Rajiv Gandhi University of Health Sciences
Degree Examination - May/June
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First Semester M.Pharm
[Time: 3 Hours] [Max. Marks: 75]
Drug Regulations and Intellectual Property Rights
Q.P. CODE: 5111
Your answers should be specific to the questions asked.
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Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- What are stages of patenting? Describe them.
- What is the impact of GATT on developing countries?
- Describe the impact of trademarks on Pharmaceutical Industry.
- Explain the role of USFDA and CDSCO in controlling drug regulations.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write the conditions to be satisfied by an invention to be patentable.
- Explain advantages and limitations of patents.
- Describe the provisions accepted under TRIPS.
- What are the features of WIPO?
- What are intellectual property rights? Briefly explain each property.
- Explain the importance of the copyright protection.
- Explain objectives, responsibilities, scope, and functions of TGA.
- Describe organizational structure, roles, and responsibilities of ANVISA.
- Write the importance of contract research organization?
- Explain regulations governing biosimilars.
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