GANPAT UNIVERSITY TEACHING SCHEME EXAMINATIN SCHEME · 2018-07-10 · ganpat university faculty of pharmacy teaching and examination scheme effective year 2018-19 programme b.pharm

GANPAT UNIVERSITY

FACULTY OF PHARMACY

TEACHING AND EXAMINATION SCHEME EFFECTIVE YEAR 2018-19

PROGRAMME B.PHARM SEMESTER VII

TEACHING SCHEME EXAMINATIN SCHEME

S.N CODE NAME OF SUBJECT THEORY PRACTICAL + TW MARKS (Theory) MARKS (Practical)

Hrs/wk Cr. Hrs/wk Cr. Int. Ext. Int. Ext.

1 BPH7A1 Biopharmaceutics and Dosage Form Design 3 3 3+1 2 40 60 40 60

2 BPH7A2 Medicinal Chemistry-II 3 3 3+1 2 40 60 40 60

3 BPH7A3 Pharmaceutical Analysis-III 3 3 3+1 2 40 60 40 60

4 BPH7A4 Pharmacology and Pharmacotherapeutics-II 3 3 3+1 2 40 60 40 60

5 BPH7A5 Pharmacognosy-V 3 3 3+1 2 40 60 40 60

6 BPH7A6 Pharmaceutical Jurisprudence 2 2 - - 40 60 - -

17 17 15+5 10 240 360 200 300

GANPAT UNIVERSITY

FACULTY OF PHARMACY Programme Bachelor of Pharmacy Branch/Spec. B.Pharm.

Semester VII Version 2.0.0.0

Effective from Academic Year 2018-19 Effective for the batch Admitted in June 2015

Subject code BPH7A1 Subject Name Biopharmaceutics And Dosage Form Design

Teaching scheme Examination scheme (Marks)

(Per week) Lecture(DT) Practical(Lab.) Total CE SEE Total

L TU P TW

Credit 3 - 2 2 Theory 40 60 100

Hours 3 - 3 1 4 Practical 40 60 100

Pre-requisites:

Nil

Learning Outcome

Equip students with fundamental knowledge of pharmaceutical dosage forms that will be useful in the co-requisite courses, pharmacotherapeutics and pharmacokinetics.

Better rationalization of selection of appropriate dosage form.

Designing of more effective and stable dosage forms specific for different route.

Theory Syllabus

Unit

Content Hrs

1. Preformulation studies: a) Study of physical properties of drug like physical form, particle size, shape, density, partition co-efficient, ionization constant, dielectric constant, wetting, solubility, dissolution and organoleptic property and their effect on formulation, stability and bioavailability. b) Study of chemical properties of drugs like hydrolysis, oxidation, reduction, polymorphisms, racemization, polymerization etc., and their influence on formulation and stability of products.

8

2. Pharmacokinetics (a) Definition and scope, significance of plasma drug concentration measurement. (b) Compartment kinetics- one compartment and two compartment models. Determination of pharmacokinetic parameters from plasma and urine data after drug administration by intra vascular and oral route. (c) Volume of distribution and distribution coefficient. (d) Clearance concept, mechanism of renal clearance, clearance ratio, determination of renal clearance. (e) Hepatic elimination of drugs, first pass effect, extraction ratio, hepatic clearance, biliary excretion, extrahepatic circulation. (f) Compartment model: Phamacokinetics of drug absorption Zero order and first order absorption rate constant using Wagner- Nelson and Loo-Riegelman method. (g) Curve fitting (Method of Residuals), regression procedures. (h) Non-linear pharmacokinetics with special reference to one compartment model after I.V. drug administration, MichaelesMenten Equation, detection of non- linearity (Saturation mechanism). (i) Numericals related to pharmacokinetic parameters using one compartmental model.

10

3. Stability of pharmaceuticals: a) Kinetic principles and stability testing: Reaction rate and order, acid base catalysis, decomposition reactions and stabilization of pharmaceuticals. b) Stability of formulation, factors affecting formulation stability, MKT, climatic zones, matrixing and bracketing instability study, accelerated stability testing, real time stability. Current WHO, USFDA and stability testing as per ICH guidelines for pharmaceutical drug substances and drug products. c) Product stability: Requirements, shelf-life, overages, containers, closures. d) Overage calculations

7

4. Biopharmaceutics: a) Introduction to biopharmaceutics and its role in formulation development. b) Passage of drugs across biological barriers (passive diffusion, active transport, facilitated diffusion and pinocytosis). c) Factors influencing absorption- physiochemical, physiological and pharmaceutical. d) Drug distribution in the body, plasma protein binding. e) Drug Metabolism. f) Drug excretion.

