Curriculum | PHARMACEUTICAL JURISPRUDENCE (Theory) | B. Pharmacy

Course: B. Pharmacy 5th Semester/ 3rd Year
Name of Subject:   PHARMACEUTICAL JURISPRUDENCE (Theory)
Subject Code:   BP505 T

S. No. Contents of the Topics Learning Objectives Teaching Guidelines Methodology Time
(Hrs)
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.
To  describe

The Pharmaceutical legislations and their implications in the development and marketing

 

The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals

The code of ethics during the pharmaceutical practice

  • 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

Didactic
PowerPoint Demonstration

10

Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the act and rulesImport 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.

To  describe :

 

Various Indian pharmaceutical Acts and Laws

The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals

 

  • 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.

PowerPoint Demonstration

10

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
To  describe

 

Various Indian pharmaceutical Acts and Laws

 

The code of ethics during the pharmaceutical practice

  • 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
  • Export of alcoholic preparations, Manufacture of Ayurvedic, Homeopathic, and Patent & Proprietary Preparations. Offences and Penalties.
  • Narcotic Drugs and Psychotropic substances Act-1985 and Rules

PowerPoint Demonstration
Industry Visit

10

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. 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)

To  describe :

 

Various Indian pharmaceutical Acts and Laws

 

The code of ethics during the pharmaceutical practice

  • Various Indian pharmaceutical Acts and Laws

 

  • The code of ethics during the pharmaceutical practice

 

  • Prevention of Cruelty to animals Act-1960
  • Study  of  Salient  Features  of  Drugs  and  magic  remedies  Act  and  its  rules
  • National Pharmaceutical Pricing Authority

Didactic
PowerPoint Demonstration

8

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 (IPR)
To  describe :

The Pharmaceutical legislations and their implications in the development and marketing

 

The code of ethics during the pharmaceutical practice

  • A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee
  • 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)

PowerPoint Demonstration

7