JNTUA B.Pharm.

R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

I B.Pharm.I Semester

SEMESTER-I
S.No. Course Course Hoursper Credits
Code Name Week
L T P
1. 23BP101T Human Anatomy and Physiology-I 3 1 -4
2. 23BP102T Pharmaceutical Analysis 3 1 -4
3. 23BP103T Pharmaceutics-I 3 - -3
4. 23BP104T PharmaceuticalInorganic Chemistry 3 - -3
5. 23BP105T CommunicationSkills 2 - -2
6. 23BP106RBTRemedialBiology$/ 2/3 - -
2/3
23BP106RMTRemedialMathematics
7. 23BP101P HumanAnatomyandPhysiology–ILab - - 3 1.5
8. 23BP102P PharmaceuticalAnalysisLab - - 3 1.5
9. 23BP103P Pharmaceutics–I Lab - - 3 1.5
10. 23BP104P PharmaceuticalInorganicChemistryLab - - 3 1.5
11. 23BP105P CommunicationSkillsLab - - 2 1
$
12. 23BP106RBPRemedialBiologyLab - - 2 1
Total 16/1 2 16/14 26
7
Applicable ONLY for the students who have studied Mathematics / Physics /
Chemistry at HSCand appearing for Remedial Biology (RB) course.

IB.Pharm.IISemester

SEMESTER
-II
S.No. Course Course Name Hoursperweek Credits
Code L T P
1. 23BP201T HumanAnatomyandPhysiology-II 3 1 - 4
2. 23BP202T PharmaceuticalOrganicChemistry-I 3 1 - 4
3. 23BP203T Biochemistry 3 1 - 4
4. 23BP204T ComputerApplicationsinPharmacy 3 - - 3
5. 23BP205T EnvironmentalSciences 2 - - 2
6. 23BP206T SocialandPreventivePharmacy(IV-II in 3 - - 3
R19 Regulations)
7. 23BP201P HumanAnatomyandPhysiology–IILab - 3 1.5
8. 23BP202P PharmaceuticalOrganicChemistry–I - 3 1.5
Lab
9. 23BP203P BiochemistryLab - 3 1.5
10. 23BP204P ComputerApplicationsinPharmacyLab - 3 1.5
Total 17 3 12 26

II B.Pharm. ISemester
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

S.No. Course CourseName Hoursper Credits

Code week
L T P
1. 23BP301T PharmaceuticalOrganic ChemistryII–Theory 3 1 - 4
2. 23BP302T PhysicalPharmaceuticsI–Theory 3 1 - 4
3. 23BP303T PharmaceuticalMicrobiology–Theory 3 1 - 4
4. 23BP304T PharmaceuticalEngineering–Theory 3 - - 3
5. 23BP305T Pathophysiology–Theory (I-II in R19 Regulations) 3 - - 3
6. 23BP301P PharmaceuticalOrganicChemistryII–Practical - - 3 1.5
7. 23BP302P PhysicalPharmaceuticsI–Practical - - 3 1.5
8. 23BP303P PharmaceuticalMicrobiology–Practical - - 3 1.5

9. 23BP304P PharmaceuticalEngineering–Practical - - 3 1.5

10. 23BP305 Skill Oriented course-1 1 - 2 2
Preparationofcosmetics (any five)
11. 23BP306 Non-CreditMandatoryCourse 3 - - -
UniversalHumanvaluesandProfessionalethics
Total 19 3 14 26

II B.Pharm.II Semester
S.No. Course CourseName Hoursper Credits
Code week
L T P
1. 23BP401T MedicinalChemistryI–Theory 3 1 - 4
2. 23BP402T PhysicalPharmaceutics II–Theory 3 1 - 4
3. 23BP403T PharmacologyI–Theory 3 1 - 4
4. 23BP404T PharmacognosyandPhytochemistryI–Theory 3 - - 3
5. 23BP405T PharmaceuticalJurisprudence–Theory (III-I in 3 - - 3
R19 Regulations)
6. 23BP401P MedicinalChemistryI–Practical - - 3 1.5
7. 23BP402P PhysicalPharmaceutics II–Practical - - 3 1.5
8. 23BP403P PharmacologyI–Practical - - 3 1.5
9. 23BP404P PharmacognosyandPhytochemistryI– - - 3 1.5
Practical
10. SkillOrientedcourse-II 1 - 2 2
23BP405 SynthesisofAPIdrugs(minimum five)
Total 16 3 14 26

Mandatorycommunityserviceinternshipfor6to8week durationduringsummer vacation

*Forexit Diploma inpharmacycertificatecandidate has
tosecureadditionalfourcreditsfromthe following courses:Pharmacotherapeutics 2 credits
1. Hospital and clinical Pharmacy 2credits OR
AnycourseofferedbyMOOCs/NPTEL/Swayam/college/
Govt.agenciesequivalenttotheabove four credits, approved by JNTUA
2. HospitalTrainingnot lessthan500 Hrsmandatory

Semester V (III-I)
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Hours per
S.No Course Code Name of the Course week Credits
L T P
1 Medicinal Chemistry II–Theory 3 1 - 4
2 Industrial Pharmacy I–Theory 3 - - 3
3 Pharmacology II–Theory 3 1 - 4
4 Pharmacognosy & Phy to Chemistry II– 3 1 - 4
Theory
5 Pharmaceutical Biotechnology -Theory 3 1 - 4
6 Open Elective – I 3 - - 3
1. Pharmacovigilance–Theory
2 Generic Product Development
3.Dietary Supplements and Nutraceuticals.
4.Artificial Intelligence in Pharmaceutical
Industry
7 Industrial Pharmacy I–Practical - - 3 1.5
8 Pharmacology II–Practical - - 3 1.5
9 Pharmacognosy & Phyto Chemistry II – - - 3 1.5
Practical
10 Skill Oriented Course – III 1 0 2 2
Life skills (JEEVAN KAUSHAL) /Soft
skills and employability
11 Non credit mandatory course 3 - - -
Yoga for Stress Management
12 Evaluation of Community Service Summer - - - 1.5
Internship
Total 22 4 11 30
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Semester VI (III-II)

Hours Per
S.No Course Code Name of the Course Week Credits
L T P
1 Medicinal Chemistry III–Theory 3 1 - 4
2 Pharmacology III–Theory 3 1 - 4
3 Herbal Drug Technology –Theory 3 - - 4
Biopharmaceutics and Pharmacokinetics– 3 1 - 4
4
Theory
5 Biostatistics and Research Methodology– 3 1 0 4
Theory(Proposed) (R19-IV-II)
Professional Elective – I 3 0 0 3
1. Computer Aided Drug Design –Theory
2. Pharmacognosy & Metabolic Engineering
6
3. Pharmaceutical Regulatory Science–
Theory
4. Drug Delivery: Principles and Engineering
7 Medicinal chemistry III –Practical - - 3 1.5
8 Pharmacology III–Practical - - 3 1.5
9 Herbal Drug Technology –Practical - - 3 1.5
Skill Oriented Course – IV 0 0 3 1.5
10
Biopharmaceutics and Pharmacokinetics
Non credit mandatory course 3 - - 0
11
Constitution of India
Total 21 4 12 29
Mandatory Industry Internship for a minimum of 6 weeks duration during summer vacation
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Semester VII (IV-I)

Course Hours per week

S.No Name of the Course Credits
Code L T P
Instrumental Methods of Analysis–Theory 3 1 0 4
Industrial Pharmacy II–Theory 3 1 0 4
Novel Drug Delivery System–Theory 3 1 0 4
Pharmaceutical Quality Assurance –Theory 3 0 0 3
Pharmacy practice 3 0 1 4
Instrumental Methods of Analysis – 0 0 3 1.5
Practical
Skill-V 0 0 3 1.5
clinical Research/Medical
coding/Biomedical equipment Training
Program/ Infection course in Medical
Toxicology
Practice School 0 0 4 2
Industry Internship during summer vacation 0 0 0 3
& Evaluation of Industry Internship
Non credit mandatory course 3 - - 0
Essence of Indian Traditional
Knowledge
Total 18 3 11 27

Semester VIII (IV-II)

Course
S.No Name of the Course L T P Credits
Code
Professional Elective – II 3 0 0 3
1. Pharma Marketing Management
2. Cell and Molecular Biology
3. Bioanalytical Techniques and Bioinformatics
4. Pharmaceutical Dosage forms
Professional Elective – III
1. Experimental Pharmacology –Theory
2. Quality Control and Standardization of
3 0 0 3
Herbals
3. AI and ML in Pharmaceutical Sciences
4. Regulatory requirements for medical devices
Project Work 0 0 24 12
Total 6 0 24 18
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Semester wise credits.

S
I
I
I
I
V
V
V
V
O
v
e
r
a
l
l

C
r
e
d
i
t
s
Credits
26
26
26
26
30
29
27
18
208

Suggestions:
1. Credits for most of the theory courses is 4 and for practical it is 2, possibility of
assigning credits based on content & significance.
2. Introducing Skill courses with hands on for 2 credits, equivalent industry
certifications for credit transfer
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

3. List of Courses for 12 credits to be pursued by students registering for B.Pharm.

(Hons.) or B.Pharm. (Research)
4. Suggest Mandatory non credit courses.

III Year B.Pharm. I Semester

L T P C
MEDICINAL CHEMISTRY II–THEORY
3 1 0 4

45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure, chemistry
and therapeutic value of drugs. The subject emphasizes on structure activity relationships of
drugs, importance of physicochemical properties and metabolism of drugs. The syllabus also
emphasizes on chemical synthesis of important drugs under each class.
Course objectives: Upon completion of the course, the student shall be able to
 Understand the chemistry of drugs with respect to their pharmacological activity
 Identify the drug metabolic pathways, adverse effect and therapeutic value of drugs
 Know the Structural Activity Relationship of different class of drugs
 Report the chemical synthesis of selected drugs

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 (*)
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

UNIT-I 10 Hours
Antihistaminic agents: Histamine, receptors and their distribution in the human body
H1–antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate, Doxylamines
cuccinate, Clemastine fumarate, Diphenylphyraline hydrochloride, Tripelenamine
hydrochloride, Chlorcyclizine hydrochloride, Meclizine hydrochloride, Buclizine
hydrochloride,Chlorpheniramine maleate, Triprolidine hydrochloride*, Phenidaminetartarate,
Promethazine hydrochloride*, Trimeprazine tartrate, Cyproheptadine hydrochloride,
Azatidine maleate, Astemizole, Loratadine, Cetirizine, Levocetrazine Cromolyn sodium
H2-antagonists:Cimetidine*,Famotidine,Ranitidin.
Gastric Proton pump inhibitors: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole
Anti-neoplastic agents:
Alkylating agents: Meclorethamine*, Cyclophosphamide, Melphalan, Chlorambucil,
Busulfan, Thiotepa
Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine, Cytarabine,
Methotrexate*, Azathioprine
Antibiotics: Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin
Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate
Miscellaneous: Cisplatin, Mitotane.

UNIT– II 10Hours
Anti-anginal:
Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate, Isosorbide dinitrite*,
Dipyridamole.
Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem hydrochloride,
Nifedipine, Amlodipine, Felodipine, Nicardipine, Nimodipine.

Diuretics:
Carbonicanhydraseinhibitors: Acetazolamide*, Methazolamide, Dichlorphenamide.
Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide, Cyclothiazide.
Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid.
Potassium sparing Diuretics: Spironolactone,Triamterene, Amiloride.
Osmotic Diuretics: Mannitol.
Anti-hypertensive Agents:
Timolol, Captopril, Lisinopril, Enalapril, Benazepril hydrochloride, Quinapril hydrochloride,
Methyldopate hydrochloride,* Clonidine hydrochloride, Guanethidine monosulphate,
Guanabenz acetate, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine, Hydralazine
hydrochloride.

UNIT-III 10 Hours
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide hydrochloride, Disopyramide

phosphate*, Phenytoin sodium, Lidocaine hydrochloride, Tocainide hydrochloride,
Mexiletine hydrochloride, Lorcainide hydrochloride, Amiodarone, Sotalol.
Anti-hyperlipidemic agents:
Clofibrate, Lovastatin, Cholesteramine and Cholestipol
Coagulant & Anticoagulants: Menadione, Acetomenadione, Warfarin*, Anisindione,
clopidogrel
Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Nesiritide, Bosentan,
Tezosentan.

UNIT-IV 08 Hours
Drugs acting on Endocrine system
Nomenclature, Stereochemistry and metabolism of steroids
Sexhormones: Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol, Oestrione,
Diethylstilbestrol.
Drugs for erectile dysfunction:Sildenafil, Tadalafil.
Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol
Corticosteroids:Cortisone, Hydrocortisone,Prednisolone,Betamethasone, Dexamethasone
Thyroidand antithyroiddrugs: L-Thyroxine,L-Thyronine, Propylthiouracil, Methimazole.

UNIT– V 07 Hours
Antidiabetic agents:
Insulin and its preparations
Sulfonylureas: Tolbutamide*, Chlorpropamide,Glipizide, Glimepiride.
Biguanides: Metformin.
Thiazolidinediones: Pioglitazone, Rosiglitazone. Meglitinides: Repaglinide, Nateglinide.
Glucosidase inhibitors: Acrabose, Voglibose.
Local Anesthetics: SAR of Local anesthetics
Benzoic Acid derivatives; Cocaine, Hexylcaine,Meprylcaine, Cyclomethycaine, Piperocaine.
Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*, Butacaine,
Propoxycaine, Tetracaine, Benoxinate.
Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine, Etidocaine.
Miscellaneous: Phenacaine, Diperodon, Dibucaine.*

Course Outcomes (COs):

Upon successful completion of this course, students will be able to:
 CO1: Describe the fundamental principles of drug action and classification for
various therapeutic categories, including antihistamines, gastric acid regulators, and
anti-cancer agents.
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

 CO2: Explain the mechanism of action, pharmacological effects, and therapeutic

applications of drugs used in cardiovascular disorders, including anti-anginal agents,
diuretics, and anti-hypertensive drugs.
 CO3:Analyze the role and application of drugs in managing cardiac arrhythmias,
dyslipidemia, coagulation disorders, and congestive heart failure, correlating their
mechanisms with clinical outcomes.
 CO4: Elucidate the structure, nomenclature, and physiological roles of key hormones,
and describe the mechanism of action and therapeutic uses of drugs affecting the
endocrine system, including sex hormones, corticosteroids, and thyroid drugs.
 CO5: Discuss the pharmacological basis and clinical utility of antidiabetic agents and
local anesthetics, including their mechanisms of action and structure-activity
relationships.
Recommended Book (Latest Editions)
1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, VolI 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.1to5.
9. Indian Pharmacopoeia.
10. Textbook of practical organic chemistry-A.I.Vogel.
III Year B.Pharm. I Semester

L T P C
INDUSTRIAL PHARMACY I (THEORY)
3 1 0 4

45Hours
Scope: Course enables the student to understand and appreciate the influence of
pharmaceutical additives and various pharmaceutical dosage forms on the performance of the
drug product.

Course Objective: Upon completion of the course the student shall be able to:
 Know the various pharmaceutical dosage forms and their manufacturing techniques.
 Knowvariousconsiderationsindevelopmentofpharmaceuticaldosageforms
 Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality

UNIT-I 07 Hours
Preformulation Studies: Introduction to preformulation, goals and objectives, studyof
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape,flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization

BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.

UNIT-II 10 Hours
Tablets:
a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients,
Formulation of tablets, granulation methods, compression and processing problems.
Equipments and tablet tooling.
b.Tablet coating: Types of coating, coating materials, formulation of coating composition,
methods ofcoating, equipment employed and defects in coating.
c. Quality control tests: Inprocess and finished product tests
Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions
and emulsions; Filling and packaging;evaluationofliquidorals official in pharmacopoeia

UNIT-III 08 Hours
Capsules:
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of
capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules,
manufacturing defects. In process and final product quality control tests for capsules.
b. Soft gelatin capsules: Nature of shell and capsule content, sizeofcapsules,importance of
base adsorption and minim/gram factors, production, in process and final product quality
control tests. Packing, storage and stability testing of soft gelatin capsules and their
applications.
Pellets: Introduction, formulation requirements, pelletization process, equipments for
manufacture of pellets

UNIT-IV 10 Hours
Parenteral Products:
a. Definition, types, advantages and limitations. Preformulation factors and essential
requirements, vehicles, additives, importance of isotonicity
b. Production procedure, production facilities and controls, aseptic processing
c. Formulation of injections, sterile powders, large volume parenterals and lyophilized
products.
d. Containers and closures selection, filling and sealing of ampoules, vials and infusion
fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye
drops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation
of ophthalmic preparations

UNIT-V 10 Hours
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks,

shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol
systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control
and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products,
factors influencing choice of containers, legal and official requirements for containers,
stability aspects of packaging materials, quality control tests.

Course Outcomes (COs)

Upon successful completion of this course, students will be able to:
 CO1: Evaluate the physicochemical properties of drug substances through
preformulation studies and predict their impact on the design, stability, and
performance of various dosage forms.
 CO2: Design, formulate, and understand the manufacturing processes of solid oral
dosage forms (Tablets), including their quality control tests and common defects.
 CO3: Formulate and discuss the manufacturing considerations for liquid oral dosage
forms, as well as other solid oral forms like Capsules and Pellets, along with their
respective quality control parameters.
 CO4: Comprehend the critical aspects of sterile product manufacturing for Parenteral
and Ophthalmic Preparations, including their formulation, production facilities,
aseptic processing, and rigorous quality control.
 CO5: Explain the formulation and manufacturing principles of specialized dosage
forms such as Pharmaceutical Aerosols and Cosmetics and describe the science and
regulatory requirements of Pharmaceutical Packaging Materials.