11

5. Introduction to BCS and dissolution study: Definition: BCS, Intrinsic dissolution rate measurement, Dissolution apparatus for various dosage forms, Dissolution profile comparison using model independent method (similarity factor, dissimilarity factor).

3

6. Clinical Pharmacokinetics a) Definition and scope b) Dosage adjustment in patients with and without renal and hepatic failure. c) Pharmacokinetic drug interactions and their significance in combination therapy

2

7. Bioavailability and Bioequivalence: a) Measures of bioavailability, Cmax, tmax and area under the curve (AUC). b) Design of single dose bio-equivalence study and relevant statistics. c) Review of regulatory requirements for conduction of bio-equivalent studies.

4

Practical Contents

Practical shall be conducted from the topics covered in theory explaining the principle involved in preformulation, stability of pharmaceuticals, bio pharmaceutics, dissolution studies and mathematical problems related to pharmacokinetics etc.

References

1. Biopharmaceutics& Pharmacokinetics, D. M. Brahmankar& S. B. Jayswal, VallabhPrakashan, New Delhi, 1995.

2. Kanig JL., Theory and Practice of Industrial Pharmacy, Leon Lachman, Lieberman, Varghese Publishing House, Bombay, 3rd Edition, 1987.

3. Pharmaceutical Preformulation; J.T. Carstensen, CRC Press, New York, 2002.

4. Remington: The Science and Practice of Pharmacy, 21stEdition. Philadelphia, PA: Lippincott Williams & Wilkins, 2005.

5. Biopharmaceutics and Relevant Pharmacokinetics; John. G. Wagner and M. Pernarowski, 1st edition, Drug Intelligence Publications, Hamilton, Illinois, 1971.

6. Drug Stability: Principal and Practices,J. T. Cartensen,2nd Edition, Marcel Dekker Inc.N.Y., 1995.

7. Pharmaceutics: The Science of Dosage form Design, M.E. Aulton, 3rd edition, Churchill Livingstone, New York, 2007.

8. Biopharmaceutics and Clinical Pharmacokinetics; Milo Gibaldi, 4th edition, Philadephia, Lea and Febiger, 1991.

9. Applied Biopharmaceutics and Pharmacokinetics; Shargel. L and Yu ABC, 2nd edition, Connecticut, Appleton Century Crofts, 1985

10. Biopharmaceutics and Clinical Pharmacokinetics- An introduction; 4thedition Revised and expanded by Rebort F Notari, Marcel Dekker Inc, New York and Basel, 1987.

11. Pharmacopoeia : I.P., U. S. P., B.P

GANPAT UNIVERSITY




Subject code BPH7A2 Subject Name Medicinal Chemistry-II



L TU P TW

Credit 3 - 2 2 Theory 40 60 100


Pre-requisites:

Nil

Learning Outcome

By the end of this course, the student should have a good understanding of the history and basic concepts of Chemotherapy and cardiovascular disease.

Students should be able to describe in detail synthetic approaches, mechanisms of action as well as structure activity relationship of some important therapeutic class of Drugs

The course may help the students in understanding rational approaches towards the design of important therapeutic agents and their biological implications.

Theory Syllabus

Unit Content Hrs

1 Antibacterial agents SAR: Sulphonamides, Quinolones Synthesis: Sulfacetamide, Sulfasalazine, Trimethoprim, Norfloxacin, Ofloxacin, Ciprofloxacin.

β-Lactam Antibiotics

SAR: Cephalosporin, Penicillin Synthesis of Penicillin-G

Tetracycline, Aminoglycosides, Macrolides and Miscellaneous Antibiotics: SAR: Aminoglycosides, Tetracycline, Macrolides. Synthesis of Chloramphenicol

Antimycobacterial Agents Synthesis: Ethambutol, Isoniazid, Pyrazinamide, Clofazimine, PAS.

