SEMESTER VI

BP601T. MEDICINAL CHEMISTRY – III (Theory)

45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasis on modern techniques of
rational drug design like quantitative structure activity relationship (QSAR), Prodrug
concept, combinatorial chemistry and Computer aided drug design (CADD). The subject
also emphasizes on the chemistry, mechanism of action, metabolism, adverse effects,
Structure Activity Relationships (SAR), therapeutic uses and synthesis of important
drugs.

Objectives: Upon completion of the course student shall be able to

1. Understand the importance of drug design and different techniques of drug
design.
2. Understand the chemistry of drugs with respect to their biological activity.
3. Know the metabolism, adverse effects and therapeutic value of drugs.
4. Know the importance of SAR of drugs.
Course Content:

Study of the development of the following classes of drugs, Classification, mechanism of

action, uses of drugs mentioned in the course, Structure activity relationship of selective
class of drugs as specified in the course and synthesis of drugs superscripted by (*)

UNIT – I 10 Hours

Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation classification and important products of
the following classes.
β-Lactam antibiotics: Penicillin, Cepholosporins, β- Lactamase inhibitors,
Monobactams
Aminoglycosides: Streptomycin, Neomycin, Kanamycin
Tetracyclines: Tetracycline, Oxytetracycline, Chlortetracycline,
Minocycline, Doxycycline

UNIT – II 10 Hours

Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation classification and important products of
the following classes.
 Macrolide: Erythromycin Clarithromycin, Azithromycin.
Miscellaneous: Chloramphenicol*, Clindamycin.

Prodrugs: Basic concepts and application of prodrugs design.

Antimalarials: Etiology of malaria.

Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine,
Primaquine phosphate, Pamaquine*, Quinacrine hydrochloride, Mefloquine.
Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquone.

UNIT – III 10 Hours

Anti-tubercular Agents
Synthetic anti tubercular agents: Isoniozid*, Ethionamide, Ethambutol,
Pyrazinamide, Para amino salicylic acid.*
Anti tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine
Streptomycine, Capreomycin sulphate.

Urinary tract anti-infective agents

Quinolones: SAR of quinolones, Nalidixic Acid,Norfloxacin, Enoxacin,
Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin,
Moxifloxacin
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.

Antiviral agents:
Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine
trifluoride, Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine,
Lamivudine, Loviride, Delavirding, Ribavirin, Saquinavir, Indinavir,
Ritonavir.

UNIT – IV 08 Hours

Antifungal agents:
Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin, Griseofulvin.
Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole,
Oxiconazole Tioconozole, Miconazole*, Ketoconazole, Terconazole,
Itraconazole, Fluconazole, Naftifine hydrochloride, Tolnaftate*.

Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole, Diloxanide,

Iodoquinol, Pentamidine Isethionate, Atovaquone, Eflornithine.

Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole, Mebendazole*,

Albendazole, Niclosamide, Oxamniquine, Praziquantal, Ivermectin.
 Sulphonamides and Sulfones
Historical development, chemistry, classification and SAR of Sulfonamides:
Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*,
Sulphapyridine, Sulfamethoxaole*, Sulphadiazine, Mefenide acetate,
Sulfasalazine.
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.
Sulfones: Dapsone*.

UNIT – V 07 Hours

Introduction to Drug Design

Various approaches used in drug design.

Physicochemical parameters used in quantitative structure activity
relationship (QSAR) such as partition coefficient, Hammet’s electronic
parameter, Tafts steric parameter and Hansch analysis.
Pharmacophore modeling and docking techniques.

Combinatorial Chemistry: Concept and applications of combinatorial

chemistry: solid phase and solution phase synthesis.
 BP607P. MEDICINAL CHEMISTRY- III (Practical)
4 Horus/ week

I Preparation of drugs and intermediates

1 Sulphanilamide
2 7-Hydroxy, 4-methyl coumarin
3 Chlorobutanol
4 Triphenyl imidazole
5 Tolbutamide
6 Hexamine

II Assay of drugs
1 Isonicotinic acid hydrazide
2 Chloroquine
3 Metronidazole
4 Dapsone
5 Chlorpheniramine maleate
6 Benzyl penicillin

