B.Pharma Important Question
BP-505T,
Pharmaceutical Jurisprudence,
V Sem, RGPV, B.Pharmacy
UNIT 1 – Drugs & Cosmetics Act, 1940 and its Rules 1945
Q.1 Explain the objectives and legal definitions of the Drugs and Cosmetics Act. (RGPV Dec 2024)
Q.2 Describe the provisions related to the import of drugs. Discuss offences and penalties related to import. (RGPV Dec 2024)
Q.3 What are the conditions for granting a license for the manufacture of drugs as per the Drugs and Cosmetics Act? Explain the types of licenses, including loan and repacking licenses. (RGPV Dec 2024)
Q.4 Describe the prohibition on the manufacture and sale of certain drugs, and explain the provisions for the manufacture of new drugs for test, examination and analysis. (RGPV Dec 2024)
Q.5 Write the precedents and subsequent conditions for grant of license to manufacture of drugs and cosmetics specified in schedule C, C₁ and X? (RGPV Nov 2023)
Q.6 Mention the places from which drugs are imported in India. Detail the classes of drugs and cosmetics which are prohibited from import and import under License. (RGPV May 2023)
UNIT 2 – Drugs & Cosmetics Act, 1940 and its Rules 1945
Q.1 Outline the requirements for wholesale, retail sale, and restricted licenses for the sale of drugs as per the Drugs and Cosmetics Act, 1940. Discuss the offences and penalties related to the sale of drugs. (RGPV Dec 2024)
Q.2 Explain the general labeling requirements and permitted colors for drugs and cosmetics under the Drugs and Cosmetics Rules. Provide examples of specimen labels for drugs. (RGPV Dec 2024)
Q.3 Describe schedule P, U and Y under Drugs and Cosmetics Act 1940. (RGPV Nov 2023)
Q.4 Explain in detail about controlling authority as per D&C Act. (RGPV Nov 2023)
Q.5 Enumerate schedule B. Describe in detail about schedule M (GMP) under D and C Act 1940. (RGPV May 2023)
Q.6 Define term Advertisements. Describe the classes of advertisements exempted provisionally under D and MR Act. (RGPV May 2023)
Q.7 Write in brief the power, qualification and duties of drug inspector. (RGPV May 2023)
UNIT 3 – Pharmacy Act 1948
Q.1 Discuss the constitution and functions of the Pharmacy Council of India (PCI) as per the Pharmacy Act, 1948. (RGPV Dec 2024)
Q.2 Explain the process and requirements for the registration of pharmacists and discuss the role of state and joint state pharmacy councils. (RGPV Dec 2024)
Q.3 Describe the objectives and licensing process for the manufacture of alcoholic preparations under the Medicinal and Toilet Preparations Act, 1955. (RGPV Dec 2024)
Q.4 Outline the key features of the Narcotic Drugs and Psychotropic Substances Act. (RGPV Dec 2024)
Q.5 Define rectified spirit as per M and TP Act. Give the design of bonded laboratory. Deliberate in detail about manufacturing of alcoholic preparations in bonded laboratory. (RGPV Nov 2023)
Q.6 Write about Narcotic and Psychotropic consultative committee. (RGPV Nov 2023)
Q.7 Write a note on profession conduct of pharmacist. (RGPV Nov 2023)
Q.8 Differentiate between State and Joint State Pharmacy Council. Write the salient feature of constitution and functions of PC1. (RGPV May 2023)
Q.9 What is objective of M and TP Act? Explain in detail about manufacturing of Ayurveda preparations. (RGPV May 2023)
UNIT 4 – Prevention of Cruelty to Animals Act 1960
Q.1 Explain the objectives and key provisions of the Drugs and Magic Remedies Act. (RGPV Dec 2024)
Q.2 Discuss the Prevention of Cruelty to Animals Act, 1960, with a focus on the CPCSEA guidelines, breeding and stocking of animals, and regulations related to animal experimentation. (RGPV Dec 2024)
Q.3 Define the objectives and roles of the National Pharmaceutical Pricing Authority (NPPA) and explain the Drugs Price Control Order (DPCO) 2013 in regulating drug prices. (RGPV Dec 2024)
Q.4 Discuss how the ceiling prices for scheduled formulations are determined and the significance of the National List of Essential Medicines (NLEM). (RGPV Dec 2024)
Q.5 Write a short note on. (RGPV Nov 2023)
a) DPCO
b) CPCSEA guidelines
Q.6 Write in detail about the constitution and functions of Institutional Animal Ethical Committee (IAEC). (RGPV May 2023)
UNIT 5 – Pharmaceutical Legislations
Q.1 Describe the Code of Pharmaceutical Ethics, focusing on a pharmacist’s duties related to their job, trade, medical profession and the oath. (RGPV Dec 2024)
Q.2 Provide an overview of the Medical Termination of Pregnancy Act and importance of Intellectual Property Rights (IPR) in the pharmaceutical industry. (RGPV Dec 2024)
Q.3 Differentiate between ethics and laws. Mention the role of pharmacist in relation to his medical profession. (RGPV Nov 2023)
Q.4 Discuss in detail about Right to Information Act (RTI), (RGPV May 2023)
EXTRA QUESTIONS
Q.1 Write short notes on any two. (RGPV Nov 2023)
a) IPR
b) Education Regulation 1991
c) DTAB
Q.2 Write short notes on: (RGPV May 2023)
a) Hathi committee
b) NLEM
c) Adulterated drugs
— Best of Luck for Exam —
