joint state pharmacy council.
- Describe the constitution and functions of Pharmacy council of India.
- Describe the constitution of State pharmacy council. Explain preparation of ‘first register and 'subsequent register'
- Explain Registration of pharmacist detailing about first register, qualifications for entry into first register, subsequent register and removal of name from the register as per Pharmacy Act.
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5 marks questions
- Define the terms first register and subsequent registers. How first register is prepared?
- What are the education regulations and how they are implemented as per Pharmacy Act?
- Write the constitution of Joint State Pharmacy Council. Enumerate its functions
- Give constitution of Pharmacy Council of India as per Pharmacy Act.
- Discuss approval and withdrawal of approval of institutions providing course of study and examination according to Pharmacy Act.
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2 marks questions
- List out the Ex-Officio Members of PCI.
- Define "Registered Pharmacist”.
- Give objectives of Pharmacy Act.
- Mention the grounds on which names of registered pharmacist can be removed.
- Mention the qualifications necessary for entering name into ‘first register'.
- Enumerate two functions of PCI Inspector
- Explain approval of foreign qualification by PCI.
- What Punishment is provided under pharmacy act for falsely claiming to be registered pharmacist?
- How to Restore to the register as per Pharmacy act.
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Chapter 5- Medicinal & Toilet Preparation Act 1955
10 marks questions
- Give the design of bonded laboratory. Discuss in detail manufacturing of alcoholic preparations in bonded laboratory.
- What is meant by “Manufacture in Bond? Discuss the conditions to be followed before and after obtaining a license for manufacture in bond.
- Discuss the procedure to be followed for manufacturing medicinal preparations without bond.
- Define manufacturing in bond. Outline the procedure to be followed in obtaining a license for manufacture in bond including the conditions that are to be fulfilled.
- Explain Warehousing of alcoholic preparation as per Medicinal and Toilet preparations act. How alcoholic goods are transported from one warehouse to another.
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5 marks questions
- Give offenses and penalties for medicinal and toilet preparations act
- What are the requirements of a bonded laboratory?
- Discuss the procedure to be followed for manufacturing medicinal preparations without bond.
- Explain Export of Alcoholic preparations under bond
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2 marks questions
- How do you procure rectified spirit as per provisions of Medicinal and Toilet Preparations Act?
- How to dispose recovered alcohol as per provisions of Medicinal and Toilet Preparations Act.
- Define 'restricted preparations' under Medicinal and Toilet Preparations Act
- Define 'London proof spirit' under Medicinal and Toilet Preparations Act.
- Define 'rectified spirit' under Medicinal and Toilet Preparations Act.
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Chapter 6- Narcotic Drugs & Psychotropic Substances Act
5 marks questions
- Define ‘Manufactured Drugs' and ‘Controlled Substances' as per NDPS Act.
- Write the constitution and functions of Narcotic and Psychotropic consultative committee
- Define the term 'Opium Derivatives' and 'Coca derivatives' under NDPS Act
- Explain manufacture, Sale and export of Opium
- Discuss cultivation and production of opium.
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2 marks questions
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- What is the punishment specified for illegal cultivation of coca plant.
- Write the constitution and functions of Narcotic and Psychotropic consultative committee
- Define 'Psychotropic substances' as per NDPS Act
- What is the punishment specified for allowing the use of premises, vehicles etc. for commission of an offence under NDPS act.
- Give four examples for psychotropic substances.
- What are objectives of NDPS act.
- Define the term coca derivatives under NDPSAct.
- Differentiate between Poppy straw and poppy concentrate
- Define Narcotic Drug as per NDPSAct.
- Define Manufactured Drug as per NDPS Act.
- What is the punishment specified for allowing the use of premises, vehicles etc. for commission of an offence under NDPS act?
- Define controlled substance
- What is the punishment specified for illegal cultivation of coca plant?
- Give four examples of Psychotropic Substances under NDPS act
- Define illicit traffic as under NDPS Act.
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Chapter 7- Drug & Magic Remedies Act
5 marks questions
- Describe the classes of advertisements exempted conditionally under the Drugs and Magic Remedies Act.
- Define magic remedy. Write the classes of advertisements prohibited under D&MR Act.
- Define 'advertisement'. Write the classes of advertisements exempted under D&MR Act.
- Define 'Drugs', ‘Advertisements', and ‘Magic Remedies' as per Drugs and Magic Remedies Act.
- What are objectives of Drugs and Magic Remedies Act. Give offences and penalties under the act.
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Chapter 8 & 9- Essential commodities Act relevant to DPCO & National Drug Pol
2 marks questions
- Define 'ceiling price' as per DPCO.
- Write objectives of National Drug Policy
- How retail price of formulation is calculated as per DPCO
- How MAPE is calculated as per DPCO
- What is MAPE as described in DPCO
- How do you calculate retail price for formulations as per DPCO?
- What is ceiling price as per DPCO
- Explain the term MAPE. How it is calculated.
- Describe facilities to be maintained for experimentation animals under CPCSEA guidelines.
- Name the Authorities under DPCO.
- Write Objectives of DPCO
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Chapter 10- Prevention of cruelty to animals act
5 marks questions
- Write objectives of ‘Prevention of cruelty to animals act'. What are the parts of CPCSEA guidelines?
- Define 'Cruelty to animals'. Explain provisions for breeding and stocking of animals as per this act.
- Describe facilities to be maintained for experimentation animals under CPCSEA guidelines
- Give constitution and function of Institute Animal Ethics(IAE) Committee
- How are experimental animals to be handled during and after experiments as per CPSCEA guidelines?
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2 marks questions
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- Under what conditions an animal for experiment is sacrificed as per CPCSEA guidelines?
- Write the objectives of Prevention of Cruelty to Animals Act.
- Define CPCSEA.
- Give the constitution of Institutional Animal Ethics Committee
- What are the functions of Institutional Animal Ethics Committee?
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Chapter 11- Patent & design Act
10 marks
- Name the types of patents granted under patents act. Give the procedure for obtaining the patent.
- Define Patent. List the inventions that are not patentable within the meaning of Patent Act. Give offence and penalties under this Act.
- Explain procedure of application of patent including revocations of patents under Indian Patent Act.
- What is Patent Coopertative Treaty. Explain Patent of addition and restoration of Lapsed patents under Patent Act.
- Describe Publication and examination of application for patents.Give offences and penalties patents act.
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5 marks question
- Define the term Patent as per Patent act. Which inventions are not patentable under the Act.
- What is the Patent of addition? What are the rights of patentees & co owners of patent.
- Explain the procedure for revocation of patents.
- Enumerate the types of patents. What are the criteria for inventions to be patentable?
- Define Invention as per patent act. Enlist the steps for obtaining a patent
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2 marks questions
- What are the rights of owner a patent under the Patent Act?
- How restoration of lapsed patent can be done?
- Define 'exclusive license' as per patent act.
- What are the rights of patentee as per the Patent Act.
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Chapter 12- Prescription & Non prescription products
2 marks questions
- What are OTC products?
- Give two examples of diagnostic aids.
- Give two examples of surgical aids
- What are prescription drugs. Give two examples
- What are Non-prescription drugs. Give two examples.
- What are diagnostic aids. Give one example.
- Name any four surgical accessories
- Distinguish between prescription and non-prescription products
- What are OTC products. Give two examples.
- Give the procedure for disposal of expiry drugs.
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