Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. PHARM. SEMESTER II EXAMINATION SUMMER 2017
Subject Code: 2920204 Date: 31/05/2017
Subject Name: Regulatory Affairs and New Drug Applications
Time: 10:30 AM to 01:30 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

Describe Drug Master File in detail.
06

What is MSDS? Give purpose and scope of each section of MSDS.
05

Give brief account on Indian Pharmacopoeia.
05
Q.2

Describe regulatory aspects of biotechnology derived products in detail.
06

Describe qualifications, duties and powers of food inspector.
05

Describe the composition and responsibilities of the ICH.
05
Q.3

Give brief account on content and format of NDA.
06

Discuss the constitution and functions of Central Drugs Laboratory.
05

Describe in brief WHO as a certification agency.
05
Q.4

Write briefly about the certification system of Bureau of Indian Standards.
06

Describe salient features of Prevention of Food Adulteration Act.
05

Explain the different types of IND applications
05
Q.5

Give brief account on sale of drug according to Drug and Cosmetic Act 1940.
06

Describe salient features of Consumer Protection Act.
05

Describe in brief the content of investigator's brochure.
05
Q. 6

Discuss CTD and e-CTD.
06

Discuss the guidelines for packaging and labeling of API and intermediates.
05

Write a brief note on objectives of The Pharmacy Act 1948.
05
Q.7

Write note on USFDA.
06

Write a note on quality and safety of herbal products.
05

How is manufacture and sale of cosmetics regulated in India?
05