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:
- The Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals.
- Various Indian pharmaceutical Acts and Laws
- The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals
- 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
Session Plan
Session -2
Import of Drugs-Classes of drugs and cosmetics prohibited from import
Session-3
Import under license or permit.Offences and penalties.
Session-4
Sale of Drugs-Wholesale,Retail sale and Restricted license
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)
session-6
manufacture of new drug,loan license and repacking license.
session-7
Manufacture of drugs for test,examination and analysis
session-8
conditions of grant of license and conditions of license for manufacturing of drugs
session-9
Manufacture of Drugs-Prohibition of manufacture and sale of certain drugs
session-10
Licensing authorites,controlling authorites
session-11
Drugs Consultative committee.Government drug alnalysts
session-12
Administration of Act and Rules-Drugs Technical Advisory Board,Central drugs Laboratory,
session-13
session-14
List of permitted colours
http://www.dcaodisha.nic.in/sites/default/files/list%20of%20colour%20permitted.pdf
session-15
Labelling and packing of Drugs-General labelling requirements and specimen labels for drugs and cosmetics
session-16
Drug Insepectors
session-17
Pharmacy Act 1948:
objectives,definitions
https://www.slideshare.net/SwapnilFernandes1/the-pharmacy-act-1948
session-18
Pharmacy council of India;its contitutionand function,Education regulations,
session-19
State and Joint State Pharmacy Councils;constitution and functions
session-20
Registration of pharmacists
session-21
Offences and Penalties
serssion-22
Medicinal and toilet preparation act 1955:
Objectives,Definitions
session-23
Licensing,In bond and outside bond
session-24
export of alcoholic preparations
session-25
Manufacture of Ayurvedic,Homeopathic,patent & proprietary preparations
session-26
offences and penalties
session -27
Constitution and function of Narcotic and psychotropic Consultative committee,
session-28
Narcotic Drugs and Psychotropic Substances Act-19875 and Rules:
Objectives,Definitions,Authorities and Officers
session-29
National fund for controlling Drug abuse,Prohibition,control and regulation
session-30
Opium poppy cultivation and production of poppy straw,manufacture,sale and export of opium
session-31
Offences and penalties
session-32
Study of salient Features of Drugs and Magic remedies Act and its rules:
Objectives,Definitions
session -33
prohibition of certain advertisements. Classes of exempted advertisements,
session-34
offences and penalties
session 35
Prevention of Cruelty to Animals Acts Act-1960:
Objectives,Definitions,Institutional animal ethics committee
session 36
CPCEA guidelines for breeding and stocking of animals,Performance of experiments
session 37
Transfer and acquisition of animals for experiment,Records, Power to suspend or revoke registration
session 38
offences and penalties
https://www.slideshare.net/RajveerBhaskar/the-prevention-of-cruelty-to-animals-act-1960
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
Hathi Committee and Mudaliar committee
https://www.slideshare.net/jcfranklinnurse/health-committees-in-community-health-nursing
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
session 44
Right to information act
https://en.wikipedia.org/wiki/Right_to_Information_Act,_2005
session 45
Introduction to Intellectual Property Right
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