Pharmaceutical Jurisprudence Question Bank and IMP QUESTIONS
Short Answers - 02 Marks:
Q 1. Add a note on Drugs Enquiry Committee.
Q 2. What is Hathi Committee?
Q 3. What is Mudaliar Committee?
Q 4. Explain role of pharmacist in relation to his trade.
Q 5. Explain role of pharmacist in relation to his job.
Q 6. Explain role of pharmacist in relation to his profession.
Q 7. Define the term Drug under D & C Act.
Q 8. Define the term Adulterated drug under D & C Act.
Q 9. Define the term Spurious drug under D & C Act.
Q 10. Define the term Misbranded drug under D & C Act.
Q 11. Define Schedule X and give 2 examples of drugs.
Q 12. Define Schedule H and give 2 examples of drugs.
Q 13. Write the objectives of Medicinal and Toilet Preparations Act.
Q 14. Define i.) Spirit ii.) Denatured Alcohol under M & TP Act.
Q 14. Define i.) Lunatic; ii.) RMP under MTP Act.
Q 15. Write the conditions for termination of Pregnancy.
Q 16. Write the objectives of pharmaceutical policy 2002.
Q 17. Define the term MAPE.
Q 18. Write the formula for calculating retail price of a formulation.
Q 19. Add a note on NLEM.
Q 20. Write the salient features of Hatch Waxman Act 1984.
Q 21. Write a note on generic drugs with two examples.
Q 22. Write the constitution of IAEC.
Q 23. Write the functions of IAEC.
Q 24. List the conditions required for breeding animals for experimentation.
Q 25. Add a note on NDA.
Q 26. Add a note on ANDA
Q 27. Revocation of Patents
Q 28. Write about the recommendations of DEC.
Q 29. Write a note on Joint State Pharmacy Council.
Q 30. Reproduce Pharmacist’s Oath.
Q 31. What are the labeling requirements for i) Colored Preparations ii.) Medicine for External use
Pharmaceutical Jurisprudence and Ethics
Short Essay - 05 Marks:
Q1. Write about the constitution and functions of PCI
Q 2. Explain about ER. Write the salient features of ER 91.
Q 3. Write the constitution and functions of state pharmacy council.
Q 4. How is the first register prepared and maintained?
Q 5. Explain in brief about registration of pharmacist.
Q 6. Write in brief about the layout of a bonded laboratory.
Q 7. Write a note on warehousing of alcoholic preparations.
Q 8. Discuss the provisions relating to manufacture of ayurvedic and homeopathic
medicines containing alcohol
Q 9. Explain in brief about manufacturing alcoholic preparations under M & TP Act.
Q 10. Write the operations controlled by Central and State Government under NDPS
Act.
Q 11. Discuss about cultivation of opium under NDPS Act.
Q 12. Explain in brief about offences and penalties under NDPS Act.
Q 13. Explain in brief about import and export of Narcotic drugs and Psychotropic
substances under NDPS Act.
Q 14. Discuss the advertisements exempted under Drugs and Magic Remedies Act.
Q 15. Discuss the advertisements prohibited under Drugs and Magic Remedies Act.
Q 16. Write the general procedures with time lines for obtaining a patent.
Q 17. What are the qualifications required for appointing a Government Analyst?
What are the functions of the Government Analyst?
Q 18. Write the labeling requirements of medicines for internal use with a model label.
Q 19. Explain in detail about Schedule N.
Q 20. Write a note on loan license and repackaging license.
Q 21. What is subsequent register and how is it prepared?
Q 22. What are the grounds on which the name of a pharmacist can be removed from
the Central Register? Write about the rights of pharmacist and procedure to appeal
against it?
Q 23. Write about Central Drugs Laboratory and its role.
Q 24. Write about the power of entry, search and seizure without warrant under NDPS
Act.
Pharmaceutical Jurisprudence and Ethics
Long Essay - 10 Marks:
Q1. Describe the constitution and functions of a)DTAB b) DCC
Q 2. What are the conditions for the grant of a license to manufacture
drugs other than those specified in Schedule C and C1 of D and C Rules
1945?