Recommended Books :(Latest Editions)

1. Pharmaceutical dosage forms-Tablets,volume1-3 by H.A. Liberman, LeonLachman &
J.B. Schwartz
2. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman &Lachman
3. Pharmaceutical dosage form disperse systemVOL-1 by Liberman & Lachman
4. Modern Pharmaceutics by Gilbert S.Banker & C.T.Rhodes, 3rdEdition
5. Remington: The Science and Practice ofPharmacy, 20th editionPharmaceutical Science
(RPS)
6. Theory and Practice of Industrial Pharmacy by Liberman &Lachman
7. Pharmaceutics-ThescienceofdosageformdesignbyM.E.Aulton,Churchilllivingstone,
Latest edition
8. Introduction to Pharmaceutical Dosage Forms by H.C.Ansel, Lea & Febiger,
Philadelphia, 5thedition, 2005
9. Drug stability-Principles and practice by Cartensen & C.J.Rhodes, 3 rdEdition, Marcel
Dekker Series, Vol 107.
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. I Semester

L T P C
PHARMACOLOGY-II (Theory)
3 1 0 4

45Hours
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 different systems of body and in addition, emphasis on
the basic concepts of bioassay.

Course Objective: Upon completion of this course the student should be able to
 Understand the mechanism of drug action and its relevance in the treatment of
different diseases
 Demonstrate isolation of different organs/tissues from the laboratory animals by
simulated experiments
 Demonstrate the various receptor actions using isolated tissue preparation
 Appreciate correlation of pharmacology with related medical sciences

UNIT-I 10hours
Pharmacology of drugs acting on cardiovascular system
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

a. Introduction to hemodynamic and electrophysiology of heart.

b. Drugs used in congestive heart failure
c. Anti-hypertensive drugs.
d. Anti-anginal drugs.
e. Anti-arrhythmic drugs.
f. Anti-hyperlipidemic drugs.

UNIT-II 10hours
Pharmacology of drugs acting on cardiovascular system
a. Drug used in the therapy of shock.
b.Hematinics, coagulants and anticoagulants.
c.Fibrinolytics and anti-platelet drugs
d. Plasmavolumeexpanders
Pharmacology of drugs acting on urinary system
a.Diuretics
b.Anti-diuretics.

UNIT-III 10hours
Autocoids and related drugs
a. Introduction to autacoids and classification
b.Histamine,5-HTandtheirantagonists.
c. Prostaglandins, Thromboxanes and Leukotrienes.
d. Angiotensin, Bradykinin and Substance P.
e. Non-steroidal anti-inflammatory agents
f. Anti-gout drugs
g. Anti rheumatic drugs

UNIT-IV 08hours
Pharmacology of drugs acting on endocrine system
a. Basic concepts in endocrine pharmacology.
b. Anterior Pituitary hormones-analogues and their inhibitors.
c. Thyroid hormones-analogues and their inhibitors.
d. Hormones regulating plasma calcium level-Parathormone, Calcitonin and Vitamin-D.
d. Insulin, Oral Hypoglycemic agents and glucagon.
e. ACTH and corticosteroids.

UNIT-V 07hours
Pharmacology of drugs acting on endocrine system
a. Androgens and Anabolic steroids.
b. Estrogens, progesterone and oral contraceptives.
c. Drugs acting on the uterus.
Bioassay
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

a. Principles and applications of bioassay.

b. Types of bioassay
c. Bioassay of insulin, oxytocin, vasopressin, ACTH, d-tubocurarine, digitalis, histamine and
5-HT

Course Outcomes (COs)

Upon successful completion of this course, students will be able to:
CO1: Analyze cardiovascular hemodynamics, electrophysiology, and the pharmacology
of cardiovascular drugs (for heart failure, hypertension, angina, arrhythmias,
hyperlipidemia).
CO2: Classify and differentiate drugs for shock, hematological disorders (coagulants,
anticoagulants, fibrinolytics, anti-platelets, hematinics), plasma volume
expanders, and understand the applicability of diuretics/anti-diuretics.
CO3: Elucidate the synthesis, release, receptors, and roles of key autacoids (Histamine,
5-HT, Prostaglandins, Leukotrienes, Angiotensin, Bradykinin, Substance P), and
evaluate the pharmacology of their antagonists, NSAIDs, anti-gout, and anti-
rheumatic drugs.
CO4: Comprehend endocrine pharmacology concepts and analyze the mechanisms,
therapeutic uses, and regulation of pituitary, thyroid, calcium-regulating
hormones, insulin, oral hypoglycemics, glucagon, ACTH, and corticosteroids.
CO5: Evaluate the pharmacological actions of sex hormones (androgens, anabolic
steroids, estrogens, progesterones, oral contraceptives) and drugs acting on the
uterus, and understand the principles of various bioassay techniques.

Recommended Books (Latest Editions)

1. RangH.P., DaleM.M., RitterJ.M., Flower R.J., Rang and Dale’s Pharmacology, Churchil
Livingstone Elsevier
2. Katzung B.G., Masters S.B., Trevor A.J., Basic and clinical pharmacology, Tata Mc
Graw-Hill.
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
4. Marry Anne K.K., Lloyd YeeY., Brian K.A., Robbin L.C., Joseph G.B., Wayne A. K.,
Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott
Williams & Wilkins.
5. Mycek M.J, Gelnet S.Band Perper M.M. Lippincott’s Illustrated Reviews-
Pharmacology.
6. K.D. Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. Sharma H.L., Sharma K.K., Principles of Pharmacology, Paras medical publisher
8. Modern Pharmacology with clinical Applications,by CharlesR. Craig & Robert.
9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.
10. Kulkarni SK. Hand book of experimental pharmacology. Vallabh Prakashan.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. I Semester

PHARMACOGNOSY & PHYTO CHEMISTRY II – L T P C

THEORY 3 - 0 4

Scope:
The main purpose of subject is to impart the students the knowledge of how the secondary
metabolites are produced in the crude drugs, how to isolate and identify and produce them
industrially. Also this subject involves the study of producing the plants and phytochemicals
through plant tissue culture, drug interactions and basic principles of traditional system of
medicine

Course Objective: Upon completion of the course, the student shall be able
 To know the modern extraction techniques, characterization and identification of the
herbal drugs and phytoconstituents
 To understand the preparation and development of herbal formulation.
 To understand the herbal drug interactions
 To carry out isolation and identification of phytoconstituents

UNIT-I 7 Hours
Metabolic pathways in higher plants and their determination
a) Brief study of basic metabolic pathways and formation of different secondary metabolites
through these pathways- Shikimic acid pathway, Acetate pathways and Amino acid pathway.
b) Study of utilization of radioactive isotopes in the investigation of Biogenetic studies.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

UNIT-II 14 Hours
General introduction, composition, chemistry & chemical classes, biosources, therapeutic
uses and commercial applications of following secondary metabolites:
Alkaloids: Vinca, Rauwolfia, Belladonna, Opium,
Phenyl propanoids and Flavonoids: Lignans, Tea, Ruta
Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea, Digitalis
Volatile oils: Mentha, Clove,Cinnamon, Fennel, Coriander,
Tannins: Catechu, Ptero carpus
Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony
Glycosides: Senna, Aloes, Bitter Almond
Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids

UNIT-III 6Hours
Isolation, Identification and Analysis of Phytoconstituents
a) Terpenoids: Menthol, Citral, Artemisin
b) Glycosides: Glycyrhetinic acid & Rutin
c) Alkaloids: Atropine, Quinine, Reserpine, Caffeine
d) Resins: Podophyllotoxin, Curcumin
UNIT-IV 10Hours
Industrial production, estimation and utilization of the following phytoconstituents:
Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine, Podophyllotoxin, Caffeine,
Taxol, Vincristine and Vinblastine.

UNIT-V 8Hours
Basics of Phytochemistry
Modern methods of extraction, application of latest techniques like Spectroscopy,
chromatographyandelectrophoresis in the isolation, purification and identification of crude
drugs

Course Outcomes (COs)

By the end of this course, students will be able to:
CO1: Analyze the fundamental metabolic pathways in higher plants and elucidate the
biogenetic formation of various secondary metabolites, including the application of
radioactive isotopes in these studies.
CO2: Classify and differentiate major chemical classes of secondary metabolites
(e.g., Alkaloids, Flavonoids, Steroids, Volatile oils, Tannins, Resins, Glycosides,
Terpenoids) based on their composition, biosources, therapeutic uses, and commercial
applications.
CO3: Apply appropriate techniques for the isolation, identification, and analysis of
key phytoconstituents from different chemical classes, demonstrating an
understanding of their chemical properties.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

CO4: Evaluate the industrial production methods, estimation techniques, and

commercial utilization of important individual phytoconstituents, recognizing their
significance in pharmaceutical and other industries.
CO5: Comprehend the basics of phytochemistry and understand the applicability of
modern extraction methods and advanced analytical techniques (Spectroscopy,
Chromatography, Electrophoresis) in the isolation, purification, and identification of
crude drugs and natural products

Recommended Books :( Latest Editions)

1. W.C.Evans, Trease and Evans Pharmacognosy,16thedition, W.B. Sounders & Co.,
London, 2009.
2. MohammadAli. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution,
New Delhi.
3. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae(2007),37thEdition,
Nirali Prakashan, New Delhi.
4. Herbal drug industry by R.D.Choudhary(1996), Ist Edn, Eastern Publisher, New Delhi.
5. Essentials of Pharmacognosy, Dr. SH.Ansari, IInd edition, Birla publications, New
Delhi, 2007
6. Herbal Cosmetics by H.Pande, Asia Pacific Business press, Inc, New Delhi.
7. A.N.Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, NewDelhi, 2005.
8. R Endress, Plant cell Biotechnology,Springer-Verlag,Berlin,1994.
9. Pharmacognosy & Pharmacobiotechnology. James Bobbers, Marilyn KS, VETylor.
10. The formulation and preparation of cosmetic, fragrances and flavours.
11. Remington’s Pharmaceutical sciences.
12. Text Book of Biotechnology by Vyas and Dixit.
13. Text Book of Biotechnology by R.C. Dubey.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. I Semester

PHARMACEUTICAL BIOTECHNOLOGY – L T P C
THEORY 3 - 0 3

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.

Course Objective: Upon successful completion of this course, the student should be
able to:
 Understanding the importance of Immobilized enzymes in Pharmaceutical Industries
 Genetic engineering applications in relation to production of pharmaceuticals
 Importance of Monoclonal antibodies in Industries
 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.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

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 8 Hours
a) Immuno blotting techniques- ELISA, Western blotting, Southern blotting.
b) Genetic organization of Eukaryotes and Prokaryotes 08Hours
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 7 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, Blood Products: Collection, Processing and Storage of whole human blood,
dried human plasma, plasma Substituties.

Course Outcomes (COs)

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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

By the end of this course, students will be able to:

CO1: Analyze fundamental biotechnology principles for pharmaceutical sciences, including
enzyme immobilization, biosensors, protein engineering, and the role of microbes and genetic
engineering in industrial enzyme production.
CO2: Elucidate recombinant DNA technology mechanisms and applications, specifically in
the production of biopharmaceuticals like interferon, hepatitis B vaccine, and insulin.
CO3: Comprehend immunity types and immunoglobulin/MHC function, and analyze
hypersensitivity, immune modulation, and the preparation/stability of vaccines, toxoids,
antitoxins, and blood derivatives.
CO4: Understand molecular biology techniques (e.g., immunoassays, blotting) and analyze
microbial and eukaryotic genetic organization, microbial genetics, microbial
biotransformation, and mutation types.
CO5: Evaluate large-scale fermentation system design and operation, and understand its
application in industrial production of antibiotics, organic acids, and vitamins, along with
blood product processing.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Recommended Books (Latest edition):

1. R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications of
Recombinant DNA: ASM Press Washington D.C.
2. RA Goldshyet. al.: Kuby Immunology.
3. J.W. Goding: Monoclonal Antibodies.
4. J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal Society
of Chemistry.
5. Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.
6. S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell Scientific
Publication.
7. Stanbury F., P., Whitakar A., and Hall J., S., Principles of fermentation technology, 2nd
edition, Aditya books Ltd., New Delhi.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. I Semester

PHARMACOVIGILANCE–THEORY L T P C
(Open Elective - I) 3 - 0 3

45Hours
Scope: This paper will provide an opportunity for the student to learn about development of
pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global
scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme
in an organization, various methods that can be used to generate safety data and signal
detection. This paper also develops the skills of classifying drugs, diseases and adverse drug
reactions.
Course Objective
 At completion of this paper it is expected that students will be able to (know, do, and
appreciate):
 Why is drug safety monitoring important?
 National and international scenario of pharmacovigilance
 Dictionaries, coding and terminologies used in pharmacovigilance,
 Detection of new adverse drug reactions and their assessment
 International standards for classification of diseases and drugs,
 Adverse drug reaction reporting systems and communication in pharmacovigilance
 Methods to generate safetydata duringpre-clinical, clinical and post approval phases
of drugs’ life cycle, Drug safety evaluation in paediatrics, geriatrics, pregnancy and
lactation
 Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India,
ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning,
CIOMS requirements for ADR reporting, Writing case narratives of adverse events
and their quality.

Unit-I 10Hours
Introduction to Pharmacovigilance: History and development of Pharmacovigilance,
Importance of safety monitoring of Medicine.WHO international drug monitoring program,
Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions: Definition and classification of ADRs, Detection
and reporting. Methods in Causality assessment, Severity and seriousness assessment,
Predictability and preventability assessment. Management of adverse drug reactions
Basic terminologies used in pharmacovigilance: Terminologies of adverse medication
related events. Regulatory terminologies.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit II 10Hours
Drug and disease classification: Anatomical, therapeutic and chemical classification of
drugs, International classification of diseases. Daily defined doses International
Nonproprietary Names for drugs.
Drug dictionaries and coding in pharmacovigilance: WHO adverse reaction terminology,
MedDRA and Standardised MedDRA queries, WHO drug dictionary. Eudravigilance
medicinal product dictionary
Information resources in pharmacovigilance: Basic drug information resources,
Specialised resources for ADRs
Establishing pharmacovigilance program: Establishing in a hospital Establishment
&operation of drug safety department in industry. Contract Research
Organisations(CROs),Establishing a national programme

Unit III 10Hours

Vaccine safety surveillance: Vaccine Pharmacovigilance, Vaccination failure, Adverse
events following immunization.
Pharmacovigilance methods: Passive surveillance–Spontaneous reports and case series.
Stimulated reporting, Active surveillance–Sentinel sites, drug event monitoring and registries.
Comparative observational studies–Cross sectional study, case control study and cohort
study. Targeted clinical investigations
Communication in pharmacovigilance: Effective communication in Pharmacovigilance.
Communication in Drug Safety Crisis management. Communicating with Regulatory
Agencies, Business Partners, Healthcare facilities &Media.

Unit- IV 8Hours
Safety data generation: Preclinical phase, Clinical phase, Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance: Organization and objectives of ICH. Expedited
reporting, Individual case safety reports. Periodic safety update reports. Post approval
expedited reporting Pharmacovigilance planning.Good clinical practice in pharmacovigilance
studies

Unit-V 7hours
Pharmacogenomics of adverse drug reactions: Genetics related ADR with example
focusing PK parameters.
Drug safety evaluation in special population: Paediatrics. Pregnancy and lactation.
Geriatrics. CIOMS. CIOMS Working Group. CIOMS Form
CDSCO (India) and Pharmacovigilance: D&C Act and Schedule Y. Differences in Indian
and global pharmacovigilance requirements.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Course Outcomes (COs)

By the end of this course, students will be able to:
CO1: Analyze the historical development and importance of pharmacovigilance,
including drug monitoring programs and the assessment of ADRs.
CO2: Apply drug and disease classification systems and specialized dictionaries for
pharmacovigilance coding, and understand program establishment in various settings.
CO3: Evaluate pharmacovigilance methodologies (surveillance, studies), analyze vaccine
safety, and demonstrate communication in crisis management.
CO4: Comprehend safety data generation across all phases and apply key ICH guidelines
for reporting (ICSRs, PSURs), planning, and GCP in pharmacovigilance.
CO5: Analyze pharmacogenomics' influence on ADRs and drug safety in special
populations, understand CIOMS's role, and differentiate Indian and global
pharmacovigilance regulations.
Recommended Books (Latest edition):
1. Textbook of Pharmacovigilance: SKGupta, Jaypee Brothers, Medical
Publishers.
2. Practical Drug Safety from A to Z By Barton Cobert, PierreBiron, Jones and
Bartlett Publishers.
3. Mann’s Pharmacovigilance: Elizabeth B. Andrews, Nicholas, Wiley
Publishers.
4. Stephens’ Detection of New Adverse Drug Reactions: John Talbot, Patrick
Walle, Wiley Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller, Wiley Publishers.
6. Cobert’s Manual of Drug Safety and Pharmacovigilance: Barton Cobert,
Jones& Bartlett Publishers.
7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, StephenE
Kimmel, Sean Hennessy, Wiley Publishers.
8. A Textbook of Clinical Pharmacy Practice-Essential Concepts and Skills:G.
Parthasarathi, Karin NyfortHansen,Milap C. Nahata
9. National Formulary of India Text Book of Medicine by Yashpal Munjal
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. I Semester

GENERIC PRODUCT DEVELOPMENT L T P C

(Open Elective - I) 3 - 0 3

45 Hours
Scope:
To learn the generic drug product development process, dosage form design and
development, analytical method development and dossier approval process.

Course Objectives: After completion of this course, the students will able to:
 To explain the concept of generic drug product development, its historical context in
the US, and the provisions of the Hatch-Waxman Act.
 To design and optimize generic dosage forms to achieve equivalence with reference
listed drugs, covering formulation, process, and packaging.
 To develop and validate analytical methods for the comprehensive assessment of
active ingredients, impurities, and finished dosage forms.
 To conduct and interpret stability studies for drug products and active ingredients, and
to apply principles of scale-up for manufacturing process optimization.
 To evaluate bioequivalence study designs, outline the eCTD structure, and compare
drug product approval processes in India and the US.

UNIT – I 8 Hours
a. Concept of generic drug product development, Hatch-Waxman act and its amendments.
b. History of generic product development in US

UNIT – II 9 Hours
Design of dosage form to meet equivalence to reference listed drug, product development
steps, formula optimization, process optimization and packaging selection.

UNIT – III 8 Hours

Analytical method development for verification and validation for active ingredient and
impurities, inprocess samples and finished dosage forms.

UNIT – IV 10 Hours
a. Stability studies on active ingredient and finished dosage forms, accelerated stability
studies, stability studies at different conditions, determination of expiration date.
b. Scale up studies to optimize manufacturing process and execution of exhibit batches.

