B Pharm Syllabus

Course Objectives

• Introduce the fundamentals of Python programming for pharmaceutical sciences.
• Develop basic programming skills using control structures, functions, and data structures.
• Provide knowledge of data handling techniques for structured dataset management.
• Familiarize students with data analysis tools such as NumPy and Pandas for healthcare datasets.
• Enable students to visualize and interpret pharmaceutical data.

Course Content

1. Unit I: Introduction to Python programming

   6 Hours

   Installing Python and an Integrated Development Environment (IDE) [Jupyter Notebook, PyCharm, VS Code etc.], Advantages of IDEs over text editors.

   Python variables and data types (integers, floats, strings, booleans), Type casting and basic operators (arithmetic, comparison, logical), Input and output operations.

   Basic string operations and manipulation techniques. Introduction to standard libraries and third-party libraries, installing and uninstalling libraries.

2. Unit II: Control Structures & Functions

   6 Hours

   Conditional statements (if, if-else, if-elif-else), nested conditions

   Loops (for loop, while loop).

   Break and continue statements.

   Defining and calling functions, passing arguments and returning values.

   Writing modular programs for simple pharmaceutical applications- dosage calculation and BMI calculation.

3. Unit III: Data Structures & File Handling

   6 Hours

   Lists, tuples, and dictionaries.

   Indexing and slicing lists, basic operations on lists and dictionaries, string manipulation techniques.

   Introduction to NumPy arrays, basic operations using NumPy (array creation, arithmetic operations).

   Reading and writing CSV files.

   Understanding structured healthcare datasets.

   Importing small pharmaceutical datasets and performing basic data access and manipulation tasks.

4. Unit IV: Data Handling with Pandas

   6 Hours

   Introduction to Pandas library.

   Pandas Series and DataFrame structures.

   Reading CSV and Excel files-PK study datasets and ADR reports

   Inspecting datasets using functions such as head(), tail(), info(), and describe().

   Data cleaning techniques and handling missing values.

   Filtering and selecting data based on conditions.

   Grouping data and performing aggregation functions.

5. Unit V: Data Visualization with Matplotlib

   6 Hours

   Introduction to Matplotlib.

   Creating line plots, histograms, scatter plots, and box plots.

   Labeling axes, titles, and legends.

   Create plots and visualize pharmaceutical datasets - concentration-time curves for oral and IV administration, ADR reporting rates across drugs, dissolution profiles.

   Scientific interpretation of plots.

Suggested Readings

• Weiss, C.J., 2017. Scientific Computing for Chemists with Python. Available at: https://weisscharlesj.github.io/SciCompforChemists/notebooks/introduction/intro.html
• Perkovic, L., 2015. Introduction to Computing Using Python: An Application Development Focus. 2nd ed. Hoboken: Wiley.
• Sweigart, A., 2025. Automate the Boring Stuff with Python. 3rd ed. Available at: https://automatetheboringstuff.com/
• W3Schools, n.d. Python Tutorial. Available at: https://www.w3schools.com/python/
• Datasets for Education and Research: Mentors and students can access healthcare datasets from sources such as Kaggle (healthcare records), government agencies (healthdata.gov, WHO, https://www.data.gov.in/), and clinical trial registries (https://ctri.nic.in/, https://clinicaltrials.gov/). Always use data responsibly.

Course Objectives

• Provide knowledge about evolution and development of Pharmacy profession in India and the growth of the Pharmaceutical Industries over the years.
• Provide understanding of different types of pharmacopoeias and other official books in maintaining the standards of medicines.
• Provide knowledge about the basic pharmaceutical calculations used in dispensing and compounding.
• Understand the role of active pharmaceutical ingredients and pharmaceutical excipients in drug formulations
• Impart basic knowledge about formulation and preparation of Various solid, liquid and semisolid dosage forms

Course Content

1. Unit I: Introduction to the Profession of Pharmacy

   9 Hours

   History of the Profession of Pharmacy in India: In relation to pharmacy education, pharmaceutical industries and organizations – evolution, development and milestones.

   Scope of the Pharmacy Profession: Role and responsibilities of pharmacists in retail/community pharmacy, hospital and clinical pharmacy, and industrial pharmacy including research and development.

   Pharmacopoeias: Introduction to IP, BP, USP, BPC, International Pharmacopoeia, other pharmacopoeias and the National Formulary of India; structure and content of the Indian Pharmacopoeia; study of one model IP monograph.

   Introduction to Prescription: Structure and format/parts of prescription, handling of prescriptions, Latin terminology related to prescriptions.

2. Unit II: Introduction to Pharmaceutical Calculations and Dosage Forms

   9 Hours

   Metric system of weights and measures; calculations based on alligation, proof spirit, isotonic solutions, dilute solutions (percentage and ratio) and geometric dilution; scientific notation of units and measures.

   Posology: Definition and dose calculation based on age, body weight and body surface area.

   Introduction to Dosage Forms: Routes of administration and classification of dosage forms.

   Introduction to Active Pharmaceutical Ingredients and Excipients: Definition, ideal characteristics and importance.

3. Unit III: Solid Dosage Forms

   9 Hours

   Powders: Classification, advantages and disadvantages; dusting powders, effervescent powders, efflorescent powders, hygroscopic powders and eutectic mixtures; introduction to excipients and methods of preparation.

   Tablets: Definition, types of tablets including moulded tablets and pills with examples; advantages and disadvantages; introduction to excipients and methods of preparation.

   Capsules: Definition, types of capsules, advantages and disadvantages, capsule sizes; introduction to excipients and methods of preparation.

4. Unit IV: Monophasic and Biphasic Liquids

   9 Hours

   For internal use – aromatic waters, syrups, elixirs and linctus (definition and preparation).

   For external use and body cavities – liniments, lotions, throat paints, applications, gargles, mouthwashes, enemas, eye drops, ear drops, nasal drops and tinctures with examples.

   Study of official preparations- Introduction to excipients and methods of preparation.

   Suspensions- Definition and types (flocculated and deflocculated), advantages and disadvantages, formulation excipients and general methods of preparation.

   Emulsions- Definition and types, emulsifying agents, tests for identification of types of emulsions, formulation excipients and general methods of preparation.

5. Unit V: Semisolid Dosage Forms

   9 Hours

   Definitions, classification, advantages and disadvantages, ointment bases and other excipients used in semisolid dosage forms; general methods of preparation of ointments, pastes, creams and gels.

   Suppositories / Pessaries: Definition, types of suppositories, advantages and disadvantages, formulation excipients used in suppositories, properties of ideal suppository bases, types of suppository bases, displacement value and general method of preparation.

Suggested Readings

• Ansel, H.C., Allen, L.V. and Popovich, N.G., Pharmaceutical Dosage Forms and Drug Delivery Systems. Lippincott Williams & Wilkins, New Delhi.
• Carter, S.J., Cooper and Gunn’s Dispensing for Pharmaceutical Students. CBS Publishers, New Delhi.
• Indian Pharmacopoeia Commission, Indian Pharmacopoeia. Ghaziabad.
• Indian Pharmacopoeia Commission, National Formulary of India. Ghaziabad, India.
• British Pharmacopoeia Commission, British Pharmacopoeia. London.
• United States Pharmacopeial Convention, United States Pharmacopeia (USP–NF). Rockville, Maryland, USA.
• Lachman, L., Lieberman, H.A. and Kanig, J.L., The Theory and Practice of Industrial Pharmacy. Lea & Febiger, University of Michigan.
• Gennaro, A.R., Remington: The Science and Practice of Pharmacy. Lippincott Williams & Wilkins, New Delhi.
• Rawlins, E.A., Bentley’s Textbook of Pharmaceutics. Elsevier Health Sciences, USA.
• Nieloud, F. and Marti-Mestres, G., Pharmaceutical Emulsions and Suspensions. Marcel Dekker Inc., New York.

Course Objectives

• Introduce the fundamental concepts and branches of psychology relevant to healthcare.
• Help students understand human behavior, development, and psychological responses to illness.
• Develop awareness of common psychological disorders and coping mechanisms in healthcare contexts.
• Equip students with effective health communication skills for clinical and community settings.
• Promote professional interaction with patients, caregivers, and healthcare teams through ethical and empathetic communication.

Course Content

1. Unit I: Introduction to Psychology in Healthcare

   3 Hours

   Definition, scope, and relevance of psychology in health sciences.

   Branches of psychology with healthcare relevance: clinical, health, behavioural, and developmental psychology.

   Sensation, perception, and attention in clinical assessment.

   Learning and memory: reinforcement in health behaviour change.

   Emotion and motivation: theories and implications in health contexts.

2. Unit II: Developmental and Behavioural Psychology

   3 Hours

   Human developmental stages and healthcare needs.