Q 3. Explain the different licenses issued for the sale of drugs. Describe
the general procedure for a license stating the conditions to be satisfied.
Q 4. Explain in detail about Schedule M (GMP) under D & C Act.
Q 5. Explain in detail about Schedule Y under D & C Act.
Q 6. What are the qualifications for appointment as a drugs inspector?
Describe the powers and duties of drugs inspector appointed under D &
C Act?
Q 7. Enumerate in detail classes of drugs totally prohibited and permitted
to be imported under license or permission under D & C Act.
Q 8. Discuss the penalty for manufacturing and sale of drugs in
contravention of the D & C Act 1940.
Q 9. Explain in detail about manufacturing, import and sale of ayurvedic
/ homoeopathic medicines.
Shorts answers of above Questions:
Short Answers - 02 Marks:
Q1. Drugs Enquiry Committee: A committee set up to investigate matters related to drugs, their quality, safety, and efficacy. It examines drug-related complaints and advises appropriate actions.
Q2. Hathi Committee: A committee appointed to review and recommend changes in the Pharmacy Act and Drug Control legislations in India.
Q3. Mudaliar Committee: A committee constituted to review and suggest improvements in the functioning of the Central and State Drug Control Organizations.
Q4. Pharmacist's Role in relation to his trade: Ensuring lawful procurement, storage, distribution, and sale of drugs as per regulations.
Q5. Pharmacist's Role in relation to his job: Carrying out drug-related tasks responsibly and ethically in the workplace.
Q6. Pharmacist's Role in relation to his profession: Upholding professional standards, ethics, and contributing to public health through pharmaceutical services.
Q7. Drug under D & C Act: Any substance used for medicinal purposes, including formulations and substances for diagnosis or contraception.
Q8. Adulterated drug under D & C Act: A drug that contains substances not declared or falls short of specified standards.
Q9. Spurious drug under D & C Act: A drug that is falsely labeled, substandard, or not meeting quality standards.
Q10. Misbranded drug under D & C Act: A drug with misleading or incorrect labeling information.
Q11. Schedule X: The schedule containing drugs that require stricter controls due to their potential for abuse. Example: Morphine, Methadone.
Q12. Schedule H: The schedule containing prescription-only drugs. Example: Diazepam, Tramadol.
Q13. Objectives of Medicinal and Toilet Preparations Act: To regulate the import, manufacture, and sale of medicines and cosmetics.
Q14. Spirit: Denatured Alcohol under M & TP Act: Spirit refers to ethanol used for medicinal, scientific, or industrial purposes. Denatured Alcohol is alcohol made unfit for human consumption.
Q14. Lunatic under MTP Act: RMP under MTP Act: A lunatic is a mentally ill person. RMP refers to a Registered Medical Practitioner.
Q15. Conditions for termination of Pregnancy: The termination should be carried out by a registered medical practitioner under specified conditions and within the gestational limits.
Q16. Objectives of pharmaceutical policy 2002: To ensure access to essential drugs at reasonable prices and promote the domestic pharmaceutical industry.
Q17. MAPE: Minimum Attractive Package of the Employer offered to pharmacists.
Q18. Formula for calculating retail price of a formulation: Cost of raw materials + Packaging + Overheads + Profit Margin.
Q19. NLEM: National List of Essential Medicines, containing essential drugs for public health programs.
Q20. Salient features of Hatch Waxman Act 1984: Encouraging generic drug development and providing patent and exclusivity provisions.
Q21. Note on generic drugs with two examples: Generic drugs are bioequivalent to brand-name drugs, offering cost savings. Example: Paracetamol and Ibuprofen.
Q22. Constitution of IAEC: Institutional Animal Ethics Committee overseeing animal research.
Q23. Functions of IAEC: Reviewing and approving animal research proposals and ensuring ethical treatment of animals.
