Download RTMNU B.Pharma 5th Semester 2016 Winter Regulatory Affairs and Intellectual Property Right Question Paper

B.Pharm Fifth Semester (C.B.S.) Examination

REGULATORY AFFAIRS AND INTELLECTUAL PROPERTY RIGHT

Paper—6 (5-T-6)

Time : Three Hours] [Maximum Marks : 80

N.B. :— (1) Q. No. 1 is compulsory.

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(2) Attempt any FOUR questions from the remaining.

(3) Draw neat labeled diagram wherever necessary.

(4) Assume suitable data wherever necessary.

(5) Use of electronic calculator, excluding programmable calculator is permitted.

1. Solve any FIVE :—
   • (a) Enlist various International Treaties and Conventions on IPR. Mention Global Drug Regulatory agencies.

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   • (b) Differentiate between Generics and Biosimilars.
   • (c) Give different types of Drug Master File (DMF).
   • (d) Explain how Drug Regulatory Affairs department acts as a link between pharmaceutical industry and regulatory agency.
   • (e) Give procedure of registering trade marks.
   • (f) Write about role and responsibility of CDSCO. 5×4=20

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2. (a) Give an account on Amendments to Indian Patent Act, 1970. 7
   (b) What do you mean by INDA ? What are the contents and format of IND application ? 8
3. (a) What are the various stages of filing patent through PCT ? Mention advantages of PCT. 7
   (b) Define New Drug. Give an account on various stages in filing New Drug Application. 8

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4. (a) Describe the role and responsibilities of Drug regulatory agency. 7
   (b) Give an account on Hatch-Waxmann Act, 1984. Describe various requirements for filing Abbreviated New Drug Application (ANDA). 8
5. (a) Define the terms :—
   1. (i) Patentability Criteria
   2. (ii) Compulsory Licensing.
   Give the scope and special features of TRIPS agreement. 8
   

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   (b) Give objectives and principles of Good Clinical Practice guideline (GCP). Add a note on Declaration of Helsinki. 7
6. (a) What do you mean by Common Technical Document (CTD) ? Give objectives and functions of ICH. 8
   (b) Give an account on Intellectual Property Laws in India. Add a note on copyright. 7
7. Write short notes on (any THREE) :—
   • (a) Patent Infringement
   • (b) GATT and WTO

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   • (c) Phases of Drug Development
   • (d) Good Manufacturing Practice guideline (GMP). 5×3=15

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