   Personality theories and patient interaction styles.

   Psychological factors affecting illness perception and recovery.

   Common psychological disorders in healthcare: anxiety, depression, and somatization.

   Coping strategies, resilience, and stress management techniques.

3. Unit III: Foundations of Health Communication

   3 Hours

   Elements and models of communication in healthcare.

   Types of communication: interpersonal, group, mass, and telehealth communication.

   Barriers to effective communication in clinical settings.

   Active listening, questioning techniques, and empathy.

   Culturally appropriate and inclusive communication.

4. Unit IV: Professional Communication in Healthcare Settings

   3 Hours

   Communication with patients, caregivers, and interdisciplinary teams.

   Delivering difficult news and handling emotionally charged situations.

   Legal and ethical issues in health communication (confidentiality, consent).

   Writing patient records, reports, and discharge summaries.

   Use of technology and digital communication tools in healthcare services.

5. Unit V: Health Psychology and Behavioural Interventions

   3 Hours

   Health belief models and illness behaviour.

   Psychosomatic illnesses and the mind–body connection.

   Behaviour change theories (e.g., CBT, TTM) in treatment adherence.

   Psychological first aid and crisis communication.

   Mental health promotion and stigma reduction through communication.

Suggested Readings

• Feldman, R.S., Understanding Psychology. McGraw-Hill Education, New York.
• Taylor, S.E., Health Psychology. McGraw-Hill Education, New York.
• Hargie, O., The Handbook of Communication Skills. Routledge, London.
• Nevid, J.S., Rathus, S.A. and Greene, B., Psychology and the Challenges of Life: Adjustment and Growth. Wiley, New York.
• Atkinson, R.L., Atkinson, R.C., Smith, E.E., Bem, D.J. and Nolen-Hoeksema, S., Introduction to Psychology. Wadsworth Publishing, Belmont.
• Kumar, A., Communication Skills for Health Professionals. Jaypee Brothers Medical Publishers, New Delhi.
• Park, K., Park’s Textbook of Preventive and Social Medicine. Banarsidas Bhanot Publishers, Jabalpur.

Course Objectives

• Understand the structural organization of the human body from cells to systems.
• Comprehend physiological functions of various body systems and the principles of homeostasis.
• Learn the cellular basis of disease including injury, adaptation, and inflammation.
• Recognize common pathological conditions related to skin, bones, joints, blood, cardiovascular system, and special senses.
• Establish the groundwork for clinical interpretation of symptoms and disease mechanisms relevant to pharmacy and therapeutics.

Course Content

1. Unit I: Introduction to human body

   12 Hours

   Cellular and tissue level of organization.

   Definition and scope of anatomy, physiology and pathophysiology.

   Levels of structural organization and body systems, basic life processes, homeostasis, basic anatomical terminologies.

   Structure and functions of cell, transport across cell membrane, cell division, cell junctions. General principles of cell communication, forms of intracellular signalling- a) Contact-dependent, b) Paracrine, c) Synaptic, d) Endocrine

   Classification of tissues, structure, location and functions of epithelial, muscular and nervous and connective tissues.

   Basic principles of cell injury and adaptation

   Components and types of feedback systems, causes of cellular injury, pathogenesis (cell membrane damage, mitochondrial damage, ribosome damage and nuclear damage), morphology of cell injury – adaptive changes (atrophy, hypertrophy, hyperplasia, metaplasia, dysplasia), cell swelling, intra cellular accumulation and cell death.

   Definitions of commonly used relevant medical terminologies.

2. Unit II: Integumentary system and wound healing

   12 Hours

   Structure and functions of skin. Skin disorders: Psoriasis and dermatitis and pathophysiology of Leprosy. Basic principles of wound healing.

   Skeletal system and joints

   Divisions of skeletal system, types of bones, salient features and functions of bones of axial and appendicular skeletal system. Organization of skeletal muscle, physiology of muscle contraction, neuromuscular junction. Structural and functional classification of joints.

   Diseases of bones and joints

   Pathophysiology of rheumatoid arthritis, osteoporosis and gout.

3. Unit III: Body fluids, blood and lymphatic system

   12 Hours

   Body fluids, composition and functions of blood, hemopoiesis, formation of haemoglobin, mechanisms of coagulation, blood grouping, Rh factors and transfusion.

   Lymphatic organs and tissues, lymphatic vessels, lymph formation, circulation and functions of lymphatic system.

   Basic mechanism of inflammation and repair

   Introduction, classification and pathophysiology of inflammation, mediators of inflammation.

   Haematological diseases

   Pathophysiology of iron deficiency, megaloblastic anaemia (Vit B12 and folic acid), sickle cell anaemia, Thalassemia, hereditary acquired anaemia and haemophilia.

4. Unit IV: Peripheral nervous system

   12 Hours

   Classification of peripheral nervous system: structure and functions of sympathetic and parasympathetic nervous system. Origin and functions of spinal and cranial nerves.

   Special senses

   Structure and functions of eye, ear, nose and tongue. Pathophysiology of special sense disorders- glaucoma, cataract, myopia, otitis externa, otitis media, vertigo and anosmia

5. Unit V: Cardiovascular system

   12 Hours

   Anatomy of heart, blood circulation, blood vessels, structure and functions of artery, vein and capillaries, elements of conduction system of heart and heartbeat, its regulation by autonomic nervous system, cardiac output, cardiac cycle. Regulation of blood pressure, pulse, electrocardiogram.

   Pathophysiology of hypertension, cardiac arrhythmias, congestive heart failure, ischemic heart disease (angina, myocardial infarction, atherosclerosis and coronary artery disease).

Suggested Readings

• Sembulingam, K. and Sembulingam, P., Essentials of Medical Physiology. Jaypee Brothers Medical Publishers, New Delhi.
• Guyton, A.C. and Hall, J.E., Textbook of Medical Physiology. Elsevier Saunders, Philadelphia, USA.
• Tortora, G.J. and Grabowski, S.R., Principles of Anatomy and Physiology. Wiley, Palmetto, GA, USA.
• Kumar, V., Cotran, R.S. and Robbins, S.L., Basic Pathology. W.B. Saunders Company, Philadelphia.

Course Objectives

• Explain the origin, history, and classification of natural drugs.
• Understand cultivation and conservation methods for medicinal plants.
• Study quality control and evaluation of crude drugs.
• Study primary and secondary metabolites with their therapeutic relevance
• Introduce traditional systems of medicine and phyto-therapeutic agents.

Course Content

1. Unit I: Fundamentals of Pharmacognosy

   10 Hours

   (a) Definition, history, present status, scope and development of pharmacognosy.

   (b) Sources of drugs: Plants, animals, microbial, marine, mineral and plant tissue culture.

   (c) Historical milestones in drug discovery: Morphine, quinine, aspirin, warfarin, penicillin, cephalosporin, taxol and artemisinin.

   (d) Introduction to different herbal / traditional pharmacopoeias: Indian Pharmacopoeia, British Herbal Pharmacopoeia, United States Pharmacopeia – Herbal Medicines and Dietary Supplements, Ayurvedic Pharmacopoeia of India, Unani Pharmacopoeia of India and American Herbal Pharmacopoeia.

   (e) Official and non-official; codified and non-codified drugs. Classification of crude drugs: alphabetical, morphological, taxonomical, chemical, pharmacological and chemotaxonomic classification along with their merits and limitations.

2. Unit II: Cultivation, Collection, Processing and Storage of Drugs of Natural Origin

   8 Hours

   Methods of plant cultivation and Good Agricultural and Collection Practices (WHO / GAP / GCP guidelines) for medicinal plants. Factors influencing cultivation, collection and storage of medicinal plants.

   Plant hormones and their applications in cultivation of medicinal plants. Application of polyploidy, mutation and hybridization concepts with reference to secondary metabolites. Ex-situ and in-situ conservation and strategies for value addition of medicinal plants. Role of eco-pharmacognosy in sustainable conservation of endangered medicinal plants such as kutki and chirata.

3. Unit III: Quality Control of Drugs of Natural Origin (WHO Guidelines)

   8 Hours

   Adulteration of drugs of natural origin. Evaluation of drugs using organoleptic, microscopic (qualitative and quantitative), physical, chemical and biological methods. Physicochemical parameters: extractive values, moisture content, foreign organic matter, ash values, bitterness value, foaming index, haemolytic potential, swelling index, viscosity, optical rotation, refractive index, acid value and saponification value. DNA barcoding.

4. Unit IV: Introduction to Metabolites of Plant Origin

   12 Hours

   Definition and general properties of plant metabolites. Primary and secondary metabolites such as carbohydrates, proteins, lipids, alkaloids, glycosides, flavonoids, tannins, terpenoids, volatile oils and resins.