Antifungal Agents: Synthesis: Clotrimazole, Ketoconazole, Fluconazole

Antimalarial, Antiamoebic and Anthelmintic Agents SAR: Quinolines Synthesis: Metronidazole, Ornidazole, Chloroquine, Primaquine, Pyrimethamine

Antiviral Agents Synthesis: Amantadine

Antineoplastic agents Synthesis of Chlorambucil, Cyclophosphamide, Thiotepa, Methotrexate, Fluorouracil

22

2 Cardiotonic Agents SAR: Cardiac glycosides Synthesis: Dobutamine

Antihypertensive Agents SAR: ACE Inhibitors, Dihydropyridines Synthesis: Nifedipine, Amlodipine, Atenolol, Metoprolol, Captopril, Hydralazine.

Antiarrhythmic Agents

12

Synthesis: Lignocaine, Flecainide.

Antianginal Agents Synthesis: Glyceryltrinitrate, Isosorbidedinitrate

Antihyperlipidemic agents SAR: HMG CoA Reductase inhibitors Synthesis : Clofibrate

3 Diuretics: SAR: Thiazide diuretics, 5-Sulfamoyl benzoic acid derivatives. Synthesis: Hydrochlorthiazide, Acetazolamide, Furosemide, Dihydroflumethiazide, Ethacrinic acid

03

4 Hormones and Related drugs:

Antidiabetic agents: Synthesis: Glipizide, Metformin, Pioglitazone, Tolbutamide, Glimipride.

Thyroid Hormones and Antithyroid Drugs Synthesis: Thyroxine, Methimazole, Carbimazole.

Steroids and Therapeutically related compounds Nomenclature and stereochemistry of steroids (ii) Adrenocorticoids – Mineralocorticoids, Glucocorticoids (iii) Estrogens, Progestins and Androgens SAR: Estrogens and Adrenocorticoids, Progestins, Androgens

08

Practical contents

1 Synthesis and purification of organic compounds based on theory syllabus

2 Reaction monitoring and characterization of synthesized compounds with the of TLC, UV and IR spectroscopy

References

1. Textbook of Organic Medicinal and Pharmaceutical Chemistry, Wilson and Giswolds J. Lippincott Co. Philadelphia.

2. Principles of medicinal chemistry, W. C. Foye, Lea and febiger, Philadelphia.

3. Burgers Medicinal chemistry, H. E. Wolff, John Wiley and sons, New York

4. Strategies for organic drug synthesis and design, Daniel Lednicer, John Wiley and Sons USA

GANPAT UNIVERSITY




Subject code BPH7A3 Subject Name Pharmaceutical Analysis-III



L TU P TW

Credit 3 - 2 2 Theory 40 60 100


Pre-requisites:

Nil

Learning Outcome

By the end of this course, the student should have a basic knowledge of all spectroscopic method with practical

hand and its application in pharmaceutical field.

Student will also aware about the validation of analytical method which is used in pharmaceutical field.

The student will learn about the different pharmaceutical guidelines applicable to national and international

level in pharmaceutical field.

Theory Syllabus

Unit Content Hrs

1 Fundamentals of Spectroscopy: Classification of spectra i.e. line, band, continuous spectra, absorption, emission spectra; EMR, properties of electromagnetic radiation; types of spectroscopy, electromagnetic spectrum.

03

2 UV-VIS spectroscopy: Theory; Beer and Lambert’s law - limitations and deviations from the law; Terminologies associated with absorption measurements; Types of transitions; Factors affecting spectral characteristics (structural and non-structural); Effect of conjugation; Wood ward Fieser rule; Photometric titrations; Instrumentation, applications ( in analysis of organic compounds and inorganic complexes), advantages and limitations of UV Visible spectroscopy; Quantitative analysis of binary mixtures of absorbing substances by simultaneous equation method; Calibration of UV Visible Spectrophotometer as per Pharmacopoeia

10

3 Atomic spectroscopy (AAS and AES): Atomic Absorption Spectroscopy (AAS): Principle, limitations, Instrumentation (including radiation sources like hollow cathode lamp, EDL), applications & advantages, interferences in AAS with remedies. Emission Spectroscopy (AES): Principle, instrumentation and applications of AES

08

4 Flame Photometry (FP) OR Flame Emission Spectroscopy (FES) Introduction, principle and limitations of FP, Instrumentation of flame photometry with various burners used in the techniques, Applications of flame photometry with quantitative determination using FP, Interferences in FP with remedies

07

5 X-ray spectroscopy 03

6 Overview of Radio Immuno Assay (RIA) 03

7 Overview of Scattering Spectroscopy like Raman spectroscopy, Nephelometry and Turbidimetry.

03

8 GLP, ISO, WHO and ICH guidelines for Pharmaceutical analysis. Analytical Method Development and Validation, Process validation, Quality audit and self-inspection.

