Second Year, D.Pharmacy Important Question
BP-206/8111, ER20-26T
Pharmacy Law and Ethics,
II Year, RGPV, D.Pharmacy
Chapter 1 General Principles of Law
Q.1 Define the terms Misbranded drugs. (RGPV 2024)
Q.2 Why should pharmacist study law? (RGPV 2023)
Chapter 2 Pharmacy Act-1948 and Rules
Q.1 Define the following terms: (RGPV 2025)
i) Absolute alcohol
ii) Dutiable goods
iii) Rectified spirit
Q.2 Describe the constitution and function of Pharmacy Council of India. (RGPV 2025)
Q.3 Compare the constitution and functions of State pharmacy councils and joint State pharmacy councils. (RGPV 2024)
Q.4 Define the term Registered pharmacist (RGPV 2024)
Q.5 Describe the functions of Pharmacy Council of India. (RGPV 2023)
Q.6 Define Registered Pharmacist and give the qualification for registration. (RGPV 2023)
Chapter 3 Drugs and Cosmetics Act 1940 and Rules 1945 and New Amendments
Q.1 Describe the constitution and function of Drug Technical Advisory Board (DTAB). (RGPV 2025)
Q.2 Give the functions of: (RGPV 2025)
- Central Consumer Protection Authority
- National Disaster Management Authority
Q.3 Discuss the background of Chopra committee and Bhore committee and their recommendations in shaping the drug legislation in India. (RGPV 2024)
Q.4 Define the term Central register (RGPV 2024)
Q.5 How many types of licences can be issued for the sale of drugs? Describe the general procedure for obtaining a sale licence stating the condition to be satisfied. (RGPV 2024)
Q.6 Describe the constitution and functions of Drug Technical Advisory Board (DTAB). (RGPV 2024)
Q.7 Describe the labelling requirement for ophthalmic products. (RGPV 2024)
Q.8 What is meant by manufacture in bond? Outline the procedure, that should be followed in obtaining a licence for manufacture in bond including the conditions that are to be filled. (RGPV 2024)
Q.9 Give qualifications for appointinent as Drug Inspector? Explain their powers and procedures. (RGPV 2023)
Q.10 State the offences and penalties relating to sale of drugs. (RGPV 2023)
Q.11 Define New Drug. (RGPV 2023)
Q.12 Describe the layout and construction of bonded laboratory. (RGPV 2023)
Chapter 4 Narcotic Drugs and Psychotropic Substances Act 1985 and Rules
Q.1 Give objectives of Narcotics drug & Psychotropic Substances Act. (RGPV 2025)
Q.2 Define Narcotic drug. (RGPV 2024)
Q.3 Define Psychotropic substance. (RGPV 2024)
Q.4 Define Spurious drugs. (RGPV 2023)
Q.5 Explain the objectives of Narcotic Drugs and Psychotropic 6 Substance Act. (RGPV 2023)
Chapter 5 Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
Q.1 Discuss the advertisements whose import and export is prohibited. (RGPV 2024)
Q.2 Compare the advertisements which are (RGPV 2023)
i) Prohibits
in) Exempted
Chapter 6 Prevention of Cruelty to Animals Act-1960:
Q.1 Mention the name of ten diseases, which should not to be claimed to cure. (RGPV 2025)
Q.2 Write brief note on CPCSEA. (RGPV 2025)
Q.3 State the objectives of prevention of cruelty to Animal Act. Explain its provisions relating to experimentation on animals. (RGPV 2024)
Q.4 Write the full form of following abbreviates. (RGPV 2024)
1) CPCSEA
ii) CDSCO
iii) BMW rules
iv) GMP
Q.5 Define Ethics. (RGPV 2023)
Q.6 Describe constitution and functions of Institutional Animal Ethics 6 Committee. (RGPV 2023)
Chapter 7 Poisons Act-1919
Q.1 Write penalties under the Poisons Act. (RGPV 2025)
Q.2 Describe the penalties under the poisons Act. (RGPV 2024)
Q.3 What is meant by specified poisons? How are the import. possession and sale of poisons regulated under the Act? (RGPV 2023)
Chapter 8 FSSAI (Food Safety and Standards Authority of India) Act and Rules:
Q.1 Explain the procedure for FSSAI registration. (RGPV 2025)
Q.2 Describe aims and objectives of FSSAI Act. (RGPV 2024)
Q.3 Explain the procesire for FSSAl registration. (RGPV 2023)
Chapter 9 National Pharmaceutical Pricing Authority
Q.1 Describe labeling requirements of ophthalmic formulations. (RGPV 2025)
Q.2 How are the prices of formulation to the wholesalers and retailers calculated? (RGPV 2025)
Q.3 Give the objectives of drug (price control) order. (RGPV 2024)
Q.4 How are the price of formulations to the whole sales and retailers calculate. (RGPV 2023)
Chapter 10 Code of Pharmaceutical Ethics
