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Sunday, September 11, 2022

Pharmaceutical Jurisprudence (Theory) | Semester 5 Notes | Handwritten Notes for Pharmacy Students as per PCI Syllabus

Pharmaceutical Jurisprudence (Theory)



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Here in Pharmaceutical Jurisprudence (Theory) you will get the following chapters,So follow us here and also our other social media platforms links Given below.

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

Objectives: Upon completion of the course student shall be able

  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

Download Semester wise PDFs,MCQs and Notes :-

Semester 1 :- Click here 
Semester  2 :- Click here 
Semester  3 :- Click here 
Semester  4 :- Click here 
Semester  5 :- Click here 
Semester  6 :- Click here 
Semester  7 :- Click here 
Semester  8 :- Click here

Syllabus Content:

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 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; 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, 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
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 D efinition, 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 

Download Following Chapters:-

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 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

Download (optional link 1)
Download (optional link 2)

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

Download (optional link 1)
Download (optional link 2)

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

Download (optional link 1)
Download (optional link 2)

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, 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)

Download (optional link 1)
Download (optional link 2)

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 D efinition, 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

Download (optional link 1)
Download (optional link 2)

The pharma courses

Also Download:
MCQs on Introduction of Glycosides:-Click here 
MCQs on Introduction of pharmacognosy :- Click here
Download and Read B pharmacy MCQs :- Click here 
MCQs From Pharmaceutical Engineering (include all chapters):- Click here 
MCQs From Biopharmaceutics and Pharmacokinetics (include all chapters) :- Click here
MCQs From Tablet chapter :- Click here 
MCQs From Pharmaceutical Jurisprudence (include all chapters):-Click here 
MCQs on Introduction of Alkaloids:- Click here
Human Anatomy and Physiology-I :- Click here 
MCQs on Introduction of Volatile Oils:-Click Here 
MCQs From Pathophysiology (include all chapters):-Click here 
Check other important Question Papers:- Click here 
MCQs From Hospital and Clinical Pharmacy(include all chapters): Click here

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