Nirali Publication Pharmacy Law & Ethics Books
| Authors Name | Prof. Bhanudas S. Kuchekar |
| Editions | 1st Jan, 2022 |
| Publishers | Nirali Publication |
| Price | Rs. 363 |
PV Publication Essential of Pharmacy Law & Ethics Books
| Authors Name | Shalini Sharma |
| Editions | 1st Jan, 2022 |
| Publishers | S Vikas & Company |
| Price | Rs. 225 |
V.N. Raje Pharmacy Law & Ethics Books
| Authors Name | V.N. Raje |
| Editions | 23 Aug, 2022 |
| Publishers | CBS Publishers & Distributor Pvt Ltd |
| Price | Rs. 265 |
N. Murugesh and Sambath Kumar Pharmacy Law & Ethics Books
| Authors Name | Prof. Dr. N. Murugesh & Prof. Dr. S. Sambath Kumar |
| Editions | 31st May, 2022 |
| Publishers | Sathya Publishers |
| Price | Rs. 300 |
Thakur Prakashan Bilingual Pharmacy Law & Ethics Books
| Authors Name | Dr. L. Bhardwaj, Dr. C. Sing, & Amit Kumar |
| Editions | 1st Jan, 2022 |
| Publishers | Thakur Publication Pvt Ltd |
| Price | Rs. 399 |
Pharmacy Law & Ethics Books Topic-wise Summary
Chapter 1:
General Principles of Law, History, and various Acts related to Drugs and Pharmacy profession
Chapter 2: Pharmacy Act-1948 and Rules
Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils, Registration of Pharmacists, Offences and
Penalties.
Chapter 3: Drugs and Cosmetics Act 1940 and Rules 1945 and New Amendments
Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or permit.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs, Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.
Study of schedule – C and C1, G, H, H1, K, P, M, N, and X.
Sale of Drugs – Wholesale, Retail sale and Restricted license, 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, Drug Inspectors.
Chapter 4: Narcotic Drugs and Psychotropic Substances Act 1985 and Rules
Objectives, Definitions, Authorities and Officers, Prohibition, Control and Regulation, Offences and
Penalties.
Chapter 5: Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements,
Offences and Penalties.
Chapter 6: Prevention of Cruelty to Animals Act-1960
Objectives, 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.
Chapter 7: Poisons Act-1919
Introduction, objective, definition, possession, possession for sales and sale of any poison, import of poisons.
Chapter 8:
FSSAI (Food Safety and Standards Authority of India) Act and Rule brief overview and aspects related to manufacture, storage, sale, and labeling of Food Supplements.
Chapter 9: National Pharmaceutical Pricing Authority
Drugs Price Control Order (DPCO) – 2013. Objectives, 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).
Chapter 10: Code of Pharmaceutical Ethics
Definition, ethical principles, ethical problem solving, registration, code of ethics for Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath.
Chapter 11: Medical Termination of Pregnancy Act and Rules
Basic understanding, salient features, and Amendments.
Chapter 12: Role of all the government pharma regulator bodies
Central Drugs Standards Control Organization (CDSCO), Indian Pharmacopoeia Commission (IPC).
Chapter 13:
Good Regulatory practices (documentation, licenses, renewals, e-governance) in Community Pharmacy, Hospital pharmacy, Pharma Manufacturing, Wholesale business, inspections, import, and export of drugs and medical devices.
Chapter 14:
Introduction to BCS system of classification, Basic concepts of Clinical Trials, ANDA, NDA, New Drug development, New Drugs and Clinical Trials Rules, 2019. Brand v/s Generic, Trade name concept, Introduction to Patent Law and Intellectual Property Rights, Emergency Use Authorization.
Chapter 15: Blood bank
Basic requirements and functions
Chapter 16:
Clinical Establishment Act and Rules – Aspects related to Pharmacy
Chapter 17:
Biomedical Waste Management Rules 2016 – Basic aspects, and aspects related to pharma manufacture to disposal of pharma / medical waste at homes, pharmacies, and hospitals.
Chapter 18:
Bioethics – Basic concepts, history and principles. Brief overview of ICMR’s National Ethical Guidelines for Biomedical and Health Research involving human participants.
Chapter 19:
Introduction to the Consumer Protection Act
Chapter 20:
Introduction to the Disaster Management Act
Chapter 21: Medical Devices
Categorization, basic aspects related to manufacture and sale