UNIT – V 10 Hours
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

a. Bioequivalence studies, various designs of bioequivalence studies, bioequivalence criteria

and in-vitro tests to ensure bioequivalence of test product.
b. Introduction to electronic Common Technical Document (eCTD), various modules and the
important information in each module.
c. Drug product approval process in India and US.

Course Outcomes (COs)

Upon successful completion of this course, students will be able to:
CO1: Analyze generic drug development concepts, US historical context, and the
impact of the Hatch-Waxman Act.
CO2: Design and optimize generic dosage forms for RLD equivalence, covering
product development, formula/process optimization, and packaging.
CO3: Apply analytical method development and validation principles for quality
testing of active ingredients, impurities, and dosage forms.
CO4: Conduct and interpret stability studies for expiry determination, and apply scale-
up principles to optimize manufacturing processes.
CO5: Evaluate bioequivalence studies, comprehend eCTD structure, and analyze drug
product approval processes in India and the US.

REFERENCE BOOKS:
1. Generic Drug product Development: Solid oral dosage forms-Leon Shargel.
2. ICH guidelines.
3. Subba Rao Chaganti, Cracking the Generics code – Your Single-Source Success Manual
for Winning in Multi-Source Product Markets, Pharma Med Press

III Year B.Pharm. I Semester

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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

DIETARY SUPPLEMENTS AND NUTRACEUTICALS L T P C

(Open Elective - I) 3 - 0 3

Scope:
This subject covers foundational topic that are important for understanding the need and
requirements of dietary supplements among different groups in the population.

Course objective: This module aims to provide an understanding of the concepts behind the
theoretical applications of dietary supplements. By the end of the course, students should be
able to:
 Understand the need of supplements by the different group of people to maintain
healthy life.
 Understand the outcome of deficiencies in dietary supplements.
 Appreciate the components in dietary supplements and the application.
 Appreciate the regulatory and commercial aspects of dietary supplements including
health claims.

UNIT I 07 hours
a. Definitions of Functional foods, Nutraceuticals and Dietary supplements. Classification of
Nutraceuticals, Health problems and diseases that can be prevented or cured by
Nutraceuticals i.e. weight control, diabetes, cancer, heart disease, stress, osteoarthritis,
hypertension etc.
b. Public health nutrition, maternal and child nutrition, nutrition and ageing, nutrition
education in community.
c. Source, Name of marker compounds and their chemical nature, Medicinal uses and health
benefits of following used as nutraceuticals/functional foods: Spirulina, Soyabean, Ginseng,
Garlic, Broccoli, Gingko, Flaxseeds

UNIT II 15 hours
Phytochemicals as nutraceuticals: Occurrence and characteristic features(chemical nature
medicinal benefits) of following
a) Carotenoids- α and β-Carotene, Lycopene, Xanthophylls, leutin
b) Sulfides: Diallyl sulfides, Allyl trisulfide.
c) Polyphenolics: Reservetrol
d) Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins, Flavones
e) Prebiotics / Probiotics.: Fructo oligosaccharides, Lactobacillum
f) Phyto estrogens : Isoflavones, daidzein, Geebustin, lignans
g) Tocopherols
h) Proteins, vitamins, minerals, cereal, vegetables and beverages as functional foods: oats,
wheat bran, rice bran, sea foods, coffee, tea and the like.
UNIT III 07 hours
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a) Introduction to free radicals: Free radicals, reactive oxygen species, production of free
radicals in cells, damaging reactions of free radicals on lipids, proteins, Carbohydrates,
nucleic acids.
b) Dietary fibres and complex carbohydrates as functional food ingredients.

UNIT IV 10 hours
a) Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion injury, Cancer,
Atherosclerosis, Free radicals in brain metabolism and pathology, kidney damage, muscle
damage. Free radicals involvement in other disorders. Free radicals theory of ageing.
b) Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic antioxidant
defence, Superoxide dismutase, catalase, Glutathione peroxidase, Glutathione Vitamin C,
Vitamin E, α- Lipoic acid, melatonin Synthetic antioxidants: Butylated hydroxy Toluene,
Butylated hydroxy Anisole.
c) Functional foods for chronic disease prevention

UNIT V 06 hours
a) Effect of processing, storage and interactions of various environmental factors on the
potential of nutraceuticals.
b) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and GMPs on Food
Safety. Adulteration of foods.
c) Pharmacopoeial Specifications for dietary supplements and nutraceuticals.

Course Outcomes (COs)

By the end of this course, students will be able to:
CO1: Analyze definitions, classifications, and health potential of functional foods,
nutraceuticals, and dietary supplements within public health nutrition.
CO2: Identify and characterize diverse phytochemicals and functional ingredients
based on their chemical nature, occurrence, and health benefits.
CO3: Elucidate free radical generation and damaging reactions, and understand the
application of dietary fibers and complex carbohydrates as functional food ingredients.
CO4: Comprehend free radical involvement in chronic diseases and evaluate the
mechanisms of endogenous and synthetic antioxidants in mitigating oxidative stress.
CO5: Analyze the impact of processing/storage on nutraceutical efficacy, and
understand the regulatory framework (FSSAI, FDA, etc.) and pharmacopoeial
specifications for dietary supplements and nutraceuticals

References:
1. Dietetics by Sri Lakshmi
2. Role of dietary fibres and neutraceuticals in preventing diseases by K.T Agusti and
P.Faizal: BSPunblication.
3. Advanced Nutritional Therapies by Cooper. K.A., (1996).
4. The Food Pharmacy by Jean Carper, Simon & Schuster, UK Ltd., (1988).
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

5. Prescription for Nutritional Healing by James F.Balch and Phyllis A.Balch 2nd Edn.,
Avery Publishing Group, NY (1997).
6. G. Gibson and C.williams Editors 2000 Functional foods Woodhead Publ.Co.London.
7. Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York.
8. Labuza, T.P. 2000 Functional Foods and Dietary Supplements: Safety, Good
Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional Foods
M.K. Sachmidl and T.P. Labuza eds. Aspen Press.
9. Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition)
10. Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease. Eighth
edition. Lea and Febiger

III Year B.Pharm. I Semester

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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

ARTIFICIAL INTELLIGENCE IN PHARMACEUTICAL L T P C

INDUSTRY
3 - 0 3
(Open Elective - I)

scope: Explore the cutting-edge intersection of Artificial Intelligence (AI) and the
Pharmaceutical Industry with our comprehensive online course. This program is
designed to equip learners with the essential knowledge and skills to navigate the
dynamic landscape where AI transforms drug discovery, development, and healthcare
in the pharmaceutical sector.

1. Introduction to Artificial Intelligence

1.1 Introduction to Artificial Intelligence
1.2. Compare Between Human and Machine
1.3. Steps in AI, How Its Work
1.4. Examples and Applications of AI in Pharma
1.5. Predictive Analytics for Patient Outcomes
1.6. Treatment Plan
1.7. Natural Language Processing
1.8. Chatbots
1.9. Drug Discovery
1.10. Remote Patient Monitoring

2. Fundamentals of Pharmaceutical Sciences and Pharmaceutical Data and Database

2.1. Drug Discovery
2.2. Virtual Screening
2.3. Lead Optimization
2.4. Predictive Modeling
2.5. Clinical Trials
2.6. Pharmaceutical Product Development
2.7. Example of AIML in Pharmaceutical Research
2.8. RD Kit
2.9. Python Libraries in Pharma
2.10. Example of AIML in Pharmaceutical Research

Course Outcome: Upon completion of the course, you'll be prepared for roles such as:
CO1: AI Pharmaceutical Scientist
CO2: Pharmaceutical Data Analyst
CO3: Drug Discovery AI Engineer
CO4: Clinical Trial Optimization Specialist

III Year B.Pharm. I Semester

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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

L T P C
INDUSTRIAL PHARMACY-I (PRACTICAL)
0 0 3 1.5

Scope: This subject will provide an opportunity for the student to learn manufacturing
of dosage forms such as tablets, capsules and parenteral.

Course Objectives: Upon completion of the subject student shall be able to

a. Manufacture the various types of tablets.
b. Evaluate the finished pharmaceutical products.

1. Preformulation studies on paracetamol/asparin/or any other drug

2. Preparation and evaluation of Paracetamol tablets
3. Preparation and evaluation of Aspirin tablets
4. Coating of tablets-film coating of tablets/granules
5. Preparation and evaluation of Tetracycline capsules
6. Preparation of Calcium Gluconate injection
7. Preparation of Ascorbic Acid injection
8. Qulaity control test of (as per IP) marketed tablets and capsules
9. Preparation of Eye drops/and Eye ointments
10. Preparation of Creams (cold/ vanishing cream)
11. Evaluation of Glass containers (asper IP)

Course Outcomes:
CO1: Acquire skills in manufacture the various types of tablets.
CO2: Learn how to evaluate the tablets and capsules.
CO3: Acquire skills of manufacturing and evaluation of parental dosage forms.

III Year B.Pharm. I Semester

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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

L T P C
PHARMACOLOGY-II (PRACTICAL)
0 0 3 1.5

Scope: This course uses simulated lab techniques and animal experiments to teach experimental
pharmacology. It covers in-vitro and in-vivo drug effects on physiological systems, emphasizing
quantitative analysis, drug-receptor interactions, bioassays, and assessing specific pharmacological
activities like diuretic, anti-inflammatory, and analgesic effects. The focus is on learning experimental
methodologies and data interpretation in a simulated environment.

Course Objectives: Upon completion of the practical student shall be able to

 Explain in-vitro pharmacology principles and physiological salt solutions.
 Demonstrate drug effects on isolated organs and in-vivo models via simulation.
 Apply methods for Dose-Response Curves (DRC) and determining pharmacological
parameters (PA2, PD2) using simulated data.
 Conduct and interpret various bioassay techniques for drug potency using simulated
data.
 Identify and analyze drug effects across different classes on simulated biological
systems.

1. Introduction to in-vitro pharmacology and physiological salt solutions.

2. Effect of drugs on isolated frog heart.
3. Effect of drugs on blood pressure and heart rate of dog.
4. Study of diuretic activity of drugs using rats/mice.
5. DRC of acetylcholine using frog rectus abdomen is muscle.
6. Effect of physostigmine and atropine on DRC of acetylcholine using frog rectus
abdomen is muscle and rat ileum respectively.
7. Bioassay of histamine using guinea pig ileum by matching method.
8. Bioassay of oxytocin using rat uterine horn by inter polation method.
9. Bioassay of serotonin using rat fund us strip by three point bioassay.
10.Bioassay of acetylcholine using rat ileum/colon by four point bioassay.
11.Determination of PA2 value of prazosin using rat anococcygeus muscle (by Schilds
plot method).
12. Determination of PD2 value using guinea pig ileum.
13. Effect of spasmogens and spasmolytics using rabbit jejunum.
14. Anti-inflammatory activity of drugs using carrageen an induced paw-edema model.
15. Analgesic activity of drug using central and peripheral methods

Note: All laboratory techniques and animal experiments are demonstrated by simulated
experiments by softwares and videos

Course Outcomes (COs): Upon completion, students will be able to:

CO1: Analyze in-vitro pharmacological principles and physiological salt solution roles.
CO2: Interpret drug effects on simulated isolated organs and in-vivo physiological
parameters.
CO3: Perform and evaluate DRCs and receptor affinity determinations from simulated
experiments.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

CO4: Execute and assess bioassay methods to quantify drug potency using simulated
data.
CO5: Distinguish and explain pharmacological actions of drug classes via simulated
models.

III Year B.Pharm. I Semester

 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

PHARMACOGNOSY AND PHYTOCHEMISTRY-II L T P C

(PRACTICAL) 0 0 3 1.5

Scope: This practical course covers the identification, characterization, extraction, and analysis of
crude drugs and their active principles. It focuses on macroscopic, microscopic, and powder
characteristics of medicinal plants, along with isolation, detection, and separation techniques for
phytoconstituents. Emphasis is on using chemical tests and chromatography (Paper, TLC) for
authentication and quality control of herbal materials.
Course Objectives:
 To identify and characterize specified crude drugs based on their morphology,
histology, and powder characteristics.
 To perform extraction and detection procedures for key active principles (e.g.,
caffeine, diosgenin, atropine, sennosides) from natural sources.
 To apply chromatographic techniques (Paper, TLC) for the separation and detection
of sugars and phytoconstituents from herbal extracts and volatile oils.
 To conduct and interpret chemical tests for the analysis and authentication of
specified crude drugs (e.g., Asafoetida, Benzoin, Colophony, Aloes, Myrrh).
 To demonstrate the process of volatile oil distillation from crude drugs.

1.Morphology, histology and powder characteristics & extraction & detection of: Cinchona,
Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander
2. Exercise involving isolation & detection of active principles
a. Caffeine-from tea dust.
b. Diosgenin from Dioscorea
c. Atropine from Belladonna
d. Sennosides from Senna
3. Separation of sugars by Paper chromatography
4. TLC of herbal extract
5. Distillation of volatile oils and detection of phytoconstitutents by TLC
6. Analysis of crude drugs by chemical tests:
(i)Asafoetida
(ii)Benzoin
(iii) Colophony
(iv) Aloes
(v) Myrrh
Course Outcomes (COs):
Upon completion of this course, students will be able to:
CO1: Identify and differentiate specified crude drugs using morphological,
histological, and powder characteristics.
CO2: Isolate and detect major active principles from medicinal plants using
appropriate laboratory techniques.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

CO3: Utilize chromatographic methods (Paper, TLC) for the effective separation and
identification of plant constituents.
CO4: Analyze crude drugs using chemical tests for their authentication and
preliminary characterization.
CO5: Perform basic distillation of volatile oils and detect their phytoconstituents.

III Year B.Pharm. I Semester

 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

SKILL ORIENTED COURSE – III L T P C

Life skills (JEEVAN KAUSHAL) /Soft skills and
1 0 2 2
employability

45 hours
Course Objectives: The objectives are to help learners
 To encourage all round development of the students by focusing on soft skills
 To enhance healthy relationship and understanding within and outside an organization
 To function effectively with heterogeneous teams
 To make the students aware of Goal setting and writing skills
 Acquire career skills and fully pursue to partake in a successful career path
 Prepare a good résumé
 Prepare for interviews and group discussions

UNIT – I 6 hours
Goal Setting and Self-Management
Definition, importance, types of Goal Setting – SMART Goal Setting –Advantages-
Motivation – Intrinsic and Extrinsic Motivation – Self-Management - Knowing about self –
SWOC Analysis

UNIT – II 10 hours
Problem Solving & Decision Making
Meaning & features of Problem Solving – Managing Conflict – Conflict resolution –
Team building - Effective decision making in teams – Methods & Styles
Activities:
Placing a problem which involves conflict of interests, choice and views – formulating the
problem – exploring solutions by proper reasoning – Discussion on important professional,
career and organizational decisions and initiate debate on the appropriateness of the decision.
Case Study & Group Discussion

UNIT – III 10 hours

Emotional Intelligence & Stress Management
Managing Emotions – Thinking before Reacting – Empathy for Others – Self-awareness –
Self-Regulation – Stress factors – Controlling Stress – Tips
Activities:
Providing situations for the participants to express emotions such as happiness, enthusiasm,
gratitude, sympathy, and confidence, compassion in the form of written or oral presentations.
Providing opportunities for the participants to narrate certain crisis and stress –ridden
situations caused by failure, anger, jealousy, resentment and frustration in the form of written
and oral presentation, Organizing Debates

UNIT – IV 10 hours
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Corporate Etiquette
Etiquette- Introduction, concept, significance - Corporate etiquette - meaning, modern
etiquette, benefits - Global and local culture sensitivity - Gender Sensitivity - Etiquette in
interaction- Cell phone etiquette - Dining etiquette - Netiquette - Job interview etiquette -
Corporate grooming tips -Overcoming challenges
Activities
Providing situations to take part in the Role Plays where the students will learn about bad and
good manners and etiquette - Group Activities to showcase gender sensitivity, dining
etiquette etc. - Conducting mock job interviews - Case Study - Business Etiquette Games
NOTE-:
1.The facilitator can guide the participants before the activity citing examples from the lives
of the great, anecdotes, epics, scriptures, autobiographies and literary sources which bear true
relevance to the prescribed skill.
2. Case studies may be given wherever feasible for example for Decision Making- The
decision of King Lear.

UNIT –V 9 hours
Professional Skills
Exploring Career Opportunities,
Team Skills: Cognitive and Non-Cognitive Skills, Trust and Collaboration, Brainstorming,
Social and Cultural Etiquette
Leadership and Management Skills: Leadership Skills, Managerial Skills, Innovative
Leadership and Design Thinking, Ethics and Integrity, Managing Personal Finance

Course Outcomes (CO):

By the end of this course, students will be able to:
 CO1 : List out various elements of soft skills; Understand the importance of goals and
try to achieve them; Develop skills required for employability.
 CO2: Create a productive workplace atmosphere using social and work-life skills
ensuring personal and emotional well-being
 CO3: Analyse the needs of an individual and team for well-being
 CO4: Assess the situation and take necessary decisions
 CO 5: Demonstrate a set of cognitive skills such as critical thinking, problem-solving
and the ability to learn for smooth and efficient functioning at a workplace

III Year B.Pharm. I Semester

L T P C
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

HEALTH AND WELLNESS, YOGA AND SPORTS

3 - 0 0
(Non credit mandatory course)

45 Hours
Scope:
The main objective of introducing this course is to make the students maintain their mental and
physical wellness by balancing emotions in their life. It mainly enhances the essential traits required
for the development of the personality.
Course Objectives :
Upon completion of this course, students will be able to:
 Explain core concepts of health, fitness, nutrition, and immunity, analyzing the impact of diet
and globalization on health, and calculating BMI for various age groups.
 Understand the historical and philosophical foundations of yoga, including Ashtanga Yoga,
and proficiently practice and describe the anatomical and physiological effects of various
yoga asanas, including Surya Namaskar.
 Master the practice of Pranayama, Shatkriyas, Bandhas, and Mudras, while comprehending
their physiological benefits and roles in holistic well-being.
 Engage in meditation practices, such as Heartfulness Odyssey for Personal Excellence
(HOPE), and articulate the benefits of meditation for personal integration and well-being.
 Comprehend the importance of sports and fitness, identify key fitness components,
understand the history of major sporting events, and actively participate in and practice
foundational exercises for general and cardiorespiratory fitness.
UNIT I 6 Hours
Concept of health and fitness, Nutrition and Balanced diet, basic concept of immunity Relationship
between diet and fitness, Globalization and its impact on health, Body Mass Index (BMI) of all age
groups.
Activities:
i) Organizing health awareness programmes in community
ii) Preparation of health profile iii) Preparation of chart for balance diet for all age groups

UNIT II 10 Hours
Concept of yoga, Ashtanga yoga (The eight fold path), need for and importance of yoga, origin and
history of yoga, origin of asana names, yoga in Indian context.
Classification of yoga, Anatomical and Physiological effects of Asanas. Preliminary asana, surya
namaskar, yoga asana-standing postures, sitting postures, supine lying postures, prone lying postures,
balancing asana, relaxation postures.
Activities: Yoga practices – Asana, Surya Namaskar
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

UNIT-III 9 Hours
Antomical and Physiological effects of Pranayama, art of breathing, types of pranayama.
Sudhrashan kriya,
shatkriyas and types,
Bandha(neuromuscular co-ordination),
Mudras and types
Activities: Yoga practices – Pranayama, kriyas, Mudra and Bandha

UNIT-IV 8 Hours
Meditation for human integration:
Heartfulness odyssey for personal excellence (HOPE), Benefit of meditation.
Activities:
Yoga practices – Meditation and cleaning

UNIT V 12 Hours
Concept of Sports and fitness, importance, fitness components, history of sports, Ancient and Modern
Olympics, Asian games and Commonwealth games.
Activities:
i) Participation in one major game and one individual sport viz., Athletics, Volleyball, Basketball,
Handball, Football, Badminton, Kabaddi, Kho-kho, Table tennis, Cricket etc. Practicing general and
specific warm up, aerobics
ii) Practicing cardio respiratory fitness, treadmill, run test, skipping and running.

