DR.

BABASAHEB AMBEDKAR
MARATHWADA UNIVERSITY,
AURANGABAD

Curriculum under Choice Based Credit &

Grading System

M.Sc. I & II year

Drug Chemistry

Run at college level from the

Academic Year 2018-2019 & onwards

The following will be the structure of syllabus for M. Sc. Drug Chemistry I & II year effective
from June 2018
Total No. Marks
of
Semester Paper No. Subject Title Credit Teaching
Total
Internal Final
Hours
M. Sc. I year Drug Chemistry
CHE-101 Analytical Chemistry 4 60 20 80 100
CHE-102 Inorganic Chemistry 4 60 20 80 100
Semester-I
CHE-103 Organic Chemistry 4 60 20 80 100
CHE-104 Physical Chemistry 4 60 20 80 100
Spectroscopic methods of
CHE-205 4 60 20 80 100
analysis
Semester-II CHE-206 Inorganic Chemistry 4 60 20 80 100
CHE-207 Organic Chemistry 4 60 20 80 100
CHE-208 Physical Chemistry 4 60 20 80 100
Laboratory Course-I
CHE-209 4.5 135 - 50 50
(Analytical & General)
Semester-I Laboratory Course-II
CHE-210 4.5 135 - 50 50
& II (Inorganic Chemistry)
Laboratory Laboratory Course-III
CHE-211 4.5 135 - 50 50
Course (Organic Chemistry)
Laboratory Course-IV
CHE-212 4.5 135 - 50 50
(Physical Chemistry)
M. Sc. II year Drug Chemistry
Applications of Organic
CHED-313 4 60 20 80 100
Spectroscopy
Bioorganic & Green
CHED-314 4 60 20 80 100
Semester-III Chemistry
Organic Reactions &
CHED-315 4 60 20 80 100
Rearrangements
CHED-316 Heterocyclic Chemistry 4 60 20 80 100
Introduction to Medicinal
CHED-417 4 60 20 80 100
Chemistry
CHED-418 Drug Synthesis 4 60 20 80 100
Semester-IV Drug Action &
CHED-419 4 60 20 80 100
Development
Pharmaceutical & Industrial
CHED-420 4 60 20 80 100
Parctices
Laboratory Course-V (Drug
CHED-421 4.5 135 - 50 50
Synthesis & Drug Assay)
Laboratory Course-VI
Semester-III
(Organic Spectral
& IV CHED-422 4.5 135 - 50 50
Interpretation & Analytical
Laboratory
Spectral Interpretation)
Course
Research Literature &
CHED-423 4.5 135 - 50 50
Seminar
CHED-424 Research Project 4.5 135 - 50 50
2.S-[F]NPW-02 June-2015-16 All Syllabus Science Dept. College M.Sc. Chemistry Ist Yr. Sem.I & II - 5-
2.S-[F]NPW-02 June-2015-16 All Syllabus Science Dept. College M.Sc. Chemistry Ist Yr. Sem.I & II - 6-
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2.S-[F]NPW-02 June-2015-16 All Syllabus Science Dept. College M.Sc. Chemistry Ist Yr. Sem.I & II - 17 -
2.S-[F]NPW-02 June-2015-16 All Syllabus Science Dept. College M.Sc. Chemistry Ist Yr. Sem.I & II - 18 -
2.S-[F]NPW-02 June-2015-16 All Syllabus Science Dept. College M.Sc. Chemistry Ist Yr. Sem.I & II - 19 -
2.S-[F]NPW-02 June-2015-16 All Syllabus Science Dept. College M.Sc. Chemistry Ist Yr. Sem.I & II - 20 -
2.S-[F]NPW-02 June-2015-16 All Syllabus Science Dept. College M.Sc. Chemistry Ist Yr. Sem.I & II - 21 -
2.S-[F]NPW-02 June-2015-16 All Syllabus Science Dept. College M.Sc. Chemistry Ist Yr. Sem.I & II - 22 -
2.S-[F]NPW-02 June-2015-16 All Syllabus Science Dept. College M.Sc. Chemistry Ist Yr. Sem.I & II - 23 -
M. Sc. Second Year Drug Chemistry
 CHED 313: APPLICATIONS OF ORGANIC SPECTROSCOPY
Teaching Hours: 60 Credit: 04

Unit I: Ultraviolet-Visible Spectroscopy 07 Hrs.

