“Textbook of Pharmaceutical Jurisprudence” is a comprehensive and student-friendly book that provides a clear understanding of the legal and regulatory framework governing the pharmaceutical profession. Written in a simple and structured manner, the book aims to present complex legal provisions in an easy-to-understand format, making it useful for both learners and professionals.
The book covers all major pharmaceutical laws, including the Drugs and Cosmetics Act and Rules, Pharmacy Act, Medicinal and Toilet Preparations Act, and Narcotic Drugs and Psychotropic Substances Act. It also explains important regulatory aspects such as licensing, manufacture, sale, import of drugs, labeling, packaging, and offences with penalties, helping readers gain a thorough understanding of legal compliance in pharmacy practice.
In addition, the text highlights key topics such as drug price regulation, pharmaceutical ethics, animal experimentation laws, and control of misleading advertisements. It also provides insights into national healthcare committees, the role of regulatory authorities, and important legislations like the Right to Information Act and Medical Termination of Pregnancy Act.
The book further introduces the fundamentals of Intellectual Property Rights, emphasizing their importance in the pharmaceutical industry. With its concise presentation and systematic arrangement of topics, this book serves as a valuable guide for understanding the legal responsibilities and ethical standards required in the field of pharmacy.
1. Drugs and Cosmetics Act, 1940 and its rules 1945
1. Introduction
2. Objectives
3. Definitions of schedules
4. Import of drug and cosmetics
4.1. Drugs and cosmetics prohibited from import
4.2. Import under license or permit.
5. Offences and penalties
6. Manufacture of drugs
6.1. Prohibitions for manufacturing and sale
7. Licencing
2. Drug and Cosmetic Act, 1940 and its Rules 1945
1. Introduction
2. Schedules of the Act
3. Sale of Drug
3.1 Wholesale
3.2 Retail sale
3.3 Restricted Licence
4. Offences and Penalties
5. Labelling and Packaging of Drug
6. Permitted colors
7. Administrative Bodies
7.1 Drugs Technical Advisory Board (DTAB)
7.2 Central Drug laboratory (CDL)
7.3 Drugs Consultative Committee (DCC)
7.4 Government drug analysts
7.5 Licensing authorities
7.6 Controlling authorities
7.7 Drugs Inspectors
3. Pharmacy Act 1948
1. Introduction
2. Objectives
3. Definitions
4. Pharmacy Council of India (PCI)
4.1. Constitution of Pharmacy Council of India
4.2. Executive committee of PCI
4.3. Functions of PCI
5. State Pharmacy Council:
5.1. Joint State Pharmacy Council (JSPC)
5.2. Functions of SPC/JSPC
6. Registration of pharmacists
7. Offences and Penalties
4. Medicinal and Toilet Preparation Act : 1955
1. Introduction
2. Objectives
3. Definitions
4. Licensing
5. Manufacture
5.1 Manufacture in bonded laboratories
5.2 Structures of the Bonded Manufactory
5.3 Verification and Storage of Alcohol
5.4 Manufacturing Outside Bond (Non-bonded Manufactory)
6. Export of alcoholic preparations
6.1. Export of duty paid goods
6.2. Export under bond
7. Manufacture of Ayurvedic preparations and homeopathic preparations
8. Excise officer
9. Offenses and penalties
5. Narcotic Drugs and Psychotropic Substances Act : 1985 and Rules
1. Introduction
2. Objectives
3. Definition
4. Authorities and officers
4.1 Central Government
4.2 Officers of central government
5. The Narcotic Drugs and Psychotropic Substances Consultative Committee
6. National fund for controller of drug abuse
7. Prohibition, control and regulation
8. Offenses and Penalties.
6. Drugs and Magic Remedies Act and Its Rules : 1954
1. Introduction
2. Objectives
3. Definitions
4. Classes of Prohibited Advertisements
5. Classes of Exempted Advertisements
6. Offenses and penalties
7. Prevention of Cruelty to Animals Act - 1960
1. Introduction
2. Objectives
3. Definitions
4. Institutional Animal Ethics Committee (IAEC)
4.1. Objectives of IAEC
4.2. Composition
4.3. Functions
4.4. Quorum requirements
4.5. Record keeping
5. The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)
5.1. Function of CPCSEA
5.2. Objectives
5.3. Guidelines for Breeding and stocking of animals
5.4. Performance of experiments:
5.5. Transfer and Acquisition of animals for Experiment
5.6. Records
5.7. Power to suspend or revoke registration
6. Offenses and Penalties
8. National Pharmaceutical Pricing Authority
1. Introduction
2. DPCO 2013
3. Objectives of DPCO
4. Definition
5. Price of bulk drug
6. Retail price calculation of formulation
7. Calculation of ceiling price of a scheduled formulation
8. National List of Essential Medicines (NLEM)
9. Pharmaceutical Legislations
1. Introduction
2. Study of drugs enquiry committee
3. Health survey and development committee
4. Hathi committee
5. Mudaliar committee
10. Code of Pharmaceutical Ethics
1. Introduction
2. Pharmacist in relation to his job, trade, medical profession and his profession
3. Pharmacist’s oath
11. Medical Termination of Pregnancy Act
1. Introduction.
2. Short title, extent and commencement.
3. Definitions.
4. Place where pregnancy may be terminated.
5. Power to make rules.
6. Power to Make Regulations.
7. Protection of action taken in good faith.
12. Right to Information Act
1. Short title, extent and commencement.
2. Definitions.
3. Right to information.
4. Obligations of Public Authorities.
5. Designation of Public Information Officers.
6. Request for Obtaining Information.
7. Disposal of Request.
8. Exemption from disclosure of information.
9. Grounds for rejection to access in certain cases.
10. Severability.
11. Third party information.
12. Constitution of Central Information commissions.
13. Term of office and conditions of service.
13. Introduction to Intellectual Property Rights (IPR)
1. Introduction
2. Objectives of IPR
3. Types of IPR
A book as per the latest syllabus given by Pharmacy Council of India (PCI) New Delhi
for B.Pharm students of all Indian Universities