Course Outcomes:
After completion of the course the student will be able to
CO1: Understand the importance of yoga and sports for Physical fitness and sound health.
CO2: Demonstrate an understanding of health-related fitness components.
CO3: Compare and contrast various activities that help enhance their health.
CO4: Assess current personal fitness levels.
CO5: Develop Positive Personality

Reference Books:
1. Gordon Edlin, Eric Golanty. Health and Wellness, 14th Edn. Jones & Bartlett Learning, 2022
2. T.K.V.Desikachar. The Heart of Yoga: Developing a Personal Practice
3. Archie J.Bahm. Yoga Sutras of Patanjali, Jain Publishing Company, 1993
4. Wiseman, John Lofty, SAS Survival Handbook: The Ultimate Guide to Surviving Anywhere Third
Edition, William Morrow Paperbacks, 2014
5. The Sports Rules Book/ Human Kinetics with Thomas Hanlon. -- 3rd ed. Human Kinetics,
Inc.2014
General Guidelines:
1. Institutes must assign slots in the Timetable for the activities of Health/Sports/Yoga.
2. Institutes must provide field/facility and offer the minimum of five choices of as many as
Games/Sports.
3. Institutes are required to provide sports instructor / yoga teacher to mentor the students.
Evaluation Guidelines:
 Evaluated for a total of 100 marks.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS
 A student can select 6 activities of his/her choice with a minimum of 01 activity per unit.
Each activity shall be evaluated by the concerned teacher for 15 marks, totalling to 90 marks.
 A student shall be evaluated by the concerned teacher for 10 marks by conducting viva voce
on the subject.
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

L T P C
MEDICINAL CHEMISTRY III–THEORY
3 1 0 4

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.

Course Objective:
Upon successful completion of this course, the student should be able to:
 Understand the importance of drug design and different techniques of drug design.
 Illustrate the chemistry of drugs with respect to their biological activity.
 Know the importance of SAR, metabolism, adverse effects and therapeutic value of
drugs.

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, Minocycline, Doxycycline

UNIT– II 9 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.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

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, CycloserineStreptomycine, Capreomycin sulphate.
Urinary tract anti-infective agents.
Quinolones:
SAR of quinolones, Nalidixic Acid,Norfloxacin, Enoxacin, Ciprofloxacin*, Ofloxacin,
Lomefloxacin, Sparfloxacin, MoxifloxacinGatifloxacin
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 10 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, Sulphapyridine, Sulphamethizine, Sulfacetamide*,
Sulfamethoxaole*, Sulphadiazine, Mefenide acetate, Sulfasalazine.
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.
Sulfones: Dapsone*.
UNIT– V 8 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 chemistry: solid phase and solution
phase synthesis.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Course Outcomes (COs)

By the end of this course, students will be able to:
CO1: Explain the classification, stereochemistry, SAR, and degradation of major antibiotic
classes including β-lactams, aminoglycosides, tetracyclines, macrolides, and others.
CO2: Describe the chemistry and SAR of antimalarial and anti-tubercular agents, and
understand the concept and application of prodrugs in therapy.
CO3: Discuss the chemical and pharmacological profiles of urinary tract anti-infectives and
antiviral agents, with emphasis on their structure–activity relationships.
CO4: Analyze various antifungal, antiprotozoal, anthelmintic agents, and sulfonamides,
including their mechanisms, SAR, and therapeutic relevance.
CO5: Apply the principles of modern drug design, including QSAR, pharmacophore
modeling, molecular docking, and combinatorial chemistry techniques.

Recommended Books (Latest Editions)

1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
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. 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.
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS
III Year B.Pharm. II Semester
L T P C
PHARMACOLOGY-III –THEORY
3 1 0 4

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.

Course Objectives:
Upon successful completion of this course, the student should be able to:
 Illustrates the general principles of chemotherapy
 Apply the knowledge of chemotherapeutic agents for the management of infectious
 diseases
 Describe the principles of animal toxicology and human toxicology
 Explain the principles of chrono pharmacology in optimization of drug therapy

UNIT-I 10 hours
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
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
Chemotherapy 10hours
a. General principles of chemotherapy.
b. Sulfonamides and cotrimoxazole.
c. Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and
fluoroquinolins, tetracycline and aminoglycosides
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

UNIT-III 10 hours
Chemotherapy
a. Antitubercular agents
b. Antileprotic agents 10hours
c. Antifungal agents
d. Antiviral drugs
e. Anthelmintics
f. Antimalarial drugs
g. Antiamoebic agents

UNIT-IV 08 hours
Chemotherapy
Urinary tract infections and sexually transmitted diseases.
Chemo therapy of malignancy.
Immuno pharmacology
a. Immuno stimulants
b. Immunosuppressant Protein drugs, monoclonal antibodies, target drugs to antigen,
biosimilars

UNIT-V 07hours
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, organo phosphosphorus
compound and lead, mercury and arsenic poisoning.
Chronopharmacology
a. Definition of rhythm and cycles.
b. Biological clock and their significance leading to chronotherapy.

Course Outcomes (COs)

By the end of this course, students will be able to:
CO1: Understand the pharmacology and therapeutic use of drugs acting on the respiratory
and gastrointestinal systems, including anti-asthmatics, antiulcer agents, and drugs for bowel
disorders.
CO2: Explain the principles of chemotherapy and describe the mechanisms, classification,
and clinical uses of major antimicrobial agents including antibiotics, antitubercular,
antifungal, antiviral, and antiparasitic drugs.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

CO3: Discuss the treatment strategies for urinary tract infections, sexually transmitted
diseases, malignancies, and explore the role of immune pharmacology including
immunostimulants, immunosuppressants, monoclonal antibodies, and biosimilars.
CO4: Describe the basic principles of toxicology, types of toxicity, and clinical management
of common poisonings caused by drugs and chemicals.
CO5: Explain the concepts of chronopharmacology, biological rhythms, and their
implications in drug therapy for optimizing therapeutic outcomes.

Recommended Books (Latest Editions)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology,
Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc
Graw-Hill
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A.
K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs. The Point
Lippincott Williams & Wilkins
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews
Pharmacology
6. K.D.Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
Modern Pharmacologywith clinical Applications, by Charles R.Craig& Robert,
8. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company,
Kolkata,
9. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan N.Udupa
and P.D. Gupta, Concepts in Chronopharmacology
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

L T P C
HERBAL DRUG TECHNOLOGY –THEORY
3 1 0 4

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
Course Objectives: Upon completion of this course the student should be able to:
 Understand raw material as source of herbal drugs from cultivation to herbal drug
product
 Know the WHO and ICH guidelines for evaluation of herbal drugs
 Know the herbal cosmetics, natural sweeteners, Nutraceuticals
 Appreciate patenting of herbal drugs, GMP.

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.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

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 equipment’s, standard operating procedures, health and
hygiene, documentation and records.

Course Outcomes (COs)

By the end of the course, students will be able to:
CO1: Understand the sourcing, cultivation, processing, and standardization of herbs used in
Indiansystems of medicine.
CO2: Explain the role of nutraceuticals and analyze herb-drug and herb-food interactions
with clinical relevance.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

CO3: Identify herbal raw materials and excipients used in cosmetics and describe
formulations of conventional and novel herbal dosage forms.
CO4: Interpret WHO/ICH guidelines for herbal drug evaluation and understand patenting
and regulatory requirements of natural products.
CO5: Describe GMP practices and the functioning of herbal drug industries, with awareness
of infrastructure, documentation, and compliance standards.

Recommended Books: (Latest Editions)

10. Textbook of Pharmacognosy by Trease & Evans.
11. Textbook of Pharmacognosy by Tyler, Brady & Robber.
12. Pharmacognosy by Kokate, Purohit and Gokhale
13. Essential of Pharmacognosy by Dr.S.H.Ansari
14. Pharmacognosy & Phytochemistry by V.D.Rangari
15. Pharmacopeial standards for Ayurvedic Formulation (Council of Research in Indian
Medicine & Homeopathy)
16. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.

III Year B.Pharm. II Semester

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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

BIOPHARMACEUTICS AND L T P C
PHARMACOKINETICS–THEORY 3 1 0 4

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 arised there in.
Course Objectives: At the end of the theory course, the student will be able to
 Understand the concepts of Absorption, Distribution, Metabolism and Elimination of
Drugs
 Estimate various pharmacokinetic parameters of drugs following various
 Compartment models with different routes of administration.
 Understand the concepts of Design of Dosage Regimen
 Demonstrate the understanding of Bioavailability and Bioequivalence

UNIT-I 10 Hours
Introduction 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 Hours 10
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.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

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 settings.

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.

Course Outcomes (COs)

By the end of the course, students will be able to:
CO1: Explain the principles of drug absorption, distribution, and the factors affecting protein
binding and tissue permeability.
CO2: Describe drug elimination mechanisms including metabolism and excretion, and
analyze bioavailability and bioequivalence concepts.
CO3: Apply compartmental and non-compartmental models to interpret pharmacokinetic
parameters for drug dosage optimization.
CO4: Interpret multicompartment models and determine dosing regimens using
pharmacokinetic calculations for steady-state drug levels.
CO5: Understand nonlinear pharmacokinetics and apply Michaelis-Menten kinetics to assess
drug behavior at different concentrations.

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 Inernationaledition.USA
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil
B.Jaiswal,Vallabh Prakashan Pitampura, Delhi
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 and
9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing
Company, Pennsylvania 1989.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised

and expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
12. Remington’s Pharmaceutical Sciences, ByMack Publishing Company, Pennsylvnia
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

BIOSTATISTICS AND RESEARCH L T P C

METHODOLOGY –THEORY 3 1 0 4

45Hours
Scope:
To understand the applications of Biostatics in Pharmacy. This subject deals with descriptive
statistics, Graphics, Correlation, Regression, logistic regression Probability theory, Sampling
technique, Parametric tests, Non Parametrictests,ANOVA, Introduction to Design of
Experiments, Phases of Clinical trials and Observational and Experimental studies, SPSS, R
and MINITAB statistical software’s, analyzing the statistical data using Excel.
Course Objective: Upon successful completion of this course, the student should beable to:
 Define Basics concepts of Statistics
 Recognize types of clinical studies, types of data distribution, data graphics and
statisticalapplications in Pharmacy.
 Formulate parametric tests and non-parametric tests.
 Able to the operation of M.S. Excel, SPSS, R and MINITAB®, DoE (Design of
Experiment)
Course Content:
UNIT-I 13 Hours
Introduction: Statistics, Biostatistics, Frequency distribution
Measures of central tendency: Mean, Median, Mode-Pharmaceutical examples Measures of
dispersion: Dispersion,Range, standard deviation, Pharmaceutical problems
Correlation: Definition, Karl Pearson’s coefficient of correlation,Multiple correlation -
Pharmaceuticals examples.

UNIT-II 13 Hours
Regression: Curve fitting by the method of least squares, fitting thelines y= a + bx and x = a
+ by, Multiple regression, standard error ofregression– Pharmaceutical Examples
Probability: Definition of probability, Binomial distribution, Normaldistribution, Poisson’s
distribution, properties – problems
Sample, Population, large sample, small sample, Null hypothesis,alternative hypothesis,
sampling, essence of sampling, types ofsampling, Error-I type, Error-II type, Standard error
of mean (SEM) -Pharmaceutical examples
Parametric test: t-test (Sample, Pooled or Unpaired and Paired) ,ANOVA, (One way and
Two way), Least Significance difference.

UNIT-III 13 Hours
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Non-Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney Utest, Kruskal-Wallis test,
Friedman Test
Introduction to Research: Need for research, Need fordesign of Experiments, Experiential
Design Technique,plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot,Counter Plot
graphDesigning the methodology: Sample size determination and Powerof a study, Report
writing and presentation of data, Protocol, Cohortsstudies, Observational studies,
Experimental studies, Designingclinical trial, various phases.
UNIT-IV 11 Hours
Blocking and confounding system for Two-level factorials
Regression modeling: Hypothesis testing in Simple and Multipleregression models
Introduction to Practical components of Industrial and Clinical Trials Problems:
Statistical Analysis Using Excel, SPSS, MINITAB® ,DESIGN OF EXPERIMENTS, R -
Online Statistical Software’s toIndustrial and Clinical trial approach
UNIT-V 10 Hours
Design and Analysis of experiments:
Factorial Design: Definition, 22, 23design.Advantage of factorial design
Response Surface methodology:Centralcomposite design, Historical design, Optimization
Techniques
Course Outcomes (COs):
By the end of the course, students will be able to:
CO1: Understand and apply fundamental concepts of statistics and biostatistics including
measures of central tendency, dispersion, and correlation with pharmaceutical data.
CO2: Demonstrate proficiency in regression analysis, probability distributions, hypothesis
testing, and parametric tests relevant to pharmaceutical research.
CO3: Apply non-parametric statistical tests, design research methodologies, and present data
effectively using appropriate graphical tools and research protocols.
CO4: Analyze and interpret statistical problems related to industrial and clinical trials using
software tools like Excel, SPSS, MINITAB®, and R.
CO5: Design and evaluate factorial experiments and optimize pharmaceutical processes
using response surface methodology and advanced experimental designs.

Recommended Books (Latest edition):

1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton, publisher
Marcel Dekker Inc. NewYork.
2. Fundamental of Statistics – Himalaya Publishing House- S.C.Guptha.
3. Design and Analysis of Experiments –PHI Learning Private Limited, R.Pannerselvam.
4. Design and Analysis of Experiments –Wiley Students Edition, Douglas and C.
Montgomery.
5. Text book of Statistical Methods and Computer applications by Dr. Ramakrishna Prasad.
6. Fundamentals of Biostatistics by Khan and Khanum.

III Year B.Pharm. II Semester

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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

COMPUTER AIDED DRUG DESIGN –THEORY L T P C

Professional Elective 3 0 0 3

45 Hours
Scope:
This subject is designed to provide detailed knowledge of rational drug design process and
various techniques used in rational drug design process.
Course Objectives: Upon completion of the course, the student shall be able to
 Design and discovery of lead molecules
 Estimate the role of drug design in drug discovery process
 Apply the concept of QSAR, docking, molecular modelling software and various
 Strategies to design &develop new drug like molecules.

UNIT-I 10 Hours
Introduction to Drug Discovery and Development
Stages of drug discovery and development
Lead discovery and Analog Based Drug Design
Rational approaches to lead discovery based on traditional medicine, Random screening,
Non-random screening, serendipitous drug discovery, lead discovery based on drug
metabolism, lead discovery based on clinical observation.
Analog Based Drug Design:
Bioisosterism, Classification, Bioisosteric replacement. Any three case studies

UNIT-II 10 Hours
Quantitative Structure Activity Relationship (QSAR)
SAR versus QSAR, History and development of QSAR, Types of physicochemical
parameters, experimental and theoretical approaches for the determination of
physicochemical parameters such as Partition coefficient, Hammet’s substituent constant and
Tafts steric constant. Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like
COMFA and COMSIA.

UNIT-III 10 Hours
Molecular Modeling and virtual screening techniques
Virtual Screening techniques: Drug likeness screening, Concept of pharmacophore
mapping and pharmacophore based Screening
Molecular docking: Rigid docking, flexible docking, manual docking, Docking based
screening. De novo drug design.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

UNIT-IV 8 Hours
Informatics & Methods in drug design
Introduction to Bioinformatics, chemoinformatics. ADME databases, chemical, biochemical
and pharmaceutical databases.

UNIT-V: 7 Hours
Molecular Modeling: Introduction to molecular mechanics and quantum mechanics. Energy
Minimization methods and Conformational Analysis, global conformational minima
determination.

Course Outcomes (COs):

By the end of the course, students will be able to:
CO1: Explain the stages of drug discovery and development, and apply rational and analog-
based approaches for lead identification and optimization.
CO2: Understand the principles of QSAR, apply physicochemical parameters, and use
analytical methods like Hansch and Free Wilson analysis in drug design.
CO3: Utilize molecular modeling tools and virtual screening techniques such as
pharmacophore mapping, molecular docking, and de novo drug design.
CO4: Describe and apply informatics tools, including bioinformatics and chemoinformatics,
and interpret relevant pharmaceutical databases for drug design.
CO5: Analyze molecular structures using molecular mechanics and quantum mechanics,
perform energy minimization and conformational analysis for drug modeling.