08

Practical contents

Practicals based on instrumental techniques eg. Pharmacopoeial or other methods for analysis of various drugs/formulation using different analytical techniques.

References

1 Principles of Instrumental Analysis by skoog, holler, Nieman, 5th edition.

2 Instrumental methods of Analysis, H.H. Willard, L.L. Meritt, J.A. Dean and F.A. Settle Wadsworath, New York

3 Pharmaceutical Analysis: Modern methods Part A, Part B, James W. Munson.

4 G. H. Jeffery, J. Basset, J. Mendham, R. C. Denny (Rev. by) Vogel’s Text Book of Quantitative Chemical Analysis, Longman, London

5 A Textbook of Pharmaceutical Analysis. Connors K.A.

6 A.H. Beckett and J.B. Stenlake, Practical Pharmaceutical chemistry, part 1&2, the athlone press, London.

7 Principles of Instrumental Analysis by Chatwal and Anand

8 Instrumental Analysis by G. Vidyasagar

9 Pharmaceutical Analysis by S. Ravishankar

10 Principles of Instrumental Analysis by AshutoshKar

11 Principles of Instrumental Analysis by B. K. Sharma

12 Pharmacopoeia of India, Govt. of India, Ministry of Health.

13 British Pharmacopoeia, ministry of health and social welfare, UK.

14 The United States Pharmacopeia–National Formulary (USP–NF)

15 Organic Spectroscopy by Pavia

16 Organic Spectroscopy by P. S. Kalsi

17 Spectroscopy by Silverstein

18 Merck Index, 14th Edition, 2006

GANPAT UNIVERSITY




Subject code BPH7A4 Subject Name Pharmacology and Pharmacotherapeutics-II



L TU P TW

Credit 3 - 2 2 Theory 40 60 100


Pre-requisites:

Nil

LearningOutcome

Upon completion of the course, learner would be able to understand the pharmacology and clinical management strategies of CNS disorders.

At the end of this course, learner would be able to apply the knowledge and skill for the management of the diseases.

Learner will be able to utilize their expertise of animal handling, training of equipments and instruments handling for studying pharmacological effects of the drugs used for above mentioned disorders.

Theory Syllabus

Unit Content Hrs

1. Neuronal transmitters in CNS 2

Pharmacology of following class of drugs

Drugs acting on Nervous system:

General Anesthetics

Ethyl and Methyl Alcohols

Sedatives and Hypnotics, Anxiolytic Agents and Centrally acting Muscle Relaxants

Antipsychotics and Drugs used in Affective Disorders

Antiepileptic Drugs

Antiparkinsonian Drugs

Analgesics, Antipyretics and Anti-Inflammatory Drugs

Opioids Analgesics and Antagonists

CNS Stimulants and Psychomimetic Agents

18

2. Definition, epidemiology, etiology, pathophysiology, signs and symptoms, diagnosis, complications, treatment and management of following diseases/conditions:

Insomnia 2

Anxiety 2

Affective disorders (Psychosis, Depression, Mania) 5

Epilepsy 2

Parkinsonism 2

Alzheimer’s disease 2

Gout 2

Rheumatoid Arthritis 2

3. Drug dependence and drug abuse- drug use, drug abuse, drug induced reward, psychological and physical dependence, tolerance, mechanisms, treatment of various drug addiction- alcohol, tobacco.

2

4. Immunomodulators- immunosuppressant drugs- classification, details of each class, immunostimulants (vaccines, antisera, immunoglobulins).

4

Practical contents

1

Demonstration ofExperiments on Central Nervous System: a) Recording of Spontaneous Motor Activityb)Recording of Stereotypyc)Recording of Analgesiad)Recording of Anti-inflammatorye)Recording of Anticonvulsant activityf)Recording of Muscle relaxant activityg)Recording of Catatoniah)Recording of Anti-depressant activity.