III Preparation of medicinally important compounds or intermediates by Microwave

irradiation technique

IV Drawing structures and reactions using chem draw®

V Determination of physicochemical properties such as logP, clogP, MR, Molecular

weight, Hydrogen bond donors and acceptors for class of drugs course content
using drug design software Drug likeliness screening (Lipinskies RO5)

Recommended Books (Latest Editions)

1. Wilson and Giswold’s Organic Medicinal and Pharmaceutical Chemistry.
2. Foyes Principles of Medicinal Chemistry, Lippincott Williams and Wilkins.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to Principles of Drug Design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s Extra Pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- A.I.Vogel.
11. Synthesis of Essential Drugs by Vardanyan and Hruby, Elsevier.
12. Medicinal and Pharmaceutical Chemistry by Singh and Kapoor, Vallabh
Prakashan.
13. Medicinal Chemistry: A Biochemical Approach by Nogrady, Oxford University
Press.
14. An Introduction to Medicinal Chemistry by Patrick Oxford University Press.
15. Comprehensive Medicinal Chemistry by Hansch, Pergamon Press.
16. Practical Organic Chemistry by Mann and Saunders, Orient Longman Limited.
17. Vogel’s Textbook of Practical Organic Chemistry, Dorling Kindersley (India) Pvt.
Ltd. (Pearson Education Ltd.).
 BP602 T. PHARMACOLOGY-III (Theory)

45 Hours

Scope: This subject is intended to impart the fundamental knowledge on various aspects
(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on respiratory and gastrointestinal system, infectious
diseases, immuno-pharmacology and in addition,emphasis on the principles of
toxicology and chronopharmacology.

Objectives: Upon completion of this course the student should be able to:
1. Understand the mechanism of drug action and its relevance in the treatment of
different infectious diseases
2. Comprehend the principles of toxicology and treatment of various poisonings and
3. Appreciate correlation of pharmacology with related medical sciences.
Course Content:

UNIT-I 10 hours
1. Pharmacology of drugs acting on Respiratory system
a. Anti -asthmatic drugs
b. Drugs used in the management of COPD
c. Expectorants and antitussives
d. Nasal decongestants
e. Respiratory stimulants

2. Pharmacology of drugs acting on the Gastrointestinal Tract

a. Antiulcer agents.
b. Drugs for constipation and diarrhoea.
c. Appetite stimulants and suppressants.
d. Digestants and carminatives.
e. Emetics and anti-emetics.

UNIT-II 10 hours
3. Chemotherapy
a. General principles of chemotherapy.
b. Sulfonamides and cotrimoxazole.
c. Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides,
quinolones and fluoroquinolins, tetracycline and aminoglycosides
UNIT-III 10 hours
3. Chemotherapy
a. Antitubercular agents
b. Antileprotic agents
 c. Antifungal agents
d. Antiviral drugs
e.Anthelmintics
f. Antimalarial drugs
g. Antiamoebic agents
UNIT-IV 08 hours
3. Chemotherapy
l. Urinary tract infections and sexually transmitted diseases.
m. Chemotherapy of malignancy.
4. Immunopharmacology
a. Immunostimulants
b. Immunosuppressant
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars

UNIT-V 07 hours
5. Principles of toxicology

a. Definition and basic knowledge of acute, subacute and chronic toxicity.

b. Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity
and mutagenicity
c. General principles of treatment of poisoning
d. Clinical symptoms and management of barbiturates, morphine,
organophosphosphorus compound and lead, mercury and arsenic poisoning.

6. Chronopharmacology
a. Definition of rhythm and cycles.
b. Biological clock and their significance leading to chronotherapy.
 BP 608 P. PHARMACOLOGY-III (Practical)
4Hrs/Week

1. Dose calculation in pharmacological experiments

2. Antiallergic activity by mast cell stabilization assay
3. Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and
NSAIDS induced ulcer model.
4. Study of effect of drugs on gastrointestinal motility
5. Effect of agonist and antagonists on guinea pig ileum
6. Estimation of serum biochemical parameters by using semi- autoanalyser
7. Effect of saline purgative on frog intestine
8. Insulin hypoglycemic effect in rabbit
9. Test for pyrogens ( rabbit method)
10. Determination of acute oral toxicity (LD50) of a drug from a given data
11. Determination of acute skin irritation / corrosion of a test substance
12. Determination of acute eye irritation / corrosion of a test substance
13. Calculation of pharmacokinetic parameters from a given data
14. Biostatistics methods in experimental pharmacology( student’s t test, ANOVA)
15. Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon
Signed Rank test)