Recommended Books (Latest Editions)

1. Robert GCK, ed., “Drug Action at the Molecular Level” University Prak Press Baltimore.
2. Martin YC. “Quantitative Drug Design” Dekker, New York.
3. Delgado JN, Remers WA eds “Wilson &Gisvolds’sText Book of Organic Medicinal &
Pharmaceutical Chemistry” Lippincott, New York.
4. Foye WO “Principles of Medicinal chemistry‘ Lea & Febiger.
5. Koro lkovas A, Burckhalter JH. “Essentials of Medicinal Chemistry” Wiley Interscience. .
6. Wolf ME, ed “The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry” John
Wiley& Sons, New York.
7. Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University Press.
8. Smith HJ, Williams H, eds, “Introduction to the principles of Drug Design” Wright
Boston.
9. Silverman R.B. The organic Chemistry of Drug Design and Drug Action” Academic Press
New York.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

PHARMACOGNOSY & METABOLIC L T P C
ENGINEERING
3 0 0 3
Professional Elective-I

Scope: This subject explores the fascinating world of plant specialized metabolism, from its
evolutionary origins to complex biochemical pathways. It focuses on modern biotechnological
approaches like metabolic engineering and genetic transformation to enhance the production of
valuable compounds such as medicinal alkaloids, terpenoids, and phenylpropanoids. The ultimate
goal is to harness plants as sustainable biofactories for pharmaceuticals, industrial chemicals, and
improved agricultural products, supporting both human health and a greener bioeconomy.
Course Objectives: Upon completion of the course, the student shall be able to
 Understand and manipulate the diverse specialized metabolic pathways in plants
through advanced biotechnological approaches.
 Engineer the biosynthesis of key plant compounds like alkaloids, terpenoids, and
phenylpropanoids for improved production and novel applications.
 Apply principles of metabolic engineering to produce high-value medicinal
compounds, industrial bioproducts, and enhanced plant traits.
 Explore the potential of plants as biofactories for pharmaceuticals through
molecular pharming.
UNIT-I
Medicinal and aromatic plants. Origin and Evolution of plant specialized metabolism.
Eliciting specialized metabolism in plant cell and organ culture. Different strategies of
metabolic engineering. Genetic transformation for manipulation of plant specialized
metabolism.
UNIT-II
Introduction to alkaloids. Engineering tropane alkaloid pathways in plants. Engineering
morphine and purine alkaloid pathways. Biosynthesis and genetic manipulation of indole
alkaloid pathways. Metabolic reprogramming for non-natural indole alkaloids in plants.
Discovery of new alkaloid pathways in plants (strychnine and colchicine).
UNIT-III
Terpenoid metabolism and pathway manipulation. Genetic manipulation of carotenoid
pathway. Emission biology of terpenoid floral volatiles. Biotechnological intervention for
production of complex terpenes viz. hyperforin and taxol.
UNIT-IV
Biochemistry of phenylpropanoid/benzenoid metabolism. Pathway manipulation for
reduction of lignin content and composition.
Biochemistry and cell biology of anthocyanin formation in flowers. Manipulation of
anthocyanin pathways and creation of blue rose. : Biochemistry of tea polyphenols.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

UNIT-V
Biosynthesis of phenolic alcohols and esters. Pathway manipulation for production of
phenolic esters. Metabolic engineering for vanillin biosynthesis.
Genetic engineering of shikonin pathway. Molecular pharming for human somatotropin
production in transplastomic plants.
Course Outcomes:
By the end of this course, students will be able to:
CO1: Define key terms related to pharmacognosy, specialized metabolites (e.g.,
alkaloids, phenolics, terpenoids), and metabolic engineering.
CO2: Explain the biosynthetic pathways involved in the production of various
phytochemicals. Describe the role of specific enzymes and genes in plant
secondary metabolism.
CO 3: Demonstrate the use of biotechnological tools to study and manipulate plant
metabolic pathways.
CO 4: Differentiate between primary and secondary metabolism and their respective
roles in plants.
CO 5: Critically assess recent research on metabolic engineering strategies for
improved phytochemical yield. Design basic metabolic engineering strategies to
increase or redirect the production of a chosen secondary metabolite.

Recommended Books: (Latest Editions)

1. Biren Shah , AK Seth, Textbook of Pharmacognosy and Phytochemistry, CBS Publishers &
Distributors, 2nd Edn 2019.
2. Prof. (Dr.) Raj Kumari, Dr. Seema Gupta, Dr. Vasundhara Saxena, Dr. Abhishek Banke, Mr.
Vitthal R. Muley, Text Book of Pharmacognosy and Phytochemistry- II, Shashwat publishers, 2025
3. https://onlinecourses.nptel.ac.in/noc24_bt08/preview
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

PHARMACEUTICAL REGULATORY SCIENCE L T P C
(THEORY) 3 0 0 3

45Hours
Scope:
This course is designed to impart the fundamental knowledge on the regulatory requirements
for approval of new drugs, and drug products in regulated markets of India & other countries
like US, EU, Japan, Australia, UK etc. It prepares the students to learn in detail on the
regulatory requirements, documentation requirements, and registration procedures for
marketing the drug products.
Course Objectives: Upon successful completion of this course, the student should be able to:
 Know about the process of drug discovery and development
 Know the regulatory authorities and agencies governing the manufacture and sale of
pharmaceuticals
 Know the regulatory approval process and their registration in Indian and
international markets

Unit I 10Hours
New Drug Discovery and development Stages of drug discovery, Drug development process,
pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept
of generics, Generic drug product development.

Unit II
Regulatory Approval Process 10Hours
Approval processes and timelines involved in Investigational New Drug (IND), New Drug
Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an approved
NDA / ANDA.
Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union, Australia, Japan,
Canada (Organization structure and types of applications)

Unit III 10Hours

Registration of Indian drug product in overseas market
Procedure for export of pharmaceutical products, Technical documentation, Drug Master
Files (DMF), Common Technical Document (CTD), electronic Common Technical
Document (eCTD), ASEAN Common Technical Document (ACTD)research.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit IV 08Hours
Clinical trials:
Developing clinical trial protocols, Institutional Review Board / Independent Ethics
committee- formation and working procedures, Informed consent process and procedures,
GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical
trials, Pharmacovigilance- safety monitoring in clinical trials
Unit V 07Hours
Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal
Register, Code of Federal Regulatory, Purple book.

Course Outcomes:
By the end of this course, students will be able to:
CO1: Describe the stages of new drug discovery and development, including pre-clinical,
clinical, and generic drug development processes.
CO2: Explain the regulatory pathways and timelines for IND, NDA, and ANDA
submissions, including the structure and roles of global regulatory agencies.
CO3: Demonstrate knowledge of the procedures and technical documentation required for
exporting and registering Indian pharmaceutical products internationally.
CO4: Design and evaluate clinical trial protocols and explain ethical and regulatory aspects
of clinical research, including pharmacovigilance and GCP compliance.
CO5: Interpret and differentiate between key regulatory documents, guidance, and databases
such as the Orange Book, Federal Register, CFR, and Purple Book.
Recommended books (Latest edition):
1. Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert
P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino,
MD, 5th edition, Drugs and the Pharmaceutical Sciences,Vol.190. \
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons.
Inc.
5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics
/edited by Douglas J. Pisano, David Mantus.
6. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader
Kaufer, Marcel Dekker series, Vol.143
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay
A. Rozovsky and RodneyK. Adams
8. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and
Frederick P. Ognibene
9. Drugs: From Discovery to Approval, Second Edition ByRick Ng
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

DRUG DELIVERY: PRINCIPLES AND L T P C

ENGINEERING 3 0 0 3

45 Hours
Scope:
This course introduces concepts of drug delivery to meet medical challenges. The course is designed
to be modular, with each module focusing on the various aspects of drug delivery.
Course Objectives: Upon successful completion of this course, the student should be able to:
 Provide a comprehensive understanding of the principles of drug delivery.
 Equip learners with the knowledge to design and evaluate novel drug delivery
systems.
 Explore different strategies for controlled and targeted drug delivery.
 Cover various delivery routes and systems.
 Introduce advanced concepts like nanocarriers, biocompatibility, and drug targeting.
 Address practical aspects like translation into clinical applications and potential issues
like nanotoxicology.

UNIT-1 10 Hours
Pharmacokinetics: Bioavailability, Elimination, Therapeutic index, Prodrugs, Controlled
release.
Polymers: Synthesis, properties, characterization, crystallinity and amorphousness
Biopolymers: Natural and Synthetic, biocompatibility, Biodegradation, commonly used
biopolymers. Polymer-Drug conjugates, PEGylation

UNIT-II 9 Hours
Diffusion controlled systems, Ficks laws, Reservoir systems, Non-erodible matrix systems,
Bio-erodible Systems
Hydrogels: Physical or chemical, pore-size calculation, in-situ cross linking

UNIT-III 7 Hours
Nano and Micro-particles: Dendrimers, Liposomes, Micelles. Metal and polymeric particles,
effect of particle shape, charge and elasticity

UNIT-IV 10 Hours
Protein Adsorption and tissue engineering, Drug delivery in tissue engineering
Implant associated infections, Route specific delivery: Oral, Subcutaneous, Intramuscular,
transdermal, inhalation, intravenous
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

UNIT-V 9 Hours
Vaccines, Cancer vaccines, Cell and gene delivery, Smart responsive drug delivery, Targeted
drug delivery, Nanotoxicology and market translation

Course Outcomes (COs):

By the end of this course, students will be able to:
CO1: Explain key pharmacokinetic concepts such as bioavailability, elimination, therapeutic
index, and controlled drug release, and their relevance in drug design and delivery.
CO2: Analyze the properties and applications of synthetic and natural polymers in drug
delivery, including biocompatibility, biodegradation, and PEGylation techniques.
CO3: Apply Fick’s laws to diffusion-controlled systems and evaluate the design and
functionality of different polymer-based drug delivery systems including hydrogels.
CO4: Compare various nano- and micro-particle drug carriers such as dendrimers,
liposomes, and micelles, and assess how their physical properties affect drug delivery
performance.
CO5: Demonstrate understanding of advanced drug delivery systems including vaccines,
targeted delivery, and smart-responsive systems, and evaluate their potential in clinical and
commercial settings.

Books and references

1. Drug Delivery: Engineering Principles for Drug Therapy, W. Mark Saltzman, Oxford
University Press, 2001
2. Drug Delivery: Fundamentals and Applications, Anya M. Hillery and Kinam Park, 2nd
Edition, CRC Press, 2016.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

L T P C
MEDICINAL CHEMISTRY-III (PRACTICAL)
0 0 3 1.5

Scope: This subject will provide an opportunity for the student on synthesis of various
compounds.
Course Objectives: Upon completion of the subject student shall be able to
 Synthesis various chemical compounds.
 Provide knowledge on monograph analysis of some chemical compounds.

I. Preparation of drugs and intermediates

Sulphanilamide
7-Hydroxy, 4-methyl coumarin
Chlorobutanol
Triphenyl imidazole
Tolbutamide
Hexamine
II. Assay of drugs
Isonicotinic acid hydrazide
Chloroquine
Metronidazole
Dapsone Chlorpheniramine maleate
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)
Course Outcomes:
By the end of this course, students will be able to:
CO1: Acquire skills in synthesis various chemical compounds.
CO2: Demonstrate of stereo models of some drugs relevant to theory.
CO3: Acquire skills of extraction of drugs from different dosage forms.
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

L T P C
PHARMACOLOGY-III (PRACTICAL)
0 0 3 1.5

Scope:
To find out the agents suitable for clinical use.
Study the toxicity and mechanism of Action and Site of action
Study the actions of drugs in Preclinical
Course Objectives:
To know and understand pharmacological investigation techniques applied in the research

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

Course Outcomes:
At the end of the course, students will be able to
 Knows to administration of drugs to experiments rats by various routes.
 Have insight fundamental difference between agonists and antagonists
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

L T P C
HERBAL DRUG TECHNOLOGY (PRACTICAL)
0 0 3 1.5

Scope
The course covers phytochemical screening, quantitative analysis of key constituents
(alcohol, aldehydes, phenols, alkaloids), and the incorporation and evaluation of standardized
herbal extracts in both cosmetic and pharmaceutical products, all while adhering to
pharmacopoeial standards.

Course Objectives:
Upon completion students will learn to:
 Perform preliminary phytochemical analysis of crude drugs.
 Quantify specific compounds like alcohol, aldehydes, phenols, and total alkaloids.
 Evaluate natural excipients and formulate/evaluate herbal extracts in cosmetic and
pharmaceutical preparations.
 Analyze herbal drug monographs from pharmacopoeias.

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

Course Outcomes (COs)

Upon completion, students will be able to:
CO1: Identify phytochemicals and quantify specific components in herbal samples.
CO2: Assess natural excipient quality and prepare/evaluate herbal formulations (cosmetic
and pharma).
CO3: Utilize pharmacopoeial standards for herbal drug quality control.
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

BIOPHARMACEUTICS AND L T P C
PHARMACOKINETICS 0 0 3 1.5
(Skill Oriented Course-IV)

Scope: This subject will provide an opportunity for the student to learn about the
Biopharmaceutics and pharmacokinetic.

Course Objective:
 The course is designed to analysis of biological samples for drug content.
 The course helps to estimation of the pharmacokinetic parameters.

I. EXPERIMENTS
1. Analysis of biological samples for drug content and estimation of the pharmacokinetic
parameters.
2. In vitro evaluation of tablet/capsule for drug release
3. Drug-protein binding studies.
4. Statistical treatment of pharmaceutical data.
5. Problems related to pharmacokinetics – determination of PK Parameters
6. Problems related to bioavailability and bioequivalence.
II. DEMO/ WORKSHOP
1. Absorption studies – in vitro.
2. Experiments designed for the estimation of various pharmacokinetic parameters.
III. SEMINAR/ASSIGNMENT/GROUP DISCUSSION
Chronopharmacokinetics

Course Outcomes:
CO1: Graduate will acquire knowledge on analysis of biological samples for drug
content.
CO2: Able to calculate the pharmacokinetic parameters based on plasma level-time
data & urine data.
CO3: Understand the statistical treatment of pharmaceutical data.

Text Books:
1. L. Shargel and ABC Yu, textbook of applied biopharmaceutics &
Pharmacokinetics, 4th edn, Appleton – centuary – crofts, Connecticut, 2004.
2. Milo Gibaldi, Biopharmaceutics and clinical pharmacokinetics 4/Edn. Pharma
BookSyndicate.Hyderabad.
3. DM Brahmankar and SB Jaiswal, biophamaceutics and pharmacokinetics- a
treatise, vallabhprakasham, Delhi.
Reference Books:
1. Ronald &trouser. Clinical pharmacokinetics concepts & applications. 3rd ed,
wolterskluwer Pvt Ltd., 2007.
2. Robert E notary, Biopharmaceutics and pharmacokinetics – an introduction,
marcel dekker inc., NY
3. Basic pharmacokinetics by Hedaya, CRC press.
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

III Year B.Pharm. II Semester

CONSTITUTION OF INDIA L T P C
(MANDATORY COURSE) 3 0 0 0

45 Hours
Course Objectives:
The objective of this course is:
• To Enable the student to understand the importance of constitution
• To understand the structure of executive, legislature and judiciary
• To understand philosophy of fundamental rights and duties
• To understand the autonomous nature of constitutional bodies like Supreme Court
and high court controller and auditor general of India and Election Commission of
India.
• To understand the central-state relation in financial and administrative control
UNIT-I 7 Hours
Introduction to Indian Constitution – Constitution -Meaning of the term - Indian Constitution-
Sources and constitutional history - Features– Citizenship – Preamble - Fundamental Rights
and Duties - Directive Principles of State Policy.

UNIT-II 10 Hours
Union Government and its Administration Structure of the Indian Union - Federalism -
Centre State relationship – President’s Role, power and position - PM and Council of
ministers - Cabinet and Central Secretariat –Lok Sabha - Rajya Sabha - The Supreme Court
and High Court - Powers and Functions

UNIT-III 7 Hours
State Government and its Administration - Governor - Role and Position -CM and Council of
ministers - State Secretariat-Organization Structure and Functions

UNIT-IV 12 Hours
Local Administration - District’s Administration Head - Role and Importance -
Municipalities - Mayor and role of Elected Representatives -CEO of Municipal Corporation
Pachayati Raj - Functions– PRI –Zilla Parishath - Elected officials and their roles –
CEO,ZillaParishath - Block level Organizational Hierarchy - (Different departments) -
Village level - Role of Elected and Appointed officials - Importance of grass root democracy

UNIT-V 9 Hours
Election Commission - Election Commission- Role of Chief Election Commissioner and
Election Commissionerate - State Election Commission -Functions of Commissions for the
welfare of SC/ST/OBC and Women
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Course Outcomes: At the end of the course, students will be able to

CO1:Understand historical background of the constitution making and its importance
for building a democratic India.
CO2: Understand the functioning of three wings of the government ie., executive,
legislative and judiciary.
CO3: Understand the value of the fundamental rights and duties for becoming good
citizen of India.
CO4: Analyze the decentralization of power between central, state and local self
government
CO5: Apply the knowledge in strengthening of the constitutional institutions like
CAG, Election Commission and UPSC for sustaining democracy.

TEXT BOOKS
1. Durga Das Basu, “ Introduction to the Constitution of India”, Prentice – Hall of India
Pvt. Ltd.. New Delhi 2. Subash Kashyap, “Indian Constitution”, National Book Trust
REFERENCES: 1. J.A. Siwach, “Dynamics of Indian Government & Politics”.
2. H.M.Sreevai, “Constitutional Law of India”, 4th edition in 3 volumes (Universal Law
Publication)
3. J.C. Johari, “Indian Government andPolitics”, Hans India
4. M.V. Pylee, “Indian Constitution Durga Das Basu, Human Rights in Constitutional
Law, Prentice”, Hall of India Pvt. Ltd.. New Delhi
E-RESOURCES:
1. nptel.ac.in/courses/109104074/8
2. nptel.ac.in/courses/109104045/
3. nptel.ac.in/courses/101104065/
4. www.hss.iitb.ac.in/en/lecture-details
5. www.iitb.ac.in/en/event/2nd-lecture-institute-lecture-series-indian-constitution
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. I Semester

INSTRUMENTAL METHODS OF ANALYSIS L T P C

(THEORY) 3 1 0 4

45 Hours
Scope: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart a fundamental knowledge on
the principles and instrumentation of spectroscopic and chromatographic technique. This also
emphasizes on theoretical and practical knowledge on modern analytical instruments that are
used for drug testing.