Various Electronic transition, Chromophores, Auxochromers, Bathochromic and Hypsochromic Shifts,
Effect of solvent on electronic transitions, Woodward–Fieser rules dienes, enones and aromatic
compounds, Applications.
Unit II: Infrared Spectroscopy 10 Hrs.
Instrumentation and sample handling, Various vibrational transitions, Characteristic vibrationl frequencies
of alkenes, alkynes, aromatic compounds, Carbonyl compounds, hydroxyl compound and amines. Factors
affecting IR group frequencies, overtone, combination bands and Fermi resonance. Applications
Unit III: Nuclear Magnetic Resonance Spectroscopy 15 Hrs.
Elementary Ideas, Chemical Shifts, Factors affecting chemical shifts, Spin–Spin coupling constants (J)
Instrumentations, Different types of coupling, Factors affecting coupling constant, Karplus equation, Spin
system (AB, AX, ABX, AMX, etc), Rate processes, Spin decoupling, Shift reagents, Nuclear over Hauser
effect (NOE).
Unit IV: C13-NMR Spectroscopy 10 Hrs.
Elementary Ideas, Instrumental aspects, chemical shift (Aliphatic, Olefinic, Alkyne, Aromatic,
Heteroaromatic & carbonyl carbon), Effects of constituents on chemical shifts. Two dimensional (2D)
NMR techniques: COSY, NOESY, DEPT, APT, INEPT & INADQUATE.
Unit V: Mass Spectrometry 8 Hrs.
Introduction, Ion production (EI, CI, FD & FAB), Ion analysis, Ion abundance, Factors affecting
fragmentation, Fragmentation of different functional groups, Molecular ion peaks, Metastable peaks
Nitrogen rule, McLafferty rearrangement, Retro-Diels Alder reaction.
Unit VI: Problems based on joint application of UV, IR, NMR & Mass spectroscopy 10 Hrs.
Reference Books:
1. Spectrometric Identification of Organic Compounds, R.M. Silverstein- 6th Edition
2. Spectroscopy of Organic Compounds, V.M. Parikh.
3. Organic Spectroscopy, P.S. Kalsi
4. Introduction to Spectroscopy, D.L. Pavia, G.M. Lampman, G.L. Nelson.
5. Mass Spectroscopy, K.G. Das & James.
7. Spectroscopy Methods in Organic Chemistry D. H. Williams and I. Fleming
 CHED 314: BIO-ORGANIC AND GREEN CHEMISTRY

Teaching Hours: 60 Credit: 04

Unit I: Enzyme 4 Hrs
Introduction, Active sites, Mechanism of enzyme action, Inhibition, Isolation and purification of enzyme,
enzyme kinetics, co-enzyme, enzyme models, chemical use of enzymes, Therapeutic application of
enzymes, recombinant DNA technology

Unit II: Carbohydrates 10Hrs

Confermation of monosaccharides; structures and function of important derivatives of monosaccharides
like Glycosides, Deoxy sugars, Myoinositol, amino sugars, N-aceylmuranic acid and sialic acid,
disaccharides and polysaccharides. Structural polysaccharides: Cellulose and Chitin. Storage
polysaccharides: Starch and Glycogen. Structure and biological function of Glucosaminogycans or
mucopolusaccharides. Carbohydrates of glycoproteins and glycolinides. Role of sugars in bio;logical
recognition. Blood group substances, Ascorbic acid. Carbohydrate metabolism: Kreb’s cycle, Glycolysis,
Glyvogenolusis, Gluconeogenesis and Pentose phosphate pathways.