Q.1 Explain the role of pharmacist in relation to Medical profession. (RGPV 2025)
Chapter 11
Chapter 12
Q.1 Explain the vision, mission and functions of Indian Pharmacopoeia Commission (IPC). (RGPV 2025)
Q.2 Discuss briefly the major regulatory bodies relating to drugs and pharmaceuticals in India. (RGPV 2024)
Chapter 13
Q.1 . Discuss the key components of Good Regulatory Practices. (RGPV 2025)
Q.2 Give the objectives and benefits of e-Governanee. (RGPV 2024)
Q.3 Define Registered medical Practitioner. (RGPV 2024)
Q.4 Discuss the key components of Good Regulatory Practices. (RGPV 2023)
Chapter 14
Q.1 Differentiate the terms “adulterated drugs”, “misbranded drugs”, “spurious drugs”. (RGPV 2025)
Q.2 What is New Drug Development? Explain its importance. (RGPV 2024)
Q.3 Discuss the functions of National Council of Clinical establishments. (RGPV 2024)
Q.4 Define Clinical trial. (RGPV 2023)
Q.5 Explain the General Guidelines for Clinical trial (RGPV 2023)
Chapter 15
Q.1 Discuss the requirements for the functioning and operation of a Blood Bank. (RGPV 2025)
Q.2 Discuss in requirements for the functioning and operation of a Blood Bank. (RGPV 2024)
Q.3 Discuss the functions of hospital blood bank. (RGPV 2023)
Chapter 16
Q.1 Define the term Clinical pharmacists. (RGPV 2024)
Q.2 Discuss the functions of Clinical Establishment Act. (RGPV 2023)
Chapter 17
Q.1 Give the objectives of Biomedical Waste Management Rules. Classify them with examples of each class. (RGPV 2025)
Chapter 18
Q.1 Explain the role of pharmacist in Health Care Team. (RGPV 2025)
Q.2 Explain the core ethical principles in pharmacy practice and healthcare. (RGPV 2024)
Q.3 Explain the role of Pharmacist in Health Care System (RGPV 2023)
Chapter 19
Q.1 Define the following terms. (RGPV 2024)
1) Guardian
ii) Lunatic
iii) Minor
Chapter 20
Chapter 210
Extra Questions
Q.1 Write note any four of the following. (RGPV 2024)
a) Schedules for BMW management
b) Functions of Ethics committee
c) Consumer Disputes Redressal Commission
d) National Policy on Disaster Management, 2009.
Q.2 Who can terttinate a pregnancy and what experience or training etc should be passes? (RGPV 2023)
Q.3 Explain the vision, mission and functions of Indian Pharmacopoeia Commission (RGPV 2023)
Q.4 Explain the terms: (RGPV 2023)
1) Genetic drugs
2) NDA
3) Patent
4) PPE
Q.5 Write notes on the following (any four): (RGPV 2023)
a) Consumer rights
b.National Disaster Management Authority
c) Medical and Non-medical Devices.
d) Importance of Pharmacist and Oath
e) Drug Enquiry Comnuntee
MCQ/ Objective Questions
Choose correct answer Questions
- The long form of IBC is (RGPV 2025)
(a) International Bioethics Council
(b) International Bioethics Committee
(c) International Biomedical Committee
(d) International Biomedical Council
- Class II medical devices are as (RGPV 2025)
(a) Lowest risk
(b) Moderate risk
(c) Highest risk
(d) None of the above
- Medical devices (Amendment) Rules 2020 came into force on the (RGPV 2025)
(a) 1.4.2020
(b) 1.1.2018
(c) 1.1.2017
(d) 1.4.2025
- Contraceptives medical devices are categorized as (RGPV 2025)
(a) Low risk
(b) Low-moderate risk
(c) Moderate high risk
(d) Highrisk
- First pass metabolism occurs in
(a) Kidney
(c) Pancreas
(b) Liver
(d) Intestine
Fill in the blanks
6.……………….. is known as the father of medicine. (RGPV 2025)
- The first Pharmacy college in India was started at………………………. (RGPV 2025)
- Education regulation is framed by………………….. (RGPV 2025)
- Standard of patent and proprietary medicine is specified in Schedule…………………. (RGPV 2025)
- Animal welfare board is established by…………………………… (RGPV 2025)
State whether True/False
- Magic remedy includes any drug or articles (RGPV 2025)
- Import of poison is regulated by Central Government (RGPV 2025)
- DPCO 1987 was replaced by 1995. (RGPV 2025)
- Code of Pharmaceutical ethics is developed by APTI. (RGPV 2025)
- MTP is a abbreviation of Medical Test for Pregnancy. (RGPV 2025)
Match the column A against column B
Column A Column B
Schedule F a) List of narcotic drugs (RGPV 2025)
Schedule M b) List of black disinfected fluids (RGPV 2025)
Schedule O c) GMP (RGPV 2025)
Schedule N d) Standard for surgical dressings (RGPV 2025)
Schedule X e) Minimum equipmerits possessed by pharmacy (RGPV 2025)
— Best of Luck for Exam —
