SCHOOL OF PHARMACEUTICAL SCIENCES

Course Plan for Pharmaceutical jurisprudence

Course Code BP505T Course Pharmaceutical jurisprudence

Prepared by Ms. Sujata Bote Date

Prerequisites N.A.

Course Outcomes
At the end of the course the students should be able to:
CLO1 State1 the objectives, terminologies, offence and penalties of various laws related to drugs.

CLO2 Explain2 the history of pharmaceutical legislation, pharmacy ethics, pharmacy act,
administration and controlling of acts and rules.
CLO3 Describe2 the drug and cosmetic act and rules and Medicinal and Toilet preparation Act
CLO4 Explain2 the act and rules to control drug price, Narcotic drugs and Psychotropic
substances, magic remedies.

CLO5 Illustrate3 the act for prevention of cruelty to animals, medical termination of pregnancy,
and rights to information and intellectual property right.

Mapping of COs with Pos

POs a b c d e f g h i j k
COs
1 1 3 2
2 3 3 3
3 2 1 1
4 2 1 1
5 1 1 1

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 SCHOOL OF PHARMACEUTICAL SCIENCES

Course Contents

Unit Title No. of

No. Hours
I Drug and Cosmetics Act, 1940 and its rules 1945 10Hrs

II Drug and Cosmetics Act, 1940 and its rules 1945 10Hrs

III Pharmacy Act 1948, Medicinal and Toilet preparation Act 1955, Narcotic Drugs 10Hrs
and Psychotropic substances Act 1985

IV Study of Salient features of Drug and Magic Remedies Act and its rules, 08Hrs
Prevention of Cruelty to Animal Act 1960, National Pharmaceutical Pricing
Authority: Drug Price Control Order 2013

V Pharmaceutical legislation, Code of Pharmaceutical Ethics, Medical Termination 07Hrs

of Pregnancy Act, Right to Information Act, Introduction to Intellectual Property
Rights (IPR)

List of text and reference books

Sr. Title of Book Author Publisher/Edition Topics
No.
1 A Textbook of Forensic Kuchekar B.S. Nirali Prakashan D & C Act 1940,
Pharmacy IPR. MTP Act
2 Textbook of Forensic C.K.Kokate, S.B.Ghokale PharmaMed Pharmacy Act,
Pharmacy Press,2008 Medicinal &
toilet preparation
act, CPCSEA.
3 Pharmacy law and Prof. Bhanudas S. Nirali Prakashan Pharmaceutical
ethics Kuchekar legislation, Code
pharmaceutical
ethics
4 Pharmaceutical Dr. B. S. Kuchekar Nirali Prakashan Drug & Magic
Jurisprudence remedies Act,
DPCO, NDPS
Act

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Evaluation scheme

Examination FET Theory Total FEP POE Total

Scheme
Max. Marks 25 75 100 NA
Contact 1hr/week 3hrs/week
Hours/ week

Unit wise Lesson Plan

Unit No Unit Title Planne Planned Counducted
d Hrs. Date Dates
I Drug and Cosmetics Act, 1940 and its rules 1945 10Hrs 10 10

Lesson schedule

Class Details to be covered

No.
1 Introduction to Jurisprudence, objective, definition, schedules to 05/09/22
the act and rules
2 Import of drugs: classes of drugs & Cosmetics prohibited from 06/09/22
import
3 Import under license or permit, Offences and penalties 07/09/22

4 Mfg. of drugs: prohibition of mfg.& sale certain drugs 12/09/22

5 Conditions for grant of license for mfg. of drugs 13/09/22

6 Mfg. of drugs for test, examination and analysis 14/09/22

7 Mfg. of the new drug 19/09/22

8 Loan licensing & repacking license 20/09/22

9 Loan licensing & repacking license 21/09/22

10 Mfg. of biological & special products 26/09/22

Review Questions

1 Write the objectives of D & C Act 1940. Actual

Hrs.
2 Write the classes of drugs which are prohibited from 10
import?
3 Define: i) Misbranded drug ii) Spurious drugs

4 Write the conditions of licensing authority for import

of drugs.

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 SCHOOL OF PHARMACEUTICAL SCIENCES
5 Enlist the types of licenses required for mfg. of drugs.

6 Write all schedules to rules under D & C Act 1940

Unit No Unit title Planne

d Hrs.
IV Study of Salient features of Drug and Magic 08Hrs 08 08
Remedies Act and its rules, Prevention of Cruelty
to Animal Act 1960, National Pharmaceutical
Pricing Authority: Drug Price Control Order 2013

Lesson schedule

Class Details to be covered

No.
1 Objectives, Definitions 27/09/22

2 Prohibition of certain advertisement, classes of exempted 28/09/22

advertisements, offences and penalties
3 Objectives, definition, IAEC 03/10/22

4 CPCSEA guidelines, performance of experiment 04/10/22

5 Transfer & acquisition of animals for experiment, records to 08/10/22

suspend or revoke registration, offences & penalties
6 DPCO-2013: objectives, definitions 17/10/22

7 Sale prices of bulk drugs, retail price of formulation, retail price 18/10/22
& ceiling price of sch. Formulations
8 National List of Essential Medicines 19/10/22

Review Questions

1 Define Magic remedy and write the objectives of Actual

Drug & magic remedies act. Hrs.
2 Write the classes of prohibited advertisements.