Unit III: Lipids 6 Hrs

Fatty acids, essential fatty acids, structures and function of triglycerides, glyceropholipids, sphingolipids,
cholesterol, bile acids, prostaglandins. Lipoproteins and function, role in antherosclerosis. Properties of
lipid aggregates-Micelles, Bilayers, liposomes and their possible biological functions. Biological
membranes, Fluid mosaic model membrane structure. Lipid metabolism: Beta oxidation of fatty acids

Unit IV: Amino acids, Peptides and Proteins 10 Hrs

Chemical and enzymatic hydrolysis of prteins to peptides, amino acid sequencing. Secondary structure of
protein, forces responsible for holding of secondary structure a helix, beta-sheets, super secondary
structure, triple helix structure of collagen.

Unit V: Nucleic Acids 10 Hrs

Purine and pyrimidine bases of nucleic acids, base pairing via H-bonding. Structure of ribonucleic acids
(RNA) and deoxyribonucleic acid (DNA), double helix model of DNA and forces responsible or Holding
it. Chemical and enzymatic hydrolysis of nucleic acids. The chemical basis for heredity, an Overview of
replication of DNA, Transcription, translation and genetic code. Chemical synthesis of mono and
dinucleosides.

Unit VI: Green Chemistry 10 Hrs

Introduction, Ideal synthesis, theoretical and functional details of following eco-friendly synthetic
protocols with suitable examples ad applications.
a) Neat synthesis (solvent free synthesis)
b) Non-volatile organic media and water as green media in organic transformations like ionic liquid, PEG
and water.
c) Microwave irradiation as alternative energy source for the chemical transformations.
d) Heterogeneous catalysis / Immobile catalysis.
e) Ultrasound assisted synthesis.

Reference Books:
1. Bioorganic chemistry By Hermann Dugas.
2. Biotransformation in organic chemistry By K. Faber.
3. Enzyme structure and Mecahanism By Alan Faber
4. Enzyme Catalysis in organic synthesis Vol. 1 By Karlheinz Drauz and Herbert Waldmann.
5. Bioorganic, Bioinorganic and Supramolecular chemistry By P. S. Kalsi and J. P. Kalsi.
6. Organic Chemistry IV Edn G.Marc Loudon.
7. Green Chemistry By Paul T. Anastas and John C. Warner
8. Green Chemistry By Rashmi Sanghi and M. M. Srivastav
 CHECD 315: ORGANIC REACTIONS & REARRANGEMENTS
Teaching Hours: 60 Credit: 04

Unit I : Organic Reactions 15 Hrs

Reaction, Mechanism and applications of following reactions: Gabriel synthesis, Streker amino acid
synthesis, Ullmann, Mitsnobu, Favorski, Hofmann-Loffler-Freytag, Shapiro, Dakin, Von Richter, Henery,
Mukaiyama reaction, Sonogishira reaction.

Unit II: Organic Rearrangements 15 Hrs

Introduction
(A) Migration to Electron deficient Carbon: i) Pinacol-Pinacolone, ii) Wagner-Meerwein, iii) Demjanov,
iv) Wolf, v) Benzil-Benzilic acid rearrangement.
(B) Migration to Electron deficient Nitrogen: i) Beckmann, ii) Hoffmann, iii)Curtius, iv) Lossen, v)
Schimidt rearrangement.
(C) Migration to Electron deficient Oxygen: i) Favorskii, ii) Neber, iii) Dakin rearrangement.
(D) Electrophilic Rearrangement: i) Stevens, ii) Wittig, iii) Smile rearrangement.