2 To evaluate case study(minimum 2 cases) of Insomnia, Anxiety, Schizophrenia, Mania, Depression, Parkinsonism, Alzheimer’s disease, Epilepsy, Drug abuse and dependence, inflammatory pain conditions.

3 To study the Effects of CNS Stimulant (Coffee/Tea) on Human Volunteers.

References

12. Goodman & Gilman’s, The Pharmacological basis of therapeutics, 12th Edition, McGraw Hill, New Delhi, 2011.

13. Rang, H.P. & Dale, M.M., Rang and Dale’s Pharmacology. 7th ed., Elsevier Churchill Living stone, London, 2012.

14. Basic and clinical pharmacology by Katzung, B.G., 12th ed., McGraw Hill, New Delhi, 2009.

15. Roger Walker and Cate Whittlesea, Clinical Pharmacy and Therapeutics, 5th ed., Churchill Livingstone, Edinburgh, 2011.

16. Eric T. Herfindal et al., Text Book of Therapeutics: Drug and Disease Management, 8th ed., Williams and Wilkins, Philadelphia, 2006.

17. Brian R. Walker et al., Davidson’s Principle and Practice of Medicine, 22nd ed., Churchill Livingstone, Edinburgh, 2014.

18. Joseph T. Dipiro et al., Pharmacotherapy: A Pathophysiological Approach, 9th ed., McGraw-Hill Education, 2014.

19. Satoskar, R.S. and Bhadarkar, S.D., Pharmacology and Pharmacotherapeutics, 21st ed., Popular Prakashan, Mumbai, 2010.

20. Richard A. Harvey et al., Pharmacology (Lippincott Illustrated Reviews Series), 5th Ed. Lippincott- Raven Company, Philadelphia, New York, 2011.

21. G. Parathsarthee, K. Nyfort-Hansen and M. C. Nahata. A Textbook of Clinical Pharmacy Practice: Essential Concepts and Skills, 2nd Ed., Universities Press, 2012.

11. K.D. Tripathi, Essential of Medical Pharmacology, 6th Ed., Jaypee Brothers Medical Publisher (P) Ltd., New Delhi, 2008.

12 Seth S.D., Vimlesh Seth, Text Book of pharmacology, 3rd Ed., Elsevier, 2008.

13. Sheth U.K. et al-Selected topics in Experimental Pharmacology, 1st Ed., The Kothari Book Depot, Mumbai, 1972.

14. R.K. Goyal et al., Elementals of Clinical Pharmacy, 6th Ed., B.S. Prakashan Ahmedabad, 2011-12.

15. Fundamentals of experimental pharmacology by Ghosh, M.N., 6th ed., Hilton & Company, Kolkatta, 2014.

16. Kulakarni S.K., Handbook of Experimental Pharmacology, 4th Ed., VallabhPrakashan, New Delhi, 2012.

17. Practicals in Pharmacology by R. K. Goyal, 9th ed., B.S. Shah Prakashan, Ahmedabad, 2010.

http://www.amazon.com/s/ref=dp_byline_sr_book_2?ie=UTF8&field-author=Cate+Whittlesea+BSc++MSc++PhD++MRPharmS&search-alias=books&text=Cate+Whittlesea+BSc++MSc++PhD++MRPharmS&sort=relevancerank

http://www.amazon.com/s/ref=dp_byline_sr_book_1?ie=UTF8&field-author=Richard+A.+Harvey+PhD&search-alias=books&text=Richard+A.+Harvey+PhD&sort=relevancerank

http://www.amazon.in/s/ref=dp_byline_sr_book_2?ie=UTF8&field-author=Vimlesh+Seth&search-alias=stripbooks

GANPAT UNIVERSITY




Subject code BPH7A5 Subject Name Pharmacognosy-V



L TU P TW

Credit 3 - 2 2 Theory 40 60 100


Pre-requisites:

Nil

Learning Outcome

Students will know in depth knowledge of traditional drugs, Ayurvedic preparations and their importance in therapeutics.

Students learn techniques of developing modern herbal based formulations, cosmetics and nutraceuticals.

