Shree Sahkar Education Trust
SHREE DHANVANTARY PHARMACY COLLEGE, KIM
(An Autonomous College U/s UGC Act 1956)
NBA-UG & NAAC Accredited, Accorded Status under UGC Sec 2 (f) of UGC Act 1956, Recognized
as SIRO by DSIR, Govt. of India. Awarding University GTU, Ahmedabad, Approved by PCI,
AICTE, New Delhi
Bachelor of Pharmacy
Sub Code: BP505T
SEMESTER: V
Subject Name: Pharmaceutical Jurisprudence
Scope: This course is designed to impart basic knowledge on important legislations related to
the profession of pharmacy in India
Course Outcomes: Upon successful completion of this course, the student should be able to:
CO 1: Know the different types of errors, its minimization and sources of impurities in
pharmaceuticals.
CO 2: Understand the principles of volumetric and electro chemical analysis methods.
CO 3: Develop analytical skills in the determination of percentage purity of the various
pharmaceuticals.
CO 4: Understand the quantitative standardization and assay methods.
Teaching scheme and examination scheme:
Teaching Scheme Evaluation Scheme
Theory Tutorial Practical Total Theory Practical
External Internal External Internal
3 1 - 4 75 25 - -
Unit Topics Hours
1. Drugs and Cosmetics Act, 1940 and its rules 1945: Objectives, 10
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.
2. Drugs and Cosmetics Act, 1940 and its rules 1945 10
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
3. Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council 10
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
Study of Salient Features of Drugs and Magic Remedies Act and 8
4. 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 EssentialMedicines
(NLEM)
5. Pharmaceutical Legislations – A brief review, Introduction, Study 7
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)
Total 45
Recommended books:(Latest Edition)
1. Forensic Pharmacy by B. Suresh 123
2. Text book of Forensic Pharmacy by B.M. Mithal
3. Hand book of drug law-byM.L. Mehra
4. A text book of Forensic Pharmacy by N.K. Jain
5. Drugs and Cosmetics Act/Rules by Govt. of India publications.
6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.
7. Narcotic drugs and psychotropic substances act by Govt. of
Indiapublications
8. Drugs and Magic Remedies act by Govt. of India publication 9. Bare
Actsof the said laws published by Government. Reference books (Theory)
