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.
————————
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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