   Traditional Systems of Medicine

   Basic principles of treatment of diseases in different systems of medicine including AYUSH and TCM. Types of dosage forms in AYUSH medicines. Role of pharmacognosy in allopathy and traditional systems of medicine such as AYUSH and TCM.

5. Unit V: Phyto-therapeutic Agents

   7 Hours

   Biological source, major constituents and uses of the following classes of drugs:

   Adaptogens and Immunomodulators: Ashwagandha, Tulsi, Amla

   Hepatoprotectives: Milk thistle, Kutki

   Cardiovascular drugs: Garlic, Arjuna

   Antidiabetics: Gymnema, Fenugreek

   Anti-inflammatory and analgesics: Turmeric, Boswellia

   CNS drugs: Brahmi

   Antimicrobial and antivirals: Giloy, Neem, Andrographis

   Gastrointestinal drugs: Psyllium

   Dermatological agents: Aloe

   Drugs used in women’s health: Chasteberry, Shatavari

   Respiratory drugs: Vasaka

Suggested Readings

• Evans, W.C., Trease and Evans Pharmacognosy. 16th ed. London: W.B. Saunders & Co., 2009.
• Tyler, V.E., Brady, L.R. and Robbers, J.E., Pharmacognosy. 9th ed. Philadelphia: Lea & Febiger, 1988.
• Wallis, T.E., Textbook of Pharmacognosy. London: J. & A. Churchill Ltd.
• World Health Organization (2002) WHO traditional medicine strategy 2002–2005. Geneva: World Health Organization
• World Health Organization (1998) Quality control methods for medicinal plant materials. Geneva: World Health Organization.
• World Health Organization (2003) WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants. Geneva: World Health Organization.

Course Objectives

• Understand the importance of errors, impurities in pharmaceuticals.
• Comprehend the principles of buffer systems.
• Develop skills in performing and interpreting limit tests and titrimetric analysis.
• Emphasize the importance of inorganic compounds and radiopharmaceuticals in Pharmacy
• Explain synthesis and analysis of inorganic compounds/products of pharmaceutical importance

Course Content

1. Unit I: Introduction to pharmaceutical analysis

   7 Hours

   Different techniques of analysis, Methods of expressing strength of solutions, Primary and secondary standards with examples.

   Errors

   Sources of errors, types of errors, methods of minimizing errors, accuracy, precision and significant figures.

   Impurities

   Definition, types, contents and regulatory importance. Sources and types of impurities in Pharmaceuticals, limit tests for chloride, sulphate, iron, arsenic, lead, heavy metals, and modified limit test for chloride and sulphate.

2. Unit II: Acid-Base Chemistry and Buffer Systems in Pharmacy

   8 Hours

   Definition of acids, bases, buffers, pH Scale and its significance, Buffer equation, calculation of pH for Buffer solution. Isotonicity and its application in IV Fluids and Ophthalmic Solutions.

   Major extra and intracellular electrolytes

   Functions of major physiological ions, Electrolytes used in the replacement therapy: Sodium chloride*, Potassium chloride, Calcium chloride and Oral Rehydration Salt (ORS), Physiological acid base balance.

3. Unit III: Acid base titrations

   14 Hours

   Theories of acid base indicators, classification of acid base titrations. Preparation and standardization of titrants viz. hydrochloric acid and sodium hydroxide. Theory involved in titrations of strong, weak, and very weak acids and bases, neutralization curves. Assay of Ammonium hydroxide.

   Non-aqueous titrations

   Types of solvents used, acidimetric and alkalimetric titration using non-aqueous solvents. Preparation and standardization of acidic and basic titrants. Estimation of weakly acidic and basic substances using non-aqueous titrants, estimation of Sodium benzoate.

   Precipitation titrations and gravimetry

   Principle and steps involved in gravimetric analysis, Mohr’s method, Volhard’s, Modified Volhard’s, Fajans method. Estimation of barium sulphate by gravimetry.

   Complexometric titrations

   Classification, metal ion indicators, masking and demasking reagents, preparation and standardization of disodium EDTA. Estimation of Magnesium sulphate and Calcium gluconate*.

   Redox titrations

   Concepts of oxidation and reduction, Types of redox titrations viz. Permanganometry, Cerimetry, Iodimetry, Iodometry and titrations with potassium iodate.

4. Unit IV: Gastrointestinal agents

   10 Hours

   Acidifiers: Sodium acid phosphate and Dilute Hydrochloric acid.

   Antacids: Ideal properties of antacids, combinations of antacids, Sodium bicarbonate*, Aluminium hydroxide gel*.

   Agents promote bowel movements: Magnesium hydroxide, Sodium orthophosphate, Sodium Potassium tartrate and magnesium trisilicate.

   Antimicrobials: Mechanism, classification, Potassium permanganate, Boric acid, Hydrogen peroxide*, Chlorinated lime*, Iodine and its preparations.

   Radiopharmaceuticals

   Basics of radioactivity, applications of radioisotopes of Sodium Iodide I-131, Technetium-99m, Cobalt-60, Phosphorus-32 including safe handling, storage, and disposal of radiopharmaceuticals, adhering to regulatory guidelines for safety.

5. Unit V: Miscellaneous Compounds

   6 Hours

   Expectorants: Potassium iodide, Ammonium chloride*.

   Emetics: Copper sulphate*, Sodium potassium tartrate.

   Haematinics: Ferrous sulphate*, Ferrous gluconate.

   Poison and Antidote: Definition, classification of antidotes, Sodium thiosulphate

Suggested Readings

• Bentley, R. and Driver, J., Bentley and Driver's Textbook of Pharmaceutical Chemistry. Oxford: Oxford University Press.
• Vogel, A.I., Vogel’s Textbook of Quantitative Chemical Analysis. Essex: Pearson Education Limited.
• Beckett, A.H. and Stenlake, J.B., Practical Pharmaceutical Chemistry. Part I & II. London: The Athlone Press, University of London.
• Schroff, M.L., Inorganic Pharmaceutical Chemistry. New Delhi: Oxford Book Company.
• Indian Pharmacopoeia Commission, Indian Pharmacopoeia. Ghaziabad, India.

Course Objectives

• Familiarize students with essential pharmaceutical calculations including dilution, concentration, and allegation methods required for accurate formulation of dosage forms.
• Impart practical skills in the preparation of official and non-official dosage forms such as solutions, syrups, powders, granules, suppositories, semisolids, gargles, and mouthwashes in accordance with pharmacopeial standards.
• Develop understanding of formulation principles related to selection of ingredients, dosage form design, stability, and patient acceptability.
• Train students in the application of pharmacopoeial specifications (IP, BPC, WHO) during compounding, labeling, and evaluation of pharmaceutical preparations.
• Enhance hands-on competency and professional confidence required for dispensing practice and pharmaceutical compounding in hospital and community pharmacy settings.

Practical / Lab Exercises

1. Pharmaceutical Calculations: Solutions based on allegation and dilution methods
2. Solutions: a) Strong solution of ammonium acetate – IP, b) Cresol with soap solution – IP, c) Lugol’s solution – BPC
3. Syrups: a) Simple Syrup – IP
4. Powders & Granules: a) ORS powder – WHO, b) Effervescent granules – IP, c) Dusting powder – IP, d) Divided powders – IP
5. Suppositories: a) Glycerogelatin suppository – BPC, b) Cocoa butter suppository – IP, c) Zinc Oxide suppository – IP
6. Semisolids: a) Sulphur ointment – IP, b) Non-staining iodine ointment with methyl salicylate – BPC
7. Gargles & Mouthwashes: a) Iodine gargle – BPC, b) Chlorhexidine mouthwash – IP
8. Note: a) Preparation of compendia of dosage forms (marketed products), is recommended. b) Any other practical relevant to the syllabus can be introduced. c) Minimum 12 experiments must be performed covering all dosage forms.

Suggested Readings

• Carter, S.J., Cooper and Gunn’s Dispensing for Pharmaceutical Students. 12th ed. New Delhi: CBS Publishers.
• Indian Pharmacopoeia Commission, Indian Pharmacopoeia, Vol. I. Ghaziabad: IPC.
• United States Pharmacopeial Convention, United States Pharmacopeia–National Formulary (USP–NF). Rockville, MD, USA.
• British Pharmacopoeia Commission, British Pharmacopoeia Codex. London: The Stationery Office.
• World Health Organization, Oral Rehydration Salts (ORS) Formulation Guidelines. Geneva: WHO.

Course Objectives

• To develop effective communication skills essential for diverse clinical and community health scenarios.
• To enhance empathetic interaction through role plays, simulations, and reflective practices.
• To promote collaborative learning and peer feedback in communication-based tasks.
• To encourage application of psychological principles in real-life healthcare contexts.
• To build confidence in delivering health education and awareness activities in community settings.