Course Objectives: Upon completion of the course the student shall be able to
1. Understand the interaction of matter with electromagnetic radiations and its applications in
drug analysis
2. Understand the chromatographic separation and analysis of drugs.
3. Perform quantitative & qualitative analysis of drugs using various analytical instruments.
.
UNIT –I 10 Hours
UV Visible spectroscopy
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on
absorption spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation- Sources of radiation, wavelength selectors, sample cells, detectors-Photo
tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.
Applications- Spectrophotometric titrations, Single component and multi component
analysis
Fluorimetry
Theory, Concepts of singlet, doublet and triplet electronic states, internal and external
conversions, factors affecting fluorescence, quenching, instrumentation and
Applications
Flame Photometry-Principle, interferences, instrumentation and applications
Atomic absorption spectroscopy- Principle, interferences, instrumentation and applications

UNIT –II 10 Hours

IR spectroscopy
Introduction, fundamental modes of vibrations in poly atomic molecules, sample handling,
factors affecting vibrations
Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell,
Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications
Nuclear Magnetic Resonance spectroscopy: Introduction, principle, instrumentation,
Applications
Mass Spectroscopy: Introduction, principle, instrumentation, Applications
UNIT –III 10 Hours
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Introduction to chromatography
Adsorption and partition column chromatography-Methodology, advantages, disadvantages
and applications.
Thin layer chromatography- Introduction, Principle, Methodology, Rf values, advantages,
disadvantages and applications.
Paper chromatography-Introduction, methodology, development techniques, advantages,
disadvantages and applications
Column Chromatography-Introduction, Principle, Methodology and applications

UNIT –IV 08 Hours

Electrophoresis-Introduction, factors affecting electrophoretic mobility, Techniques of
paper, gel, capillary electrophoresis, applications
Ion exchange chromatography- Introduction, classification, ion exchange resins, properties,
mechanism of ion exchange process, factors affecting ion exchange, methodology and
applications
Gel chromatography- Introduction, theory, instrumentation and applications
Affinity chromatography- Introduction, theory, instrumentation and applications

UNIT –V 07 Hours
Gas chromatography - Introduction, theory, instrumentation, derivatization, temperature
programming, advantages, disadvantages and applications
High performance liquid chromatography (HPLC)-Introduction, theory,
instrumentation, advantages and applications.
Introduction to Hyphenated –LC-MS/MS, GC-MS/MS,HPTLC-MS.

Course Outcomes (COs): Upon successful completion of the course, the student will be able to:
CO1: Understand the principles and instrumentation of UV-Visible, Fluorimetry, Flame
Photometry, and AAS.
CO2: Apply IR, NMR, and Mass spectroscopy for structural elucidation and compound
analysis.
CO3: Analyze chromatographic techniques like TLC, Paper, Column, and Partition
chromatography.
CO4: Apply electrophoresis and specialized chromatographic methods for biomolecular
separation
CO5: Evaluate the performance and applications of GC and HPLC in analytical procedures
CO6: Create analytical strategies using hyphenated techniques such as LC-MS/MS and GC-
MS/MS

Recommended Books (Latest Editions)

 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

1. Instrumental Methods of Chemical Analysis by B.K Sharma

2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy byWilliam Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein

IV Year B.Pharm. I Semester

 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

L T P C
INDUSTRIAL PHARMACY II (THEORY)
3 1 0 4

45 Hours

Scope: This course is designed to impart fundamental knowledge on pharmaceutical product

development and translation from laboratory to market

Course Objectives: Upon completion of the course, the student shall be able to:
 Know the process of pilot plant and scale up of pharmaceutical dosage forms
 Understand the process of technology transfer from lab scale to commercial batch
 Know different Laws and Acts that regulate pharmaceutical industry
 Understand the approval process and regulatory requirements for drug products

UNIT-I 10 Hours
Pilot plant scale up techniques: General considerations - including significance ofpersonnel
requirements, space requirements, raw materials, Pilot plant scale upconsiderations for solids,
liquid orals, semi solids and relevant documentation, SUPAC
guidelines, Introduction to platform technology

UNIT-II 10 Hours
Technology development and transfer: WHO guidelines for Technology Transfer(TT):
Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D
to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients,
finished products, packaging materials) Documentation, Premises and equipments,
qualification and validation, quality control, analytical method transfer, Approved regulatory
bodies and agencies, Commercialization - practical aspects and problems (case studies), TT
agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation
- confidentiality agreement, licensing, MoUs, legal issues

UNIT-III 10 Hours
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory
authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs
Professionals
Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical
Drug Development, Pharmacology, Drug Metabolism and Toxicology, General
considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB)
and New Drug Application (NDA), Clinical research / BE studies, Clinical Research
Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA
Submissions, Management of Clinical Studies.
UNIT-IV 08 Hours
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Quality management systems: Quality management & Certifications: Concept of Quality,

Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of
Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems
standards, ISO 14000, NABL, GLP.

UNIT-V 07 Hours
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO)
and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical
Product (COPP), Regulatory requirements and approval procedures for New Drugs.

Course Outcomes (COs): Upon successful completion of the course, the student will be able to:
CO1: Understand the principles and considerations involved in pilot plant scale-up for
various dosage forms, including SUPAC guidelines and platform technologies.
CO2: Apply WHO guidelines for technology transfer processes from R&D to production,
including documentation, equipment qualification, and legal agreements.
CO3: Analyze regulatory frameworks and drug approval processes including IND, NDA,
clinical trials, and the role of regulatory authorities and professionals.
CO4: Evaluate the implementation and impact of pharmaceutical quality management
systems such as QbD, Six Sigma, ISO standards, NABL, and GLP.
CO5: Understand Indian drug regulatory systems, including CDSCO, State Licensing
Authority, COPP certification, and new drug approval processes. Create and integrate
documentation, protocols, and compliance strategies for technology transfer, regulatory
submissions, and quality assurance in pharma production.

Recommended Books: (Latest Editions)

1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April
available at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
2. International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/
about.php
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide
for Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc. available at
http.//www.cgmp.com/ra.htm.

IV Year B.Pharm. I Semester

 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

NOVEL DRUG DELIVERY SYSTEMS L T P C

(THEORY) 3 1 0 4

45 Hours

Scope: This subject is designed to impart basic knowledge on the area of novel drug delivery
systems.
Course Objectives: Upon completion of the course student shall be able
 To understand various approaches for development of novel drug delivery systems.
 To understand the criteria for selection of drugs and polymers for the development of
Novel drug delivery systems, their formulation and evaluation
Course content:
Unit-I 10 Hours
Controlled drug delivery systems: Introduction, terminology/definitions and rationale,
advantages, disadvantages, selection of drug candidates.Approaches to design controlled
release formulations based on diffusion, dissolution and ion exchange principles.
Physicochemical and biological properties of drugs relevant to controlled release
formulations
Polymers: Introduction, classification, properties, advantages and application of polymers in
formulation of controlled release drug delivery systems.

Unit-II 10 Hours
Microencapsulation: Definition, advantages and disadvantages, microspheres
/microcapsules, microparticles, methods of microencapsulation, applications
Mucosal Drug Delivery system: Introduction, Principles of bioadhesion / mucoadhesion,
concepts, advantages and disadvantages, transmucosal permeability and formulation
considerations of buccal delivery systems.
Implantable Drug Delivery Systems: Introduction, advantages and disadvantages, concept
of implants and osmotic pump.

Unit-III 10 Hours
Transdermal Drug Delivery Systems: Introduction, Permeation through skin, factors
affecting permeation, permeation enhancers, basic components of TDDS, formulation
approaches
Gastro retentive drug delivery systems: Introduction, advantages, disadvantages,
approaches for GRDDS – Floating, high density systems, inflatable and gastroadhesive
systems and their applications
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary routes of drug
delivery, Formulation of Inhalers (dry powder and metered dose), nasal sprays, nebulizers

Unit-IV 08 Hours
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Targeted drug Delivery: Concepts and approaches advantages and disadvantages,

introduction to liposomes, niosomes, nanoparticles, monoclonal antibodies and their
applications.

Unit-V 07
Hours
Ocular Drug Delivery Systems: Introduction, intra ocular barriers and methods to overcome
–Preliminary study, ocular formulations and ocuserts
Intrauterine Drug Delivery Systems: Introduction, advantages and disadvantages,
development of intra uterine devices (IUDs) and applications

Course Outcomes (COs): Upon successful completion of the course, the student will be able to:
CO1: Understand the principles, drug selection criteria, and formulation approaches for
controlled drug delivery systems and polymers used in their development.
CO2: Apply knowledge of microencapsulation techniques and mucosal, buccal, and
implantable delivery systems to develop novel dosage forms.
CO3: Analyze formulation strategies, components, and permeation mechanisms in
transdermal, gastroretentive, and nasopulmonary drug delivery systems.
CO4: Understand targeted drug delivery approaches including the use of liposomes,
niosomes, nanoparticles, and monoclonal antibodies for site-specific drug action.
CO5: Apply formulation techniques to design effective ocular and intrauterine drug delivery
systems by understanding anatomical barriers and delivery challenges.Evaluate the
advantages and limitations of various advanced drug delivery technologies to select
appropriate systems for specific therapeutic needs

Recommended Books: (Latest Editions)

1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel
Dekker, Inc., New York, 1992.
2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker, Inc.,
New York, 1992.
3. Encyclopedia of Controlled Delivery. Edith Mathiowitz, Published by Wiley Interscience
Publication, John Wiley and Sons, Inc, New York. Chichester/Weinheim
4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New
Delhi, First edition 1997 (reprint in 2001).
5. S.P. Vyas and R.K. Khar, Controlled Drug Delivery -concepts and advances, Vallabh
Prakashan, New Delhi, First edition 2002.
Journals
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian Drugs (IDMA)
3. Journal of Controlled Release (Elsevier Sciences)
4. Drug Development and Industrial Pharmacy (Marcel & Decker)
5. International Journal of Pharmaceutics (Elsevier Sciences)
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. I Semester

PHARMACEUTICAL QUALITY ASSURANCE L T P C
(THEORY) 3 0 0 3

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
.
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.
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

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

Course Outcomes (COs): Upon successful completion of the course, the student will be able
to
CO1: Understand key quality concepts including QA, QC, GMP, TQM, ICH guidelines,
QbD, ISO standards, and NABL accreditation.
CO2: Apply principles of personnel management, facility and equipment design, and raw
material handling to meet quality requirements.
CO3: Implement quality control procedures, GLP, and regulatory practices in pharmaceutical
testing and packaging.
CO4: Manage complaints, recalls, waste, and documentation to ensure pharmaceutical
quality and compliance.
CO5: Evaluate and apply calibration, qualification, validation, warehousing, and materials
management for consistent product quality.

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 IWHO 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
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. I Semester

L T P C
PHARMACY PRACTICE (THEORY)
3 1 0 4

45 Hours
Scope: In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution,
drug information, and therapeutic drug monitoring for improved patient care. In community
pharmacy, students will be learning various skills such as dispensing of drugs, responding to
minor ailments by providing suitable safe medication, patient counselling for improved
patient care in the community set up.

Course Objectives: Upon completion of the course, the student shall be able to
1. Know various drug distribution methods in a hospital
2. Appreciate the pharmacy stores management and inventory control
3. Monitor drug therapy of patient through medication chart review and clinicalreview
4. Obtain medication history interview and counsel the patients
5. Identify drug related problems
6. Detect and assess adverse drug reactions
7.Interpret selected laboratory results (as monitoring parameters in therapeutics) of
specific disease states
8. Know pharmaceutical care services

Unit I 10Hours
a) Hospital and it’s organization
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals,
Classification based on clinical and non- clinical basis, Organization Structure of a Hospital,
and Medical staffs involved in the hospital and their functions.
b) Hospital pharmacy and its organization Definition, functions of hospital pharmacy,
Organization structure, Location, Layout and staff requirements, and Responsibilities and
functions of hospital pharmacists.
c) Adverse drug reaction
Classifications - Excessive pharmacological effects, secondary pharmacological effects,
idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following
sudden withdrawal of drugs, Drug interaction- beneficial interactions, adverse interactions,
and pharmacokinetic drug interactions, Methods for detecting drug reaction reporting and
management.
d) Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legal
requirements for establishment and maintenance of a drug store, Dispensing of proprietary
products, maintenance of records of retail and wholesale drug store.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit-II 10Hoursa)
Drug distribution system in a hospital
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy and
labelling, Dispensing of drugs to ambulatory patients, and Dispensingof controlled drugs.
b) Hospital formulary
Definition, contents of hospital formulary, Differentiation of hospital formulary and Drug list,
preparation and revision, and addition and deletion of drug from hospital formulary.
c) Therapeutic drug monitoring
Need for Therapeutic Drug Monitoring, Factors to be considered during the TherapeuticDrug
Monitoring, and Indian scenario for Therapeutic Drug Monitoring.
d) Medication adherence
Causes of medication non-adherence, pharmacist role in the medication adherence, and
monitoring of patient medication adherence.
e) Patient medication history interview
Need for the patient medication history interview, medication interview forms.
f) Community pharmacy management
Financial, materials, staff, and infrastructure requirements.

Unit-III 10 Hours
a) Pharmacy and therapeutic committee
Organization, functions, Policies of the pharmacy and therapeutic committee inincluding
drugs into formulary, inpatient and outpatient prescription, automatic stoporder, and
emergency drug list preparation.
b) Drug information services
Drug and Poison information centre, Sources of drug information, Computerisedservices, and
storage and retrieval of information.
c) Patient counselling
Definition of patient counselling; steps involved in patient counselling, and Special cases that
require the pharmacist
d) Education and training program in the hospital
Role of pharmacist in the education and training program, Internal and external training
program, Services to the nursing homes/clinics, Code of ethics for community pharmacy, and
Role of pharmacist in the interdepartmental communication and community health education.
e) Prescribed medication order and communication skills
Prescribed medication order- interpretation and legal requirements, and Communication
skills- communication with prescribers and patients.

Unit IV 8 Hours
a) preparation and implementation
Budget preparation and implementation
b) Clinical Pharmacy
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and

responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart review,
clinical review, pharmacist intervention, Ward round participation, Medication history and
Pharmaceutical care.
Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern.
c) Over the counter (OTC) sales
Introduction and sale of over the counter, and Rational use of common over thecounter
medications.

Unit V 7Hours
a) Drug store management and inventory control
Organisation of drug store, types of materials stocked and storage conditions, Purchase and
inventory control: principles, purchase procedure, purchase order, procurement and stocking,
Economic order quantity, Reorder quantity level, and Methods used for the analysis of the
drug expenditure
b) Investigational use of drugs
Description, principles involved, classification, control, identification, role of hospital
pharmacist, advisory committee.
c) Interpretation of Clinical Laboratory Tests
Blood chemistry, haematology, and urinalysis

Course Outcomes: Upon successful completion of this course, the student should beable to:
CO 1:Define the professional practice like drug distribution and management skills in
hospital pharmacy, community pharmacy and clinical pharmacy in association with
respect to various committees of the hospitals.
CO 2:Assess the drug therapy of patient through drug therapy chart review, medication
history interview; recognize and manage drug related problems effectively.
CO 3: Equip unbiased drug and poison information.
CO 4: Interpret the laboratory investigations of specific diseased states.
CO 5: Provide the pharmaceutical care services

Recommended Books (Latest Edition):

1. Merchant S.H. and Dr.J.S.Quadry. A textbook of hospital pharmacy, 4th ed.Ahmadabad:
B.S. Shah Prakakshan; 2001.
2. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of ClinicalPharmacy
Practice- essential concepts and skills, 1st ed. Chennai: OrientLongman Private Limited;
2004.
3. William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea &Febiger;1986.
4. Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.
5. Scott LT. Basic skills in interpreting laboratory data, 4thed. American Society ofHealth
System Pharmacists Inc; 2009.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

6. Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBS Publishers
& Distributers; 2008.
Journals:
1. Therapeutic drug monitoring. ISSN: 0163-4356
2. Journal of pharmacy practice. ISSN : 0974-8326
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. I Semester

INSTRUMENTAL METHODS OF ANALYSIS L T P C
(PRACTICAL) 0 0 3 1.5

Scope:
This subject will provide an opportunity for the student on handling of modern analytical
instruments or equipment.
Course Objective:
 The course is designed to explore the knowledge in handling of modern analytical
instruments or equipment.
 The course helps to understand the instrumental or equipment operational procedures

1. Determination of absorption maxima and effect of solvents on absorption maxima of

organic compounds
2. Estimation of dextrose by colorimetry
3. Estimation of sulfanilamide by colorimetry
4. Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy
5. Assay of paracetamol by UV- Spectrophotometry
6. Estimation of quinine sulfate by fluorimetry
7. Study of quenching of fluorescence
8. Determination of sodium by flame photometry
9. Determination of potassium by flame photometry
10. Determination of chlorides and sulphates by nepheloturbidometry
11. Separation of amino acids by paper chromatography
12. Separation of sugars by thin layer chromatography
13. Separation of plant pigments by column chromatography
14. Demonstration experiment on HPLC
15. Demonstration experiment on Gas Chromatography

Course Outcomes:
CO1: Analyze the drug compound independently by using the instrument.
CO2: Design and deepen their practical skills so as to be capable of performing the
analysis in a good manner.
CO3: Compare the results in determination of percent purity of drug performed by self
with monographs
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Skill-V
Clinical Research/ Medical coding/Biomedical equipment Training Program/ Infection
course in Medical Toxicology
IV Year B.Pharm. I Semester L T P C
Clinical Research (Skill Dzire) 0 0 3 1.5
Scope: This subject will provide an opportunity for the student to learn about the
Introduction to clinical trials.
Course Objective:
 To learn Phase I, II and III levels of clinical trials.
 To gain knowledge on statistical approaches for various endpoints.

