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G.Pulla Reddy College of Pharmacy

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Code No. 6005FACULTY OF PHARMACY

M. Pharmacy (Common to All) II-Semester (Main & Backlog) Examination,November 2015

Subject: Intellectual Property Rights & Regulatory Affairs (Common to All)Time: 3 Hours Max. Marks: 70

Note: Answer any five questions. All questions carry equal marks.

1 (a) What is your understanding about patents, copyright and trademarks?Discuss in detail about importance of IP and their rights related to Drugs andPharmaceutical industries. (9)

(b) Discuss briefly about regional agreements. (5)

2 Write briefly on the following:(i) Salient features of product and process patent (5)(ii) Copy Rights Act (5)(iii) Importance of trademarks (4)

3 (a) Discuss the disputes and settlements between member nations in trade andtarrif. (7)

(b) Explain the fundamental principles and objectives and of WTO. (7)

4 Write a detailed note on drugs and cosmetics Act 1940 and their applicablerules form 1940 to 1945. Explain why the rules are to be changed in the globalcontext? (14)

5 (a) Discuss the quality systems of USFDA. (7)(b) Explain ISO series and their importance. (7)

6 (a) Discuss the objectives and guide lines of WHO in relation to quality systems. (7)(b) Explain ICH guidelines. (7)

7 Write brief notes on the following:(i) Protocols of pharmaceutical industries (4)(ii) Documents of pharmaceutical industries, their protection and labeling. (5)(iii) CTD and post approval changes (5)

8 Discuss the following briefly:(i) Maintenance of electronic documentation (4)(ii) Formulation development and filings. (5)(iii) NDA – ANDA importance and significance (5)

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M. Pharmacy (Pharmacognosy) II-Semester (Main & Backlog) Examination,November 2015

Subject: Herbal Drug Development and Standardization

Time: 3 Hours Max. Marks: 70


1 List the natural Hepatoprotective drugs and screening methods. Explain any threeIn vivo screening techniques with merits and demerits. (14)

2 Discuss the importance of Herbal drugs standardization and write in detail about theWHO guide lines. (14)

3 (a) Give an informative note on the Herbal cosmetics. (6)(b) Give the method of preparation and analytical techniques of Herbal

shampoos. (8)

4 Write a note on :(a) Regression Analysis (4)(b) Chi Square test (4)(c) Preparation and standardization of Garcinea (6)

5 Write the importance of immunomodulators and give examples. List screeningmethods and explain any three in vivo screening with merits and demerits oftechnique. (14)

6 (a) Write the importance of natural excipients in manufacturing of tablets withexamples. (6)

(b) Discuss the different methods of Herbal tablets preparation and analyticaltechniques. (8)

7 (a) Explain “Probit analysis”. (7)(b) Write a note on staff and equipment requirement for Herbal industry. (7)

8 Explain the concepts and good laboratory practices of Herbal drug industry. (14)

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Subject: Advanced Pharmacognosy - IITime: 3 Hours Max. Marks: 70


1 (a) Discuss the application of Tracer technique in elucidation of biosyntheticpathways. (7)

(b) Enlist various methods for extraction of plant drugs. Write about Soxhlet andmicrowave assisted extraction methods. (7)

2 What are ‘Terpenoids’? Classify. Explain the various physical and chemicalmethods for structural determination of Terpenoids. (14)

3 (a) Differentiate TLC / HPTLC. Discuss the important features and applications ofthese two techniques. (6)

(b) Discuss constitution of camphor. (8)

4 (a) Write source, structure and uses of : (6)(i) Lycopene (ii) Eugenol(iii) Emetine (iv) Digoxin

(b) Write the methods for isolation and estimation of caffeine and glycerhetinicacid. (8)

5 (a) What are ‘Flavonoids’? Classify giving one structural example for each class. (4)(b) Write the chemistry and identification test of each class of flavonoid. (4)(c) Discuss constitution of Quercetin. (6)

6 Write about the following National products. (14)(a) Atropine(b) Ergometin(c) Car vone

7 (a) Discuss biosynthetic pathway of Reserpine. (6)(b) Discuss constitution of Vitamin A. (8)

8 (a) Write the source, structure, chemistry and uses of : (6)(i) Podophyllotoxin (ii) -Carotene(iii) Eugenol

(b) Discuss chemistry, isolation and estimation of curcumin and sennosides. (8)

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Subject: NutraceuticalsTime: 3 Hours Max. Marks: 70


