S.

S Agrawal Institute of Pharmacy, Navsari

Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)
S.S Agrawal Institute of Pharmacy, Navasari.
Question Bank of Pharmacy Law and Ethics (DP206TT)

Chapter 1
1. Write a note on origin and nature of Pharmaceutical Legislation in India*
2. Give the scope of pharmaceutical legislation in India
3. Write the definition of pharmaceutical law and ethics and give general
principle of Law
4. Enlist the various Act Related to the Pharmacy Profession
5. Describe history of pharmaceutical Legislation in India*
6. Write about MUDLIAR COMMITTEE and HATHI COMMITTEE

Chapter 2
1. Discuss Constitution and Function of PCI*
2. Write Constitution of Central Pharmacy Council *
3. Differentiate state and Joint State Pharmacy Council*
4. Explain Function of PCI*
5. Discuss Constitution and function of State Pharmacy Council*
6. Discuss objective and function of pharmacy council of India
7. Write about Registration Process of Pharmacist*
8. Detail note on Pharmacy practice Regulation 2015*
9. Discuss objective and function of state pharmacy councils.
10. Describe procedure and qualification required for entry of name as a
pharmacist in first register
11. discuss subsequent registration of pharmacist in detail.
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)
Chapter 3
(1) Explain import of drug in detail*
(2) Write a short note on loan licence and repacking licence
(3) Define adultrated drug , spourious drug, cosmetic, allopathic drug,
chemist and druggist, pharmacist, patent and propritory medicine,
bulk drug, patent, advertisement
(4) Explain labeling and packing of drug.
(5) Write a short note on schedule C and schedule N.
(6) What are the qualification for appointment as drug inspector? Discuss
their power and duties.*
(7) Write a short note on DTAB and CDL.
(8) Explain schedule M.
(9) Explain qualification and duties of government analyst.*
(10) Write a constituents and function of DTAB.*
(11) write a short note on power and duties of drug inspecter.*
(12) Discuss qualification and responsibilities of Drug inspector*
(13) Write a short note CDL (central drug laboratory)*
(14) Write a note on loan licence.*
(15) Give a statement of drug and cosmetic act 1940, schedule D, schedule J,
schedule K, schedule N, schedule X, schedule B,.
(16) Write a short note on classes of the drugs and cosmetics prohibited
from import.
(17) Explain the condition for the issue of licence to manufacturing schedule
C,C1 and X.
(18) Give statement on schedule FF, schedule Q, schedule M, schedule U1,
schedule j, schedule C1, schedule Y, schedule N.
(19) Explain the condition for the issue of licence to manufacturing other
than specified in schedule C,C1 and X.
(20) Write down a condition for sale of the drug as per drug and cosmetic
act.
(21) What classes of the drug is prohibited to imported in india?
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)
(22) Write a short note on drug inspector under drug and cosmetic act.
(23) Discuss the requirements of factory premises given under schedule M
of drug and cosmetic act.*
(24) Give object of drug and cosmetic act 1940.
(25) Write a short note on DTAB.*
(26) Note on in detail schedule to rule A to X.
(27) Write offence and penalties related to import.
(28) Write a note on prohibition of manufacture of certain drug.
(29) Write a note on manufacture of drug for test, examination and analysis.
(30) Write a note on manufacture of new drug , loan licence, and
repacking licence.
(31) Write note on Retail sale of Schedule X and H drugs*
(32) Write a note on in detail schedule N, schedule T.
(33) Write a note on sale of wholesale and retail sale of drug.
(34) What are offences and penalties related to sales of the drug.
(35) Write a note on labelling and repacking of Drug *

Chapter 4

1. Discuss objective, offences, penalties of narcotic and psychotropic substance

Act, 1985.*
2. Write function and constitution of Narcotic and psychotropic consultative
committee*
3. Explain procedure for cultivation and collection of opium under Narcotic
Drugs and Psychotropic Substance Act, 1985*
4. Give the offences and penalties under NDPS Act*
5. Explain the prohibition ,control and Regulation for opium by central and
state government of India under NDPS Act.
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)
6. Define following terms in relation to NDPS Act
 Cannabis
 Coca derivatives
 Illicit derivative
 Opium derivative
 Opium poppy
7. Give the objective of NDPS Act