Practical / Lab Exercises

1. Role Plays and Simulations: Counselling a patient with chronic illness; Breaking bad news in a clinical setting; Empathetic listening in crisis response
2. Case Study Discussions: Mental health cases in primary care; Impact of miscommunication in healthcare errors
3. Peer-to-Peer Practice Sessions: Reflective listening and paraphrasing; Effective team communication and decision-making
4. Community Engagement Tasks: Designing IEC materials for public health awareness; Conducting mock health education sessions
5. Journaling & Self-Reflection Logs: Weekly reflection on emotional responses during care simulations; Growth in communication skill development over the semester

Suggested Readings

• Morgan, C.T. and King, R.A., Introduction to Psychology. New York: McGraw-Hill.
• Taylor, S.E., Health Psychology. New York: McGraw-Hill Education.
• Hargie, O., Skilled Interpersonal Communication: Research, Theory and Practice. London: Routledge.
• Balzer-Riley, J., Communication in Nursing and Healthcare. Boston: Pearson.
• Weinman, J., Petrie, K.J. and Moss-Morris, R., The Psychology of Health and Illness. London: Routledge.

Course Objectives

• Provide fundamental knowledge of the structure and functions of various organ systems of the human body.
• Understand the mechanisms of homeostasis and their role in maintaining normal physiological functions.
• Introduce the basic concepts of pathophysiology and the causes of diseases affecting different organ systems.
• Explain the body’s physiological responses to disease-producing agents.
• Lay the foundation for understanding clinical conditions through the study of functional alterations in organs and systems.

Practical / Lab Exercises

1. (Minimum 12 experiments must be performed) Practical HAPP allows the verification of physiological processes discussed in theory classes through experiments on living tissues, simulated videos, models and charts.
2. Study of compound microscopes.
3. Microscopic study of epithelial and connective tissue.
4. Microscopic study of muscular and nervous tissue.
5. Identification of axial bones.
6. Identification of appendicular bones.
7. Introduction to hemocytometry.
8. Demonstration of total blood count by cell analyser.
9. Enumeration and interpretation of white blood cell (WBC) count, differential count.
10. Enumeration and interpretation of total red blood corpuscles (RBC) count.
11. Determination of bleeding time and clotting time.
12. Estimation and interpretation of hemoglobin content.
13. Determination of blood group.
14. Determination and interpretation of erythrocyte sedimentation rate (ESR).
15. Determination of pulse rate, heart rate and blood pressure.
16. Recording and interpretation of ECG.
17. To study the cardiovascular system and integumentary system.
18. Case studies/files of patients with anaemia, thalassemia, haemophilia, leprosy, gout, hypertension and ischemic heart disease.

Suggested Readings

• Wilson, K.J.W., Anatomy and Physiology in Health and Illness. New York: Churchill Livingstone.
• Guyton, A.C. and Hall, J.E., Textbook of Medical Physiology. Philadelphia: Elsevier.
• Tortora, G.J. and Grabowski, S.R., Principles of Anatomy and Physiology. New York: Wiley.

Course Objectives

• Identify medicinal plants and crude drugs using morphological and microscopical characters.
• Analyze powdered drugs and perform quantitative microscopy.
• Evaluate crude drugs using physicochemical parameters.
• Introduce standardization and quality control of herbal materials.
• Collect medicinal plants and prepare voucher specimens.

Practical / Lab Exercises

1. (Minimum 12 experiments must be performed)
2. Morphological study of medicinal plants (as mentioned in Unit V Theory).
3. Organoleptic evaluation and powder microscopical characters of the following drugs: Tulsi and Ashwagandha.
4. Organoleptic evaluation and powder microscopical characters of the following drugs: Amla and Arjuna.
5. Organoleptic evaluation and powder microscopical characters of the following drugs: Turmeric and Psyllium husk.
6. Organoleptic evaluation and powder microscopical characters of the following drugs: Brahmi and Fenugreek.
7. Determination of moisture content of crude drugs.
8. Determination of swelling index and foaming index of crude drugs.
9. Determination of stomatal number and stomatal index of leaf.
10. Determination of vein islet and vein termination number of leaf.
11. Determination of ash value and extractive values of crude drugs.
12. Determination of foreign organic matter of crude drugs.
13. Determination of dimensions of calcium oxalate crystals and phloem fibers by eyepiece micrometry.
14. Determination of percentage purity of powder drug using lycopodium spore method.
15. Experiential learning-based experiments involving collection, identification of medicinal plant material, preparation of voucher specimens and excursion visits to medicinal plant garden.

Suggested Readings

• Evans, W.C., 2009. Trease and Evans Pharmacognosy. 16th ed. London: W.B. Saunders & Co.
• Tyler, V.E., Brady, L.R. and Robbers, J.E., 1988. Pharmacognosy. 9th ed. Philadelphia: Lea & Febiger.
• Wallis, T.E., Textbook of Pharmacognosy. London: J. & A. Churchill Ltd.

Course Objectives

• Gain practical knowledge on various volumetric titration techniques.
• Learn the principles of volumetric analysis.
• Study the preparation and assessment of inorganic compounds.
• Determine the assay of various inorganic compounds in pharmaceutical use.
• Develop analytical skill for the qualitative and quantitative analysis of various inorganic compounds.

Practical / Lab Exercises

1. Limit tests (Any 4 Experiments) a. Limit test and modified limit test for Chloride as per Indian Pharmacopoeia b. Limit test and modified limit test for sulphate as per Indian Pharmacopoeia c. Limit test for Iron d. Limit test for Lead e. Limit test for arsenic
2. Preparation of inorganic pharmaceuticals (Any 3 Experiments) a. Preparation of Aluminium hydroxide b. Preparation of potash alum c. Preparation of ferrous sulphate d. Preparation of Magnesium sulphate from magnesium hydroxide or magnesium carbonate
3. Test for Purity (Any 2 Experiments) a. Assessment of swelling power of bentonite as per Indian Pharmacopoeia b. Evaluation of acid neutralizing capacity of aluminium hydroxide gel c. Determination of potassium iodate and iodine in potassium Iodide
4. Assay of the following inorganic compounds including standardization of titrant (Any 5 Experiments) a. Assay of ammonium chloride by acid base titration, b. Assay of Ferrous sulphate by Cerimetry, c. Assay of Copper sulphate by Iodometry, d. Assay of Calcium gluconate by Complexometry, e. Assay of Hydrogen peroxide by Permanganometry, f. Assay of Sodium benzoate by non-aqueous titration, g. Assay of Sodium Chloride by precipitation titration (Modified Volhard’s method)

Suggested Readings

• Bentley, R. and Driver, J., Bentley and Driver’s Textbook of Pharmaceutical Chemistry. Oxford: Oxford University Press.
• Vogel, A.I., Vogel’s Textbook of Quantitative Chemical Analysis. Essex: Pearson Education Limited.
• Beckett, A.H. and Stenlake, J.B., Practical Pharmaceutical Chemistry. Part I & II. London: The Athlone Press, University of London.
• Kennedy, J.H., Analytical Chemistry: Principles. New York: Saunders College Publishing.
• Schroff, M.L., Inorganic Pharmaceutical Chemistry. New Delhi: Oxford Book Company.
• Indian Pharmacopoeia Commission, Indian Pharmacopoeia. Ghaziabad, India.

Course Objectives

• Explain fundamental statistical concepts relevant to pharmaceutical sciences.
• Develop the ability to interpret clinical and experimental data scientifically.
• Apply statistical methods for analysing pharmaceutical and biomedical data.
• Demonstrate the use of Python-based tools for statistical analysis and data handling.
• Recognize the role of statistical analysis in evidence-based decision making and machine learning applications in healthcare.