UNIT-I 8 Hours
Introduction to Clinical Research
Overview of Clinical Research
Guidelines for Clinical Trials
Pre-clinical Studies

UNIT-II 10 Hours
Bioequivalence (BE) Studies
Introduction to BE Studies
BE Clinical Phase
Analytical Phase in BE Studies
BE Clinical Study Report (CSR)
Bioequivalence & Bioavailability
Bioequivalence Case Study: Metformin IR
Bioequivalence Study of Olmesartan
Topical Product Bioequivalence

UNIT-III 7 Hours
Clinical Trial Phases
Phase 1 Clinical Trials
Phase II, III, & IV Clinical Trials
Phase III IR
Phase 3 Rosuvastatin + Ezetimibe

UNIT-IV 10 Hours
Special Topics in Clinical Research
Clinical Pharmacology
Hypertension and its Clinical Trials
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Letrozole: A Case Study

Olmesartan IR: Clinical Study Overview

UNIT-V 10 Hours
Real-Time Tasks
MetaforminIR_04
Olmesartan IR_11
Letrozole IR_18
Phase 1 - Topical Product
Phase III (Efficacy & Safety) Study of Rosuvastatin/Ezetimibe Tablets (FDC) in
Hypercholesterolemia Volunteers

Course Outcome:
CO1: To gain knowledge on clinical trials.
CO2: To acquire knowledge on Phase I, II, III toxicity studies and dosage calculations.
CO3: To learn the selection of volunteers for clinical trials.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Clinical Research 75 Hrs/week (KLE)

Scope:
This course aims to provide the students an opportunity to learn drug development process
especially the phases of clinical trials and also the ethical issues involved in the conduct of
clinical research. Also, it aims to imparts knowledge and develop skills on conceptualizing,
designing, conducting and managing clinical trials.
Course Objectives: Upon completion of this course it is expected that students shall be able
to:
 Know the new drug development process.
 Understand the regulatory and ethical requirements.
 Appreciate and conduct the clinical trials activities
 Know safety monitoring and reporting in clinical trials
 Manage the trial coordination process
1. Historical Perspectives: 06 Hrs
• Nuremberg Code Study,
 The Belmont Report
• The declaration of Helsinki
• Origin and Principles of International Conference on Harmonization – Good Clinical
Practice (ICH-GCP) guidelines
2. Informed Consent Process: 06 Hrs
• Ethical principles governing informed consent process
• Structure and content of a Patient Information Sheet
 Structure and content of an Informed Consent Form
• The process of taking informed consent and documentation
3. Types and Designs used in Clinical Research: 08 Hrs
Types of research designs based on Controlling Method (Experimental, Quasi experimental,
and Observational methods) Randomization techniques (Simple randomization, restricted
randomization, blocking method and stratification),Time Sequences (Prospective and
Retrospective), Sampling methods (Cohort study, case Control study and cross sectional
study), Health outcome measures (Clinical & Physiological, Humanistic and economic)
4. Clinical Trial Study team: 06 Hrs
Roles and responsibilities of: Investigator, Study Coordinator, Sponsor, Monitor, Contract
Research Organization, Site management Organizations.
5. Clinical trial Documents: 08 Hrs
Guidelines to the preparation of following documents: Protocols, Investigator’s Brochure,
Informed Consent Form, Case report forms, Contracts and agreements, Trial Master File
preparation and maintenance, Investigator Site File, Pharmacy File, Dairy Cards
6. Clinical Trial Start up activities: 06 Hrs
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Site Feasibility Studies, Site/Investigator selection, Pre-study visit, Investigator meeting,

Clinical trial agreement execution, Ethics committee document preparation and submission,
Site initiation visit,
02 Hrs
7. Investigational Product: Procurement and Storage of investigation product
8. Preparation and conduct of monitoring visit: 10 Hrs
Review of source documents, CRF, ICF, IP storage, accountability and reconciliation, Study
Procedure, EC communications, Safety reporting, Monitoring visit reporting and follow-up
Close-Out visit: Study related documents collection, Archival requirement, Investigational
Product reconciliation and destruction, Close-Out visit report.

9. Quality Assurance and Quality Control in Clinical Trials: 05 Hrs

Audit criteria, Audit process, Responsibilities of stakeholders in audit process, Audit follow-
up and documentation, Audit resolution and Preparing for FDA inspections, Fraud and
misconduct management
10. Clinical Data Management 06 Hrs
Infrastructure and System Requirement for Data Management: Electronic data capture
systems, Selection and implementation of new systems, System validation and test
procedures, Coding dictionaries, Data migration and archival
Clinical Trial Data Management: 12 Hrs
Standard Operating Procedures, Data management plan, CRF & Data base design
considerations, Study set-up, Data entry, CRF tracking and corrections, Central lab, IVRS,
source data. Data cleaning, managing laboratory and ADR data, Data transfer and database
lock, Quality Control and Quality Assurance in CDM, Data mining and warehousing

RECOMMENDED BOOKS: Theory

1.Handbook of clinical research. Julia Lloyd and Ann Raven Ed. Churchill
Livingstone c.
2. Principles of Clinical Research edited by Giovanna di Ignazio, DiGiovanna and Haynes
Reference books:
1. Recent Central Drugs Standard Control Organization. Good Clinical
Practices-Guidelines for Clinical Trials on Pharmaceutical Products in India.
New Delhi: Ministry of Health; 2013,2017.
2. International Conference on Harmonization of Technical requirements for
registration of Pharmaceuticals for human use. ICH Harmonized Tripartite
Guideline. Guideline for Good Clinical Practice.E6; May 1996.
3. Ethical Guidelines for Biomedical Research on Human Subjects 2000,
2014, 2017. Indian Council of Medical Research, New Delhi.
4. Textbook of Clinical Trials edited by David Machin, Simon Day and
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Sylvan Green, March 2005, John Wiley and Sons.

5. Clinical Data Management edited by R K Rondels, S A Varley, C F
Webbs. Second Edition, Jan 2000, Wiley Publications

Practicals:
Suggested List of Practical: Total: 50 Hrs 3Hrs/week
3. To prepare and submit Informed Consent Process (ICF) for thefollowing population 15 Hrs
Geriatric Patients
34
 Paediatric patients
 Psychiatric patients
 Unconscious patients
4. To prepare and submit dummy patient information sheet (PIS) for the below mentioned
population 15 Hrs
 Geriatric Patients
 Paediatric patients
 Psychiatric patients
 Unconscious patients
5. To prepare and submit the standard operating procedures(SOP) for procurement and
storage filing of Investigational product(IP) 10Hrs
6. To prepare and submit e-CRF(Electronic Case Report Form) for
dummy clinical data 10 Hrs
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. I Semester

ESSENCE OF INDIAN TRADITIONAL L T P C

KNOWLEDGE
3 0 0 0
(Non credit mandatory course)

45 hours
Scope: To facilitate the students with the concepts of Indian traditional knowledge and to
make them understand the Importance of roots of knowledge system.
Course Objectives:

UNIT-I 10 hours
Introduction to traditional knowledge:
Define traditional knowledge, nature and characteristics, scope and importance, kinds of
traditional knowledge, the physical and social contexts in which traditional knowledge
develop, the historical impact of social change on traditional knowledge systems. Indigenous
Knowledge (IK), characteristics, traditional knowledge vis-à-vis indigenous knowledge,
traditional knowledge Vs western knowledge traditional knowledge vis-à-vis formal
knowledge

Unit-II 7 hours
Protection of traditional knowledge :
The need for protecting traditional knowledge Significance of TK Protection, the value of TK
in the global economy, Role of Government to harness TK.

Unit-III 10 hours
Legal framework and Traditional Knowledge:
A: The Scheduled Tribes and Other Traditional Forest Dwellers (Recognition of Forest
Rights) Act, 2006, Plant Varieties Protection and Farmers Rights Act, 2001 (PPVFR Act);
B: The Biological Diversity Act 2002 and Rules 2004, the protection of traditional
knowledge bill, 2016. Geographical indications act 2003.

Unit-IV 9 hours
Traditional knowledge and intellectual property
Systems of traditional knowledge protection, Legal concepts for the protection of traditional
knowledge, Certain non IPR mechanisms of traditional knowledge protection, Patents and
traditional knowledge, Strategies to increase protection of traditional knowledge, global legal
FORA for increasing protection of Indian Traditional Knowledge.

Unit-V 9 hours
Traditional knowledge in different sectors
Traditional knowledge and engineering, Traditional medicine system, TK and biotechnology,
TK in agriculture, Traditional societies depend on it for their food and healthcare needs,
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Importance of conservation and sustainable development of environment, Management of

biodiversity, Food security of the country and protection of TK.

Course Outcomes: At the end of this course students will be able to:
CO 1: Understand the concept of Traditional knowledge and its importance.
CO 2: Know the need and importance of protecting traditional knowledge.
CO 3: Know the various enactments related to the protection of traditional knowledge.
CO 4: Understand the concepts of Intellectual property to protect the traditional knowledge.
CO 5: Understand the traditional knowledge in different sectors.

Text Books:
1. Traditional Knowledge System in India, by Amit Jha, 2009.
2. Traditional Knowledge System and Technology in India by Basanta Kumar Mohanta and
Vipin Kumar Singh, Pratibha Prakashan 2012. .
References:
1. Traditional Knowledge System in India by Amit Jha Atlantic publishers, 2002
2. "Knowledge Traditions and Practices of India" Kapil Kapoor, Michel Danino
E-resources:
1. https://www.youtube.com/watch?v=LZP1StpYEPM.
2. http://nptel.ac.in/courses/121106003/
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. II Semester

PHARMA MARKETING MANAGEMENT L T P C
(Professional Elective – II) 3 0 0 3

45 Hours
Scope:
The pharmaceutical industry not only needs highly qualified researchers, chemists and,
technical people, but also requires skilled managers who can take the industry forward by
managing and taking the complex decisions which are imperative for the growth of the
industry. The Knowledge and Know-how of marketing management groom the people for
taking a challenging role in Sales and Product management.
Course Objective:
The course aims to provide an understanding of marketing concepts and techniques and their
applications in the pharmaceutical industry.

Unit-I 10 Hours
Marketing:
Definition, general concepts and scope of marketing; Distinction between marketing
&selling; Marketing environment; Industry and competitive analysis; Analyzing consumer
buying behavior; industrial buying behavior.
Pharmaceutical market:
Quantitative and qualitative aspects; size and composition of the market; demographic
descriptions and socio-psychological characteristics of the consumer; market segmentation &
targeting. Consumer profile; Motivation and prescribing habits of the physician; patients'
choice of physician and retail pharmacist. Analyzing the Market; Role of market research.

Unit-II 7 Hours
Product decision:
Classification, product line and product mix decisions, product lifecycle, product portfolio
analysis; product positioning; New product decisions; Product branding, packaging and
labeling decisions, Product management in pharmaceutical industry.

Unit-III 8 Hours
Promotion:
Methods, determinants of promotional mix, promotional budget; An overview of personal
selling, advertising, direct mail, journals, sampling, retailing, medical exhibition, public
relations, online promotional techniques for OTC Products.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit-IV 10 Hours
Pharmaceutical marketing channels:
Designing channel, channel members, selecting the appropriate channel, conflict inchannels,
physical distribution management: Strategic importance, tasks in physicaldistribution
management.
Professional sales representative (PSR):
Duties of PSR, purpose of detailing, selection and training, supervising, norms for customer
calls, motivating, evaluating, compensation and future prospects of the PSR.
Unit-V 10 Hours
Pricing:
Meaning, importance, objectives, determinants of price; pricing methods and strategies,issues
in price management in pharmaceutical industry. An overview of DPCO(Drug Price Control
Order)and NPPA (National Pharmaceutical Pricing Authority).
Emerging concepts in marketing:
Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial Marketing;
Global Marketing.
Course Outcomes (COs) :Upon successful completion of the course, the student will be able to
CO1: Understand the basic concepts of marketing, pharmaceutical market dynamics,
consumer and industrial buying behavior.
CO2: Analyze product decisions including product lifecycle, branding, packaging, and
management in the pharmaceutical industry.
CO3: Apply various promotional strategies and tools effectively for marketing
pharmaceutical products.
CO4: Evaluate pharmaceutical marketing channels, distribution management, and the role
and responsibilities of professional sales representatives.
CO5: .emerging marketing concepts such as rural, global, vertical, and horizontal marketing
to pharmaceutical business strategies Understand pricing concepts, strategies, and regulatory
frameworks like DPCO and NPPA in pharmaceutical pricing.
Recommended Books: (Latest Editions)
1. Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India,
New Delhi.
2. Walker, Boyd and Larreche : Marketing Strategy- Planning and Implementation, Tata
MC GrawHill, New Delhi.
3. Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill
4. Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India
5. Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition)
6. Ramaswamy, U.S &Nanakamari, S: Marketing Managemnt: Global Perspective,
7. Indian Context, Macmilan India, New Delhi.
8. Shanker, Ravi: Service Marketing, Excell Books, New Delhi
9. Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel series) Excel
Publications.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. II Semester

CELL AND MOLECULAR BIOLOGY L T P C

(Professional Elective – II) 3 0 0 3

45 Hours
Scope:
Cell biology is a branch of biology that studies cells – their physiological properties, their
structure, the organelles they contain, interactions with their environment, their life cycle,
division, death and cell function. This is done both on a microscopic and molecular level.
Cell biology research encompasses both the great diversity of single-celled organisms like
bacteria and protozoa, as well as the many specialized cells in multi-cellular organisms such
as humans, plants, and sponges.

Course Objectives:
 This course is to provide a comprehensive understanding of cell and molecular
biology, covering key topics such as cellular structure, molecular processes, genetic
mechanisms, and protein synthesis.
 Students will gain insights into the historical developments, functions, and
applications of cellular biology, including the flow of molecular information, cell
cycle regulation, and signaling pathway

Unit-I 10Hours
a) Cell and Molecular Biology: Definitions theory and basics and Applications.
b) Cell and Molecular Biology: History and Summation.
c) Properties of cells and cell membrane.
d) Prokaryotic versus Eukaryotic
e) Cellular Reproduction
f) Chemical Foundations – an Introduction and Reactions (Types)

Unit-II 10 Hours
a) DNA and the Flow of Molecular Information
b) DNA Functioning
c) DNA and RNA
d) Types of RNA
e) Transcription and Translation

Unit-III 10 Hours
a) Proteins: Defined and Amino Acids
b) Protein Structure
c) Regularities in Protein Pathways
d) Cellular Processes
e) Positive Control and significance of Protein Synthesis
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit-IV 08 Hours
a) Science of Genetics
b) Transgenics and Genomic Analysis
c) Cell Cycle analysis
d) Mitosis and Meiosis
e) Cellular Activities and Checkpoints

Unit V 07 Hours
a) Cell Signals: Introduction
b) Receptors for Cell Signals
c) Signaling Pathways: Overview
d) Misregulation of Signaling Pathways
e) Protein-Kinases: Functioning

Course outcome: Upon completion of the subject, student shall be able to:
CO1:Understand the fundamental principles, history, and applications of cell and
molecular biology, including cell structure and membrane dynamics.
CO2: Explain the roles and interactions of DNA, RNA, and proteins in genetic
information flow, transcription, translation, and regulation.
CO3: Describe protein structure and function, and the mechanisms regulating cellular
activities and processes.
CO4: Demonstrate knowledge of genetics, cell cycle regulation, and mechanisms of cell
division including mitosis and meiosis.
CO5:Analyze cell signaling pathways, receptor functions, and their implications in health,
disease, and biotechnological applications.

Recommended Books (latest edition):

1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific
publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers &
Distributors, Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. Edward: Fundamentals of Microbiology.
10. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
11. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly
company
12. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and
1. Applications of Recombinant DNA: ASM Press Washington D.C.
13. RA Goldshyet.al.,: Kuby Immunology.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. II Semester

BIOANALYTICAL TECHNIQUES AND L T P C
BIOINFORMATICS
3 0 0 3
(Professional Elective – II)

45 Hours
Scope: Course offers a comprehensive overview of bioinformatics, focusing on sequence and
structural analysis of DNA and proteins. It also covers protein modeling, molecular
interactions, and computational drug design using advanced tools, algorithms, and machine
learning techniques

Course Objective:
 Introduction, Modern approaches in Bioanalysis and Bioassays.
 Spectroscopic techniques: UV-Visible spectroscopy, Fluorescence spectroscopy, IR
spectroscopy, CD spectroscopy, and Mass spectroscopy.
 To equip students with core knowledge and computational skills in bioinformatics for
analyzing biological sequences and protein structures.
 The course also aims to develop proficiency in tools and techniques for drug design,
data mining, and algorithm development in life sciences
.
Unit-I 12 Hours
Introduction, Modern approaches in Bioanalysis and Bioassays, Microscopic Techniques:
Light Microscopy; Fluorescence microscopy, Atomic force microscope, Electron microscope,
Scanning electron microscopy, Transmission Electron microscope. Application of
microscope in analyzing biological samples
Electrophoretic Techniques Electrophoresis; Principle, Design of horizontal and vertical gel
electrophoresis apparatus, performing electrophoresis techniques, application of
electrophoresis in analyzing macromolecules.

Unit-II 10 Hours
Introduction, DNA sequence analysis, DNA Databases, Protein structure and function,
protein sequence databases, sequence alignment PAM matrix, Global and local alignment,
BLAST: features and scores, Multiple sequence alignment, Conservation score, phylogenetic
trees, Protein sequence analysis, hydrophobicity profiles, non-redundant datasets

Unit-III 7 Hours
protein secondary structures, Ramachandran plot, propensity, secondary structure prediction,
Protein tertiary structure, Protein Data Bank, visualization tools, structural classification,
contact maps
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit-IV 8 Hours
Protein structural analysis, protein structure prediction, Protein stability, energetic
contributions, database, stabilizing residues, stability upon mutations, Protein folding rates,
proteins interactions, binding site residues
Unit-V 8 Hours
Computer aided drug design, docking, screening, QSAR, Development of algorithms, awk
programming, machine learning techniques, applications using WEKA
Bioinformatics Tools: Computational approaches in analyzing protein and nucleic acid
sequences; Analysis of protein structures.