Chapter 5
1. Describe objective and function of drugs and Magic Remedies Act*
2. Discuss Prohibited and exempted Advertisement under Drug and Magic
Remedies Act*
3. Write objective and prohibition of certain advertisement of drug as per
magic remedies act-1954*
4. Explain the rules of drug and magic remedies Act
5. Discuss the offences and penalties of the drugs and Magic Remedies Act
6. Discuss provision of Drugs and magic Remedies Act,1954*

Chapter 6
1. Discuss the function of CPCSEA *
2. Write in brief about Institution Animal Ethics Committee (IAEC)*
3. Describe CPCSEA guidelines for breeding and Stocking of Animals*
4. Discuss about the prevention of cruelty to animal Act , 1960
5. Write the offences and penalties of the prevention of cruelty to animal Act,
1960*
6. Write provisions for prevention of cruelty to Animal Act 1960
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)
Chapter 7
1. Explain Poison Act in detail*
Chapter 8
1. What is FSSAI? Give the objectives and function of FSSAI*
2. Write in brief about Packaging and labelling of foods and food products
3. Define food analyst .give the functions of food Analyst
4. Give the offences and penalties under FSSAI act and rules
5.Write a detail note on food Analyst*

Chapter 9
1. Write objectives of DPCO-2013 .Explain retail price of formulations.*
2. Discuss National list of essential medicines (NLEM)*
3. Objective and functions of DPCO Act -2013*
4. Discuss silent Features of DPCO Act and how the MRP of Drug is Calculated.*
5. Write about pharmaceutical policy 2002
6. How is Retail price of formulation calculated as per DPCO ,1995
7 .Discuss about regulation of drug Price Control Order Act
8.Explain how the sale price of bulk drugs can be fixed under DPCO Act

Chapter 10
1. Describe role of Pharmacist in relation to his job, trade/profession*
2. Discuss the code of pharmaceutical ethics drafted by PCI*
3. Define code of pharmaceutical Ethics. Discuss it in relation to Pharmacist’s
job.*
4. Describe role of pharmacist in relation to his job and medical profession*
5. Described the Pharmacist’s Oath*
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)
6. Write the code of ethics of pharmacist in relation to his trade
Chapter 11
1. Write short note on Medical termination of pregnancy Act
2. Write note on provisions of Medical Termination of Pregnancy Act

Chapter 12
1. What is Central drug Standard Control Organization (CDSCO) Give
the objective of CDSCO.
2. What is IPC ? Give the objective, function of IPC
Chapter 13
1. Documentation Required for export of drug and medical devices
2. Write a note on Documentation required for Community pharmacy (Retail
sale)
3. Write a note on Good Pharmacy Practice in community and hospital
pharmacy
4.Write a short note on Good Pharmacy Practice

Chapter 14
1. What is BCS system of classification and Explain various classes in detail.*
2. What is clinical Trial and explain Various phases of clinical Trial*
3. Define New Drug .Enlist different steps involved in the New Drug
Development.**
4. Write in brief Brand drug and Generic Drug
5. Write note on Trademark
6. Write short note on Patent and copyright*
7. Write detail note on IPR( intellectual Property Right)*
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)
8. Write note about Emergency Use Authorization(EUA)*
9. What do you mean by NDA, ANDA, INDA
10. Give the Aims , objectives and features of New Drug and clinical Trial (NDCT
Rule,2019*
11. Write short note on Abbreviated New Drug Application (ANDA)*

Chapter 15
1. Write a note on Requirement of Blood Bank*
2. Discuss Blood Bank in Detail*

Chapter 16
1. Write short note on Clinical Establishment Act

Chapter 17
1. What is Biomedical Waste ? Give its Sources and classification of Biomedical
Waste
2. Explain Different method of disposal of biomedical waste
3. Short note on Biomedical Waste management Rules 2016

Chapter 18
1. Give the history , principle, and scope of Bioethics
2. What are ICMR’S National Ethical Guideline for Biomedical and Health
Research involving human Participants.*

Chapter 19
1. Write about Consumer Protection Act or Education Regulation*
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)
Chapter 20
1. Write about Disaster Management Act*
Chapter 21
1. Documention required for Export of drugs and medical Devices*
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)

