GUJARAT TECHNOLOGICAL UNIVERSITY

Bachelor of Pharmacy
Subject Code: BP405TT
SEMESTER: IV
Subject Name: PHARMACEUTICAL JURISPRUDENCE

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 the student shall be able to

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

Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme

Theory Tutorial Practical Total Theory Practical
External Internal External Internal
3 1 0 4 80 20 0 0

Course Content:

Sr No Topics %
weightage
1. Drugs and Cosmetics Act, 1940 and its rules 1945: 10
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.
2. Drugs and Cosmetics Act, 1940 and its rules 1945. 10
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
3.  Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of 10
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.

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 GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP405TT
 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
 Study of Salient Features of Drugs and Magic Remedies Act and its 8
4. 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 EssentialMedicines (NLEM)
5.  Pharmaceutical Legislations – A brief review, Introduction, Study of 7
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)

Recommended books: (Latest Edition)

1. Forensic Pharmacy by B. Suresh 123
2. Text book of Forensic Pharmacy by B.M. Mithal
3. Hand book of drug law-byM.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)

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B. PHARM SEMESTER–IV EXAMINATION – WINTER 2023

Subject Code: BP405TT Date: 20/01/2024

Subject Name: Pharmaceutical Jurisprudence
Time: 2:30 PM TO 5:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Explain the conditions for the issue of License to manufacture schedule C, C1 and X 06
drugs.
(b) What is schedule M? Explain its provision in manufacture of drugs. 05
(c) Write a short note on Loan License and Repacking License. 05
Q.2 (a) What is PTC? Discus function and constitution of PTC. 06
(b) Write a short note on DTAB and CDL 05
(c) Explain qualification and duties of government analyst. 05
Q.3 (a) What is schedule N? Explain its provision in manufacture of drugs. 06
(b) Explain Medical Termination of Pregnancy Act. 05
(c) State objective and function of DPCO Act-2013 05
Q.4 (a) Give the function of narcotic and psychotropic substances. 06
(b) Write a note on manufacturing in bonded Laboratories as per Medical & Toilet 05
Preparation Act.
(c) Write in detail about IPR. 05
Q.5 (a) Explain the full form of DI. Discuss the power and duties of DI. 06
(b) What is the code of Ethics for the pharmacist in relation to his job? 05
(c) Explain the following terms: 05
i) Adulterated drug ii) Spurious Drug iii) Cannabis
iv) Chemists & Druggists v) Advertisements
Q. 6 (a) Explain the rules of drug and magic remedies Act. 06
(b) What classes of drug are prohibited to be imported in India. 05
(c) Discuss constitution and function of State Pharmacy Council 05
Q.7 (a) Write provisions for prevention of cruelty to Animal Act 1960. 06
(b) Give procedure and qualification for entry of name as a pharmacist in first register. 05
(c) What are the special labeling requirements for following category: 05
i) 1. Schedule –G drug.
ii) 2. Ophthalmic Preparation.

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.Pharm- SEMESTER– IV • EXAMINATION – WINTER -2022

Subject Code: BP405TT Date: 31/12/2022

Subject Name: Pharmaceutical Jurisprudence
Time: 02:30pm to 05:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Define the following: i) Cosmetics ii) Coca derivatives 06

iii)Toilet preparations iv) Adulterated drugs.
(b) Explain the conditions for the issue of license to manufacture schedule C, C1 05
drugs.
(c) Explain in brief : i) Loan license ii) Repacking license. 05
Q.2 (a) Explain importance of IPR in pharmaceuticals, describe schedule V in this 06
reference.
(b) Write labelling requirements of Schedule G, Schedule H and Schedule X drugs. 05
(c) Write objectives of DPCO-2013. Explain retail price of formulations. 05
Q.3 (a) Write a short note on Right to Information Act-2005. 06
(b) Write CPCSEA guidelines for Breeding and Stocking of Animals. 05
(c) Prepare a note on Education regulation as per Pharmacy Act-1948 for B.Pharm 05
program.
Q.4 (a) Explain in detail the procedure for the import of drugs. 06
(b) Write the provisions to carry out experiments as per of Prevention of Cruelty to 05
Animals act – 1960.
(c) Write objectives & prohibition of certain advertisements of drugs as per magic 05
remedies act - 1954.
Q.5 (a) Write a detail note on provisions medical termination pregnancy Act- 1955. 06
(b) i) Write difference between bonded and non-bonded laboratory. 05
ii) Write difference between state Pharmacy council and Joint state Pharmacy.
(c) Write a role of drug Inspector in monitoring and control of drug store/factory 05
premises activities.
Q. 6 (a) Describe control and regulation in manufacturing, transporting and sealing 06
operations of narcotic drugs and psychotropic substances as per act 1985.
(b) Describe role of pharmacist in relation to his job, trade/ profession. 05
(c) Write a short note on pharmaceutical legislation in India. 05
Q.7 (a) Write constitution and functions of i) Hathi committee ii) Mudaliar committee 06
(b) Write constitution & functions of Drug Technical Advisory Board (DTAB) 05
(c) Write a note on building facilities requirement as per schedule “M”. 05