Theory Syllabus

Unit Content Hrs

1. Traditional drugs: Common and vernacular names, Botanical sources, morphology, chemical nature of chief constituents Pharmacology categories and common uses, marketed formulations of following traditional drugs: Stem: Galo Root & Rhizome: Satavari, Chitrak, Majith, Vaj Bark: Arjuna, Ashoka, Sirish, Kanchnar Entire herb: Apamarg, Methi, Eclipta, Kantakari. Underground Stem: Garlic Unorganized: Shilajit, Guggal. Wood: Biyo Seed : Chakramadu, Karanj Flower: Dhatakipushpa, Palash Leaf: Karen, Adusa, Nagod, Gimnema, Tilophora, Talispatra, Neem. Fruit: Amla, Baheda, Harde, Malkangni, Kalijiri, Vidang, Ghokharu, Bhilama, Piper.

25

2. Principle of Ayurveda. Introduction to Ayurvedic preparations and evaluation of Churna, Kwath, Gutika,

Taila, Ghrita, Lehya, Asavas and Arista, Bhasma and Pisti with example.

10

3. Herbal Cosmetics: Special role of herbals used in various cosmetics.preparation and evaluation of herbal skin care cream, herbal shampoo, herbal hair oil.

4

4. Herbs as health food and Nutraceuticals. General information of drugs used as health food and Nutraceuticalsand dietary supplements.

3

5. Regulatory requirements for manufacturing of AYUSH products as per Schedule T. 3

Practical contents

1. Morphological identification of Traditional drugs mentioned in theory.

2. Histological study of Important Traditional drugs.

3. Practicals based on preparation and evaluation of Ayurvedic formulations like Churna, Avleha, Kwath and Gutika.

4. Practicals based on preparation and evaluation of herbal based cosmetics.

5. Collection and preparation of herbariums of important traditional drugs.

References

1. Quality Control of Herbal Drugs, Mukherjee P. K., Business Horizon Pharma. Publishers, 1st Edition, 2002.

2. Quality control methods for medicinal plant materials, W.H.O., Geneva, A.I.T.B.S. Publishers and distributors, 1st Indian Edition, 2002.

3. Microscopic profile of powdered drugs used in Indian systems of medicine, Malti G. Chauhan andPillai A.P.G., volume 1, Leaf drugs, (2005), Gujarat Ayurved University, Jamnagar.

4. Microscopic profile of powdered drugs used in Indian systems of medicine, Malti G. Chauhan and Pillai A.P.G., volume 2, bark drugs, (2007), Gujarat Ayurved University, Jamnagar

5. Anonymous, Handbook on Herbal Products (Cosmetics, Toiletories, Medicine and Perfumes), National Institute of Industrial Research, New Delhi

6. Indian Herbal Pharmacopoeias, Vol. I and Vol. II. A Joint Publication of R.R.L. Jammu and IDMA, Mumbai. 1999.

7. Herbal Drug Industry. Chief Editor R.D. Chaudhary, Eastern Publishers, New Delhi, 1st Edition, 1996.

8. Compendium of Indian Medicinal Plants; R.P. Rastogi and B.N. Mehrotra, CDRL Lucknow, Vol. I, II, III, IV ; 1993.

9. The wealth of India. Raw Materials, Publication and Information Directorate, CSIR, New Delhi. Revised Edition 1985.

10. Kiritkar K.R. and Basu B.D. Indian Medicinal Plants. Text Volume I, II, III and IV 1987. International Book Distributors, Dehradun.

11. Herbal Drug Technology, S. S. Agrawal and M. Paridhavi, Univeristies Press, 1st Edition, 2007.

12. The ayurvedic Formulary of India, Part I and II, Department of Indian system of Medicine and Homoeopathy, Govt, of India, 1st English Edition, 2000.

13. Indian Materia Medica. Edited by K.M. Naadkarni. Volume Iand II. Reprint 1996. Bombay Popular Parkashan.

14. The Useful Plants of India, 3rd Reprint, 1994. Pub. & Information Directorate CSIR, New Delhi.

15. Quality Standards of Indian Medicinal Plants, Volume I to X, A. K. Gupta, ICMR, 2003.

16. Hand Book of Herbal Cosmetics, Panda H., Asia pacific business press

17. Anonymous, Ayurvedic Pharmacopoeia of India, Govt. of India.

18. Standardization of botanicals: testing and extraction methods of medicinal herbs: Rajpal V., vol-1 & 2, Eastern Publisher, New Delhi.