Unit III: Pericyclic Reactions 15 Hrs

Introduction, Classification, Molecular Orbital Conservation Approach
(A) Cycloaddition reaction: Cycloaddition reactions and their stereochemical aspects, Woodward-
Haffman rule, Selection rule for cycloaddition reaction, Details with examples of Diels-Alder reaction,
(2+2) cycloaddition, (1, 3) polar cycloaddition, Cycloaddition of alkenes with OsO4 and ozone,
Cheleotropic reactions, Analyses of cycloaddition by FMO, Mobius-Huckel and Corrlaion diagram
methods.
(B) Electrocyclic Reaction: Electrocyclic reactions and their stereochemical aspects, Selection rule of
electrocyclic reaction, Con-rotations and dis-rotations, Methods of analyses of the electrocyclic reactions:
FMO, Mobius-Huckel and Correlation diagram approaches.
(C) Sigmatropic rearrangements: Sigmatropic rearrangements and their stereochemistry, Rules for
Sigmatropic rearrangements, Examples on (1, 3), (1, 5), (1, 7), (3, 3), (2, 3) Sigmatropic shifts, Claisen,
Cope, Oxy-cope, Aza-cope, Sommelet-Hauser rearrangements, Ene reaction, Methods of analyses of the
rearrangements: FMO, Mobius-Huckel and Correlation diagram approaches.
Unit IV: Photochemical Reaction 10 Hrs
(A) Photochemistry of Alkenes: Intermolecular reactions of the Olefinic Bond-Geometrical Isomerism,
Cyclization reactions, Rearrangement of 1, 4- and 1, 5-dienes.
(B) Photochemistry of Carbonyl compounds: Intermolecular reactions of the Carbonyl compounds-
saturated, Cyclic and acyclic, β, γ-gamma unsaturated and α, β-unsaturated compounds,
Cyclohexadienones, Intermolecular Cycloaddition reactions, Dimerizations and Oxetane formation.
(C) Photochemistry of Aromatic Compounds: Isomerization, Additions and Substitutions.

Unit V: Protecting Groups 5 Hrs

Introduction, Principle, Protecting groups for alcohols, carbonyl, carboxylic acids, amino groups.

Reference Books:
1. Designing Organic Synthesis: S. Warren, Wiley.
2. Organic Chemistry: J. Clayden, N. Greeves, S. Warren and P. Wothers
3. Protective Groups in Organic Synthesis: T. W. Greene, G. M. Wuts.
4. Organic Syntheis: Jagdama Singh and L. D. S. Yadav
5. Advanced organic Chemistry: Part A & B, Reactions and Synthesis, F. A. Carey and R. J. Sundberg.
6. Organic Synthesis: M. B. Smith.
7. Principle of organic synthesis: Norman and Coxon
8. Advanced organic chemistry: Jerry March
9. Organic Photochemistry: Robert Kan
 CHED 316: HETEROCYCLIC CHEMISTRY

Teaching Hours: 60 Credit: 04

Unit I 15 Hrs
Five and six membered heterocycles with one and two hetero atoms:
Synthesis, reactivity, aromatic character and importance of following heterocyclic rings: Furan, Pyrrole,
Thiophene, Pyrazole, Imidazole, Pyridine

Unit II 15 Hrs
Condensed five and six membered heterocycles: Benzofuran, Indole, Quinoline

Unit III 15 Hrs

Condensed five membered heterocycles: Benzoxazole, Benzthiazole, Benzimidazole

Unit IV 15 Hrs
Five and six membered heterocycles with more than two hetero atoms: Synthesis, reactivity, aromatic
character and importance of following heterocycles: 1,2,3-triazole, 1,2,4-oxadiazole, 1,2,5-oxadiazole,
tetrazole

Reference Books:
1. Heterocyclic Chemistry: vol. I, II, III: R. R. Gupta, M. Kumar and M. Gupta
2. Heterocyclic Chemistry: Joules and Mills
3. Modern heterocyclic Chemistry: L. A. Paquette (Benjamin)
4. Organic Chemistry: Jonathan Clayden
 M. Sc. Second Year (Fourth Semester) Drug Chemistry

