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Pharmaceutical Jurisprudence(B. Pharm 5th Semester)

Pharmaceutical Jurisprudence(B. Pharm 5th Semester)

Teacher

Binapani Barik

Category

Core Courses

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Course Name : Pharmaceutical Jurisprudence

Code(Credit) : BP505T(4-0-0)

Course Objectives

Upon completion of the course, the student shall be able to understand:

  1. To impart basic knowledge on important legislations related to the profession of pharmacy in India.

  2. To understand the importance of ethics in the practice of pharmacy and its impact on patient care.

  3. To analyze the roles and responsibilities of regulatory bodies in drug approval, manufacturing, and distribution.

Course Outcomes

CO

Statements

Cos & POs Mapping

CO-1

Design legal frameworks for drug

manufacturing and sale.

PO1,PO2,PO3,PO6,PO7,PO12

CO-2

Combine pharmaceutical laws with licensing and labeling practices.

PO1,PO2,PO3,PO6,PO7,PO12

CO-3

Develop understanding of pharmacy ethics and the pharmacist’s role.

PO1,PO2,PO3,PO6,PO7,PO12

CO-4

Formulate strategies for compliance with drug pricing and regulatory bodies.

PO1,PO2,PO3,PO6,PO7,PO12

CO-5

Roleplay drug legislation enforcement scenarios.

PO1,PO2,PO3,PO6,PO7,PO12

PROGRAMME OUTCOMES: 

PO 1

Pharmacy Knowledge: Possess knowledge and comprehension of the core and basic knowledge associated with the profession of pharmacy, including biomedical sciences; pharmaceutical sciences; behavioral, social, and administrative pharmacy sciences; and manufacturing practices.

PO 2

Planning Abilities: Demonstrate effective planning abilities including time management, resource management, delegation skills and organizational skills. Develop and implement plans and organize work to meet deadlines.

PO 3

Problem analysis: Utilize the principles of scientific enquiry, thinking analytically, clearly and critically, while solving problems and making decisions during daily practice. Find, analyze, evaluate and apply information systematically and shall make defensible decisions.

PO 4

Modern tool usage: Learn, select, and apply appropriate methods and procedures, resources, and modern pharmacy-related computing tools with an understanding of the limitations.

PO 5

Leadership skills: Understand and consider the human reaction to change, motivation issues, leadership and team-building when planning changes required for fulfilment of practice, professional and societal responsibilities. Assume participatory roles as responsible citizens or leadership roles when appropriate to facilitate improvement in health and well-being.

PO 6

Professional Identity: Understand, analyze and communicate the value of their professional roles in society (e.g. health care professionals, promoters of health, educators, managers, employers, employees).

PO 7

Pharmaceutical Ethics: Honour personal values and apply ethical principles in professional and social contexts. Demonstrate behaviour that recognizes cultural and personal variability in values, communication and lifestyles. Use ethical frameworks; apply ethical principles while making decisions and take responsibility for the outcomes associated with the decisions.

PO 8

Communication: Communicate effectively with the pharmacy community and with society at large, such as, being able to comprehend and write effective reports, make effective presentations and documentation, and give and receive clear instructions.

PO 9

The Pharmacist and society: Apply reasoning informed by the contextual knowledge to assess societal, health, safety and legal issues and the consequent responsibilities relevant to the professional pharmacy practice.

PO 10

Environment and sustainability: Understand the impact of the professional pharmacy solutions in societal and environmental contexts, and demonstrate the knowledge of, and need for sustainable development.

PO11

Entrepreneurship: Develop entrepreneurship skills that support the growth of Pharmaceutical Industry / Pharmaceutical Services leading to economic development.

PO 12

Life-long learning: Recognize the need for, and have the preparation and ability to engage in independent and life-long learning in the broadest context of technological change. Self-assess and use feedback effectively from others to identify learning needs and to satisfy these needs on an ongoing basis.

CO,POMappingMatrix

CO/PO

PO1

PO2

PO3

PO4

PO5

PO6

PO7

PO8

PO9

PO10

PO11

PO12

PSO1

PSO2

PSO3

CO1

1

1

1

1

1

1

CO2

2

2

2

2

2

2

CO3

3

3

3

3

3

3

CO4

4

4

4

4

4

4

CO5

5

5

5

5

5

5

Course Contents

Unit I                                                                                                                                       10 hours

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                                                                                                                                       10 Hours

    • 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  10 Hours

    • Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; itsconstitution and functions, Education Regulations, State and Joint state pharmacy:councils; constitution andfunctions, 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   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  08 Hours

    • Study of Salient Features of Drugs and Magic Remedies Act and its rules: Objectives, Definitions, Prohibition of certain advertisements, Classes ofExempted 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  07 Hours

    • 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)

Recommended books: (Latest Edition)

  1. Forensic Pharmacy by B. Suresh

  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 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 Plan

UNIT-I

 

Session 1:

Introduction class

Introduction to pharmaceutical jurisprudence

Priorto the Classroom Session

 

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’s PPT(To be shared)

Classroom Session

Topicstobediscussed:

Terminologies of Jurisprudenece

Session 2:

Introduction to pharmaceutical jurisprudence

 

Quiz

Topics:What are the general terminologies of jurisprudence?

