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AKTU Pharmaceutical Jurisprudence (Theory) (BP606T) Syllabus PDF – B.Pharm 6th Semester
Pharmaceutical Jurisprudence (Theory) BP606T
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Official AKTU syllabus of Pharmaceutical Jurisprudence (Theory) (BP606T) for B.Pharm 6th Semester – 3 credits, L-T-P 3-0-0. Read the unit-wise course content, course outcomes, evaluation pattern and recommended books online, or download the PDF.
Syllabus — Pharmaceutical Jurisprudence (Theory)
Download PDFBP606T · 3 credits · L-T-P 3-0-0
Course Objectives
- Understand the fundamental principles and scope of pharmaceutical legislations governing drug development, manufacture, distribution, and marketing.
- Gain comprehensive knowledge of Indian pharmaceutical Acts and Rules, including Drugs and Cosmetics Act, Pharmacy Act, NDPS Act, and related regulations.
- Learn the roles, responsibilities, and functions of regulatory authorities involved in regulation and control of pharmaceuticals in India.
- Learn the code of pharmaceutical ethics and legal responsibilities in professional pharmacy practice.
- Develop the ability to analyse regulatory frameworks, pricing controls, and emerging regulations, and assess their impact on public health, industry compliance, and patient safety.
Course Outcomes
| CO | Upon successful completion of this course, the students will be able to: |
| No. | |
| 1 | Demonstrate understanding of major pharmaceutical legislations and explain their relevance in pharmaceutical product development and marketing. |
| 2 | Interpret and apply the provisions of various Indian pharmaceutical Acts and laws in real-world scenarios. |
| 3 | Identify regulatory bodies such as CDSCO, IPC, and state regulatory authorities, and explain their roles in drug approval, manufacturing, and distribution. |
| 4 | Exhibit ethical awareness by applying the code of ethics in professional pharmaceutical practices. |
| 5 | Critically analyze regulatory frameworks and assess their impact on public health, industry operations, and compliance requirements. |
Course Content
| Unit | Topics | No. of |
|---|---|---|
| I | Drugs and Cosmetics Act, 1940 and its rules 1945: Objectives, Definitions, Legal definitions of schedules to the Act and Rules, CDSCO guidelines for Import & export of Pharmaceuticals 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. | 10 hours |
| II | Drugs and Cosmetics Act, 1940 and its rules 1945. Detailed study of Schedule G, H, H1, M, N, P, T, U, V, X, Y, Sch F, Part XII B. Sale of Drugs Wholesale, Retail sale and Restricted license. Offences and penalties Labeling & packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties. 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 | 10 hours |
| III | Pharmacy Act 1948: Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations including ER20, State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties Medicinal and Toilet Preparation Act 1955: Objectives, Definitions, Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations, Offences and Penalties. 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 | 8 hours |
| IV | 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 Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional Animal Ethics Committee, CCSEA 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 | 8 hours |
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).
| V | Pharmaceutical Legislations A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee Code of Pharmaceutical ethics: Definition, Pharmacist in relation to his job, trade, medical profession and his profession, Medical Termination of Pregnancy Act Brief Introduction to Right to Information Act Introduction New Drugs and Clinical Trials Rules, 2019 and amendments. Cosmetic rules 2020 Regulatory guidelines on similar biologics. Overview of Medical Device Regulations, Guidelines on Probiotics, Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 | 9 hours |
Recommended References
- Government of India. Drugs and Cosmetics Act and Rules. Government of India.
- Government of India. Drugs and Magic Remedies (Objectionable Advertisements) Act. Government of India.
- Government of India. Medicinal and Toilet Preparations (Excise Duties) Act. Government of India.
- Government of India. Narcotic Drugs and Psychotropic Substances Act. Government of India.
- Government of India. New Drugs and Clinical Trials Rules, 2019. Government of India.
- Central Drugs Standard Control Organization and Department of Biotechnology. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India. Government of India.
| Course Code* | Course Title* | Course Type |
| BP607T AEC1 | Green Chemistry | Elective |
| BP607T AEC2 | Materiovigilance and Hemovigilance | |
| BP607T AEC3 | Scientific Writing | |
| BP607T AEC4 | Drug Store and Business Management | |
| BP607T AEC5 | Career Building in Cultivation of Medicinal Plants | |
| BP607T AEC6 | Active Pharmaceutical Ingredients and Excipient Sciences | |
| Credit | Hours Per Week (L-T-P) | Max. |
| L | T | P Hours. |
| 1 | -- | 15 |
| Maximum Marks | SE | ESE |
| 50 | 20 | 30 |
* One course shall be selected from the list The syllabi for elective subjects are given in the APPENDIX
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