CHED 417: INTRODUCTION TO MEDICINAL CHEMISTRY

Teaching Hours: 60 Credit: 04

Unit I: Introduction to Drug 30 Hrs
What are Drugs? Definition, Characteristics of ideal drugs, Why do you need drugs?
(A) Classification of Drugs: i) Based on the chemical structures; examples of each class; ii) Based on the
Pharmacological action; examples of each class, Physiological action, Pro-drug; mode of action
(B) Sources of Drugs: i) Plant sources; examples of methods of isolation; ii) Marine sources; examples of
methods of isolation; iii) Micro-organism sources; examples of methods of isolation
(C) Historical development of Medicinal Chemistry, Genetic engineering
(D) Development of drugs: Lead discovery, lead development; Pharmacological / Microbiological /
Biochemical evaluation of drugs; Clinical trials; Pharmacokinetic: i) Absorption, ii) Distribution, iii)
Metabolism, iv) Elimination
(E) Dosage forms; Need and Benefits; Mode of administration of drugs; Types, Advantages;
Disadvantages.
(F) Drug Toxicity and its prevention: Principles of toxicology, abnormal action of drugs such as tolerance,
addiction, habituation, idiosyncracy, allergy, hypersensitivity, antagonism, synergism, potentiation,
tachyphylaxis. Adverse drug reactions and its monitoring.
Unit II: Alkaloids 15 Hrs
Introduction, Occurrence, Functions of alkaloids in plants, Nomenclature, Isolation, Structure
determination and synthesis of papavarine, morphine, quinine, nicotine, atropine, cocaine, ephedrine,
adrenaline, piperine.
Unit III: Terpenoids 15 Hrs
Introduction, Classification, Isolation, Structure elucidation and synthesis of Monoterpenoids,
Sesquiterpenoids, Diterpenoids, Triterpenoids, Carotenes.
Reference books:
1. Medicinal chemistry (Vol. I and II)-Burger.
2. The organic chemistry of drug design and drug action-R. B. Silverman (Academic Press)
3. Strategies for organic drug synthesis and designing - D. Lednicer Wiley.
4. Medicinal Chemistry- Ashutosh Kar
5. Medicinal Chemistry- Balkishen Razdan
6. Natural Products: Chemistry and Applications- S.V. Bhat, B.A. Nagasampagi, S. Meenakshi
 CHED 418: DRUG SYNTHESIS

Teaching Hours: 60 Credit: 04

Chemical synthesis of different classes of drugs:

Unit I: Anti-Infective 08Hr
Introduction, Different classes, Mode of action examples of synthesis of each class e.g. Penicillin,
Cephalosporins (semi-synthetic), Chloramphenicol, Ciprofloxacin, Sulphonamides, Metronidazoie,
Clotrimazole, Griseofulvin
Unit II: Psychoactive Drugs 10Hr
Introduction, neurotransmitters, CNS depressant, general anaesthetics, mode of action of hypotics
sedatives, anti-anxiety drugs, synthesis of some psychoactive drugs e.g. Diazepam, Barbiturates,
Fluoxetine, Alprazolam.
Unit III: Cardiovascular drugs 08Hr
Introduction, Cardiovascular diseases, Drug inhibitors of peripheral sympathetic function, central
intercention of cardiovascular output, direct acting anterior dilators, synthesis of some cardiovascular
drugs e.g. Atenelol, Captopril, Diltiazem, Reserpine, Prostaglandins.
Unit IV: Anti-neoplastic agent 08Hr
Introduction, cancer chemotherapy, special problems; Role of alkylating agent and anti-metabolites in
treatment of cancer. Mention of carcinolytic antibiotics and mitotic inhibiters, synthesis of some
antineoplastic agent-e.g. Taxol.
Unit V: Analgesics and Anti-inflammatory 08Hr
Introduction, Synthesis of some: Analgesis and Anti-inflammatory compounds e.g. Ibuprofen,
Indomethacin, Diclofenac, Rofecoxib, Steroids: Introduction, Nomenclature, Structure elucidation
Cholesterol, Bile acids, Estrogens, Gestogens, Androgens, Cortisone, Vitamins: A, D, E, K, Vitamin B,
Complex, B1, B2, B6, B12, C, H.
Unit VI: Antiacids / Antiulcer 08Hr
Introduction, synthesis: Omeprazole, Ranitidine.
Unit VII: QSAR Method 10Hr
Introduction, Methods used in QSAR studies, Hansch method, Free-Wilson method, Advantage and
disadvantage of free approach, Computer based methods of QSAR related to receptor binding, Physico-
Chemical properties, Lipophilicity, Electronic parameters, Steric substituent constants, Experimental
determination of partition coefficints.
Reference Books:
1. Synthesis of Essential Drugs- R. S. Vardanyan and V. J. Hruby, Elsevier.
2. Contemporary Drug Synthesis- J. J. Li, D. S. Johnson, D. R. Sliskovic, B. D. Roth, John Wiley.
3. Natural Products Chemistry- J. Singh, S. M. Alia and J. Singh, Pragati Prakashan.
4. Principals of Organic Synthesis- R. O. C. Norman and J. M. Coxon, CRC Press.
5. Advanced Organic Chemistry Part B: Reactions and Synthesis- F. A. Carey and R. J. Sundberg,
Springer.
6. Natural Products: Chemistry and Applications- S.V. Bhat, B.A. Nagasampagi, S. Meenakshi.
7. Medicinal chemistry (Vol. I and II)-Burger.
8. The organic chemistry of drug design and drug action-R. B. Silverman (Academic Press)
9. Strategies for organic drug synthesis and designing - D. Lednicer Wiley.
10. Medicinal Chemistry- Ashutosh Kar
11. Medicinal Chemistry- Balkishen Razdan
 CHED 419: DRUG ACTION AND DEVELOPMENT