*Experiments are demonstrated by simulated experiments/videos

Recommended Books (Latest Editions)

1. Rang and Dale’s Pharmacology, Churchil Livingstone Elsevier.
2. Basic and clinical pharmacology by Katzung B. G., Masters S. B., Trevor A. J., Tata
McGraw-Hill.
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics.
4. Applied Therapeutics, The Clinical use of Drugs by Marry Anne K. K., Lloyd Yee Y.,
Brian K. A., Robbin L.C., Joseph G. B., Wayne A.K., Bradley R.W. The Point
Lippincott Williams & Wilkins.
5. Lippincott’s Illustrated Reviews- Pharmacology by Mycek M.J, Gelnet S.B
and Perper M.M.
6. Essentials of Medical Pharmacology by K.D.Tripathi, Jaypee Brothers
Medical Publishers (P) Ltd.
7. Principles of Pharmacology by Sharma H. L., Sharma K. K., Paras Medical
P ublisher.
8. Modern Pharmacology with clinical Applications, by Charles R.Craig & Robert,
9. Fundamentals of Experimental Pharmacology by Ghosh, Hilton & Company.
10. Handbook of Experimental Pharmacology by Kulkarni S.K., Vallabh Prakashan.
11. Clinical Pharmacology by Laurene, D.R. & Bennet P.N., Churchill Livingstone.
12. Principles of Pharmacology by Paul, Chapman and Hall.
13. Concepts in Chronopharmacology by N.Udupa and P.D. Gupta.
14. Text Book of Pharmacology by Barar, Interprint.
 BP 603 T. HERBAL DRUG TECHNOLOGY (Theory)
45 hours
Scope: This subject gives the student the knowledge of basic understanding of herbal drug
industry, the quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics,
natural sweeteners, nutraceutical etc. The subject also emphasizes on Good Manufacturing
Practices (GMP), patenting and regulatory issues of herbal drugs

Objectives: Upon completion of this course the student should be able to:
1. understand raw material as source of herbal drugs from cultivation to herbal drug
product
2. know the WHO and ICH guidelines for evaluation of herbal drugs
3. know the herbal cosmetics, natural sweeteners, nutraceuticals
4. appreciate patenting of herbal drugs, GMP .

Course content:
UNIT-I 11 Hours
Herbs as raw materials
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation
Source of Herbs
Selection, identification and authentication of herbal materials
Processing of herbal raw material

Biodynamic Agriculture
Good agricultural practices in cultivation of medicinal plants including Organic farming.
Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.

Indian Systems of Medicine

a) Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy
b) Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas,
Ghutika,Churna, Lehya and Bhasma.

UNIT-II 7 Hours
Nutraceuticals
General aspects, Market, growth, scope and types of products available in the market. Health
benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable
bowel syndrome and various Gastro intestinal diseases.
Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic,
Honey, Amla, Ginseng, Ashwagandha, Spirulina

Herbal-Drug and Herb-Food Interactions: General introduction to interaction and

classification. Study of following drugs and their possible side effects and interactions:
Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra.

UNIT-III 10 Hours
Herbal Cosmetics
Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums
colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skin
care, hair care and oral hygiene products.
Herbal excipients:
Herbal Excipients – Significance of substances of natural origin as excipients – colorants,
sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.

Herbal formulations :
Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms
like phytosomes

UNIT- IV 10 Hours
Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs
Stability testing of herbal drugs.

Patenting and Regulatory requirements of natural products:

a) Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and
Biopiracy
b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma
& Neem.

Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation of

manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.

UNIT-V 07 Hours
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India.