1.       Define drugs and cosmetics as per Drugs and Cosmetics Act

Session 3:

Drugs and Cosmetics Act, 1940 and its rules 1945: Objectives, Definitions

Priorto the Classroom Session

 

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom Session

Topics to be discussed:

1.       Define drugs and cosmetics as per Drugs and Cosmetics Act

2.       Mention the rules for drugs and cosmetics.

Session4:

Legal definitions of schedules to the Act and Rules

Priorto the Classroom Session

 

 

 

 

 

 

 

 Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom

Session

 

 

 

 

 

 

 

 

 

Topics to be discussed:

1.       Define spurious drugs as under Drugs and Cosmetics Act

2.       Define misbranded and adulterated drugs

Session 5:

Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offences and penalties

Priorto the Classroom Session

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom Session

Topicstobediscussed:

1.       Give offences and penalties about import of drugs.

2.       Write about import of drugs for personal use.

3.       Write about import of new drugs.

Session6:

Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offences and penalties.

Priorto the Classroom Session

 

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom Session

Topicstobediscussed:

1.       Give offences and penalties about import of drugs.

2.       Write about import of drugs for personal use.

3.       Write about import of new drugs.

Session7:

 

Manufacture of drugs – Prohibition of manufacture and sale of certain drugs, Conditions for grant of license and conditions of license for manufacture of drugs

Priorto the Classroom Session

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom Session

Topics to be discussed:

1.          Write about manufacturing of new drugs.

Session 8:

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

Quiz

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

Session 9:

Loan license and repacking license.

Prior to the Classroom

Session

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom Session

Topics to be discussed:

1.       Discuss in detail about loan licenses.

Session 10:

 

Drugs and Cosmetics Act, 1940 and its rules 1945: Detailed study of Schedule G, H, M

Priorto

the Classroom Session

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom Session

Topics to be discussed:

1.       Discuss in detail about Schedule G, H, M.

Session 11:

Detailed study of Schedule M

 

Priorto

the Classroom Session

 Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom Session

Topics to be discussed:

 1. Explain in detail about schedule M.

 2. Discuss the penalties for manufacturing and sale of drugs in contravention of Drugs and Cosmetics Act 1940.

 

 

Session 12:

Detailed study of Schedule N, P,T,U, V, X, Y, Part XII B, Sch F

Priorto

the Classroom Session

Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom Session

Topics to be discussed:

Write a note about Schedule N, P, T, U, V, X, Y, Part XII B, Sch F

Session 13:

Detailed study on schedules

Class Test

 

Topics: Unit I

Write a note about Schedules.

 

 

UNIT II

Session 14:

Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties

Priorto

the Classroom Session

 

 

 

 

 

 

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom

Session

 

 

 

 

Topics to be discussed:

1.       Write a note on retail sale.

 

 

Session15:

 

 

 

 

Group Discussion

Topics:

Restricted license. Offences and penalties

Session 16:

Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee

 

Priorto

the Classroom Session

 

 

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’sPPT(Tobeshared)

Classroom

Session

 

 

  Topics to be discussed:

 

1.       Enumerate two functions of PCI Inspector.

2.       Give the labelling requirements and write specimen label for schedule G.

3.       What is Drug Consultative Committee (DCC)?

 

 

 

 

Session 17:

Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee

 

Prior to

the Classroom Session

 

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’s PPT (To be shared)

 

Classroom

Session

 

Topics to be discussed:

 

1.       Enumerate two functions of PCI Inspector.

2.       Give the labelling requirements and write specimen label for schedule G.

3.       What is Drug Consultative Committee (DCC)?

 

 

 

 

Session 18:

Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee

Prior to

the Classroom Session

 

Text Book:

Forensic Pharmacy by B. Suresh

Instructor’s PPT (To be shared)

Classroom Session

Topics to be discussed:

1.       Enumerate two functions of PCI Inspector.

2.       Give the labelling requirements and write specimen label for schedule G.

3.       What is Drug Consultative Committee (DCC)?

4.   Write the constitution and functions of Drug Technical Advisory Board (DTAB).

 

Session19:

 

Government drug analysts, Licensing

authorities, controlling authorities, Drugs Inspectors

Prior to

the Classroom Session

Text Book:

Forensic Pharmacy by B. Suresh

Instructor’s PPT (To be shared)

Classroom Session

Topics to be discussed:

Give detailed note about Government drug analysts, Licensing

authorities, controlling authorities, Drugs Inspectors.