Teaching Hours: 60 Credit: 04

Unit I: Drug Design- A Rational Approach

Introduction, Analogus and prodrugs, Concept of lead, Factors governing drug-design, Rational Approach
to drug-design, Drug design-methods of variations, Drug design and development, Molecular
hybridisation, rigidity and flexibility vs Drug-design.

Unit II: Physical-Chemical Factors and Biological Activities

Introduction, Physical properties, Factors governing ability of drugs, Dissociation constants, Isosterism
and bio-isosterism, Stereochemistry and drug action, Chemical properties.
Unit III: Target of action of drugs
a) Receptors: Definition, mode of action: agonists, antagonists (description): Families of receptors
b) Cell: Definition, types, structure
c) Nucleus: Definition, types, nucleic acid, DNA (structure, drug, that work on DNA); RNA
(structure, that work on RNA) Drugs related to nucleic acid and building blocks.
Unit IV: Mode of action and development of following classes of drugs
a) Cancer and anticancer drugs: Mechloroethamines hydrochlorides, Chloroambucil, Methotrexate,
Daunorubicin, Colchicine.
b) Analgesics and anti-inflammatory: Indomethacin, Ibuprofen, Ibufenac, Indoprofen, Naproxen.
c) Antibiotic-Historical development and semi synthesis e.g. Penicillin,Cephalosporin’s, Macrolides,
Quinolones, Sulplhonamides and sulphones
d) Anti-malerials: Chloroquine phosphate, Pamaquine, Pyrimethamine, Dapsone, Trimethoprim.
e) Anti-virals and AIDS: Amantidine hydrochloride, Idoxuridine, Acyclovir, Ribavirin, Vitrasert,
foscarnet.
f) Anti-fungals: Griseofulvin, Chlormidazole, Naftifine, Flucytosine.
g) Cardiovascular disorders and managements: Hypertension, Myocardial infraction, angina, Arrythemia:
Hydralazine, Clonidine, Diazoxide, Sodium nitroprusside, Propranolol.
h) Antidiabetics: Chlorpropamide, Metformin, Nateglinide, Rosiglitazone, Pioglitazone
i) Central nervous system and disorder managements Anticonvulsant, Antidepressant, Sedatives:
Caffenie, Theobromine, Pemoline, Phentermine, Bemegride.
Reference Books:
1. Medicinal chemistry (Vol. I and II)-Burger.
2. The organic chemistry of drug design and drug action-R. B. Silverman (Academic Press)
3. Strategies for organic drug synthesis and designing - D. Lednicer Wiley.
4. Medicinal Chemistry- Ashutosh Kar
5. Medicinal Chemistry- Balkishen Razdan
 CHED 420: PHARMACEUTICAL & INDUSTRIAL PRACTICES

