Course

UNIT I                                                                                                                       5 Hours

Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, The Pharmacy Enquiry Committee, Hathi committee and Mudaliar committee                                           (3 hr)

Code of Pharmaceutical Ethics Definition, Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath (2 hr)

UNIT II                                                                                                                       18 Hours

Drugs and Cosmetics Act, 1940 and its rules 1945

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. Offences and penalties. (3 hrs)

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. (3 hrs) 

Detailed study of Schedule G, H, H1, HX, J, K, L1, M, N, P, P1, T, U, V, X, Y, Sch F. Part XII B, (3 hrs) 

Sale of Drugs – Wholesale, Retail sale and Restricted license. Offenses and penalties. ( 2 hrs) 

Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs, List of permitted colors used in formulations of drugs. Offenses and penalties. (2 hrs)

Objectives of Medical devices Rules 2017, Cosmetic rules 2020, The Drugs Clinical Trial rules 2019, Classification of Medical devices ( 2 hrs)

Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing authorities,

controlling authorities, Drugs Inspectors. Brief study of prescription and Non-prescription Products. (3 hrs)

UNIT III                                                                                                                      15 Hours

Pharmacy Act –1948

Objectives, Definitions. Pharmacy Council of India; Its constitution and functions, Education Regulations. State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties. Essentials of Pharmacy Practice Regulations (5hrs) Medicinal and Toilet Preparation Act –1955

Objectives, Definitions. Licensing. Manufacture In bond and Outside bond. Export of alcoholic preparations. Manufacture of Ayurvedic Homeopathic. Patent & Proprietary Preparations. Offences and Penalties. (5 hrs)

Narcotic Drugs and Psychotropic Substances Act-1985 and Rules

Objectives,Definitions, Authorities and Officers. Constitution and Functions of narcotic & Psychotropic Consultative Committee. National Fund for Controlling the Drug Abuse. Prohibition, Control and Regulation. Opium poppy cultivation and production of poppy straw, manufacture, sale and export of opium, Offences and Penalties (5 hrs) 

UNIT IV                                                                                                                         7 Hours

Study of Salient Features of Drugs and Magic Remedies Act and its rules

Objectives, Definitions, Prohibition of certain advertisements. Classes of Exempted advertisements. Offences and Penalties (2 hrs)

Prevention of Cruelty to animals Act-1960

Objectives, Definitions. Institutional Animal Ethics Committee. CPCSEA guidelines for 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 (2 hrs)

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, National List of Essential Medicines (NLEM) National Pharmaceutical Pricing Authority(NPPA) (3 hrs)

UNIT V                                                                                                                        05 Hours

Medical Termination of Pregnancy Act: Termination of Pregnancies, Offences& Penalties, Rules& Regulations (1 hr)

Right to Service Act (1hr)

Right to Information Act: Historical Background, Objectives, Features of the Act and its importance. Request for obtaining information, Exemptions. Designation of Public Information Officers; Constitution of Central and State Information Commissions; their Powers and Functions. Appeal and Penalties. (1 hr)

Right to Service Act (1hr)

Introduction to Intellectual Property Rights (IPR): Different forms of IPR and their protection. (1 hr)

ASSIGNMENTS:

1. Case studies relating to Drugs and Cosmetics Act and rules along with its amendments, Dangerous Drugs Act, Medicinal and Toilet Preparation Act, New Drug Policy, Professional Ethics, Drugs Price Control Order, Patent and Design Act.
2. Various prescription and non-prescription
3. Diagnostic aids and appliances available in the

4. Collect Specimen Labels of selected drugs
5. Functioning of the Drugs control system in India
6. Important Amendments as per the current Year

SCOPE :

The Pharmaceutical Jurisprudence course provides students with a fundamental understanding of the essential laws and their latest amendments relevant to the pharmacy profession in India. This specialised field seamlessly integrates pharmacy principles with the legal domain. Through this course, students will gain a comprehensive understanding of the legal and regulatory frameworks governing the pharmaceutical sector. This course explores into a detailed analysis of all Acts and Rules, focusing on the latest amendments. By doing so, students will stay up-to-date with the most recent changes in the legal landscape, enhancing their ability to accurately comprehend and interpret legal requirements. Throughout the course, students will delve into key legal areas that significantly influence professional pharmacists’ daily decisions.

By exploring laws in related fields, students will gain a holistic perspective on the regulatory framework that governs the pharmacy profession. Encompassing various areas of law, this course strongly emphasises empowering students to apply legal and ethical principles in their practice, ensuring optimal patient care and promoting public welfare. This comprehensive approach enables students to navigate complex legal scenarios confidently and make informed choices aligned with ethical principles. Ultimately, the Pharmaceutical Jurisprudence course lays a strong foundation for students to comprehend and apply essential laws, fostering a sense of responsibility and dedication in their professional practice as pharmacists. 

COURSE LEARNING OUTCOMES:

Upon successful completion of the course, the student shall be able to;

KNOWLEDGE

K1. Explain key pharmaceutical laws and regulations. (Remembering)

K2. Enumerate the importance of Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals (Remembering)

K3. Review various Indian Pharmaceutical Acts and Laws (Understanding)

K4. Describe the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals (Understanding)

K5. Adapt the code of ethics during the pharmaceutical practice (Applying)

K6. Relate the various concepts of Drug policy, DPCO, Patent and Designing act (Applying)

SKILL

S1. Predict specific drug approval processes and regulatory bodies. (Understanding)

S2. Interpret legal language and terminology used in drug laws and regulations. (Understanding)

S3. Summarise ethical guidelines and principles relevant to the pharmaceutical sector (Understanding)

S4. Assess the role of regulatory agencies in ensuring drug safety and efficacy. (Applying)

S5. Adapt knowledge of pharmaceutical laws to assess compliance issues in the industry (Applying)

S6. Analyze pharmaceutical laws and regulations and their implications for various stakeholders. 

ATTITUDE

A1. Identify the societal impact of pharmaceutical practices and the need for responsible engagement. (Remembering)

A2. Express a receptive attitude towards learning about the impact of laws and regulations on the pharmaceutical industry. (Understanding)

A3. Apply legal principles to resolve ethical dilemmas in the pharmacy profession. (Applying)

A4. Practice Professional ethics (Applying)

A5. Analyse the ethical and legal implications of emerging trends in the pharmaceutical industry. (Analysing)

A6. Embrace the value of lifelong learning and staying updated with legal and ethical developments in the field. (Analysing)

TEXT BOOKS:

1. Mithal , B Textbook of Forensic Pharmacy. Calcutta: National; 1988.
2. Jain, A Textbook of Forensic Pharmacy. Delhi: Vallabh prakashan ; 1995.
3. Deshapande, W. The drugs and magic remedies act 1954 and rules 1955. Mumbai: Susmit Publications; 1998.
4. Eastern Book The narcotic and psychotropic substances act 1985, Lucknow: Eastern; 1987.
5. Suresh A Textbook of Forensic Pharmacy. Birla Publication; 2010
6. Mehra M Hand book of drug law. University Book Agency;1997

REFERENCE BOOKS: (LATEST EDITION)

1. Drugs and Cosmetics Act/Rules by of India publications.
2. Medicinal and Toilet preparations act 1955 by of India publications.
3. Narcotic drugs and psychotropic substances act by Govt. of India publications
4. Drugs and Magic Remedies act by of India publication
5. Bare Acts of the said laws published by