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Pharmaceutical Jurisprudence (B. Pharm 5th Semester)

Pharmaceutical Jurisprudence (B. Pharm 5th Semester)

Teacher

Binapani Barik

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Core Courses

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Course Name : Pharmaceutical Jurisprudence

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

Course Objectives

This course is designed to impart basic knowledge on important legislations related to the profession of pharmacy in India.

Learning Outcomes

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.

Course Syllabus

UNIT-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 150 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                                                                                                                                                                                                                                                  

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                                                                                                             

Pharmacy Act –1948:

Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils; its 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.

UNIT-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 Act-1960: Objectives, Definitions, Institutional Animal Ethics Committee, 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. 151 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                                                                                                                                            

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)

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

1 D & C ACT 1940 History, Objectives (1)

Session -2

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

 

2 Legal definitions of schedules to the Act and Rules

(1)3 IMPORT OF DRUGS

(1)IMPORT OF DRUGS

Session-3

Import under license or permit.Offences and penalties.

3 IMPORT OF DRUGS (1)

Session-4

Sale of Drugs-Wholesale,Retail sale and Restricted license

SALE OF DRUGS

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

STUDY OF SCHEDULE

session-6

manufacture of new drug,loan license and repacking license.

MANUFACTURE OF DRUGS

session-7

Manufacture of drugs for test,examination and analysis

MANUFACTURE OF DRUGS

session-8

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

MANUFACTURE OF DRUGS

session-9

Manufacture of Drugs-Prohibition of manufacture and sale of certain drugs

MANUFACTURE OF DRUGS

session-10

Licensing authorites,controlling authorites

ADMINISTRATION OF THE ACT AND RULES

session-11

Drugs Consultative committee.Government drug alnalysts

ADMINISTRATION OF THE ACT AND RULES

session-12

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

ADMINISTRATION OF THE ACT AND RULES

session-13

offences and penalties

ADMINISTRATION OF THE ACT AND RULES

session-14

List of permitted colours

session-15

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

PROVINCIAL PHARMACY COUNCIL

session-16

session-17

Pharmacy Act 1948:

objectives,definitions

BP505T-PJ-UNIT_III

session-18

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

PHARMACY PRACTICE REGULATION 2015

session-19

State and Joint State Pharmacy Councils;constitution and functions

PHARMACY PRACTICE REGULATION 2015

session-20

Registration of pharmacists

PHARMACY PRACTICE REGULATION 2015

session-21

Offences and Penalties

PHARMACY PRACTICE REGULATION 2015

serssion-22

Medicinal and toilet preparation act 1955:

Objectives,Definitions

MTP ACT

session-23

Licensing,In bond and outside bond

MTP ACT

session-24

export of alcoholic preparations

MTP ACT

session-25

Manufacture of  Ayurvedic,Homeopathic,patent & proprietary preparations

MTP ACT

session-26

offences and penalties

MTP ACT

session -27

Constitution and function of Narcotic and psychotropic Consultative committee,

NARCOTICS DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND RULE

session-28

Narcotic Drugs and Psychotropic Substances Act-19875 and Rules:

Objectives,Definitions,Authorities and Officers

NARCOTICS DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND RULE

session-29

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

NARCOTICS DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND RULE

session-30

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

NARCOTICS DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND RULE

session-31

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,

DRUGS AND MAGIC REMEDIES ACT

session-34

offences and penalties

DRUGS AND MAGIC REMEDIES ACT

session 35

Prevention of Cruelty to Animals Acts Act-1960:

Objectives,Definitions,Institutional animal ethics committee

PREVENTION OF ANIMAL CRUELTY ACT

session 36

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

cpcsea guideline

session 37

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

PREVENTION OF ANIMAL CRUELTY ACT

session 38

offences and penalties

cpcsea guideline

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

BP505T-PJ-UNIT_V

session 41

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

BP505T-PJ-UNIT_V

session 42

medical profession and his profession,Pharmacist's Oath

BP505T-PJ-UNIT_V

session 43

Medical termination of Pregnancy act

BP505T-PJ-UNIT_V

session 44

Right to information act

NPPA-1997

session 45

Introduction to Intellectual Property Right

BP505T-PJ-UNIT_V

Suggested Books:

1.Forensic Pharmacy by B. Suresh

  1. Text book of Forensic Pharmacy by B.M. Mithal
  2. Hand book of drug law-by M.L. Mehra
  3. A text book of Forensic Pharmacy by N.K. Jain
  4. Drugs and Cosmetics Act/Rules by Govt. of India publications.
  5. Medicinal and Toilet preparations act 1955 by Govt. of India publications.

7.Narcotic drugs and psychotropic substances act by Govt. of India publications

  1. Drugs and Magic Remedies act by Govt. of India publication 9. Bare Acts of the said laws published by Government. Reference books (Theory)

Our Main Teachers

Binapani Barik

Assistant Professor
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Drug Design and Nano formulations

I am Himansu Sekhor Panda, currently working as an Assistant Professor at Centurion University of Technology and Management, Balasore Campus.   I have completed my B. Pharm and M.Pharm (Pharmaceutics) at CUTM, Bhubaneswar on 2021 and 2023 respectively, having a teaching experience of around 2 years.