Course outcome: Upon completion of the subject student shall be able to:
CO1: Understand the fundamentals of cell and molecular biology, including cell structure,
membrane dynamics, and differences between prokaryotic and eukaryotic cells.
CO2: Explain the structure and function of DNA and RNA, and the molecular processes of
transcription, translation, and genetic information flow.
CO3: Analyze protein structure, synthesis, and regulation within cellular processes.
CO4: Demonstrate knowledge of genetics, including transgenics, genomic analysis, and
regulation of the cell cycle through mitosis and meiosis.
CO5: Describe cell signaling pathways, receptor functions, and their implications in disease
and biotechnology

Books and references

• M. Michael Gromiha, Protein Bioinformatics: From Sequence to Function, Academic
Press, 2010
• D.E. Krane and M.L. Raymer, Fundamental concepts of bioinformatics, Pearson
Education Inc. 2006
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. II Semester

PHARMACEUTICAL DOSAGE FORMS L T P C

(Professional Elective – II) 3 0 0 3

45 Hours
Scope: Course provides comprehensive knowledge of pharmaceutical processes, dosage form
development, and advanced drug delivery systems, including formulation, evaluation, and
quality control. It also covers regulatory affairs, packaging, and manufacturing practices
essential for ensuring drug safety, efficacy, and compliance with industry standards.

Course Objective:
 To provide foundational and advanced knowledge in pharmaceutical formulation,
processing, and quality control.
 The course aims to prepare students for industry roles by integrating principles of
drug development, regulatory affairs, and manufacturing practices.

Unit-I 10 Hours
Introduction to Course and Course Plan, Fundamentals of pharmaceutical processes- Unit
operations- milling, Fundamentals of pharmaceutical processes- Unit operations- mixing,
Fundamentals of pharmaceutical processes- Unit operations –clarification, Fundamentals of
pharmaceutical processes- Unit operations –Drying.
Fundamentals of pharmaceutical processes- Unit operations –Compaction, Pharmaceutical
Rheology, Dosage form development: Pre-formulation studies-Bulk Characterization-I,
Dosage form development: Pre-formulation studies-Bulk Characterization-II, Pre-formulation
studies-Solubility and stability Analysis –I

Unit-II 10 Hours
Pre-formulation studies-Solubility and stability Analysis–II, Biopharmaceutics and
Pharmacokinetics Principles and PK models, Biopharmaceutics and Pharmacokinetics:
Factors affecting drug kinetics , Biopharmaceutics and Pharmacokinetics: Dosage form
design and evaluation, Tablets: Types of tablets
Tablet design and Excipients , Tablets: Granulation and compression , Evaluation of tablets
and defects, Tablet coating: Types of coating and process of coating , Tablet coating:
Evaluation and defects
Capsules: Hard Gelatin capsules and formulation components ,Soft gelatin capsules:
formulation and evaluation , Capsules: Evaluation and quality control, Microencapsulation,
Sustained release dosage forms-I
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit-III 10 Hours
Sustained release dosage forms-II, Sustained release dosage forms-III, Monophasic Liquid
Dosage forms- Classification and Components, Monophasic Liquid Dosage forms-
Formulation and Evaluation , Pharmaceutical suspensions-Types and formulation excipients
Pharmaceutical suspensions- properties and evaluation , Pharmaceutical Emulsion-types,
theories of emulsification , Pharmaceutical Emulsion- formulation excipients and evaluation,
Stability of Biphasic liquids , Semi Solid Dosage forms- Types and excipient selection
Semi Solid Dosage forms- properties, evaluation and stability, Sterile products –I, Sterile
Products-II, Suppositories-types, bases and properties, Suppositories-evaluation and stability.

Unit-IV 7 Hours
Pharmaceutical aerosols- properties and excipients, Pharmaceutical aerosols- evaluation and
stability, Novel drug delivery systems –II , Targeted drug delivery systems-I, Targeted drug
delivery systems-II, Targeted drug delivery systems-III, Dissolution , Pilot plant scale up and
Manufacturing design-I, Sampling
Unit-V 8 Hours
Pharmaceutical Packaging: Types and Process-I , Pharmaceutical Packaging: Types and
Process-II, Pharmaceutical Packaging: Types and Process-II, Stability testing and kinetic
principles: I, Stability testing and kinetic principles: II
Concept of Statistical Quality Control , Manufacturing Working Formula Procedures, Quality
Management , Drug Regulatory Affairs-I ,Drug Regulatory Affairs-II

Course Outcome: Upon successful completion of the course, the student will be able to
CO1: Describe the fundamental pharmaceutical unit operations including milling, mixing,
drying, compaction, and rheology, and explain pre-formulation studies such as bulk
characterization and solubility analysis.
CO2: Apply biopharmaceutics and pharmacokinetic principles to drug dosage form design
and evaluate various tablet and capsule formulations including their manufacturing
processes and quality control.
CO3:Classify and formulate different dosage forms including sustained release,
monophasic liquids, suspensions, emulsions, semi-solids, sterile products, and
suppositories, and assess their stability and evaluation parameters.
CO4: Explain pharmaceutical aerosols, novel and targeted drug delivery systems, pilot
plant scale-up, and manufacturing design principles, including sampling techniques.
CO5: Describe pharmaceutical packaging types and processes, apply stability testing and
kinetic principles, and demonstrate knowledge of quality control, quality
management, and drug regulatory affairs.
Books and references
1. Leon Lachmen, H.A.Lieberman and J.L.Kanig, “The Theory and Practice of Industrial
Pharmacy”
2. Cooper and Gunns’ “Tutorial Pharmacy” ed. S.J.Carter
3. Modern Pharmaceutics:,G.S.Banker and C.T.Rhodes, Marcel Dekker Inc., NY.
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. II Semester

EXPERIMENTAL PHARMACOLOGY – THEORY L T P C

(Professional Elective – III) 3 0 0 3

Scope: This subject is designed to impart the basic knowledge of preclinical studies in
experimental animals including design, conduct and interpretations of results.

Course Objectives: Upon completion of the course the student shall be able to,
Appreciate the applications of various commonly used laboratory animals.
 Appreciate and demonstrate the various screening methods used in preclinical research
 Appreciate and demonstrate the importance of biostatistics and research methodology
 Design and execute a research hypothesis independently

Unit –I 08 Hours
Laboratory Animals: Study of CPCSEA and OECD guidelines for maintenance, breeding and
conduct of experiments on laboratory animals, Common lab animals: Description and
applications of different species and strains of animals. Popular transgenic and mutant
animals. Techniques for collection of blood and common routes of drug administration in
laboratory animals, Techniques of blood collection and euthanasia.

Unit –II 10 Hours

Preclinical screening models
a. Introduction: Dose selection, calculation and conversions, preparation of drug solution/
suspensions, grouping of animals and importance of sham negative and positive control
groups. Rationale for selection of animal species and sex for the study.
b. Study of screening animal models for Diuretics, nootropics, anti-Parkinson’s, anti
asthmatics, Preclinical screening models: for CNS activity- analgesic, antipyretic, anti-
inflammatory, general anaesthetics, sedative and hypnotics, antipsychotic, antidepressant,
antiepileptic, antiparkinsonism, alzheimer’s disease

Unit –III 5 HOURS

Preclinical screening models: for ANS activity, sympathomimetics, sympatholytics,
parasympathomimetics, parasympatholytics, skeletal muscle relaxants, drugs acting on eye,
local anaesthetics

Unit –IV 7 HOURS

Preclinical screening models: for CVS activity- antihypertensives, diuretics, antiarrhythmic,
antidyslepidemic, anti aggregatory, coagulants, and anticoagulants Preclinical screening
models for other important drugs like antiulcer, antidiabetic, anticancer and antiasthmatics.
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit –V 5 HOURS
Research methodology and Bio-statistics Selection of research topic, review of literature,
research hypothesis and study design Pre-clinical data analysis and interpretation using
Students ‘t’ test and One-way ANOVA. Graphical representation of data

Course Learning Outcomes: Upon successful completion of this course, the student
shouldbeable to:
CO1: Appreciate the applications of various commonly used laboratory animals.
CO2: Appreciate and demonstrate the various screening methods used in preclinical research
CO3: Appreciate and demonstrate the importance of biostatistics and research methodology
CO4: Design and execute a research hypothesis independently

Recommended Books (latest edition):

1. Fundamentals of experimental Pharmacology-by M.N.Ghosh
2. Hand book of Experimental Pharmacology-S.K.Kulakarni
3. CPCSEA guidelines for laboratory animal facility.
4. Drug discovery and Evaluation by Vogel H.G.
5. Drug Screening Methods by Suresh Kumar Gupta and S. K. Gupta
6. Introduction to biostatistics and research methods by PSS Sundar Rao and J Richard
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. II Semester

QUALITY CONTROL AND STANDARDIZATION L T P C

OF HERBALS
3 0 0 3
(Professional Elective – III)

45 hours
Scope: In this subject the student learns about the various methods and guidelines for
evaluation and standardization of herbs and herbal drugs. The subject also provides an
opportunity for the student to learn cGMP, GAP and GLP in traditional system of medicines.

Course Objectives: Upon completion of the subject student shall be able to;
 know WHO guidelines for quality control of herbal drugs
 know Quality assurance in herbal drug industry
 know the regulatory approval process and their registration in Indian and international
markets
 appreciate EU and ICH guidelines for quality control of herbal drugs

Unit I 10hours
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage
forms. WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude
drugs intended for use

Unit II 10hours
Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in traditional
system of medicine. WHO Guidelines on current good manufacturing Practices (cGMP) for
Herbal Medicines. WHO Guidelines on GACP for Medicinal Plants.

Unit III 7hours

EU and ICH guidelines for quality control of herbal drugs. Research Guidelines for
Evaluating the Safety and Efficacy of Herbal Medicines
Unit IV 08hours
Stability testing of herbal medicines. Application of various chromatographic techniques in
standardization of herbal products. Preparation of documents for new drug application and
export registration GMP requirements and Drugs & Cosmetics Act provisions.

Unit V 10hours
Regulatory requirements for herbal medicines. WHO guidelines on safety monitoring of
herbal medicines in pharmacovigilance systems Comparison of various Herbal
Pharmacopoeias. Role of chemical and biological markers in standardization of herbal
products

Course Learning Outcomes: Upon completion of the subjectstudent shall be able to;
CO1: Know WHO guidelines for quality control of herbal drugs
CO2: Know Quality assurance in herbal drug industry
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

CO3: Know the regulatory approval process and their registration in Indian and
international markets.
CO4: Appreciate EU and ICH guidelines for quality control of herbal drugs

Recommended Books: (Latest Editions

1. Pharmacognosy by Trease and Evans
2. Pharmacognosy by Kokate, Purohit and Gokhale
3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol.Carrier Pub.,
2006.
4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal
Products,
6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
7. Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control
principles to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8.
8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health
Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal
Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO
Regional office for the Western Pacific, Manila, 1998.
9. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn.
World Health Organization, Geneva, 1981.
10. WHO. Quality Control Methods for Medicinal Plant Materials. World Health
Organization, Geneva, 1999.
11. WHO Global Atlas of Traditional, Complementary and Alternative Medicine. 2 vol.
set. Vol. 1 contains text and Vol. 2, maps. World Health Organization, Geneva, 2005.
12. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for
Medicinal Plants. World Health Organization, Geneva, 2004.
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. II Semester

AI AND ML IN PHARMACEUTICAL SCIENCES L T P C

(Professional Elective – III) 3 0 0 3

45 hours
Scope:
This subject explores the fundamentals and applications of Artificial Intelligence (AI) and Machine
Learning (ML) in the pharmaceutical industry, focusing on their roles in drug discovery, clinical
development, manufacturing, and healthcare delivery. It provides insights into modern digital trends,
tools, and regulatory frameworks, while addressing the challenges and ethical considerations of
implementing AI/ML technologies. Students will gain practical knowledge to assess and apply AI/ML
solutions across the pharmaceutical value chain, preparing them for innovation-driven roles in the
evolving healthcare landscape.

Course Objectives:
 Key elements of Artificial Intelligence (AI) and Machine learning (ML) in the
pharmaceutical sector.
 Modernization in Pharmaceutical Research and Discovery.
 Basics of newly developed pharmaceutical products and services with Artificial
Intelligence (AI) and Machine learning (ML) technology.
 Challenges and opportunities of AI/ML Adoption in the pharmaceutical Industries.

Unit - I 10 hours
Basics of AI and ML: Introduction of Artificial Intelligence (AI) and Machine learning (ML),
Brief History of Artificial Intelligence and Machine learning, Major component of Artificial
Intelligence (AI) and Machine learning (ML), Supervised, Unsupervised and Reinforcement
Learning, Deep Learning, Neural Networks, Artificial Neural Network, Data types and
resources, Data management.
Unit – II 10 hours
AI and ML concepts in Pharmaceutical :Pharmaceutical Industry 4.0, Digital Technology
trends in the pharmaceutical industry, Current implementation and application of Artificial
Intelligence and Machine Learning in Pharmaceuticals, Artificial Intelligence and Machine
Learning derived drug discovery Good machine learning practice (GMLP); Tools in AI and
ML-driven drug discovery (de novo and repurposing approach)

Unit – III 10 hours

Modern Pharmaceutical Sector Clinical Development (Trial design, trial start-up, trial
conduct, trial closeout), CONSORT-AI (Consolidated Standards of Reporting Trials
Artificial Intelligence), Clinical evaluation of software, Manufacturing with quality of
experience (QoE) and quality of service (QoS), supply chain management, Launch,
commercialization, Post Market surveillance, Role of Artificial Intelligence and Machine
learning in Diagnosing, Retail and Distribution, AI/ML based software as a medical device.
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B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit – IV 10 hours
Challenges and Opportunities Benefits and Opportunities of AI/ML in the Pharmaceutical
Industry, Real-world performance (RWP) monitoring for AI/ML software, Digital Unfamiliar
technology, Future with Covid-19 digital Opportunities and challenges, Technical and
Logistical challenges, Modern Regulatory challenges in drug discovery, clinical trial, Product
registration, Ethical consideration and Cyber security.

Course Learning Outcomes: Upon the completion of this course, the student shall be able to
CO1: Basics of AI and ML
CO2: Values of Artificial Intelligence (AI) and Machine learning (ML) in the
pharmaceutical sector.
CO3: Modern approaches and requirements pharmaceutical market.
CO4: Digitalization aspects in the pharmaceutical sector.

Suggested Readings:
1. Ashenden, S. K. (2021). ERA of Artificial Intelligence, Machine Learning, and data
science in the pharmaceutical industry. Academic Press.
2. Philip, A., Shahiwala, A., Rashid, M., &Faiyazuddin, M. (2023). A Handbook of
Artificial Intelligence in Drug Delivery. Academic Press, an imprint of Elsevier.
3. Artificial Intelligence in Pharma: From Drug Discovery to Patient Care by Yseop
4. Artificial Intelligence: Emerging Applications in Biotechnology and Pharma David
Sahner, David C Spellmeyer. Biotechnology Entrepreneurship, 399-417, 2020
5. Daniel D. Lee AI Pharma: Artificial Intelligence in Drug Discovery and Development
(Code and Compassion
6. Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again by Eric
Topol
 JNTUA B.Pharm. R23 Regulations

JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

IV Year B.Pharm. II Semester

REGULATORY REQUIREMENTS FOR MEDICAL L T P C

DEVICES INCLUDING IN VITRO DIAGNOSTICS IN
INDIA 3 0 0 3
(Professional Elective – III)

45 hours

Scope: Demonstration of safety, efficacy, and performance of the medical device and in vitro
diagnostic (IVD) kit for use in humans is essential before the product can be approved for
import or manufacture and marketing in the country. Medical devices are currently regulated
under the definition of ‘drug’. Recent amendments made in the Rule by incorporating specific
rules i.e., “Medical Devices Rules 2017’’ [G.S.R. 78 (E) dated the 31st January 2017] are
published and are mandatory with effect from 1st January 2018.
These rules provides requirements for import, manufacture, clinical investigation, medical
device and in vitro diagnostics. All these had been effectively addressed in this course.
Course Objective:
 The objective of this course is to provide students with comprehensive knowledge of
medical devices and in vitro diagnostics (IVDs), including their classification,
regulation, manufacturing, quality assurance, and global standards.
 The course aims to equip students with the skills to navigate regulatory frameworks,
understand clinical and biocompatibility requirements, and apply quality and risk
management principles in the medical device industry.

Unit I 10 hours
Introduction to Medical Devices and IVDs
 Overview of medical devices and in vitro diagnostics (IVDs)
 Types of medical devices, including combination devices
 Distinction: Drug vs. Device vs. IVD
 Introduction to Medical Device Rules, 2017
 Implications of rules on device regulation
 Classification and labeling of medical devices

Unit II 7 hours
Regulatory Framework and Classification
 Detailed review of Medical Device Rules, 2017
 Classification criteria and regulatory pathways
 Labeling requirements and regulatory compliance
 Introduction to national regulatory authorities and their roles
 Registration process overview
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JAWAHRALAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR

B.PHARMACY III & IV YEAR COURSE STRUTURE AND SYLLABUS

Unit III 10 hours

Standards, Quality Assurance, and Clinical Evaluation
 Standards of medical devices (national and international)
 Quality assurance and testing procedures
 Biocompatibility studies and preclinical evaluations
 Clinical investigation requirements and protocols

Unit IV 8 hours
Manufacturing, Licensing, and Risk Management
 Overview of medical device and IVD manufacturing processes
 Quality Management Systems (QMS) in device manufacturing
 Licensing procedures for medical device manufacturing
 Risk Management Systems for medical devices (ISO 14971)

Unit V 10 hours
Inspection, Trade, and Global Regulatory Practices
 Inspection of medical device and IVD establishments
 Import and export regulations for medical devices and IVDs
 Overview of international regulatory practices (e.g., FDA, EU MDR, WHO)
 Harmonization and global acceptance of medical devices

Course Outcomes: Upon successful completion of this course, students will be able to:
CO1: Understand the classification, labeling, and regulatory implications of medical
devices, IVDs, and combination products as per Medical Device Rules, 2017.
CO2: Describe the quality assurance practices, standards, and testing requirements,
including biocompatibility and clinical investigation for medical devices.
CO3: Explain the processes involved in the manufacture and licensing of medical
devices and IVDs, and apply principles of quality and risk management systems,
including ISO14971.
CO4: Evaluate inspection procedures and compliance requirements for medical device
and IVD establishments, including import and export regulations.
CO5: Analyze international regulatory frameworks and harmonization practices related
to the global movement and acceptance of medical devices and IVDs.