Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MRA104T Date: 07/01/2019
Subject Name: Regulations and Legislation for Drugs Cosmetics, Medical Devices, Biologicals Herbals, and Food Nutraceuticals In India and Intellectual Property Rights
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 guidelines and standard for Regulatory filling of Medical devices in India.
06

Discuss role of Bureau of Indian Standards and certifying its standards.
05

Discuss ICMR-DBT Guidelines for Stem Cell Research.
05
Q.2

Discuss regulation guidelines and standard for Regulatory filling of herbals in European countries.
06

Write brief note on Indian Patent Scenario.
05

Describe organizational chart responsibilities for State Licensing Authority.
05
Q.3

Discuss standard for Regulatory filling of neutraceutical in India.
06

Describe format and contents of Regulatory dossier filing for solid dosage form in India.
05

What are objective offences of Prevention of Cruelty to Animals Act.
05
Q.4

Describe organization functions for Central Drug Standard Control Organization.
06

Discuss objective functions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1955.
05

What is the Rationale for conducting animal testing studies?
05
Q.5

Discuss ICH Regulatory Requirements for Bioequivalence studies.
06

Write short note on Intellectual Property Right.
05

What are CPCSEA Ethical guidelines for human participants?
05
Q. 6

Write objectives function of Pharmacy Act 1948.
06

Describe briefly design and conduct of bioequivalence study.
05

Describe ISO and other relevant standards in certifying the standards.
05
Q.7

Write note on DPCO NPPA.
06

Discuss history of Indian Pharmacopoeia. Describe content of current edition of Indian Pharmacopoeia.
05

Write short note on Trademark Copyright.
05