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St.James College of Pharmaceutical Sciences
St.James medical Academy
River Bank, Chalakudy
Programme: B.Pharm Sem.: V
Name of Course: Pharmaceutical Jurisprudence Course BP 505 T
(Subject) Code:
Teaching faculty Aravind R
of the course
Summary of the Lecture Plan
Topic Lectures Hours
Drug and Cosmetic act, 1940 and its rules 1945- 1
Unit I Objective, definition, Legal definition of Schedules to
the Act and rule
Import of Drugs 2
Manufacture of Drugs- Condition of grant of License 2
for manufacture for new drug
Condition of grant of License for manufacture of 4
drug for test, examination and analysis, loan licence
and repacking license.
Detailed study of Schedule G, H, M, N, P, T, U, V, X, Y, 4
B, F
Sale of Drugs- whole sale, Retail sale and Restricted 2
license
Unit II General labelling requirements and specimen label 1
for drugs and cosmetics, list of permitted colours.
Offences and penalties covering under D & C Act, 1
1940.
Administration of the act and rules 3
Pharmacy Act 1948-Objectives, Definition, PCI 1
State and Joint state Pharmacy council 1
Registration of Pharmacist, Offences and penalties 1
Medicinal and Toilet Preparation Act-1955 2
Objectives, Definition, licensing, Manufacture in
Unit III bond and outside bond.
Export of alcoholic Preparation 1
Manufacture of Ayurvedic, Homeopathic, Patent & 1
Proprietary Preparation. Offences and Penalties
Narcotic Drugs and Psychotropic substances Act- 1
1985 Objectives, Definition, Authorities, Officers and
committee.
Regulation of cultivation and production of opium 3
Manufacture, sale and Export of opium, Offences and
Penalties
Drugs and Magic remedies Act- Objectives, 2
Definition, Prohibition of certain advertisement,
Unit IV class of exempted advertisement, offences and
penalties
Prevention of Cruelty to animal act-1960 Objectives, 2
Definition, IAEC Regulations, Offences and Penalties
National Pharmaceutical Pricing Policy 3
DPC) 2013
Pharmaceutical Legislations 3
Unit V Code of Pharmaceutical Ethics 1
Medical termination of Pregnancy Act-1971 1
Right to information act 1
Introduction to intellectual Property Right (IPR). 1
Major issues or Core aspects addressed/ covered:
Drug and cosmetic Act, 1940 and its rule 1945
Objective, definition, Legal definition of Schedules to the Act and rule
Classes of drugs and cosmetics prohibited from import including Misbranded,
adulterated and spurious drugs.
Procedure for import and export drug and cosmetics, Offences and penalties.
Prohibition of manufacture and sale of certain drugs.
Conditions for the grand of license for manufacture, Type of License.
Procedure to be followed in manufacturing of new drug, drug for test, examination and
analysis, loan license and repacking license.
Detailed study of Schedule G, H, M, N, P, T, U, V, X, Y, B, F
Application of license for Whole sale trade, Retailer trade, and restricted license
Procedure for the sale of drug in whole sale and motor vehicle.
Offence and Penalties during Sale of drugs.
Packing of drugs- General label Requirement and specimen label for drugs.
List of Permitted colours.
Constitution and functions of Drug Technical Advisory Board, Drug Consultative
Committee
Role of Licensing authorities
Qualification, Duties and Procedures for Government analyst, Controlling authorities
and drug inspectors.
Pharmacy act 1948
Objective of Pharmacy act.
Pharmacy council of India: its constitution and functions
Educational regulations
State and joint state Pharmacy council: its constitution and functions, Registration of
Pharmacist
Offences and Penalties in Pharmacy Act
Medicinal and toilet Preparation Act, 1955
Objectives of Act, Definition covering the act,
Construction, design and procedure for manufacturing of alcoholic preparation in bond
and outside bond.
Export of medicinal preparation containing alcohol
Procedure for manufacturing of Ayurvedic and homeopathic preparation containing
alcohol.
Offences and penalties in Medicinal and toilet Preparation Act
Narcotic drugs and Psychotropic substance Act,1985
Objectives, Definition, Cannabis, Opium
Authorities- Controlled operations by Central government and state government
Administrative Agencies, Constitution and functions of Narcotic commissioner, NDPS
consultative committee, Deaddiction center
Search, Seizures and arrest
Disposal and attachment of seized articles
Cultivation of poppy and Manufacture of opium, Sale and Export
Offences and Penalties of NDPS Act.
Study of Salient features of Drugs and Magic remedies Act and its rules
Definition and objectives of the act
Prohibited advertisements
Prohibition on Import and export of certain products.
Offences and Penalties
Prevention of Cruelty to animal act-1960
Objectives, definitions.
Institutional animal Ethical Committee
Breeding and stocking of animals
Transfer and acquisition of animals for experiment, Record maintenance
Offences and Penalties
National Pharmaceutical Pricing authorities
DPCO 2013
Sale Price of bulk drugs
Retail Price of formulation
Retail price and ceiling price of scheduled formulation
National List of Essential Medicine (NLEM)
Pharmaceutical Legislations
Chopra Committee
Hathi Committee
Mudaliar Committee
Indian Pharmacopoeial committee
Code of Pharmaceutical Ethics
Pharmacist in relation to his job, trade and medical Profession
Medical termination of Pregnancy act,1971
Medical termination of Pregnancy act,1971
Offences and Penalties
Right to information and act
Right to information and act
Introduction to intellectual Property Rights (IPR)
Patents, Design, Trade mark and Industrial Design
Indian Patent act 1970
Articles patentable and nonpatentable
Procedure for applying patent
Sample Question From the chapters
Drug and cosmetic Act, 1940 and its rule 1945
What are the objectives of D &C act?
Describe various Classes of drugs and cosmetics prohibited from import?
Explain the procedure for import and export drug and cosmetics?
Write notes on duties of custom collectors under the provision of D and C Act.
Explain various type of manufacturing License and procedure for obtaining the same.
Write notes on loan license and repacking license.
Detailed study of Schedule G, H, M, N, P, T, U, V, X, Y, B, F
Write note trade of Drugs and cosmetics.
Procedure for the sale of drug in whole sale and motor vehicle.
Give offence and Penalties during Sale of drugs.
Mention the general requirements of packing, and labelling of drug
Write notes on qualification, duties and procedures to be followed by drug inspectors?
Give the constitution and functions of Drug Technical Advisory Board.
Give the role of Licensing authorities and Government analyst
Explain the qualification, Duties and Procedures for Government analyst.
Pharmacy act 1948
Give the objective of Pharmacy act.
Write the constitution and functions of Pharmacy council of India.
Write the constitution and functions of State Pharmacy council
Give the offences and Penalties in Pharmacy Act
Write notes on registration of Pharmacist.
Medicinal and toilet Preparation Act, 1955
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