Teaching Hours: 60 Credit: 04

Unit I: Various departments in a Pharmaceutical Industry 30 Hrs

Information about each section-their organization, work carried out, monitoring, interactions with various
departments.
Overall idea of each department: Drug discovery, Process development, Pharmaceutical formulation,
Production (Bulk drugs & Fine chemicals), Analysis (Intermediates, Finished goods & formulations),
Regulatory affairs: (Product protection, Patenting, Regulated-non regulated markets), Packaging:
(Designing & Stability), Distribution: (Local & Overseas), Selling: (Local & Overseas), Advertising:
(Local & Overseas), Waste disposal: An environment protection

Unit II: Agents for organ imagine OR Diagnostic agents. 15 Hrs

Introduction, Classification, Radiopagues agents (contrast media), Water soluble and Water insoluble
contrast media. Synthesis of Metrizamide, Iopanoic acid and Pyropylidone. Diognostic chemicals: i)
Drugs used to test kidney functions, ii) Drugs used to test liver functions, iii) Agents used to test gastric
function, iv) Agents used to test cardiac function, v) Miscellaneous diagnostic chemicals.

Unit III: Drug acting on Gastrointestinal tract (Drug acting on GIT) 15 Hrs
Introduction a) Gastric antacid: i) Treatment of gastric hyperacidity, ii) H2-receptor antagonists-Synthesis
of Ranitidine (Zantac) and Famotidine. b) Ulcerative colitis. c) Antispansmodics agents (Spasmolytic
agents), d) Anthelmintic agents: Introduction, anthelmintic agents, synthesis of mebendazole.

Reference books
1. Medicinal chemistry (Vol. I and II)-Burger.
2. The organic chemistry of drug design and drug action-R. B. Silverman (Academic Press)
3. Strategies for organic drug synthesis and designing - D. Lednicer Wiley.
4. Medicinal chemistry-William O. Foye
5. T. B. of Organic medicinal and pharmaceutical chemistry-Wilson and Gisvold’s (Ed. Robert F.
Dorge)
6. An introduction to medicinal chemistry-Graham L. Patrick.
7. An introduction to drug design-S. S. Pandeya and J. R. Dimmock (New age international)
8. Pharmacological basis of therapeutics-Goodman and Gilman’s (McGraw Hill)
9. Manual of patent practice and procedure-Patent office, India (2005)
 OR
CHED 420: DRUG REGULATORY AFFAIRS

