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Monday, December 28, 2015

Fourth Year B.Pharm.,University Of Pune Question Paper,2010 Question Paper,PHARMACEUTICAL JURISPRUDENCE AND REGULATORY AFFAIRS

University Of Pune Question Paper
Fourth Year B.Pharm. Examination, 2010
PHARMACEUTICAL JURISPRUDENCE AND REGULATORY AFFAIRS
(2004 Course)
Time : 3 Hours
Max. Marks : 80
 Instructions: 1) Question Nos. 1 and 5 are compulsory. Out of remaining,
attempt 2 questions from Section I and 2 questions from
Section II.
2) Answers to the two Sections should be written in separate
books.
3) Figures to the right indicate full marks.
SECTION – I
1. Define “Illicit Traffic”. Discuss power of Central Government to permit, control
and regulate certain operations under NDPS 1985. 10
2. A) What are the qualifications and duties of Drug Inspector ? Give procedure of
Inspections. 9
B) Discuss the requirements of Non-bonded Laboratory. Write procedure for
obtaining rectified spirite under Non-bonded Laboratory. 6
3. A) Define ‘Advertisement’. Describe the provisions pertaining classes of
prohibited advertisement and Exempted advertisement. 10
B) Differentiate in between State and Joint State Pharmacy Council under Pharmacy
Act 1948. 5
4. Write short notes on (any three) : 15
1) Industrial Safety and Health
2) Consumer Protection Act
3) Public Analyst
4) D.T.A.B.
SECTION – II
5. A) Define Patents. Discuss in brief the filling and processing of Patents. 7
B) Define IPR, add note on Trade marks. 3
6. A) Discuss in brief about 8
a) Europe-European Agency for the Evaluation of medicinal product.
b) Medicine Control Agency
B) Discuss ICH Guidelines. 7
7. A) Discuss in brief salient features of Indian Patents Act 1970. 7
B) Differentiate between NDA and ANDA. Write note on ‘contents of ANDA. 8
8. Write short note on (any three) : 15
1) US-FDA
2) Exclusive Marketing Right
3) Patent infringement
4) TGA.
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