GANPAT UNIVERSITY




Subject code BPH7A6 Subject Name Pharmaceutical Jurisprudence



L TU P TW

Credit 2 - - - Theory 40 60 100

Hours 2 - - - - Practical - - -

Pre-requisites:

Nil

Learning Outcome

Make student responsible person while discharging duty as a pharmacist in different facets of pharmacy profession.

Provide basic knowledge related to laws that help in becoming a pharma entrepreneur.

Update student ethical vision with special concern to selective categories.

Theory Syllabus

Unit Content Hrs

1. Pharmaceutical Legislation in India-brief review. 1

2. Drug & Pharmaceutical Industries in India- brief review. 1

3. Pharmaceutical Education in India- brief review. 1

4. Pharmaceutical Ethics: Principles and significance of professional Ethics. Critical study of the Code of Pharmaceutical Ethics drafted by Pharmacy Council of India. Pharmacist’s oath.

2

5. Pharmacy Act 1948: Objective of the Act, Definitions, Pharmacy Education Regulations. Working of State and Central Councils, Constitution & functions of Councils. Registration procedures for Pharmacist under the Act and its renewal. Offence & Penalties.

3

6. Drug and Cosmetic Act 1940 6

7. Medicinal & Toilet Preparations [Excise Duties] Act1955 Objective, definitions, licensing procedures for manufacturing of different preparation in bonded and non-bonded laboratory, Offences & Penalties.

2

8. Narcotic Drugs & Psychotropic Substance Act 1985 & Rules Objective, definitions, constitution and functions of narcotic and psychotropic consultative committee, national fund for controlling the drug abuse, prohibition, control and regulation for import, manufacture and shipments of these drugs. Power of Inspector. Offences and Penalties.

2

9. Drug Price Control Order 1995 General study of the order with its Objectives, Definitions, Fixation price of bulk drugs and retail price of formulations. Powers of Central Govt. Records to be maintain. DPEA. Offence & Penalties.

2

10. Prevention of Cruelty to Animals Act 1960. Objectives, definitions and provisions of Act like constitution of committee. Breeding of animals, maintenance of records. Detail of forms.

2

11. States shops & Establishment Act 1960. Introduction, objectives, definitions and provisions of Act like registration of establishment, hours of work, wages, appointment, inspection, offences and penalties.

2

12. Factories Act 1948. Introduction, objectives, definition and provisions of Act like licensing procedure, health, safety & welfare of workers, working hours, employment of women & young children, leaves. Offences and Penalties.

3

13. Drug and Magic Remedy act, Medical Termination of Pregnancy 2

14. Drug Policy 2002 1

References

1. 1 A textbook of Forensic Pharmacy; N.K. Jain, VallabhPrakashan, New Delhi, 2002.

2. 3 Textbook of Pharmaceutical Jurisprudence; AtulPrakashan, G.K.Jani.

3. 5 The Drugs and Cosmetics Act, 1940, Together with Drugs and Cosmetic Rules, 1945, and Drugs (Prices Control) Order, 1979, and Notifications & Short Notes; Vijay Malik, Eastern Book Company, Lucknow.

4. 6 Forensic Pharmacy; B. S Kuchekar., A. M. Khadtare S. C. ,Itkar, , 6thEdition, NiraliPrakashan; 2006.

5. 7 Drugs & Cosmetics Act; S. W Deshpande. -; 4thEdition;2006

6. 8 Latest Acts and Rules Published by Government of India:

The patents act 1970 with patents rules 1972.

The narcotic drugs and psychotropic substance act, 1985 with the prevention of illicit traffic in narcotic drugs and psychotropic substance act, 1988 along with Allied rules and orders, 1993.

The medical termination of pregnancy act 1971, along with the medical termination of pregnancy rules 1975.

Insecticides act 1963 together with insecticides rules 1971 and insecticides (price, stock, display and submission of reports) order 1986 along with selected notifications (5th edition 1998).

The drugs (price control) order 1987 – along with new drug policy 1994 and drugs (price control) order 1995

The Pharmacy Act 1998. States shops & Establishment Act 1960.

The drug and cosmetics act 1940.

The medicinal and toilet preparation act 1955.

The factories act 1948.

Prevention of cruelty to animals act 1960

GANPAT UNIVERSITY TEACHING SCHEME EXAMINATIN SCHEME · 2018-07-10 · ganpat university faculty of pharmacy teaching and examination scheme effective year 2018-19 programme b.pharm

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