Pharmaceutical Jurisprudence

Teacher

Jyoshna Rani Dash

Category

Core Courses

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Course Name : Pharmaceutical Jurisprudence

Code(Credit) : BPHT3105(4-0-0)

Course 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

Program Outcomes

CO Statements PO MAPPING
CO-1 The Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals. PO1, PO3, PO6
CO-2 Various Indian pharmaceutical Acts and Laws PO1, PO2,  PO3, PO4,
CO-3 Develop entrepreneurship skills Pharmaceutical field PO1, PO2, PO6, PO7
CO-4 The code of ethics during the pharmaceutical practice PO1, PO2, PO8
CO-5 Able to apply knowledge in the area of pharmaceutical legislation, rules, laws, ethics, acts and amendments related to drugs. PO1, PO2, PO11, PO3, PO6

Course Syllabus

Module-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 of grant of license and conditions of license for manufacturing of drugs

Manufacture of drugs for test,examination and analysis,manufacture of new drug,loan license and repacking license.

Module-II

Drugs and Cosmetics Act,1940 and its rules 1945,

Detailed study of schedule G,H,M,N,P,T,U,V,Y,Part XIIB,Sch F & DMR(OA)

Sale of Drugs-Wholesale,Retail sale and Restricted license,offences and penalties

Labelling and packing of Drugs-General labelling requirements and specimen labels for drugs and cosmetics,List of permitted colours,offences and penalties

Administration of Act and Rules-Drugs Technical Advisory Board,Central drugs Laboratory,Drugs Consultative committee.Government drug alnalysts,Licensing authorites,controlling authorites,Drug Insepectors

Module-III

Pharmacy Act 1948:

objectives,definitions,Pharmacy council of India;its contitutionand function,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,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 function of Narcotic and psychotropic Consultative committee,National fund for controlling Drug abuse,Prohibition,control and regulation.Opium poppy cultivation and production of poppy straw,manufacture,sale and export of opium.Offences and penalties

Module-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 Acts Act-1960:

Objectives,Definitions,Institutional animal ethics committee,CPCEA 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 pricing control  Authority:-Drugs(DPCO-2013),Objective,Definition,sale Prices of bulk drugs,Retail prices of formulations,Retail price and ceiling price of scheduled formulations,National list of essential medicines(NLEM).

Module-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-Definitions,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 Right

REFERENCES-

1. Forensic Pharmacy by B. Suresh
2. Text book of Forensic Pharmacy by B.M. Mithal
3. Hand book of drug law-by M.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 India publications
8. Drugs and Magic Remedies act by Govt. of India publication
9.Bare Acts of the said laws published by Government. Reference books (Theory)

Session 1

Drugs and Cosmetics Act,1940 and its rules 1945:

Objectives,Definitions,Legal definitions of schedules to the act and Rules

Drug and Cosmetic Act 1940 and Rules thereunder 1945

1 D & C ACT 1940 History, Objectives

Session Plan

Session -2

Import of Drugs-Classes of drugs and cosmetics prohibited from import

3 IMPORT OF DRUGS

Session-3

Session-4

Sale of Drugs-Wholesale,Retail sale and Restricted license

https://www.youtube.com/watch?v=2_Gj4446ulU

session-5

Drugs and Cosmetics Act,1940 and its rules 1945,

Detailed study of schedule G,H,M,N,P,T,U,V,Y,Part XIIB,Sch F & DMR(OA)

schedules and others

https://www.youtube.com/watch?v=8huz_0Uwvi8

session-6

manufacture of new drug,loan license and repacking license.

https://www.youtube.com/watch?v=OtnCqRAgVdU

session-7

Manufacture of drugs for test,examination and analysis

https://www.youtube.com/watch?v=kvnSKGmLgh4

session-8

conditions of grant of license and conditions of license for manufacturing of drugs

https://globi-reg.com/wp-content/uploads/2019/01/PROCEDURE-FOR-GRANT-OF-DRUGS-MANUFACTURING-LICENSE.pdf

session-9

session-10

Licensing authorites,controlling authorites

licensing authority,controlling authority

session-11

Drugs Consultative committee.Government drug alnalysts

https://www.youtube.com/watch?v=YU-f73IRI0I

session-12

Administration of Act and Rules-Drugs Technical Advisory Board,Central drugs Laboratory,

https://www.youtube.com/watch?v=-YSrK_xDlqw

session-13

session-14

session-15

Labelling and packing of Drugs-General labelling requirements and specimen labels for drugs and cosmetics

https://www.slideshare.net/bdvfgbdhg/labeling-in-india

session-16

session-17

session-18

Pharmacy council of India;its contitutionand function,Education regulations,

pci

session-19

State and Joint State Pharmacy Councils;constitution and functions

state pharmacy council

session-20

Registration of pharmacists

registration of pharmacists

session-21

Offences and Penalties

offences and penalties

serssion-22

session-23

Licensing,In bond and outside bond

bonded and non bonded licensing

session-24

export of alcoholic preparations

export of alcoholic preparation

session-25

Manufacture of  Ayurvedic,Homeopathic,patent & proprietary preparations

allopathic ayurvedic homeopathic preparation

session-26

offences and penalties

offences and penalties (2)

session -27

Constitution and function of Narcotic and psychotropic Consultative committee,

narcotic c committee

session-28

Narcotic Drugs and Psychotropic Substances Act-19875 and Rules:

Objectives,Definitions,Authorities and Officers

https://www.youtube.com/watch?v=XkOEX_4cYrE

authorities and officers

session-29

National fund for controlling Drug abuse,Prohibition,control and regulation

funds

session-30

Opium poppy cultivation and production of poppy straw,manufacture,sale and export of opium

http://dca.ap.nic.in/sites/default/files/2017-11/Narcotics-Drugs-Psychotropic-Substances-Rules-1987.pdf

session-31

Offences and penalties

offences and penLTIES

session-32

Study of  salient Features of Drugs and Magic remedies Act and its rules:

Objectives,Definitions

Drug and Magic Remedies Act

https://www.youtube.com/watch?v=leYwVnJKYAs

session -33

prohibition of certain advertisements. Classes of exempted advertisements,

PROHIBITIONOF ADVERTISEMENT

session-34

offences and penalties

PENALTIES

session 35

Prevention of Cruelty to Animals Acts Act-1960:

Objectives,Definitions,Institutional animal ethics committee

https://www.youtube.com/watch?v=9zKlng4EztU

session 36

CPCEA guidelines for breeding and stocking of animals,Performance of experiments

https://www.slideshare.net/DrSahilKumar/cpcsea

session 37

Transfer and acquisition of animals for experiment,Records, Power to suspend or revoke registration

http://cpcsea.nic.in/WriteReadData/userfiles/file/1998.pdf

session 38

session-39

Pharmaceutical legislations-A brief review,Introduction,study of drugs enquiry committee,health survey and development committee

https://www.slideshare.net/CharudattaJog/1-pharmaceutical-legislation-in-india-96883854

session 40

session 41

Code of Pharmaceutical Ethics-Definitions,Pharmacist in relation to his job,trade

https://www.slideshare.net/GaneshShevalkar/code-of-pharmaceutical-ethics-170472784

session 42

medical profession and his profession,Pharmacist's Oath

https://www.slideshare.net/GaneshShevalkar/code-of-pharmaceutical-ethics-170472784

session 43

Medical termination of Pregnancy act

https://www.youtube.com/watch?v=GDyRi5l9fl0

session 44

session 45

Introduction to Intellectual Property Right

https://www.youtube.com/watch?v=Bj1_z56VEJ0

Our Main Teachers

Jyoshna Rani Dash

Assistant Professor
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