Course Content

1. Unit I: Descriptive Statistics

   6 Hours

   Types of data in pharmaceutical sciences (nominal, ordinal, interval, ratio)

   Sources of data in pharmacy: clinical trials, pharmacovigilance, quality control, PK studies

   Measures of central tendency: mean, median, mode, their calculation and interpretation

   Measures of dispersion (range, variance, standard deviation) and their interpretation using pharmaceutical data

   Skewness and understanding distribution shape in biological measurements

   Perform descriptive statistical analysis using Python libraries such as NumPy and Pandas, with focus on Interpretation of results

2. Unit II: Probability & Statistical Distributions in Healthcare

   6 Hours

   Basic probability concepts and laws (addition and multiplication rules), conditional probability and its interpretation

   Bayes' theorem and its application in clinical decision-making

   Concept of random variables (discrete and continuous)

   Normal distribution and its importance in biological and pharmaceutical measurements,

   Binomial distribution demonstrating applications in clinical trial outcomes

   Poisson distribution for modeling rare events such as adverse drug reactions

   Graphical visualization of these probability distributions using Python

3. Unit III: Sampling & Statistical Inference

   6 Hours

   Population versus sample, sampling techniques used in clinical research, Sampling error and bias

   Conceptual understanding of the Central Limit Theorem

   Confidence intervals and their interpretation

   Hypothesis testing framework (null and alternative hypotheses)

   Type I and Type II errors, p-value and statistical significance

   Demonstration, calculation and interpretation of these parameters using python with pharmaceutical data

4. Unit IV: Basics of Correlation & Regression

   6 Hours

   Conceptual understanding of the following concepts with emphasis on their interpretation-

   correlation and Pearson correlation coefficients

   Interpretation of positive and negative correlations

   Scatter plots and trend visualization using pharmaceutical data such as dose-response relationships

   Simple linear regression concept, interpretation of regression coefficients

   Introduction to odds ratio and its application in clinical risk analysis

5. Unit V: Statistical Analysis Using Python – Case based learning

   6 Hours

   Demonstration of descriptive statistics, correlation analysis and linear regression using Python libraries- SciPy / Statsmodels / Scikit-learn on pharmaceutical datasets

   Interpretation of the output summaries and p-values

   Preparation of statistical reports

Suggested Readings

• Lane, D.M., Introduction to Statistics. Houston: Rice University. Available at: https://onlinestatbook.com/2/index.html
• Walters, S.J., Campbell, M.J. and Machin, D., Medical Statistics: A Textbook for the Health Sciences. Hoboken, NJ: Wiley-Blackwell.
• Rowe, P., Essential Statistics for the Pharmaceutical Sciences. London: Pharmaceutical Press.
• Bolton, S. and Bon, C., Pharmaceutical Statistics: Practical and Clinical Applications. New York: Informa Healthcare.
• De Muth, J.E., Basic Statistics and Pharmaceutical Statistical Applications. Boca Raton, FL: CRC Press.

Course Objectives

• Know about enzymology and various tests in clinical chemistry
• Understand the biochemical pathways and clinical relevance of carbohydrate, lipid and protein metabolism.
• Describe energetics and biological oxidation.
• Explain aminoacid and protein metabolism
• Understand Nucleic acid metabolism and genetic information.

Course Content

1. Unit I: Enzymology

   10 Hours

   a. Introduction, properties, nomenclature, and IUB classification of enzymes and coenzymes. Enzyme kinetics (Michaelis plot, Lineweaver–Burk plot). Enzyme inhibitors with examples. Regulation of enzymes: enzyme induction and repression, allosteric enzyme regulation. Therapeutic and diagnostic application of enzymes and isoenzymes. Factors affecting enzyme activity. Digestion, absorption function of dietary Macro and Micronutrients, including Vitamins and Minerals, Biochemical functions of vitamins and associated diseases.

   b. Clinical Chemistry: Liver function tests (routinely performed tests based on liver function). Renal function tests (routinely performed tests based on kidney function, ELISA test)

2. Unit II

   10 Hours

   a. Introduction about biomolecules – Introduction of carbohydrate, lipids, nucleic acids, amino acids and proteins.

   b. Bioenergetics: Concept of free energy; relationship between free energy, enthalpy, and entropy; redox potential; energy-rich compounds (ATP, GTP, etc.) and their biological significance.

   c. Carbohydrate Metabolism and their role in diabetis mellitus: Overview and significance of major pathways: Glycolysis, Citric Acid Cycle (TCA), Gluconeogenesis, Hexose Monophosphate (HMP) shunt, and Glycogen metabolism; regulation of blood glucose levels; metabolic adaptations during fed state, fasting, and prolonged starvation; metabolic derangements in diabetes mellitus and related disorders.

   d. Biological Oxidation: Electron Transport Chain (ETC), oxidative phosphorylation, and mechanisms of ATP synthesis; regulation and clinical implications of mitochondrial dysfunction and oxidative stress.

3. Unit III: Lipid metabolism

   7 Hours

   a. Classification, functions, and properties of lipids and lipoproteins (HDL, LDL, VLDL, chylomicrons)

   b. β-oxidation and de-novo synthesis of fatty acids: Ketone bodies: synthesis, utilization, and clinical significance

   c. Biological significance of cholesterol, lipid profile, and its clinical significance

   d. Disorders associated with lipid metabolism: Hyperlipidaemias and hypercholesterolemia, lipid storage diseases, atherosclerosis, fatty liver disease, and obesity

4. Unit IV: Amino acids and protein metabolism

   10 Hours

   a. Classification and Biological Functions: Classification and physiological roles of amino acids. Structure and functions of proteins and plasma proteins

   b. General Metabolism of Amino Acids: Transamination, oxidative and non-oxidative deamination, decarboxylation. Urea cycle – nitrogen disposal and detoxification. Fate of carbon skeletons of amino acids (glucogenic vs ketogenic).

   c. Catabolism of Specific Amino Acids and Related Disorders: Catabolism of phenylalanine and tyrosine and their metabolic disorders (Phenylketonuria, Albinism, Alkaptonuria, Tyrosinemia) and Inborn errors of branched chain and aromatic amino acids

   d. Biochemical significance of neurotransmitters and hormones derived from amino acids: 5-HT (serotonin), melatonin, dopamine, noradrenaline, adrenaline

   e. Catabolism of heme and related disorders (jaundice).

5. Unit V: Nucleic acid metabolism and genetic information transfer

   8 Hours

   a. Nucleotide Metabolism and their related disorders: Biosynthesis of purine and pyrimidine nucleotides. Catabolism of purine nucleotides (uric acid formation). Clinical significance of Hyperuricemia and Gout.

   b. Genome Structure and Central Dogma: Organization of the mammalian genome. Introduction to DNA replication, Transcription, and Translation.

   c. Genetic Code and Regulation of Protein Synthesis: Properties of the genetic code: Inhibitors of transcription and translation (antibiotics, toxins)

   d. DNA Repair and Related Disorders: DNA damage types, Repair mechanisms. Overview of clinical disorders associated with faulty DNA repair.

Suggested Readings

• Nelson, D.L., Cox, M.M. and Hoskins, A., Lehninger Principles of Biochemistry. New York: W.H. Freeman.
• Kennelly, P.J., Rodwell, V.W., Bender, D.A., Botham, K.M. and Weil, P.A., Harper’s Illustrated Biochemistry. New York: McGraw-Hill Education.
• Murray, R.K., Bender, D.A., Botham, K.M., Kennelly, P.J., Rodwell, V.W. and Weil, P.A., Harper’s Biochemistry. New York: McGraw-Hill.
• Voet, D. and Voet, J.G., Biochemistry. New York: John Wiley & Sons.
• Devlin, T.M., Textbook of Biochemistry with Clinical Correlations. New York: Wiley-Liss.
• Satyanarayana, U. and Chakrapani, U., Biochemistry. Kolkata: Books and Allied (P) Ltd.
• Stryer, L., Biochemistry. New York: W.H. Freeman.

Course Objectives

• Understand the anatomy and physiology of major body systems.
• Learn mechanisms of neurological, gastrointestinal, respiratory, renal, endocrine, and reproductive functions.
• Identify common pathophysiological conditions affecting each organ system.
• Correlate structural and functional abnormalities with disease symptoms.
• Equip students with foundational knowledge for interpreting disease processes and planning rational pharmacotherapy.

Course Content

1. Unit I: Nervous System

   14 Hours

   a) Organization of nervous system, neuron, neuroglia, classification and properties of nerve fibre, electrophysiology, action potential, nerve impulse, receptors, synapse and neurotransmitters.

   Central nervous system: Meninges, ventricles of brain and cerebrospinal fluid. Structure and functions of brain (cerebrum, brain stem and cerebellum), spinal cord (gross structure, functions of afferent and efferent nerve tracts, reflex activity).

   b) Pathophysiology of epilepsy, Parkinson’s disease, stroke, migraine, depression, schizophrenia, Alzheimer’s disease and meningitis.