Schedule T – Good Manufacturing Practice of Indian systems of medicine

Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
 BP 609 P. HERBAL DRUG TECHNOLOGY (Practical)
4 hours/ week

1. To perform preliminary phytochemical screening of crude drugs.

2. Determination of the alcohol content of Asava and Arista
3. Evaluation of excipients of natural origin
4. Incorporation of prepared and standardized extract in cosmetic formulations like
creams, lotions and shampoos and their evaluation.
5. Incorporation of prepared and standardized extract in formulations like syrups,
mixtures and tablets and their evaluation as per Pharmacopoeial requirements.
6. Monograph analysis of herbal drugs from recent Pharmacopoeias
7. Determination of Aldehyde content
8. Determination of Phenol content
9. Determination of total alkaloids

Recommended Books: (Latest Editions)

1. Textbook of Pharmacognosy by Trease & Evans.
2. Textbook of Pharmacognosy by Tyler, Brady & Robber.
3. Pharmacognosy by Kokate, Purohit and Gokhale.
4. Essential of Pharmacognosy by Dr.S.H.Ansari.
5. Pharmacognosy & Phytochemistry by V.D.Rangari.
6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in
Indian Medicine & Homeopathy).
7. Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
8. Pharmacognosy by Tyler V.E., Lynnr B. and Robbers J.E., 8th Edition, Lea &
Febiger, Philadelphia.
9. Harborne J.B., Phytochemical Methods, Chapman & Hall International Edition.
10. Medicinal Plants of India, Vol. I & II, Indian Council of Medical Research.
11. Indian Materia Medica by Nadkarni A.K.Vol- 1&2, Popular Prakashan (P) Ltd.
12. A Selection of Prime Ayurvedic Plant Drugs by Sukh Dev, Anamaya Publisher.
13. Indian Herbal Pharmacopoeia, Vol. I & II, ICMR & RRL, Jammu.
14. Indian Ayurvedic Pharmacopoeia, Govt. of India.
15. The Wealth of India, Raw Materials (All volumes), Council of Scientific &
Industrial Research.
16. Rastogi R. P. and Mehrotra B.N., Compendium of Indian Medicinal Plants I-IV,
Publications & Information Directorate/Central Drug Research Institute.
17. Wallis T.E., Analytical Microscopy, J&A Churchill Ltd.
18. Practical Pharmacognosy by Kokate C.K., Vallabh Prakashan.
19. Pharmacognosy of Powdered Crude Drugs by Iyengar M.A., PharmaMed Press.
20. Anatomy of Powdered Crude Drugsby Iyengar, M.A. and Nayak S.C.K.,
PharmaMed Press.
 BP 604 T. BIOPHARMACEUTICS AND PHARMACOKINETICS (Theory)
45 Hours
Scope: This subject is designed to impart knowledge and skills of Biopharmaceutics
and pharmacokinetics and their applications in pharmaceutical development, design of
dose and dosage regimen and in solving the problems arising therein.
Objectives: Upon completion of the course student shall be able to:
1. Understand the basic concepts in biopharmaceutics and pharmacokinetics and
their significance.
2. Use of plasma drug concentration-time data to calculate the pharmacokinetic
parameters to describe the kinetics of drug absorption, distribution,
metabolism, excretion, elimination.
3. To understand the concepts of bioavailability and bioequivalence of drug
products and their significance.
4. Understand various pharmacokinetic parameters, their significance &
applications.
Course Content:
UNIT-I 10 Hours
Introduction to Biopharmaceutics
Absorption; Mechanisms of drug absorption through GIT, factors influencing drug
absorption though GIT, absorption of drug from Non per oral extra-vascular
routes, Distribution Tissue permeability of drugs, binding of drugs, apparent, volume
of drug distribution, plasma and tissue protein binding of drugs, factors affecting
protein-drug binding. Kinetics of protein binding, Clinical significance of protein
binding of drugs

UNIT- II 10 Hours
Elimination: Drug metabolism and basic understanding metabolic pathways renal
excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non renal
routes of drug excretion of drugs
Bioavailability and Bioequivalence: Definition and Objectives of bioavailability,
absolute and relative bioavailability, measurement of bioavailability, in-vitro drug
dissolution models, in-vitro-in-vivo correlations, bioequivalence studies, methods to
enhance the dissolution rates and bioavailability of poorly soluble drugs.

UNIT- III 10 Hours

Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment
models, Non compartment models, physiological models, One compartment open
model. (a). Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extra
vascular administrations. Pharmacokinetics parameters - KE ,t1/2,Vd,AUC,Ka, Clt and
CLR- definitions methods of eliminations, understanding of their significance and
application.
UNIT- IV 08 Hours

Multicompartment models: Two compartment open model. IV bolus

Kinetics of multiple dosing, steady state drug levels, calculation of loading
and mainetnance doses and their significance in clinical settins.