1. Define pharmaceutical legislation. Discuss its scope SUMMER - 2024

and objectives in India
2. Describe History of pharmaceutical legislation in WINTER - 2023
detail
3. Write a note on history of Pharmaceutical WINTER-2021
Chapter
Jurisprudence
1
4. Define pharmaceutical jurisprudence. Explain origin WINTER - 2019
and history of pharmaceutical legislations in India.
5. Discuss the history, scope and objectives of WINTER -2020
pharmaceutical legislation in India
1. Discuss the constitution and function of PCI. – SUMMER –
2024, SUMMER –
2023, WINTER -
2019
2. Write constitution and functions of Pharmacy council WINTER -2020,
of India SUMMER -2021,
3. Discuss constitution of PCI WINTER -2018
4. Function of PCI WINTER -2018,
5. Write a detail note on subsequent registration of WINTER -2018,
Pharmacist WINTER – 2023,
SUMMER 2022
6. Write reasons for the removal of name of registered SUMMER -2021,
pharmacist from register WINTER - 2019
Chapter 2
7. Write about Consumer protection Act OR Education WINTER - 2023
Regulation
8. Discuss Subsequent registration of pharmacists in WINTER - 2023
detail
9. Give objectives of Pharmacy Act. Write procedure, WINTER -2020
requirement and qualification for first register for
registration of pharmacist.
10. Explain state council. Differentiate state council and WINTER -2020,
joint state council SUMMER -2021,
WINTER – 2019,
WINTER -2018
11. Write objectives of Pharmacy Act 1948? Write a note SUMMER 2022
on Education regulation
Chapter 3 1. Give the general procedure and conditions for – SUMMER –
obtaining a license for the sale of drugs under D & C 2024
Act 1940
2. Discuss the qualification and responsibilities of drug SUMMER – 2024
inspector
3. Discuss qualification and responsibilities of Drug – SUMMER -
Inspecto 2023
4. Write a detailed short note on DTAB SUMMER – 2023,
WINTER -2020,
SUMMER -2021,
WINTER – 2019,
WINTER -2018
5. Discuss loan license and repacking license in detail. SUMMER - 2023
6. Write a detailed note on labeling and packing of drug SUMMER – 2023
7. Write a detailed note on General labelling WINTER – 2023
requirements for drugs
8. Describe at length Powers and Procedure for Drug WINTER - 2023
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)

Inspector.
9. Describe the requirement necessary to obtain the SUMMER -2021
manufacturing license for the drug specified in
schedule C and C (1) under drugs and cosmetic act
1940
10. Write the content of the following schedule with WINTER -2020
examples : a) Schedule X b) Schedule R c) Schedule J
d) Schedule P e) Schedule Y f) Schedule N
11. What are the salient features and objectives of Drugs WINTER -2020
and cosmetic Act1940.
12. Write short note on Schedule M. WINTER -2020,
SUMMER -2021,
WINTER - 2019
13. Write note on Retail sale of schedule X and H drugs WINTER – 2023,
WINTER -2018
14. What are schedule C and C1 drugs ? Mention WINTER -2020,
conditions for their manufacturing and lisencing WINTER - 2019
15. Write functions of central drug laboratory WINTER -2020
16. Write short note on loan licence. SUMMER -2021
17. Explain qualification, powers, duties and WINTER – 2019,
responsibilities of drug inspector WINTER -2018
18. Discuss on Advisory board which is given under SUMMER 2022
chapter II of D&C Act-1940
1. Write in detail special provision made for cultivation, SUMMER – 2024
production, manufacturing of Opium under NDPS
Act, 1985.
2. Discuss objective, offences, penalties of narcotic SUMMER - 2023
Drugs and psychotropic 06 Substance act, 1985
3. Write about cultivation, collection ,manufacturing and WINTER -2020,
sale of opium as per Narcotic drugs and psychotropic SUMMER 2022
Chapter 4 substances act.
4. Discuss the offences and penalties under narcotic and WINTER -2020,
Psychotropic substances Act. WINTER - 2019
5. Write a note on offences and penalties of narcotic SUMMER -2021
drugs and psychotropic substances
6. Write the controlled operation by State and Central SUMMER 2022
government as per the Narcotic Drugs and
Psychotropic substances Act-1985
1. Write in detail about prohibited advertisements under SUMMER – 2024
Drug and Magic Remedies Act
2. Discuss prohibited and exempted Advertisement SUMMER - 2023
under Drug and Magic Remedies act
3. Discuss provisions of Drugs and Magic Remedies act’ WINTER - 2023
1954
4. Define Magic remedies. Explain the prohibited WINTER -2020,
Chapter 5 advertisement under the provisions of Drugs and SUMMER 2022
magic remedies act
5. Define ‘Advertisements’. Discuss the advertisements SUMMER 2022
with their specific conditions, exempted from the
provisions of Drugs and magic remedies act
6. What are the objectives of drugs and magic remedies SUMMER -2021,
act 1954. Give a note on prohibited advertisements WINTER - 2019
under the objectionable advertisement act-1954
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)