2. Unit II: Gastrointestinal System

   12 Hours

   a) Anatomy of GI tract with special reference to anatomy and functions of stomach (acid production in the stomach and its regulation through parasympathetic nervous system; role of pepsin in protein digestion). Anatomy and functions of small intestine and large intestine. Anatomy and functions of salivary glands, pancreas and liver. Movements of GIT, digestion and absorption of nutrients.

   b) Pathophysiology of inflammatory bowel diseases, peptic ulcer, jaundice, hepatitis, typhoid and alcoholic and non alcoholic fatty liver disease

3. Unit III

   12 Hours

   a) Respiratory System: Anatomy of respiratory system with special reference to anatomy of lungs. Mechanism of respiration and regulation of respiration. Lung volumes and capacities, transport of respiratory gases, artificial respiration and resuscitation methods.

   b) Pathophysiology of asthma, chronic obstructive pulmonary diseases and tuberculosis.

   c) Urinary System: Anatomy of urinary tract with special reference to anatomy of kidney and nephrons. Functions of kidney and urinary tract. Physiology of urine formation, micturition reflex and role of kidneys in acid–base balance. Role of Renin Angitensin Aldosterone System in kidney.

   d) Pathophysiology of acute and chronic renal failure and urinary tract infections.

4. Unit IV: Endocrine System

   10 Hours

   a) Classification of hormones and mechanism of hormone action. Structure and functions of pituitary gland, thyroid gland, parathyroid gland, adrenal gland, pancreas, pineal gland and thymus.

   b) Pathophysiology of diabetes, hypothyroidism, hyperthyroidism, goitre and polycystic ovary syndrome.

5. Unit V: Reproductive System and Cancer

   12 Hours

   a) Anatomy of male and female reproductive system. Functions of male and female reproductive system, sex hormones, physiology of menstruation, fertilization, spermatogenesis, oogenesis, pregnancy and parturition.

   b) Pathophysiology of sexually transmitted diseases: AIDS, syphilis and gonorrhea.

   c) Etiology and pathogenesis of cancer.

Suggested Readings

• Wilson, K.J.W., Ross and Wilson Anatomy and Physiology in Health and Illness. Churchill Livingstone, New York.
• Tortora, G.J. and Grabowski, S.R., Principles of Anatomy and Physiology. Palmetto, GA, U.S.A.
• Guyton, A.C. and Hall, J.E., Textbook of Medical Physiology. Elsevier.
• Chatterjee, C.C., Human Physiology (Vol. I & II). Academic Publishers, Kolkata.
• Mohan, H., Textbook of Pathology. Jaypee Publishers.
• Porth, C.M., Pathophysiology: Concepts of Altered Health States. Lippincott Williams & Wilkins.
• Kumar, V., Abbas, A.K., Aster, J.C. and Deyrup, A.T., Robbins and Kumar Basic Pathology. Elsevier.

Course Objectives

• Develop a clear understanding of the chemistry of saturated hydrocarbons.
• Study the chemistry and reactions of unsaturated hydrocarbons.
• Understand the chemistry and reaction mechanisms of alkyl halides.
• Explain the chemistry of aromatic hydrocarbons and their derivatives.
• Provide an understanding of carbonyl compounds and fundamental organic reaction mechanisms relevant to pharmaceuticals.

Course Content

1. Unit I: Aliphatic Saturated Hydrocarbons

   12 Hours

   Alkanes

   Methods of preparation: Wurtz reaction, Kolbe’s reaction, Clemmensen reduction, Wolff–Kishner reduction

   Chemical reactions of alkanes

   Mechanism of free radical substitution (halogenation)

   Pharmaceutical applications of alkanes: Liquid paraffin, soft paraffin, hard paraffin

   Cycloalkanes

   Baeyer’s strain theory and its limitations

   Coulson–Moffitt modification

   Sachse–Mohr theory

2. Unit II: Aliphatic Unsaturated Hydrocarbons

   12 Hours

   Alkenes

   Methods of preparation: Dehydration of alcohols; Dehydrohalogenation of alkyl halides; Dehalogenation of vicinal dihalides; Wittig reaction

   Chemical reactions of alkenes

   Mechanism of electrophilic addition reactions

   Markovnikov’s and anti-Markovnikov’s rule

   Ozonolysis

   Conjugated Dienes

   Stability of conjugated dienes

   Mechanism of Diels–Alder reaction

   Electrophilic and free radical addition reactions

   1,2- and 1,4-addition reactions

3. Unit III: Alkyl Halides

   12 Hours

   Nucleophilic substitution reactions: SN1 and SN2 – Mechanism, kinetics, substrate structure, solvent effect, stereochemistry

   Elimination reactions: E1 and E2 – Mechanism, kinetics, substrate structure, solvent effect, stereochemistry

   Zaitsev’s (Saytzeff’s) rule with examples

   Comparison of substitution vs elimination reactions

4. Unit IV: Benzene and Its Derivatives

   12 Hours

   IUPAC nomenclature of mono- and di-substituted benzene derivatives

   Structure of benzene

   Molecular orbital picture and resonance

   Aromaticity and Hückel’s rule

   Electrophilic aromatic substitution reactions: Nitration; Halogenation; Friedel–Crafts alkylation and its limitations; Friedel–Crafts acylation; Sulphonation and desulphonation

   Effect of substituents on reactivity and orientation

5. Unit V: Carbonyl Compounds

   12 Hours

   Aldehydes and Ketones

   Preparation and properties of carbonyl compounds

   Nucleophilic addition reactions

   Aldol condensation and crossed aldol condensation

   Cannizzaro and crossed Cannizzaro reactions

   Benzoin and Perkin condensation

   Oxidation and reduction reactions

   Pharmaceutical applications of carbonyl compounds: Chloral, Paraldehyde, Ketoprofen

Suggested Readings

• Morrison, R.T., Boyd, R.N. and Bhattacharjee, S.K., Organic Chemistry. Pearson Education India.
• Finar, I.L., Organic Chemistry, Vol. I. Pearson Books.
• Bahl, B.S. and Bahl, A., Textbook of Organic Chemistry. S. Chand & Company.
• Furniss, B.S., Vogel’s Textbook of Practical Organic Chemistry.

Course Objectives

• Understand major metabolic pathways and the biogenetic origin of primary and secondary phytoconstituents, including the use of modern tools for pathway studies.
• Study and interpret the pharmacognostic features of crude drugs containing primary metabolites such as carbohydrates, proteins/enzymes, and lipids.
• Study and interpret the pharmacognostic features of crude drugs containing secondary metabolites such as alkaloids, glycosides, tannins, resins, volatile oils, flavonoids, phenolics, and terpenoids.
• Impart knowledge of conventional and modern extraction techniques and enable selection of appropriate extraction methods.
• Develop competency in isolation, identification, characterization, and quality evaluation of medicinal plants and botanicals.

Course Content

1. Unit I: Metabolic Pathways and Biogenetic Studies

   10 Hours

   Brief study of basic metabolic pathways and biosynthesis of secondary metabolites including: Shikimic acid pathway, Acetate pathway, Amino acid pathways

   Utilization of radioactive isotopes in biogenetic studies.

   Introduction to pathway prediction tools and modern genetic tools such as CRISPR/Cas9.

2. Unit II: Primary Metabolites

   12 Hours

   General classification and identification tests

   Pharmacognostic study (biological source, distribution, identifying characters, chemical constituents, specific tests, therapeutic uses, and commercial applications) of:

   Carbohydrates: Acacia, Agar, Tragacanth, Honey

   Proteins and Enzymes: Gelatin, Casein, Proteolytic enzymes: Papain, Bromelain, Serratiopeptidase, Urokinase, Streptokinase, Pepsin

   Lipids (Waxes, Fats, Fixed Oils): Castor oil, Olive oil, Cocoa butter, Wool fat, Beeswax

3. Unit III: Secondary Metabolites

   12 Hours

   General classification and identification tests

   Pharmacognostic study (biological source, distribution, cultivation of underlined drugs, identifying characters, chemical constituents, specific tests, therapeutic uses, and commercial applications) of:

   Alkaloids: Vinca, Rauwolfia, Opium

   Volatile Oils: Lemongrass, Clove, Cinnamon, Fennel

   Tannins: Myrobalans, Catechu, Pomegranate

   Resins: Guggul, Asafoetida

   Glycosides: Senna, Liquorice, Digitalis

   Phenylpropanoids and Flavonoids: Green Tea, Ginkgo, Flax seed

   Iridoids, Other Terpenoids and Naphthoquinones: Gentian, Artemisia

4. Unit IV: Extraction Methods for Medicinal Plants

   12 Hours

   Conventional Methods of Extraction: Infusion, Decoction, Digestion, Maceration, Percolation, Reflux, Distillation, Soxhlet extraction, Successive solvent extraction

   Modern Methods of Extraction: Supercritical fluid extraction, Microwave-assisted extraction, Ultrasonic-assisted extraction, Enzyme-assisted extraction, Pressurized liquid extraction

5. Unit V: Overview of Isolation, Identification and Characterization Techniques

   14 Hours

   Separation and Isolation Techniques: Planar chromatography, Column chromatography, Preparative TLC, Flash chromatography

   Identification Techniques: Phytochemical tests, Chromatographic techniques, Spectroscopic techniques

   Fingerprinting of medicinal plants using TLC/HPTLC.