UNIT- V 07 Hours
Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity.
c. Michaelis-menton method of estimating parameters, Explanation with example
of drugs.

Recommended Books: (Latest Editions)

1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.
2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew
B.C.YU 4th edition, Prentice-Hall International edition.
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and
Sunil B.Jaiswal,Vallabh Prakashan Pitampura.
5. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
6. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott
by ADIS Health Science Press.
7. Biopharmaceutics; By Swarbrick.
8. Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland .
9. Thomas, N. Tozen, Lea and Febiger, Philadelphia, 1995.
10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M,
Mack, Publishing Company,Pennsylvania 1989.
11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th
edition Revised and expanded by Robert F Notari Marcel Dekker Inn.
12. Remington’s Pharmaceutical Sciences, Mack Publishing Company.
13. Drug Disposition & Pharmacokinetics by Curry, S. H., Pharma Book Syndicate.
14. Analytical Techniques for Biopharmaceuticals Development, by Robert,
Rodriguezdiaz.
15. Clinical Pharmacokinetics, by Rowland M, and Tozer T.N. Lea and Febriger.
16. Fundamentals of Clinical Pharmacokinetics by Wagner J.G. Drugs Intelligence
Publishers.
17. Pharmacokinetics for the Pharmaceutical Scientist by Wagner J.G. Technomic
Publishing A.G.
 BP 605 T. PHARMACEUTICAL BIOTECHNOLOGY (Theory)
45 Hours
Scope:
 Biotechnology has a long promise to revolutionize the biological sciences and
technology.
 Scientific application of biotechnology in the field of genetic engineering,
medicine and fermentation technology makes the subject interesting.
 Biotechnology is leading to new biological revolutions in diagnosis, prevention
and cure of diseases, new and cheaper pharmaceutical drugs.
 Biotechnology has already produced transgenic crops and animals and the future
promises lot more.
 It is basically a research-based subject.
Objectives: Upon completion of the subject student shall be able to;
1. Understanding the importance of Immobilized enzymes in Pharmaceutical
Industries
2. Genetic engineering applications in relation to production of pharmaceuticals
3. Importance of Monoclonal antibodies in Industries
4. Appreciate the use of microorganisms in fermentation technology

Unit I 10 Hours

a) Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.

b) Enzyme Biotechnology- Methods of enzyme immobilization and applications.
c) Biosensors- Working and applications of biosensors in Pharmaceutical Industries.
d) Brief introduction to Protein Engineering.
e) Use of microbes in industry. Production of Enzymes- General consideration -
Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.
f) Basic principles of genetic engineering.

Unit II 10 Hours

a) Study of cloning vectors, restriction endonucleases and DNA ligase.

b) Recombinant DNA technology. Application of genetic engineering in medicine.
c) Application of r DNA technology and genetic engineering in the production of:
i) Interferon ii) Vaccines- hepatitis- B iii) Hormones-Insulin.
d) Brief introduction to PCR
 Unit III 10 Hours
Types of immunity- humoral immunity, cellular immunity
a) Structure of Immunoglobulins
b) Structure and Function of MHC
c) Hypersensitivity reactions, Immune stimulation and Immune suppressions.
d) General method of the preparation of bacterial vaccines, toxoids, viral vaccine,
antitoxins, serum-immune blood derivatives and other products relative to immunity.
e) Storage conditions and stability of official vaccines
f) Hybridoma technology- Production, Purification and Applications g)

Blood products and Plasma Substitutes.

Unit IV 08Hours
a) Immuno blotting techniques- ELISA, Western blotting, Southern blotting. b)
Genetic organization of Eukaryotes and Prokaryotes
c) Microbial genetics including transformation, transduction, conjugation, plasmids and
transposons.
d) Introduction to Microbial biotransformation and applications.
e) Mutation: Types of mutation/mutants.

