PHARMACEUTICAL JURISPRUDENCE

Teacher

Dinesh Kumar Sharma

Category

Core Courses

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Course Name : Pharmaceutical Jurisprudence

Code(Credit) : DCPY1204 (2-0-0)

Course Objectives

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

Learning Outcomes

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

  • The Pharmaceutical legislations and their implications in the development and marketing of
  • 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

Course Syllabus

  1. Origin and nature of pharmaceutical legislation in India, its scope and objectives. Evolution of the "Concept of pharmacy" as an integral part of the Health care system.
  2. Principles and significance of professional Ethics. Critical study of the code of pharmaceutical Ethics drafted by pharmacy council of India.
  3. Pharmacy Act, 1948-The General study of the pharmacy Act with special reference to Education Regulations, Working of state and central councils, constitution of these councils and functions, Registration procedures under the Act.
  4. The Drugs and Cosmetics Act, 1940-General study of the Drugs and cosmetics Act and the Rules there under. Definitions and salient features related to retail and whole sale distribution of drugs. The powers of Inspectors, the sampling procedures and the procedure and formalities in obtaining licenses under the rule. Facilities to be provided for running a pharmacy effectively. General study of the schedules with special reference to schedules C,C1,F,G,J,H,P and X and salient features of labeling and storage conditions of drugs.
  5. The Drugs and Magic Remedies (objectionable Advertisement)Act, 1954-General study of the Act, objectives , special reference to be laid on Advertisements, magic remedies and objections and permitted advertisements -diseases which cannot be claimed to be cured.
  6. Narcotic Drugs and psychotropic substances Act, 1985-A brief study of the act with special reference to its objectives, offences and punishment.
  7. Latest Drugs (price control) order in force.
  8. Poisons Act 1919(as amended to date)
  9. Medicinal and Toilet preparations (excise Duties) Act, 1955 (as amended to date).
  10. Medical Termination of Pregnancy Act, 1971(as amended to date).

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 Plan

Session 1

Origin and nature of pharmaceutical legislation in India

1 pharmaceutical legislation in India

Session 2

Session 3

Evolution of the "Concept of pharmacy" as an integral part of the Health care system

3 history or evolution of pharmacy

Session 4

Evolution of the Pharmacist’s role

4 Evolution of the Pharmacist’s role

Session 5

Principles of Professional Ethics

5 Pharmaceutical ethics

Session 6

significance of professional Ethics

6 significance of pharmaceuticsl ethics

Session 7

Pharmacy Act, 1948-The General study of the pharmacy

7 Pharmacy act 1948

Session 8

Act with special reference to Education Regulations.

8 Pharmacy act 1948 education regulation

Session 9

Working of state and central councils

9 Pharmacy act 1948 state & central council

Session 10

constitution of these councils and functions

10 Pharmacy act 1948 constitution

Session 11

Registration procedures under the Act

11 Pharmacy act 1948 Regitration procedure

Session 12

The Drugs and Cosmetics Act, 1940- History and Objective

12 D & C ACT 1940 History, Objectives

Session 13

Definitions under the act

13 D & C Act Definition

Session 14

Schedule to the Drugs and cosmetics Act and the Rules there under

14 D & C ACT 1940 Schedules to the act and rules - Copy

Session 15

Salient features of this act

15 D & C ACT 1940 Salient features

Session 16

Session 17

provision related to import

17 Provision related to import

Session 18

Government analyst

18 govt analyst

Session 19

Power of Drug Inspector

19 DI

Session 20

Sampling procedures and the procedure and formalities in obtaining licenses under the rule

20 sampling procedure

Session 21

Facilities to be provided for running a pharmacy

21 DI, facility to provide running of pharmacy

Session 22

Provision related to manufacture

22 Provisions related to Manufacture

Session 23

Provision related to sale

23 Provisions related to sale

Session 24

Provision related to labeling and packaging

24 Provisions related to labelling and packaging

Session 25

General study of the schedules with special reference to schedules C,C1,F,G,J,H,P and X

25 D & C ACT 1940 Schedules to the act and rules

Session 26

The Drugs and Magic Remedies (objectionable Advertisement)Act, 1954

26 drugs and magic remedies act 1954 and rules - Copy (2)

Session 27

Magic remedies and objections

27 magic remedies

Session 29

Narcotic Drugs and psychotropic substances Act, 1985

29 Narcotic Drugs and psychotropic substances Act, 1985

Session 32

Latest Drugs (price control) order in force

32 Latest Drugs (price control) order in force

Session 33

Retail Price of Formulation

33 Retail Price

Session 34

Ceiling Price, offenses and punishment

34 ceiling price, offences and penalties

Session 35

Poisons Act 1919(as amended to date)

35 Poisons Act 1919

Session 36

Medicinal and Toilet preparations (Excise Duties) Act, 1955

36 medicinal and toilat preparation act 1955

Session 37

Manufacture and Warehousing of Alcoholic Preparation

37 Manufacture and Warehousing of Alcoholic Preparation

Session 38

Export of Alcoholic Preparation

38 exports of alcoholic preparation

Session 39

Medical Termination of Pregnancy Act, 1971

39 medical termination of pregnancy act-1971

Session 40

Experience or training

40 MTP Experience or training

Case Studies

Case Studies

Our Main Teachers

M. Pharm (Pharmaceutics)