Teaching Hours: 60 Credit: 04

UNIT I 12 Hrs
1.1 Drug Regulatory Aspects (India) -
Indian drug regulatory authorities, Central and State regulatory bodies (State FDA, DCGI, CDSO); Drugs
and Cosmetics Act and Rules with latest Amendments (Special emphasis - Schedule M and Y); New
Drugs - (Importation, Registration, Development, Clinical Trials, B.E. studies);Various licenses - (Test
license, Import license for testing of drugs and API’s, Mfg., Contract and Loan license manufacturing.)
1.2 Good Manufacturing Practices (GMP) -Indian GMP certification, WHO GMP certification; ICH
guidelines for stability testing and other relevant ones (Q1 - Q10); Export permissions and manufacturing
for semi-regulated countries; Understanding of the plant lay-outs with special emphasis on the
environment & safety (HVAC, Water systems, Stores management, Effluent etc.); Quality Assurance and
Quality Control - Basic understanding for in-built quality.
UNIT II 12 Hrs
1.3 D rug Regulatory Aspects (International & highly regulated markets) - US Requirements - (for
Generic Drugs especially formulations); CDER, INDA, NDA, ANDA’s (types), CTD Formats of dossiers,
E-submission, US DMF (various types), IIG Limits, Orphan Drugs, Exhibit/Pivotal batches, Validation
batches, Various Guidance issued by CDER, OGD, Orange Book (and patents), RLD (Reference listed
drug) for BE studies and the norms for US
submission, Bioequivalence and dissolution recommendations, Packaging, Stability studies and the
Product Information Leaflet, US FDA Inspection (audits), Pre-approval Inspections and approvals; A brief
introduction to the guidelines for Europe, Japan, Australia, South Africa, Rest of the World (ROW) and
South & Latin American countries; GMP audits, role of Quality Assurance, product approvals and
supplies.
1.4 Introduction to IPR & Patents - Development of IP law in India, IPR regime, Introduction to IP laws in
India, Role of IP in Pharma industry growth.
UNIT III 12 Hrs
1.5 Patenting in India - Introduction, Patent legislation, Indian Patents Act 1970 and amendments,
Procedure for patent application, Grant and opposition proceedings, Patent licensing, Patent infringement
proceedings, IPAB - Role and functions (IP Appellate Board).
1.6 Patent search, Patent analysis & Patent drafting.
1.7 Allied Patents Related Issues:
1.8 Indian IP case studies- The Novartis case, Lipitor case, Natco versus Bayer case of compulsory
license, Patenting and traditional knowledge [Neem, Basmati, Haldi patent], Patenting of life forms
[Diamond versus Chakravarty case].
UNIT IV 12 Hrs
1.9 American & European patent system - Requirements for patenting: utility, novelty, non-obviousness.
Patent specification & claims, Patent infringement and Doctrine of Equivalents, Federal circuit and Patent
system in Europe 2.0 International treaties and conventions on IPR - Paris convention, PCT - an
introduction, PCT application & general rules, WTO / GATT system & Uruguay TRIPS, WIPO, Doha
declaration.
UNIT V 12 Hrs
2.1 Hatch Waxman Act and amendments, FDA Medicare Modernization Act,2003
2.2 Introduction to Geographical indication / Trademark/ copyright: Filing Procedures
Exploitation of patent, Abuse of patents, Compulsory licensing, Infringement analysis, Drug-
Patent Linkage

Reference books:
1. CDSO publications and updates of drug and Cosmetics act and rules (Govt. of India).
2. CDER Publications and Guidance
3. EMEA Publications and Guidance
4. Orange Book, ICH guidelines, Indian Patents Act
5. Country specific Regulatory Guidelines (available from internet)
6. Govt. Publications on issues affecting sales, distribution, manufacturing, excise, etc.
7. J. D. Nally, “Good manufacturing Practice for Pharmaceuticals” Informa Healthcare.
8. I. Kanfer & L. Shargel, “Generic Product Development BE issued” Informa Healthcare.
9. R. A. Guarino, “New Drug Approval Process. The Global challenges”. Informa Healthcare.
10. Watcher and Nash, “Pharmaceutical Process Validation”. Marcel Dekker.
11. Pharmaceutical Product Dev. IVIVC by Murthy, Sunkara and David
12. USPTO and WIPO Guidelines.
13. S. W. Deshpande, Drugs and Cosmetics Act, 1940 and Rules, 1945 and Drugs [Price
Control] Order, 1995.
 CHED 421: LABORATORY COURSE V
(PART A: DRUG SYNTHESIS & PART B: DRUG ASSAY)
Laboratory Work Hours: 135 Credit: 4.5
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PART A: DRUG SYNTHESIS (25 Marks)

PART B: DRUG ASSAY (25 Marks)

CHED 422: LABORATORY COURSE VI

(PART A: Organic Spectral interpretation & PART B: Analytical Spectral interpretation)

Laboratory Work Hours: 135 Credit: 4.5

=========================================================================
PART A: Organic Spectral interpretation (25 Marks)
1. UV-Visible
1
2. H NMR
13
3. C NMR
4. Mass Spectroscopic

PART B: Analytical Spectral interpretation (25 Marks)

1. XRD
2. Mossbauer Method
3. ESR
4. Polarographic methods
 CHED 423: RESEARCH LITERATURE & SEMINAR

Laboratory Work Hours: 135 Credit: 4.5

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CHED 424: RESEARCH PROJECT

Laboratory Work Hours: 135 Credit: 4.5

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