Unit V 07 Hours
a) Fermentation methods and general requirements, study of media, equipments,
sterilization methods, aeration process, stirring.
b) Large scale production fermenter design and its various controls.
c) Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid,
Griseofulvin,
d) Blood Products: Collection, Processing and Storage of whole human blood, dried
human plasma, plasma Substitutes.
Recommended Books (Latest edition):
1. Molecular Biotechnology: Principles and Applications of Recombinant DNA by B.R.
Glick and J.J. Pasternak, ASM Press.
2. Kuby Immunology by RA Goldshy et. al.
3. Monoclonal Antibodies by J.W. Goding.
4. Molecular Biology and Biotechnology by J.M. Walker and E.B. Gingold, Royal Society
of Chemistry.
5. Immobilized Enzymes by Zaborsky, CRC Press.
6. Molecular Biotechnology (Second Edition) by S.B. Primrose, Blackwell Scientific
Publication.
7. Principles of fermentation technology by Stanbury F., P., Whitakar A., and Hall J., S., 2nd
edition, Aditya Books.
8. Prescott and Dunn’s Industrial Microbiology, CBS Publishers and Distributors
9. Pharmaceutical Biotechnology by Vyas S.P. and Dixit V.K., CBS Publication.
10. Biotechnology by Kieslich K., Verleg Chernie.
11. Principles of Fermentation by Standury P.F.,Whitaker A. & Hall S.J., Aditya
Book Private Limited.
12. Biotechnology- A Textbook of Industrial Microbiology by Crueger W. & Crueger
A, Panima Publishing Corporation.
 BP606T. PHARMACEUTICAL QUALITY ASSURANCE (Theory)
45 Hours
Scope: This course deals with the various aspects of quality control and quality
assurance aspects of pharmaceutical industries. It deals with the important aspects like
cGMP, QC tests, documentation, quality certifications and regulatory affairs.
Objectives: Upon completion of the course student shall be able to:
 understand the cGMP aspects in a pharmaceutical industry
 appreciate the importance of documentation
 understand the scope of quality certifications applicable to pharmaceutical
industries
 understand the responsibilities of QA & QC departments
Course content:
UNIT – I 10 Hours
Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM,
with special emphasis on Q-series guidelines, ICH stability testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program, tools
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures

UNIT - II 10 Hours
Organization and personnel: Personnel responsibilities, training, hygiene and personal records.
Premises: Design, construction and plant layout, maintenance, sanitation, environmental
control, utilities and maintenance of sterile areas, control of contamination.
Equipments and raw materials: Equipment selection, purchase specifications, maintenance,
purchase specifications and maintenance of stores for raw materials.

UNIT – III 10 Hours

Quality Control: Quality control test for containers, rubber closures and secondary packing
materials.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a
Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities
UNIT – IV 08 Hours
Complaints: Complaints and evaluation of complaints, Handling of return good,
recalling and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master
Formula Record, SOP, Quality audit, Quality Review and Quality documentation,
Reports and documents, distribution records.

UNIT – V 07 Hours
Calibration and Validation: Introduction, definition and general principles of
calibration, qualification and validation, importance and scope of validation, types of
validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible
spectrophotometer, General principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management

Recommended Books: (Latest Edition)

1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and
Related materials Vol I WHO Publications.
4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMP’s – P P Sharma.
6. ISO 9000 and Total Quality Management – Sadhank G Ghosh
7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of
Analysis and Quality specification for Pharmaceutical Substances,
Excipients and Dosage forms
8. Good laboratory Practices – Marcel Deckker Series.
9. ICH guidelines, ISO 9000 and 14000 guidelines.
10. Pharmacopoeia of India, Ministry of Health, Govt. of India.
11. WHO-Quality Assurance of Pharmaceuticals, Vol. I & II, AITBS Publisher &
Distributors.
12. Validation of API by Berry I.R. and Harpaz, D., 2ndEdition, CRC Press.
13. Analytical Profile of Drug Substance, by Florey K., (All volume), Academic Press,
Elsevier.
TURNITIN, VIPER etc., responsibility and accountability of the researchers. Academia-Industry
interface and research.
Project cost management: Cost analysis of the project, cost incurred on raw materials,
procedure, instrumentation and biological testing.

Unit V
Funding agencies and research grants: Introduction to various research funding agencies
such as-DST, DBT, AICTE, UGC, CSIR, ICMR, AAYUSH, and DRDO along with their
functions in India. Writing a research project and procurement of research grant.