Q24. Conditions for breeding animals for experimentation: Compliance with animal welfare laws, proper facilities, and ethical treatment.
Q25. Note on NDA: New Drug Application submitted by pharmaceutical companies to seek approval for a new drug.
Q26. Note on ANDA: Abbreviated New Drug Application for generic drug approval based on the reference of a previously approved drug.
Q27. Revocation of Patents: Cancelling a patent's legal rights.
Q28. Recommendations of DEC: Recommendations on drug manufacturing and quality control standards.
Q29. Note on Joint State Pharmacy Council: Collaboration of state pharmacy councils to address common issues.
Q30. Pharmacist's Oath: A pledge taken by pharmacists to serve society responsibly.
Q31. Labeling requirements for i) Colored Preparations ii) Medicine for External use: Clear labeling of ingredients and usage instructions for safe and proper use.
Short Essay - 05 Marks:
Q1. Constitution and functions of PCI: The Pharmacy Council of India (PCI) is constituted under the Pharmacy Act, 1948. Its functions include regulating pharmacy education, profession, and practice in India.
Q2. ER and its salient features: ER stands for Essentiality Certificate. ER 91 provides guidelines for the establishment and recognition of new pharmacy colleges in India.
Q3. Constitution and functions of state pharmacy council: State Pharmacy Councils regulate pharmacy practice within their respective states and ensure adherence to professional ethics.
Q4. Preparation and maintenance of the first register: The first register of pharmacists is prepared by the State Pharmacy Council and contains details of registered pharmacists. It is maintained and updated regularly.
Q5. Registration of pharmacist: Pharmacist registration is the process of getting licensed to practice pharmacy after fulfilling the educational and regulatory requirements.
Q6. Layout of a bonded laboratory: A bonded laboratory layout includes areas for storing and testing controlled substances under strict security.
Q7. Warehousing of alcoholic preparations: Specific requirements and regulations for storing alcoholic preparations in a warehouse.
Q8. Provisions for manufacturing ayurvedic and homeopathic medicines containing alcohol: Guidelines and regulations for producing these medicines.
Q9. Manufacturing alcoholic preparations under M & TP Act: Regulations and processes for manufacturing medicinal and toilet preparations containing alcohol.
Q10. Operations controlled by Central and State Governments under NDPS Act: The NDPS Act gives Central and State Governments authority over operations related to narcotic drugs and psychotropic substances.
Q11. Cultivation of opium under NDPS Act: Guidelines and regulations for opium cultivation under the NDPS Act.
Q12. Offences and penalties under NDPS Act: The NDPS Act specifies various offenses and corresponding penalties related to narcotic drugs and psychotropic substances.
Q13. Import and export of Narcotic drugs and Psychotropic substances under NDPS Act: Regulations governing the international trade of controlled substances.
Q14. Advertisements exempted under Drugs and Magic Remedies Act: Types of advertisements not covered by the Act's restrictions.
Q15. Advertisements prohibited under Drugs and Magic Remedies Act: Types of advertisements banned due to false claims or misleading information.
Q16. General procedures and timelines for obtaining a patent: The steps and timeframes involved in securing a patent.
Q17. Qualifications and functions of a Government Analyst: Requirements and duties of analysts appointed by the Government for drug analysis.
Q18. Labeling requirements of medicines for internal use with a model label: Guidelines for proper labeling of medicines intended for internal use.
Q19. Schedule N: The schedule containing requirements for the manufacture of Ayurvedic, Siddha, and Unani drugs.
Q20. Note on loan license and repackaging license: Loan license allows manufacturing on another company's behalf, while repackaging license permits repackaging of bulk drugs into retail packs.
Q21. Subsequent register and its preparation: A register containing additional entries after the first register is filled, maintained by the State Pharmacy Council.
Q22. Grounds for removal from the Central Register, pharmacist rights, and appeal procedure: Circumstances leading to removal, rights of pharmacists, and the process of appeal.
Q23. Central Drugs Laboratory and its role: A national laboratory responsible for drug testing and quality control
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