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.Ph. - SEM– IV EXAMINATION – SUMMER -2022

Subject Code: BP405TT Date: 22/07/2022

Subject Name: Pharmaceutical Jurisprudence
Time: 10:30AM TO 1:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Give statement of followings related to D & C ACT 1940: 06

Schedule G, Schedule J, Schedule H, Schedule N, Schedule X, Schedule U.
(b) Discuss on Bonded Laboratory. 05
(c) Give a note on DTAB and DCC. 05
Q.2 (a) Define and explain: loan license and repacking license. 06
(b) Give the difference between State & Joint state Pharmacy council. 05
(c) Give the methods of cultivation and collection of Opium. 05
Q.3 (a) What are the qualification and duties of government analyst. 06
(b) Discuss the conditions for the issue of license to manufacture schedule C, C1 05
and X drugs.
(c) Write a short note on CDL. 05
Q.4 (a) Discuss the power and duties of drug inspector. 06
(b) Write a note on Medical termination of Pregnancy Act. 05
(c) Give discussion on Drugs Price Control Order-2013. 05
Q.5 (a) Write a note on National Fund for Controlling the drug abuse and prohibition. 06
(b) Write a note on import of Drug. 05
(c) Discuss the different classes of exempted advertisements. 05
Q. 6 (a) Define Registered Pharmacist. What is the procedure for subsequent 06
registration?
(b) Give labeling conditions of ophthalmic preparations and narcotic preparations. 05
(c) Write a note on code of Pharmaceutical Ethics OR IPR. 05
Q.7 (a) Write CPCSEA guidelines for Breeding and Stocking of Animals. 06
(b) Write a note on wholesale and retail sale of drugs. 05
(c) Write a note on Hathi and Mudalier committee. 05

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.Pharm –SEMESTER – IV EXAMINATION – WINTER -2021

Subject Code:BP405TT Date: 15/02/2022

Subject Name: Pharmaceutical Jurisprudence
Time: 02:30PM to 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Write requirements of Factory premises as per Schedule “M ”. 06

(b) Write objectives of pharmacy Act – 1948 and constitution of PCI. 05
(c) Explain the procedure and conditions for manufacturing under Loan Licenses 05
as per Drugs & Cosmetics act 1940.
Q.2 (a) Write totally prohibited & controlled operations under narcotic & psychotropic 06
substances Act 1985.
(b) Write qualifications required for entry on First register and subsequent register. 05
(c) Explain brief note on Schedule “ T & Y”. 05
Q.3 (a) Describe licensing procedure for manufacturing of alcoholic preparations as per 06
The Medicinal and Toilet Preparation Act- 1955.
(b) Write down provisions of The Medical Termination of Pregnancy Act-1971. 05
(c) Explain power, duties and responsibilities of Excise officer. 05
Q.4 (a) Define: Cannabis , Opium derivatives, Patent. 06
(b) Write constitution and functions of Drug Technical Advisory Board (DTAB). 05
(c) Describe duties and responsibilities of Drug Inspector. 05
Q.5 (a) Write formulation retail price formula. Which are provisions under The drugs 06
price control order -2013(DPCO)?
(b) Explain patentable and Non patentable inventions with examples. 05
(c) Describe cultivation and sale procedure of opium and its derivatives. 05
Q. 6 (a) Write objectives and provisions to carry out animal experiments under 06
Prevention of cruelty to animal Act- 1960.
(b) Write a short note on provision of RTI Act-2005. 05
(c) Which classes of advertisements are prohibited under Drugs and Magic 05
Remedies Act?
Q.7 (a) Explain the role of pharmacist in relation to his job. 06
(b) Write a short note on evolution of drug laws. 05
(c) Write a note on Health survey and development committees. 05

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 GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm - SEMESTER–IV • EXAMINATION – SUMMER - 2021

Subject Code: BP405TT Date: 07/08/2021

Subject Name: PHARMACEUTICAL JURISPRUDENCE
Time: 10:30AM to 01:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.Pharm - SEMESTER–IV • EXAMINATION – WINTER -2020

Subject Code: BP405TT Date:15/02/2021

Subject Name: PHARMACEUTICAL JURISPRUDENCE
Time: 02:30PM TO 04:30PM Total Marks: 54
Instructions:
1. Attempt any THREE questions from Q-1 to Q-6.
2. Q.7 is compulsory to attempt.
3. Make suitable assumptions wherever necessary.
4. Figures to the right indicate full marks.