   Types and significance of markers (phytochemical reference standards).

   Screening and analysis of major metabolites: Alkaloids, Glycosides, Saponins, Tannins, Resins, Flavonoids, Phenolics, Steroids

Suggested Readings

• Dewick, P.M., Medicinal Natural Products: A Biosynthetic Approach. John Wiley & Sons.
• Evans, W.C., Trease and Evans’ Pharmacognosy. W.B. Saunders & Co., London.
• Wagner, H., and Bladt, S., Plant Drug Analysis: A Thin Layer Chromatography Atlas. Springer-Verlag.
• Harborne, J.B., Phytochemical Methods: A Guide to Modern Techniques of Plant Analysis. Chapman & Hall.

Course Objectives

• Provide a comprehensive understanding of the theory and principles of pharmaceutical processes and unit operations involved in drug manufacturing.
• Impart knowledge of physicochemical phenomena such as solubility, dissolution, interfacial phenomena, rheology, and micromeritics relevant to dosage form design.
• Develop understanding of colloidal and coarse dispersions, including suspensions and emulsions, and their pharmaceutical applications.
• Familiarize students with rheological and micromeritic properties of powders and dispersions and their role in formulation development and evaluation.
• Build a strong foundation for formulation development, process optimization, and quality control of pharmaceutical dosage forms.

Course Content

1. Unit I: Solubility distribution phenomenon & buffers

   9 Hours

   Solubility expression, Solute solvent interactions, Solubility of liquid and liquids, Solubility of solids and liquids, Solubility of Gas in Liquids, Raoult’s Law. Factors affecting solubility, Measurement of saturation Solubility, Effect of pH on solubility, Partition Coefficient – Measurement and significance, Critical Solution Temperature and Applications.

   Introduction to buffers, Buffers in pharmaceutical and biological system, pH determination methos (Electrometry and colorimetry). Buffer equation / Factor influencing the pH of buffer solutions, Factor influencing Buffer capacity, General procedure for preparing buffers, Indicators.

2. Unit II: Interfacial phenomenon

   8 Hours

   Liquid interface: Surface and interfacial tension, surface free energy, Measurement of surface and interfacial tension, Spreading coefficient, surface active agent, HLB, detergency, types of monolayers at liquid surface. Adsorption at solid interface, Liquid Interface (contact angle, activated charcoal and Wetting). Adsorption of surface-active agents. Electric properties of interface / Electric double layer, Nernst and zeta potential effect of electrolytes

3. Unit III: Colloidal and Coarse Dispersion

   12 Hours

   Colloidal dispersions: Types of colloidal dispersions (Lyophobic, Lyophilic, Association colloids), Optical properties of colloids, Kinetic properties of colloids, Electrical properties of colloids, Size and shape of colloidal systems, Stability of colloidal system (peptization and protective action), Application of Colloidal System.

   Coarse Dispersions: Suspensions, stokes law (Theory of sedimentation), Effect of Brownian movement / Sedimentation of flocculated particles, sedimentation parameters. Flocculation and controlled structure flocculation. Theories of emulsification and stabilizaition (DLVO Theory, Monomolecular adsorption, Multimolecular adsorption, Film formation, Solid particle adsorption). Physical instabilities of emulsions (creaming, coalescence and breaking, and phase inversion).

4. Unit IV: Rheological studies

   8 Hours

   Newtonian systems and non-Newtonian systems. Thixotropy – measurement / Bulges and spurs. Negative thixotropy, Determination of rheological properties (Viscometers / single and multi-point).

   Viscoelasticity, psycho-rheology. Applications of rheology in pharm

5. Unit V: Micromeritics

   8 Hours

   Particle size and size distribution, Particle Shape and Surface area: Methods for determination and significance. Flow properties of powders: determination, significance and methods of enhancement. Advanced flow properties of powers (Powder flow tester).

Suggested Readings

• Sinko, P.J., Martin's Physical Pharmacy and Pharmaceutical Sciences.
• Allen, L.V. and McPherson, T.B., Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems.
• Adejare, A., Remington: The Science and Practice of Pharmacy.
• Aulton, M.E. and Taylor, K.M.G., Aulton Pharmaceutics: The Design and Manufacture of Medicines. Elsevier.
• Lachman, L. and Libbermann, H.A., The Theory and Practice of Industrial Pharmacy.
• Mendham, J., Denney, R.C., Barnes, J.D. and Thomas, M.J.K., Vogel's Textbook of Quantitative Chemical Analysis.
• Myers, D., Surfaces, Interfaces, and Colloids: Principles and Applications.
• Ladisch, M.R., Rheology of Fluid and Semisolid Foods. Springer.

Course Objectives

• To develop skills to identify and differentiate carbohydrates and proteins through classical qualitative biochemical tests.
• To apply biochemical techniques for analysis of pathological conditions using urine and blood samples.
• To perform estimations of clinically important biomolecules such as glucose, cholesterol, urea, creatinine, uric acid, and proteins in biological fluids.
• To demonstrate enzymatic activity and study factors affecting enzyme function, including substrate concentration and temperature.
• To interpret biochemical results and correlate them with clinical conditions such as diabetes, renal dysfunction, and lipid disorders.

Practical / Lab Exercises

1. Identification tests for proteins (Albumin and Casein).
2. Qualitative analysis of carbohydrates* (Glucose, Fructose, Lactose, Sucrose, and Starch).
3. Qualitative analysis of urine for normal and abnormal constituents.
4. Estimation of blood glucose.
5. Estimation of total cholesterol and HDL cholesterol.
6. Estimation of urea, creatinine, and uric acid in serum.
7. Estimation of serum total protein and albumin.
8. Study of enzymatic hydrolysis of starch.
9. Study of the effect of temperature on salivary amylase activity.
10. Study of the effect of substrate concentration on salivary amylase activity.
11. Estimation of hemoglobin in blood by Sahli’s method / Cyanmethemoglobin method.
12. Estimation of serum bilirubin (total and direct bilirubin).
13. Estimation of glycogen content
14. Estimation of SGOT and SGPT

Suggested Readings

• Plummer, D. T. An Introduction to Practical Biochemistry. McGraw-Hill, New York.
• Wilson, K., and Walker, J. Principles and Techniques of Biochemistry and Molecular Biology. Cambridge University Press.
• Varley, H., Gowenlock, A. H., Bell, M., and Bell, J. L. Varley’s Practical Clinical Biochemistry. Heinemann Medical Books.
• Burtis, C. A., Ashwood, E. R., and Bruns, D. E. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Elsevier.
• Rodwell, V. W., Bender, D. A., Botham, K. M., Kennelly, P. J., and Weil, P. A. Harper’s Illustrated Biochemistry. McGraw-Hill.
• Freifelder, D. Essential Molecular Biology: A Practical Approach. Oxford University Press.

Course Objectives

• Provide foundational knowledge of the structure and functions of major organ systems of the human body.
• Develop understanding of physiological mechanisms responsible for maintenance of homeostasis.
• Explain the pathophysiology of diseases affecting different organ systems.
• Explore causes of diseases and the body’s responses to pathological conditions.
• Build a strong base for clinical learning through the study of functional and structural changes in disease states.

Practical / Lab Exercises

1. Practical HAPP allows the verification of physiological processes discussed in theory classes through experiments on living tissues, simulated videos, models, and charts.
2. Study of nervous system using specimens and models.
3. Study of respiratory system using models.
4. Study of gastrointestinal system using models.
5. Study of reproductive system using models.
6. Demonstration of general neurological examination.
7. Demonstration of function of olfactory nerve.
8. Examination of different types of taste.
9. Demonstration of visual acuity.
10. Demonstration of reflex activity.
11. Recording of body temperature.
12. Determination of tidal volume and vital capacity.
13. Recording of body mass index (BMI).
14. Study of family planning devices and pregnancy diagnosis tests.
15. Understanding pathophysiology of IBD, peptic ulcer, jaundice, hepatitis, typhoid, asthma, tuberculosis, diabetes, and thyroid disorders through case files / case reports.
16. Hands-on training in cardiopulmonary resuscitation (CPR).

Suggested Readings

• Wilson, K. J. W., and Waugh, A. Anatomy and Physiology in Health and Illness. Churchill Livingstone, New York.
• Best, C. H., and Taylor, N. B. The Physiological Basis of Medical Practice. Williams & Wilkins, Baltimore.
• Guyton, A. C., and Hall, J. E. Textbook of Medical Physiology. Elsevier / W.B. Saunders, Philadelphia.
• Tortora, G. J., and Grabowski, S. R. Principles of Anatomy and Physiology. John Wiley & Sons.
• Brunton, L., Chabner, B., and Knollmann, B. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. McGraw-Hill, New York.
• Colledge, N. R., Walker, B. R., and Ralston, S. H. Davidson’s Principles and Practice of Medicine. Churchill Livingstone, London.