1. Discuss the constitution and functions of CPCSE. SUMMER – 2024

Chapter 6
2. Discuss the function of CPCSEA
1. Briefly describe Poison Act 1919. SUMMER – 2024,
WINTER -2018
2. Explain poison act in detail SUMMER – 2023,
SUMMER -2021,
Chapter 7
SUMMER 2022
3. Write objectives and provisions of Poison act 1919. WINTER -2020
1. Specify requirements of primary food packaging. SUMMER – 2024
Chapter8
2. Write a detailed note on food Analyst SUMMER - 2023
1. Discuss the salient features of DPCO and how the SUMMER – 2024,
MRP of drugs is calculated? SUMMER - 2023
2. Define ceiling price and write formulas for calculation WINTER -2020,
Chapter 9 of retail price as per Drug Price control order 1979 WINTER -2018
and 1995.
3. Write the objective of the DPCO. How will you SUMMER 2022
calculate Retail prices of formulations?
1. Write a detail note on code of pharmaceutical ethics – SUMMER -
2024
2. Discuss the code of pharmaceutical ethics drafted by SUMMER - 2023
PCI
Chapter 3. Define Code of Pharmaceutical Ethics. Discuss it in WINTER – 2023,
10 relation to pharmacist’s Job SUMMER -2021,
SUMMER 2022,
WINTER -2018
4. Write the duties of pharmacist in relation to his trade SUMMER -2021,
and profession WINTER - 2019
1. Describe provisions of Medical Termination of – SUMMER –
Pregnancy Act 2024, WINTER –
2019, SUMMER
2022
Chapter 2. Write a short note on Medical termination of SUMMER - 2023
11 pregnancy act
3. Write a note on Provisions of Medical Termination of WINTER – 2023,
Pregnancy Act SUMMER -2021
4. What are the provisions of Medical termination of WINTER -2020
Pregnancy act.
1. What is Central drug Standard Control
Organization (CDSCO) Give the objective
Chapter of CDSCO.
12

2. What is IPC ? Give the objective, function of IPC

Chapter 1. Discuss various drugs regulatory bodies in India – SUMMER -

13 2024
2. Discuss in detail Good Regulatory Practices – SUMMER –
2024, SUMMER -
2023
3. Explain Import of drug in detail SUMMER - 2023
4. Write a note on Documentation required for WINTER - 2023
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)

Community pharmacy (Retail sale)

5. Write a note on Good Manufacturing Practice OR WINTER - 2023
Requirements of Blood Bank
1. What is BCS system of classification and explain SUMMER - 2023
various classes in detail.
2. Write Short note on Abbreviated New Drug WINTER - 2023
Application (ANDA)
Chapter 3. Write in brief about Institutional Animal Ethics WINTER - 2023
14 Committee (IAEC)
4. Write short note on Patent and Copyright SUMMER - 2023
5. Write a note about Emergency Use Authorization WINTER - 2023
(EUA)
1. What type of training require for operating the blood SUMMER – 2024
bank?
Chapter15
2. Discuss the blood bank in detail SUMMER - 2023
1. What is clinical trial? Explain various phases of – SUMMER -
clinical trial. 2024
Chapter
2. What is clinical trials and explain various phases of SUMMER - 2023
16
clinical trials
3. Discuss various phases of Clinical Trials in detail WINTER - 2023
1. Write a brief note on treatment of biomedical waste. SUMMER – 2024
2. Explain Different method of disposal of biomedical
waste
Chapter
17
3. Short note on Biomedical Waste management Rules
2016

1. Give the history , principle, and scope of Bioethics

Chapter18 2. What are ICMR’S National Ethical Guideline for
Biomedical and Health Research involving human
Participants
1. Discuss the power of central consumer protection SUMMER – 2024
Chapter authority.
19 2. Write about Consumer protection Act OR Education WINTER - 2023
Regulation
Chapter 1. Write about Disaster Management Act*
20
Chapter 1. Documentation required for Export of drugs and WINTER - 2023
21 medical devices
 S.S Agrawal Institute of Pharmacy, Navsari
Question Bank
Subject Name: Pharmacy Law and Ethics (DP206TT)

Discuss Constitution and Function of PCI

Write a detailed short note on DTAB
Discuss the qualification and responsibilities of drug inspector