Chapter Wise Important Questions BTEUP 2026 EXAM
By Arvind Sharma, B.Pharm, M.Pharm, Assistant Professor, MUIT
PHARMACY LAW & ETHICS – BTEUP MASTER NOTES
Chapter-Wise Important Questions & Downloadable PDFs
Welcome to the Pharmacy Law & Ethics Master Notes Section for BTEUP D.Pharm students.
This page provides chapter-wise important exam questions and downloadable PDF notes based on the ER-20 syllabus and previous BTEUP examination patterns.
These notes help students:
- Focus on most expected exam questions
- Understand topics with simple explanations
- Revise the syllabus quickly before exams
- Download complete chapter PDFs
Chapter 11 Medical Termination of Pregnancy (MTP) Act
This chapter explains the legal provisions for medical termination of pregnancy in India.
Important Questions
- What are the conditions under which pregnancy can be legally terminated?
- Discuss the amendments made to the MTP Act.
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Chapter 12 Government Pharmaceutical Regulatory Bodies (CDSCO & IPC)
This chapter explains the roles of major drug regulatory authorities in India.
Important Questions
- Explain the role of CDSCO.
- Explain the role of Indian Pharmacopoeia Commission (IPC).
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Chapter 13 Good Regulatory Practices
This chapter explains documentation, licensing and regulatory compliance in pharmacy practice.
Important Questions
- Explain Good Regulatory Practices in pharmacy.
- Explain documentation, licensing and inspections in pharmacy practice.
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Chapter 14 Drug Development, Clinical Trials & Patent Law
This chapter explains drug classification, clinical research and intellectual property concepts.
Important Questions
- Explain BCS classification system.
- Explain clinical trial phases.
- Explain NDA and ANDA.
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Chapter 15 Blood Bank
This chapter explains blood bank requirements, storage and blood safety procedures.
Important Questions
- Explain basic requirements for establishing a blood bank.
- Explain functions of a blood bank.
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Chapter 16 Clinical Establishments Act
This Act regulates registration and standards of hospitals and healthcare facilities.
Important Questions
- Explain the Clinical Establishments Act.
- Explain aspects related to pharmacy services in hospitals.
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Chapter 17 Biomedical Waste Management Rules 2016
This chapter explains safe handling, segregation and disposal of biomedical waste.
Important Questions
- Explain Biomedical Waste Management Rules 2016.
- Explain pharmaceutical waste disposal in hospitals, pharmacies and households.
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Chapter 18 Bioethics & ICMR Ethical Guidelines
This chapter explains ethical principles in healthcare and biomedical research.
Important Questions
- Explain basic concepts and principles of bioethics.
- Explain ICMR ethical guidelines for biomedical research.
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Chapter 19 Consumer Protection Act
This Act protects consumer rights and provides legal remedies for defective products and services.
Important Questions
- Explain the Consumer Protection Act.
- Explain consumer rights and grievance redressal system.
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Chapter 20 Disaster Management Act
This Act provides a legal framework for disaster preparedness and emergency response.
Important Questions
- Explain the Disaster Management Act.
- Explain the roles of NDMA, SDMA and DDMA.
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Chapter 21 Medical Devices
This chapter explains classification, manufacture and sale regulation of medical devices in India.
Important Questions
- Explain classification of medical devices.
- Explain regulation of manufacture and sale of medical devices.
