Download chapter-wise Pharmacy Law and Ethics notes for D.Pharm second-year students. Review the syllabus and access PDF notes for all 21 chapters using the download buttons below.
Looking for Pharmacy Law and Ethics D.Pharm 2nd Year notes PDF? PharmDBM provides chapter-wise study material covering pharmacy legislation, drug and cosmetics rules, professional ethics, regulatory authorities, pharmaceutical pricing, clinical trials, medical devices and related topics. Use the chapter list to jump to a topic, review its syllabus, and download the corresponding PDF.
Pharmacy Law and Ethics Notes: Chapter List
Chapter 1: General Principles of LawChapter 2: Pharmacy Act, 1948 and RulesChapter 3: Drugs and Cosmetics Act, 1940 and Rules, 1945, and New AmendmentsChapter 4: Narcotic Drugs and Psychotropic Substances Act, 1985 and RulesChapter 5: Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954Chapter 6: Prevention of Cruelty to Animals Act, 1960Chapter 7: Poisons Act, 1919Chapter 8: FSSAI (Food Safety and Standards Authority of India) Act and RulesChapter 9: National Pharmaceutical Pricing Authority (NPPA)Chapter 10: Code of Pharmaceutical EthicsChapter 11: Medical Termination of Pregnancy Act and RulesChapter 12: Role of Government Pharma Regulatory BodiesChapter 13: Good Regulatory PracticesChapter 14: BCS System, Clinical Trials and Drug DevelopmentChapter 15: Blood BankChapter 16: Clinical Establishment Act and RulesChapter 17: Biomedical Waste Management Rules, 2016Chapter 18: BioethicsChapter 19: Consumer Protection ActChapter 20: Disaster Management ActChapter 21: Medical Devices
Chapter-wise Pharmacy Law and Ethics Syllabus and PDF Downloads
1
Chapter 1: General Principles of Law
- History and various Acts related to Drugs and the Pharmacy profession.
2
Chapter 2: Pharmacy Act, 1948 and Rules
- Objectives and definitions
- Pharmacy Council of India: its constitution and functions
- Education Regulations
- State and Joint State Pharmacy Councils
- Registration of Pharmacists
- Offences and penalties
- Pharmacy Practice Regulations, 2015
3
Chapter 3: Drugs and Cosmetics Act, 1940 and Rules, 1945, and New Amendments
- Objectives, definitions and legal definitions of schedules to the Act and Rules
- Import of drugs: classes of drugs and cosmetics prohibited from import; import under licence or permit
- Manufacture of drugs: prohibition of manufacture and sale of certain drugs; conditions for grant of licence and licence conditions; manufacture for test, examination and analysis; manufacture of a new drug; loan licence and repacking licence
- Study of Schedules C and C1, G, H, H1, K, P, M, N and X
- Sale of drugs: wholesale, retail and restricted licences; records to be kept in a pharmacy; drugs prohibited for manufacture and sale in India
- Administration of the Act and Rules: Drugs Technical Advisory Board, Central Drugs Laboratory, Drugs Consultative Committee, government analysts, licensing authorities, controlling authorities and Drug Inspectors
4
Chapter 4: Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules
- Objectives and definitions
- Authorities and officers
- Prohibition, control and regulation
- Offences and penalties
5
Chapter 5: Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
- Objectives and definitions
- Prohibition of certain advertisements
- Classes of exempted advertisements
- Offences and penalties
6
Chapter 6: Prevention of Cruelty to Animals Act, 1960
- Objectives and definitions
- CPCSEA: brief overview
- Institutional Animal Ethics Committee
- Breeding and stocking of animals
- Performance of experiments
- Transfer and acquisition of animals for experiment
- Records
- Power to suspend or revoke registration
- Offences and penalties
7
Chapter 7: Poisons Act, 1919
- Introduction, objectives and definitions
- Possession, possession for sale and sale of any poison
- Import of poisons
8
Chapter 8: FSSAI (Food Safety and Standards Authority of India) Act and Rules
- Brief overview and aspects related to manufacture, storage, sale and labelling of food supplements
9
Chapter 9: National Pharmaceutical Pricing Authority (NPPA)
- Drugs Price Control Order (DPCO), 2013: objectives and definitions
- Sale prices of bulk drugs
- Retail price of formulations
- Retail price and ceiling price of scheduled formulations
- Pharmaceutical Policy, 2002
- National List of Essential Medicines (NLEM)
10
Chapter 10: Code of Pharmaceutical Ethics
- Definition, ethical principles and ethical problem-solving
- Registration
- Code of ethics for pharmacists in relation to their job, trade, medical profession and profession
- Pharmacist’s oath
11
Chapter 11: Medical Termination of Pregnancy Act and Rules
- Basic understanding, salient features and amendments
12
Chapter 12: Role of Government Pharma Regulatory Bodies
- Central Drugs Standards Control Organization (CDSCO)
- Indian Pharmacopoeia Commission (IPC)
13
Chapter 13: Good Regulatory Practices
- Documentation, licences, renewals and e-governance in community pharmacy, hospital pharmacy, pharmaceutical manufacturing and wholesale business
- Inspections
- Import and export of drugs and medical devices
14
Chapter 14: BCS System, Clinical Trials and Drug Development
- Introduction to the BCS system of classification
- Basic concepts of clinical trials
- ANDA and NDA
- New drug development and new drugs and clinical trials rules, 2019
- Brand versus generic medicines
- Trade-name concept
- Introduction to patent law and intellectual property rights
- Emergency Use Authorization
15
Chapter 15: Blood Bank
- Basic requirements and functions
16
Chapter 16: Clinical Establishment Act and Rules
- Aspects related to pharmacy
17
Chapter 17: Biomedical Waste Management Rules, 2016
- Basic aspects
- Pharmaceutical/medical waste management from generation to disposal at homes, pharmacies and hospitals
18
Chapter 18: Bioethics
- Basic concepts, history and principles
- Brief overview of ICMR’s National Ethical Guidelines for Biomedical and Health Research involving human participants
19
Chapter 19: Consumer Protection Act
- Introduction to the Consumer Protection Act
20
Chapter 20: Disaster Management Act
- Introduction to the Disaster Management Act
21
Chapter 21: Medical Devices
- Categorization and basic aspects related to manufacture and sale
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Frequently Asked Questions
1. Where can I download D.Pharm 2nd Year Pharmacy Law and Ethics notes?
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2. How many chapters are included?
This page includes 21 chapters, each with its syllabus topics and a corresponding PDF download button.
3. Can I use these notes for exam preparation?
Yes. Use the notes to revise the listed topics alongside your prescribed syllabus, class materials and current applicable regulations.
