Download RGUHS M.Pharm 2019 Jan 1st Year 5122 Regulations Legislations For Food Pmbc In India Question Paper

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M.Sc. Health Sciences

First Semester M.Sc. Degree Examination

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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.

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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.

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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks

1. BCS classification of drugs.
2. Ethical guidelines for human participants in clinical studies
3. Write a note on ICH stability requirements.
4. Write a note on fixed dose combinations.

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5. FNPCMB approval procedures.
6. Indian Pharmacopoeial Standards.
7. Write a note on Indian patent scenario.
8. Guidelines for regulatory filing of FPMB.
9. Bioavailability and Bioequivalence data requirements

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10. Write a note on patent and trademark.

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