Q.1 (a) Explain the conditions for the issue of licence to manufacture schedule C, C1 06
and X drugs.
(b) Give statement of i) Schedule F ii) Schedule G iii) Schedule U iv) Schedule J 05
v) Schedule H as per Drugs and Cosmetics Act, 1940.
(c) What is schedule M? Explain its provision in manufacture of drugs. 05
Q.2 (a) Write a note on pharmacist relation to job, medical profession and his 06
profession.
(b) Write the constitution and functions of DTAB. 05
(c) Define as per D & C act and rules i) Chemists ii) Spurious drugs iii) 05
Adulterated drugs iv) Cosmetics v) Ayurvedic drugs.
Q.3 (a) Write a note on central drug laboratory. 06
(b) Give a note on provisions medical termination pregnancy Act. 05
(c) Write about offences and Penalties related to Narcotic & Psychotropic 05
substances Act-1985 and Rules.
Q.4 (a) Write the constitution and functions of PCI. 06
(b) Define Registered Pharmacist. Discuss the procedure for subsequent 05
registration.
(c) Give the detail note on drugs enquiry committee and its recommendation. 05
Q.5 (a) Discuss the operations which are totally prohibited and controlled by central 06
government and state government under narcotic drugs and psychotropic
substances act.
(b) What are the special labeling requirements for following category: 05
(i) Schedule - G drugs (ii) Ophthalmic preparations.
(c) Write a short note on Bonded Laboratory. 05
Q. 6 (a) Write a short note on definitions, objective and prohibited advertisements of 06
drugs and magic remedies act.
(b) Write a short note on Right to Information Act. 05
(c) What are the provisions of Prevention of Cruelty to Animals act? 05
Q.7 (a) Write a short note on powers and duties of drugs Inspectors. 06
OR
(a) Write a short note on Drugs Price Control Order-2013. 06
OR
(a) What are offences and penalties in prevention of Cruelty to Animals Act-1960? 06

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.PHARM - SEMESTER– 4 EXAMINATION – SUMMER -2020

Subject Code: BP405TT Date:02-11-2020

Subject Name: Pharmaceutical Jurisprudence
Time: 10:30 AM TO 1:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.PHARM - SEMESTER– 4 EXAMINATION – WINTER -2019

Subject Code: BP405TT Date: 20-12-2019

Subject Name: Pharmaceutical Jurisprudence
Time: 02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Explain import of Drug. 06

(b) Write a short note on loan license and repacking license. 05
(c) Write a note on PCI. 05
Q.2 (a) Explain schedule M. 06
(b) Write a short note on DTAB and CDL. 05
(c) Explain Qualification and duties of government analyst. 05
Q.3 (a) Write a procedure for manufacturing of alcoholic preparation from bonded 06
laboratories.
(b) Differentiate State & Joint state Pharmacy council. 05
(c) Give definition, objective, constitution and function of Narcotic and 05
psychotropic substances.
Q.4 (a) Describe in detail about Prevention of cruelty to animal act 1960. 06
(b) Write a note on DPCO. 05
(c) Discuss classes of exempted advertisement according to Drug & Magic 05
remedies act 1954.
Q.5 (a) Write a note on IPR. 06
(b) Explain Medical termination of Pregnancy Act. 05
(c) Write a note on code of Pharmaceutical Ethics. 05
Q. 6 (a) Define: Adulterate drug, Spurious drug, Hemp, Spirit, Poppy straw & Medicinal 06
preparation
(b) Explain cultivation and collection of Opium. 05
(c) Write a note on Pharmaceutical Legislation. 05
Q.7 (a) What are the qualifications for appointment as drug inspector? Discuss their 06
power and duties.
(b) Write a note on Schedule C and Schedule N. 05
(c) Explain Labeling and packaging of Drugs. 05

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.Pharm - SEMESTER–IV • EXAMINATION – SUMMER -2019

Subject Code: BP405TT Date: 17/05/2019

Subject Name: PHARMACEUTICAL JURISPRUDENCE
Time: 10:30 AM to 1:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Define: Cosmetics, Allopathic drugs, Chemist and druggist, Pharmacist, 06
Adulterated drugs, Patent and proprietary medicines
(b) Write the constitution and functions of DTAB. 05
(c) Explain the function of PCI (Pharmacy Council Of India). 05
Q.2 (a) Write a detailed note on licensing procedure for the preparations containing 06
alcohol and narcotics.
(b) Write a short note on powers and duties of drugs Inspectors. 05
(c) Write a short note on special provisions for opium. 05
Q.3 (a) Write a short note on definitions, objective and prohibited advertisements of 06
drugs and magic remedies act.
(b) Write a short note on registration of pharmacist. 05
(c) How the retail price of formulation is calculated? 05
Q.4 (a) Write a note on pharmacist relation to trade and job. 06
(b) Write a short note on pharmacist oath. 05
(c) Give the types of patterns. 05
Q.5 (a) Give a note on provisions medical termination pregnancy Act, 1971. 06
(b) Write a note on central drug laboratory. 05
(c) Write a note on loan license. 05
Q. 6 (a) Give the detail note on hathi and mudalier committee. 06
(b) Give statement of drugs and cosmetics ACT,1940. 05
Schedule D, Schedule J, Schedule K, Schedule N, Schedule X.
(c) Write CPCSEA guidelines for Breeding and Stocking of Animals. 05
Q.7 (a) Write a short note on DPCO-2013. 06
(b) Write a short note on Right to Information Act. 05
(c) Write in details of IPR. 05

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