BP 505 T. PHARMACEUTICAL JURISPRUDENCE (Theory)
Scope: This course is designed to impart basic knowledge on
important legislations related to the profession of pharmacy in India.
Objectives: Upon
completion of the course, the student shall be able to understand:
1. The Pharmaceutical
legislations and their implications in the development and marketing of
pharmaceuticals.
2. Various Indian
pharmaceutical Acts and Laws
3. The regulatory
authorities and agencies governing the manufacture and sale of pharmaceuticals
4. The code of ethics
during the pharmaceutical practice
Course
Content:
UNIT-I
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.
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.
UNIT-II
Drugs and Cosmetics Act, 1940 and its rules 1945.
Detailed study of
Schedule G, H, M, N, P, T, U, V, X, Y, Part XII B, Sch F & DMR (OA) 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
UNIT-III
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
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.
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
UNIT-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, 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
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)
UNIT-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, Pharmacist’s oath
Medical Termination
of Pregnancy Act
Right to Information
Act
Introduction to Intellectual Property Rights (IPR)
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