Session20:

Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations

 

 

 

 

 

 

 

 

 

 

Prior to

the Classroom Session

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’s PPT (To be shared)

 

Classroom Session

Topics to be discussed:

Write in details about Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations.

 

Session 21:

Pharmacy Council of India; its constitution and functions, Education Regulations

Prior to

the

Classroom Session

Text Book: Forensic Pharmacy by B. Suresh

Instructor’s PPT (To be shared)

Classroom Session

Topics to be discussed:

Write about Pharmacy Council of India; its constitution and functions, Education Regulations.

Session 22:

State and Joint state pharmacy

councils; constitution and functions, Registration of Pharmacists, Offences and Penalties

Prior to

the

Classroom Session

 

Text Book: Forensic Pharmacy by B. Suresh

Instructor’s PPT (To be shared)

Classroom Session

Topics to be discussed:

Write about State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties.

 

Session 23:

 

Quiz

Topics:

DTAB,DCC

Session 24:

 

Class Test

Topics: UNIT II

 

UNITIII

Session 25:

Medicinal and Toilet Preparation Act –1955: Objectives, Definitions

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prior to

the

Classroom Session

 

 

Text Book: Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

 

Classroom Session

Topicstobediscussed:

 Write details about Medicinal and Toilet Preparation Act –1955: Objectives.

 

Session 26:

Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations

 

Priorto

the

Classroom Session

Text Book: Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

Classroom Session

Topicstobediscussed:

  Prepare a details note about Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations.

Session 27:

 

Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and Penalties.

Priorto

the

Classroom Session

 

Text Book:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

 

Classroom Session

Topicstobediscussed:

Wite about Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and Penalties.

Session 28:

 

 

Group Discussion

Topics:

Medicinal and toilet preparation act

Session 29:

 

Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives, Definitions

Priorto

the

Classroom Session

 

TextBook:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

 

Classroom Session

Topicstobediscussed:

What do you mean by NDPS act?

Session 30:

 

Authorities and Officers, Constitution and Functions of narcotic &

Psychotropic Consultative Committee

 

 

 

 

 

 

 

 

 

Prior to

the

Classroom Session

 

Text Book:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’s PPT (To be shared)

 

Classroom Session

Topicstobediscussed:

Write about constitution and function of NDPS act.

Session 31:

National Fund for Controlling the Drug Abuse, Prohibition, Control and Regulation

Prior to

the

Classroom Session

 

TextBook:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’s PPT(To be shared)

Classroom Session

Topics to be discussed:

Write about National Fund for Controlling the Drug Abuse, Prohibition, Control and Regulation.

Session32:

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

 

Prior to

the

Classroom Session

 

Text Book:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

Classroom Session

Topicstobediscussed:

What do you mean by Opium poppy cultivation and production of poppy straw, manufacture, sale and export of opium, Offences and Penalties?

Session 33:

 

Study of Salient Features of Drugs and Magic Remedies Act and its

rules: Objectives, Definitions

 

Prior to

the

Classroom Session

Text Book:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’s PPT(To be shared)

Classroom Session

Topics to be discussed:

Write about the Salient Features of Drugs and Magic Remedies Act and its

rules: Objectives, Definitions.

Session34:

Quiz test

Topics:

Drugs and Magic Remedies Act

Session 35:

 

Class Test

Unit III

UNIT-IV

Session36:

Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties

Prior to the Classroom Session

 

Text Book:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

Classroom Session

Topicstobediscussed:

1.       Define magic remedies. Write the classes of advertisements prohibited under D&MR Act.

2.       Define drugs, advertisements and magic remedies as per D&MR Act.

3.       Discuss the classes of advertisements exempted conditionally under D&MR Act.

4.       Define magic remedies. Give the classes of advertisements.

5.       Write the offences and penalties in contravention of D&MR Act.

6.       Define advertisement and mention the objectives of D&MR Act.

7.       Define magic remedies. Write a note on scrutiny of misguiding advertisements related to drugs.

Session37:

Flip Class

Topics:

Session38:

Prevention of Cruelty to animals Act-1960: Objectives, Definitions

Prior to

the

Classroom Session

 

TextBook:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

Classroom Session

Topicstobediscussed:

1.       Give the constitution and functions of Institutional Animal Ethical Committee (IAEC).

2.       Write the objectives and prevention of cruelty to animals. What are the parts of CPCSEA guidelines?

3.       What are CPCSEA guidelines for breeding and stocking of animals?

4.       Write about transport and acquisition of animals for experiment.

5.       Write a note on power to suspend or revoke of registration as per Prevention of Cruelty to animals Act.

6.       Describe the facilities to be maintained for experimentation on animals under CPCSEA guidelines.

Session39:

Institutional Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of Animals

Prior to

the

Classroom Session

 

Text Book:

Text book of Forensic Pharmacy by B.M. Mithal

Classroom Session

 

Topicstobediscussed:

1.       Give the constitution and functions of Institutional Animal Ethical Committee (IAEC).

2.       Write the objectives and prevention of cruelty to animals. What are the parts of CPCSEA guidelines?

3.       What are CPCSEA guidelines for breeding and stocking of animals?

4.       Write about transport and acquisition of animals for experiment.

5.       Write a note on power to suspend or revoke of registration as per Prevention of Cruelty to animals Act.

6.       Describe the facilities to be maintained for experimentation on animals under CPCSEA guidelines.

 

Session40:

 

Institutional Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of Animals

Prior to

the

Classroom Session

 

Text Book:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’s PPT (To be shared)

Classroom Session

 

Topicstobediscussed:

1.       Give the constitution and functions of Institutional Animal Ethical Committee (IAEC).

2.       Write the objectives and prevention of cruelty to animals. What are the parts of CPCSEA guidelines?

3.       What are CPCSEA guidelines for breeding and stocking of animals?

4.       Write about transport and acquisition of animals for experiment.

5.       Write a note on power to suspend or revoke of registration as per Prevention of Cruelty to animals Act.

6.       Describe the facilities to be maintained for experimentation on animals under CPCSEA guidelines.

 

Session41:

Performance of Experiments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties

Prior to

the

Classroom Session

 

TextBook:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

Classroom Session

 

Topicstobediscussed:

1.       Give the constitution and functions of Institutional Animal Ethical Committee (IAEC).

2.       Write the objectives and prevention of cruelty to animals. What are the parts of CPCSEA guidelines?

3.       What are CPCSEA guidelines for breeding and stocking of animals?

4.       Write about transport and acquisition of animals for experiment.

5.       Write a note on power to suspend or revoke of registration as per Prevention of Cruelty to animals Act.

6.       Describe the facilities to be maintained for experimentation on animals under CPCSEA guidelines.

 

Session 42:

Performance of Experiments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties

 

Prior to

the

Classroom Session

 

 

TextBook:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

Classroom Session

 

Topicstobediscussed:

Describe the Performance of Experiments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties.

Session43:

National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)- 2013. Objectives, Definitions

Prior to

the

Classroom Session

 

Text Book:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

Class room Session

Topicstobediscussed:

What is National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)- 2013. Objectives, Definitions?

Session44:

Medical Termination of Pregnancy Act

Quiz test

 Topics:

Medical Termination of Pregnancy Act

Session45:

 

Class Test

 UNIT IV

UNIT V

Session46:

Sale prices of bulk drugs, Retail price of formulations

Prior to

the

Classroom       Session

 

Text Book:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’s PPT(To be shared)

Classroom       Session

Topicstobediscussed:

Write a note on Sale prices of bulk drugs, Retail price of formulations.

Session47:

Retail price and ceiling price of scheduled formulations, National List of Essential Medicines(NLEM)

Prior to

the

Classroom       Session

 

TextBook:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

 

Classroom       Session

Topicstobediscussed:

 

Retail price and ceiling price of scheduled formulations, National List of Essential Medicines (NLEM)

 

Session48:

 

Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee

Prior to

the

Classroom       Session

 

 

TextBook:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

Classroom       Session

Topicstobediscussed:

What isPharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee?

 

 

Session49:

Health survey and development committee, Hathi committee and Mudaliar committee

 

 

Prior to

the

Classroom       Session

 

TextBook:

Text book of Forensic Pharmacy by B.M. Mithal

Instructor’sPPT(Tobeshared)

Classroom       Session

Topicstobediscussed:

Health survey and development committee, Hathi committee and Mudaliar committee.

Session50:

Code of Pharmaceutical ethics D efinition, Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’soath

Quiz test

Topics:

Code of Pharmaceutical ethics D efinition, Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath

Session51:

 

Class Test

UNIT V

Session52:

 

Doubt Clearing Class

UNIT I & II

Session53:

 

Doubt Clearing Class

UNIT III, IV & V

Session 1

BPHT505T UNIT_I

Drugs and Cosmetics Act,1940 and its rules 1945:

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

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)

BP505T-PJ-UNIT_II

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

offences and penalties

session-14

List of permitted colours

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

BP505T-PJ-UNIT_III

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

BP505T-PJ-UNIT_IV

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

session-39

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

BP505T-PJ-UNIT_V

session 40

Hathi Committee and Mudaliar committee

 

session 41

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

session 42

medical profession and his profession,Pharmacist's Oath

session 43

Medical termination of Pregnancy act

session 44

Right to information act

session 45

Introduction to Intellectual Property Right