Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2019 January (Master of Pharmacy) 1st Year (First Year) 1st Year 5122 Regulations Legislations For Food Pmbc In India Previous Question Paper

Rajiv Gandhi University of Health Sciences
First Semester M. Pharm Degree Examination - JAN-2019
Time: Three Hours
Max. Marks: 75 Marks
Regulations Legislations for Food PMBC in India
Q.P. CODE: 5122
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three)
3 X 10 = 30 Marks
1.
Write in detail about import, manufacture, sale and packing of drugs as per D&C Act 1940.
2.
Write in detail on rationale for conducting animal studies.
3.
Describe ICMR-DBT guidelines for stem cell research.
4.
What are Intellectual Property Rights? Write in detail about industrial designs and geographical
indications.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
BCS classification of drugs.
6.
Ethical guidelines for human participants in clinical studies
7.
Write a note on ICH stability requirements.
8.
Write a note on fixed dose combinations.
9.
FNPCMB approval procedures.
10.
Indian Pharmacopoeial Standards.
11.
Write a note on Indian patent scenario.
12.
Guidelines for regulatory filing of FPMB.
13.
Bioavailability and Bioequivalence data requirements
14.
Write a note on patent and trademark.
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