|Publishers||R. Narain Publishers & Distributors|
|Author||Dr. Manoj Katual & Dr. Gurfateh Singh|
|Subject||Text Book of Pharmacy Law & Ethics (ER2020-26T)|
Text Book of Pharmacy Law & Ethics (ER2020-26T)
Pharmacy Law means study of fundamental laws and in case of Jurisprudence, it is laws relating to pharmacy. Pharmaceutical laws & ethics is that branch of pharmacy, which deals with various legislations pertaining to drugs and pharmaceuticals, and profession of pharmacy. This subject encompasses the knowledge of various Acts, Rules, Statutes, Schedules, Sections etc., which directly or indirectly influence the profession of pharmacy in the country and various operations pertaining to procurement, manufacture and distribution of different kinds of dosage forms. Three important components of pharmacy profession – education, industry and pharmacy practice are regulated by the pieces of legislation enacted from time to time. The knowledge of Forensic Pharmacy is essential to understand the legal aspects pertaining to practice of pharmacy. The qualified persons are required to profess and should also be engaged in manufacturing, sales and distribution of drugs. Pharmacy is a noble and dedicated profession with a commitment to the cause of health care system of the country.
Estimated Delivery for Urban Areas 3 to 4 Days
Estimated Delivery for Rural Areas 5 to 7 Days
Table of Content
|1||General Principles of Law, History and various Acts related
to Drugs and Pharmacy profession
|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.
Pharmacy Practice Regulations 2015
|3||Drugs and Cosmetics Act 1940 and Rules 1945 and
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.
|4||Narcotic Drugs and Psychotropic Substances Act 1985
and Rules Objectives, Definitions, Authorities and Officers, Prohibition, Control and Regulation, Offences and Penalties.
|5||Drugs and Magic Remedies (Objectionable
Advertisements) Act 1954
Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties.
|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.
|7||Poisons Act-1919: Introduction, objective, definition,
possession, possession for sales and sale of any poison, import of poisons
|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||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)
|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.
|11||Medical Termination of Pregnancy Act and Rules – basic
understanding, salient features, and Amendments
|12||Role of all the government pharma regulator bodies –
Central Drugs Standards Control Organization (CDSCO), Indian Pharmacopoeia Commission (IPC)
|13||Good Regulatory practices (documentation, licenses,
renewals, e-governance) in Community Pharmacy, Hospital pharmacy, Pharma Manufacturing, Wholesale business, inspections, import, export of drugs and medical devices
|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
|15||Blood bank – basic requirements and functions||2|
|16||Clinical Establishment Act and Rules – Aspects related to
|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
|18||Bioethics – Basic concepts, history and principles. Brief
overview of ICMR’s National Ethical Guidelines for Biomedical and Health Research involving human participants
|19||Introduction to the Consumer Protection Act||1|
|20||Introduction to the Disaster Management Act||1|
|21||Medical Devices – Categorization, basic aspects related to
manufacture and sale
- Comprehensive coverage of theoretical and diagrammatical aspects of pharmaceutics.
- All intricate aspects are explained by simple, lucid and specific explanations and substantiated with neat and elaborate diagrammatic sketches.
- Examples from pharmaceutics are included extensively.