3 Enlist the members of IAEC.

4 Write guidelines for breeding & stocking of animals.

5 Write guidelines for performing expt. on animals.

6 Write the objectives of DPCO Act 2013.

7 Give the formula for RP of formulation.

8 Define: i) ceiling price ii) MRP iii) Distributor

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 SCHOOL OF PHARMACEUTICAL SCIENCES
Unit No Unit title Planne
d Hrs.
II Drug and Cosmetics Act, 1940 and its rules 1945 10Hrs 10 10

Lesson schedule

Class Details to be covered

No.
1 Detailed study of schedule G,H,M,N,P,T,U,V,X,Y,F 31/10/22

2 Sale of drugs: wholesale, retail sale and restricted license 01/11/22

3 Offences and penalties 02/11/22

4 Labelling and packaging of drugs 07/11/22

5 List of permitted colours, offences and penalties 09/11/22

6 Drug Technical Advisory Board 12/11/22

7 Drug Consultative Committee 14/11/22

8 Govt. drug analyst 15/11/22

9 Licensing authorities, controlling authorities 16/11/22

10 Drug inspectors 21/11/22

Review Questions

1 Explain in detail sch. M, G,H,N,F Actual

Hrs.
2 Explain in detail sch. P,T,U,V,X,Y

3 Write general labelling requirements of drugs.

4 Enlist administrative bodies of D & C Act. Write the

members & functions of DTAB & DCC.
4 Give a detail note on Drug Inspector

5 Write the qualification and duties of Govt. analyst.

Unit No Unit title Planne

d Hrs.
III Pharmacy Act 1948, Medicinal and Toilet 10Hrs 10 10
preparation Act 1955, Narcotic Drugs and
Psychotropic substances Act 1985
Lesson schedule

Class Details to be covered

No.

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 SCHOOL OF PHARMACEUTICAL SCIENCES
1. Pharmacy Act 1948: objectives, definitions, ,pharmacy council 22/11/22
of India its constitution and function, education regulation
2. State & joint state pharmacy councils; constitution & function. 23/11/22

3. Registration of pharmacist, offences. 28/11/22

4. Medicinal & toilet preparation act-1955; Objective & definition. 29/11/22

5. Licencing, mfg. in bond & outside bond, export of alcoholic 30/11/22

preparation.
6. Mfg. of Ayurvedic, homeopathic patent & propriety preparation 05/11/22
offences penalties.
7. Narcotic drugs & psychotic substance act-1985; objective, 06/12/22
definitions, Authorities & officers.
8. Constitution & function of NDDS consultative committee. 07/12/22

9. National fund for controlling drug abuse prohibition, control & 12/12/22
regulation.
10. Opium poppy cultivation, mfg. sale, offence. 13/12/22

Review Questions

1 Define Pharmacy Act 1948. Write its objectives. Actual

Hrs.
2 Write the important provisions included in PCI.

3 Write members and functions of PCI.

4 What is registered pharmacist? What particulars are

maintained in register of pharmacist?
5 Define: i) Medicinal preparation ii) Toilet preparation
iii) Bonded manufactory iv) Nonbonded manufactory
6 Classify medicinal and toilet preparations.

7 Explain in detail mfg. under bonded & nonbonded

manufactory.
8 Write objective of NDPS Act 1985 & define NDPS
Act 1985 and Psychotropic substances.
9 Give a short note on NDPS consultative committee.

10 Write offences & penalties related to NDPS Act 1985.

Unit No Unit title Planne

d Hrs.
V Pharmaceutical Legislation 07 07 07

Lesson schedule

Class Details to be covered

No.

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1. A brief review, introduction study of drugs inquiry committee 14/12/22
health survey & development committee.
2. Hathi committee & mudaliar committee. 26/12/22

3. Code of pharmaceutical ethics; Def pharmacist in relation to job 27/12/22

code.
4. The medical profession & his profession, pharmacist oath. 28/12/22

5. Medical termination of pregnancy act. 02/01/23

6 Right to information Act

7. Introduction to intellectual property right (IPR) 04/01/23

Review Questions

1 Give note on :i) Hathi committee ii) Mudaliar Actual

committee Hrs.
2 Give the role of pharmacist in relation to his job.

3 Define RMP and write objective of MTP Act.

4 Define Right to information. write its objective.

5 Give a detail note on ‘Parent’

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