1 Write a note on :(a) Food Vs. Drug (10)(b) Dietary Guidelines (4)

2 Write the source, structure, functions and deficiency states of Vitamin A andVitamin E. (7+7)

3 (a) Write about the source, structure, and functions of Essential Fats and Oils. (9)(b) Write a note on Fatty acids and fat substitutes. (5)

4 Write the source, structure and functions of (7+7)(a) Glucosamine (b) L-Carnitine

5 Write a note on : (8+6)(a) HACCP (b) FPO

6 What is the role of food in prevention and treatment of Cancer? (14)

7 Write a note on : (8+6)(a) AGMARK (b) Adultration of Foods

8 Write the source and functions of : (8+6)(a) Ginseng (b) Phosphatidyl choline

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Code No. 8005 / S

FACULTY OF PHARMACYM. Pharmacy (Common to All) II-Semester (Suppl.) Examination, April 2015Subject: Intellectual Property Rights & Regulatory Affairs (Common to All)

Time: 3 Hours Max.Marks: 70


1 Explain the essential conditions for grant of a patent for an invention.Discuss the different steps involved in patenting an invention. 14

2 Outline the legal and regulatory mechanism relating to clinical trials in India. 14

3 Discuss the historical perspectives of GATT and WTO. How did the WTO regimeimpact on India in the field of pharmaceuticals? 14

4 Discuss ICH guidelines relating to registration of pharmaceutical products globally. 14

5 What are the different kinds of documentation types related to pharmaceuticalindustry? Explain with special reference to electronic documentation. 14

6 Write short notes on:(a) Product patent and its importance 5(b) SUPAC 9

7 Write short notes on:(a) GMP Guidelines 7(b) ISO objectives and importance 7

8 (a) Discuss the guidelines of USFDA with reference to approval of Drugmanufacturing facilities for Pharmaceuticals. 6

(b) Briefly outline the procedure of ANDA submission. 8

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Code No. 8017 / S

FACULTY OF PHARMACYM. Pharmacy (Pharmacognosy) II-Semester(Suppl.) Examination, April 2015

Subject : Advanced Pharmacognosy – IITime : 3 hours Max. Marks : 70

Note : Answer any FIVE questions. All questions carry equal marks.

1 a) What is extraction? Define different extracts. 4b) Discuss any five important extraction techniques and give their merits and

demerits. 10

2 Write the source, chemistry, route of biosynthesis and therapeutic uses ofergometrine. 14

3 Write abouta) Chemistry of Atropine 5b) Chemistry of curcunin 5c) Color reaction of steroidal and flavonoidal glycosides 4

4 a) What are cardiac glycosides and classify? Write the chemistry, mechanism ofaction and color reaction of digitals glycosides. 9

b) Write about the nomenclature and properties of carotenoids. 5

5 a) Give the source, structure and method of isolation of curcunin and vasicine. 7b) Write the source, structure and estimation of sennosides and capsanthin. 7

6 Define and classify the terpenoids. Explain the structure elucidation of camphor. 14

7 a) What is chromatography and classify different techniques. 7b) Discuss the principle, technique and application of GLC. 7

8 Write a note on :a) Structural determination of terpenoids 4b) Chemistry and sources of Lycopene 4c) Chemistry and properties of flavonoids 6

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Code No. 8019 / S

FACULTY OF PHARMACYM. Pharmacy (Pharmacognosy) II – Semester (Suppl.) Examination, April 2015

Subject : NutraceuticalsTime : 3 hours Max. Marks : 70

Note : Answer any FIVE questions. All questions carry equal marks.

1 a) Explain the relationship between nutrition health and disease. Elucidate therole of nutraceuticals in prevention of diseases. 8

b) Write a note on infant formulas. 6

2 Write source, structure, functions and uses of :a) Carotenoids 5b) Vitamin C 4c) Calcium and zinc 5

3 Write about the importance of functional foods, nutraceuticals and dietarysupplements.

4 Write a note on :a) Ginseng 4b) Weight control products 5c) Food guide pyramid 5

5 Explain the preventive or curative role of various foods in diabetes and ulcer.

6 a) Define ‘Antioxidants’. Explain their mechanism of action in protection ofhealth or prevention of disease. 7

b) Write a detailed note on any five phytochemicals which are antioxidants. 7

7 Write about the importance and therapeutic benefit of the following in maintaininggood health.a) Essential oils & fats 7b) Flavanoids 7

8 Write about 2 x 7a) Adulteration of foodsb) Food regulations in India

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