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Unit 2

The document is an assignment for the course Pharmaceutical Jurisprudence at Late Laxmibai Phadtare College of Pharmacy. It includes objective type questions, short answer questions, and long answer questions related to drug manufacturing provisions, regulatory bodies, and Good Manufacturing Practices (GMP) under the Drugs and Cosmetics Act. The assignment aims to assess students' understanding of pharmaceutical laws and regulations.

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Pruthviraj Pawar
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99 views1 page

Unit 2

The document is an assignment for the course Pharmaceutical Jurisprudence at Late Laxmibai Phadtare College of Pharmacy. It includes objective type questions, short answer questions, and long answer questions related to drug manufacturing provisions, regulatory bodies, and Good Manufacturing Practices (GMP) under the Drugs and Cosmetics Act. The assignment aims to assess students' understanding of pharmaceutical laws and regulations.

Uploaded by

Pruthviraj Pawar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Dnyan Kala Krida and KrushiPratishthan’s

Late Laxmibai Phadtare College of Pharmacy


Kalamb – Walchandnagar, Tal: Indapur, Dist: Pune, Pin: 413114
Approved by PCI, New Delhi, DTE, Mumbai, Recognized by Govt. of Maharashtra
Affiliated to MSBTE, Mumbai & Dr. BabasahebAmbedkar Technological University, Lonere,

Assignment 2

Subject Code: BP505T


Title of the course: PHARMACEUTICAL JURISPRUDENCE (Theory)

Q.1 Objective type Question (2marks)

1. Provisions for the manufacture of drug


2. Drugs and cosmetics prohibited from import and manufacture of drug.
3. Offences and penalty for import and manufacture of drug.
4. Enlist the member in administrative bodies.
5. Explain in detail about Schedule Y.

Q.2 Short Answer Question (5 marks)

1. What are the qualifications required for appointing a Government Analyst? What are the
functions of the Government Analyst?
2. Explain in detail about Schedule M (GMP) under D & C Act.
3. Write about Central Drugs Laboratory and its role.
4. Describe the constitution and functions of a) DTAB b) DCC.

Q.3 Long Answer Question (10 marks)


1. Explain in detail about Schedule M (GMP) under D & C Act.
2. What are the qualifications for appointment as a drugs inspector? Describe the powers and
duties of drugs inspector appointed under D & C Act?

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