Course Objectives

• Understand and follow essential laboratory safety protocols for handling chemicals, glassware, and equipment.
• Identify and analyze organic compounds through their physical properties and functional group reactivity.
• Apply ball-and-stick molecular models to visualize and interpret the structure of organic compounds.
• Perform purification techniques such as crystallization to isolate and refine organic substances.
• Synthesize simple organic compounds and their derivatives using standard laboratory methods.

Practical / Lab Exercises

1. Systematic qualitative analysis of minimum of five water-insoluble or water-immiscible unknown organic compounds from different chemical classes: a. Preliminary tests: Color, odour, Solubility tests, test for aromaticity, test for saturation/unsaturation etc. b. Detection of elements such as nitrogen, sulphur and halogens by Lassaigne’s test c. Determination of Functional group tests such as phenols, amides, amines, carboxylic acids, aldehydes and ketones, alcohols, esters, aromatic and halogenated hydrocarbons and nitro compounds. d. Preparation of the derivatives and confirmation of the unknown organic compound by melting point / boiling point.
2. Building Molecular Models: Students will use ball-and-stick models to create structures of molecules and understand their shapes and bonding.
3. Crystallization Method: Students will learn how to purify three organic compounds using the crystallization technique.

Suggested Readings

• Furniss, B. S., Hannaford, A. J., Smith, P. W. G. and Tatchell, A. R. Vogel’s Textbook of Practical Organic Chemistry. Longman Scientific & Technical, London.
• Mann, F. G. and Saunders, B. C. Practical Organic Chemistry. Pearson Education.
• Shriner, R. L., Hermann, C. K. F., Morrill, T. C., Curtin, D. Y. and Fuson, R. C. The Systematic Identification of Organic Compounds. John Wiley & Sons.
• Vogel, A. I. Elementary Practical Organic Chemistry. Longman Group Ltd.
• Pavia, D. L., Lampman, G. M., Kriz, G. S. and Engel, R. Introduction to Organic Laboratory Techniques. Cengage Learning.

Course Objectives

• Perform chemical tests for the identification of gums, resins, oils, fats, waxes, and unorganized drugs.
• Examine crude drugs using transverse section and powder microscopy for correct identification.
• Apply suitable extraction techniques and study their effect on yield of crude extracts.
• Isolate and identify important phytoconstituents and volatile oils using standard procedures.
• Evaluate herbal raw materials collected from field/market sources as per Pharmacopoeial standards.

Practical / Lab Exercises

1. Chemical tests for identification of Agar, Acacia, Tragacanth, Honey.
2. Chemical tests for identification of Castor oil, Olive oil, Wool fat, Beeswax.
3. Chemical tests for identification of Asafoetida, Catechu, Aloe.
4. Transverse section and powder microscopy of a vinca leaf.
5. Transverse section and powder microscopy of a cinnamon bark.
6. Transverse section and powder microscopy of a fennel fruit.
7. Transverse section and powder microscopy of a clove flower bud.
8. Transverse section and powder microscopy of a Tulsi stem.
9. Transverse section and powder microscopy of a Liquorice roots.
10. Study of effect on different extraction techniques on yield of crude extract (maceration, decoction, soxhlation).
11. Isolation of volatile oil and it’s TLC.
12. Isolation of caffeine from tea.
13. Isolation of Hesperidin from lemon peel.
14. Isolation of Glycyrhizin from liquorice roots.
15. Isolation of Pectin from orange peel.
16. Experiential learning based experiment involving evaluation and comparison of field/market collected herbal raw materials with Pharmacopoeial standards.

Suggested Readings

• Trease, G. E. and Evans, W. C. Pharmacognosy. Elsevier.
• Harborne, J. B. Phytochemical Methods: A Guide to Modern Techniques of Plant Analysis. Springer.
• Wallis, T. E. Textbook of Pharmacognosy. CBS Publishers & Distributors, New Delhi.
• Tyler, V. E., Brady, L. R. and Robbers, J. E. Pharmacognosy. Lea & Febiger.

Course Objectives

• Introduce basic laboratory techniques for determining physicochemical properties such as surface tension, viscosity, and density in pharmaceutical systems.
• Develop understanding of interfacial phenomena and surfactant behavior, including micelles, critical micellar concentration (CMC), and HLB in formulation design.
• Train students in evaluating disperse systems through sedimentation studies and the effect of suspending agents.
• Provide practical experience in powder characterization, including particle size distribution, density, flow properties, porosity, and the role of glidants.
• Develop skills in determining solubility, partition coefficient, buffer capacity, and related equilibria relevant to drug formulation.

Practical / Lab Exercises

1. Determination of surface tension of given liquids by drop count method and drop weight method.
2. Determination of critical micellar concentration (CMC) of surfactants.
3. Determination of viscosity of liquids using Ostwald’s viscometer and Brookfield viscometer.
4. Determination of HLB value of a surfactant.
5. Calculation of isotonicity by different methods (Sodium Chloride Equivalent Method).
6. Determination of particle size and particle size distribution using sieving method.
7. Determination of particle size and particle size distribution using microscopic method.
8. Determination of densities and derived properties of powders (bulk density, tapped density, Hausner ratio, Carr’s compressibility index), true density, and porosity.
9. Determination of angle of repose and influence of glidants on angle of repose.
10. Determination of solubility of a drug at different pH/buffer systems at room temperature.
11. Determination of partition coefficient of a drug in n-octanol and water system.
12. Determination of partition coefficient of a drug in benzene and water system.
13. Determination of critical solution temperature and composition of phenol–water system.
14. Determination of specific surface area of charcoal by adsorption of acetic acid on activated charcoal.
15. Determination of buffer capacity at various stages of titration of a weak acid against a strong base and determination of pKa.
16. Note: Compare the values of various physicochemical properties with marketed formulations wherever possible.

Suggested Readings

• Sinko, P. J. Martin’s Physical Pharmacy and Pharmaceutical Sciences. Lippincott Williams & Wilkins.
• Aulton, M. E. and Taylor, K. M. G. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. Elsevier.
• Lachman, L., Lieberman, H. A. and Kanig, J. L. The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors.
• Allen, L. V., Popovich, N. G. and Ansel, H. C. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Lippincott Williams & Wilkins.
• Cooper, S. J. and Gunn, C. Cooper and Gunn’s Tutorial Pharmacy. CBS Publishers & Distributors.

Course Objectives

• Introduce the fundamental concepts of Artificial Intelligence, Machine Learning, and Data Science and their relevance to pharmaceutical sciences.
• Develop conceptual understanding of machine learning workflows, including model building, training–testing strategies, and evaluation.
• Explain the principles and applications of regression models for predicting continuous outcomes in pharmaceutical and healthcare data.
• Familiarize students with classification and tree-based models used for clinical prediction and decision-making.
• Introduce unsupervised learning techniques and demonstrate their applications in pattern recognition and healthcare data analysis.

Course Content

1. Unit I: Foundations of Machine Learning

   6 Hours

   Definition and scope of Artificial Intelligence, Machine Learning, and Data Science

   Types of machine learning: supervised, unsupervised, and reinforcement learning

   Features and labels, training data and testing data

   Concept of model building and prediction

   Train-test split, overfitting and underfitting

   Conceptual explanation of bias-variance trade-off

   Overview of the basic ML workflow

2. Unit II: Regression Models in Healthcare

   6 Hours

   Overview of the concepts in predictive modeling for continuous outcomes, with emphasis on interpretation of outputs, and applications in pharmaceutical sciences.

   Linear regression and multiple linear regression

   Model coefficients and their interpretation

   Residuals and goodness-of-fit

   Performance metrics such as Mean Squared Error (MSE), Root Mean Squared Error (RMSE), R² score

   Implementation of regression models on pharmaceutical data (e.g. dose–response relationships, predicting drug dissolution rates, estimating PK parameters), and demonstration of predictive modeling using python libraries such as sklearn

3. Unit III: Classification Models in Clinical Applications

   6 Hours

   Overview of the following ML models used for categorical prediction, with emphasis on conceptual understanding, interpretation of outputs and applications in pharmaceutical sciences.

   Logistic regression

   Probability output and threshold selection

   Confusion matrix

   Accuracy, sensitivity, specificity, precision, recall

   Intuitive understanding of ROC curve and AUC, and k-Nearest Neighbors

   Demonstration of predictive modeling using pharmaceutical and clinical examples such as predicting adverse drug reactions, disease risk prediction, binary therapeutic outcome modeling.

4. Unit IV: Tree-Based Models & Ensemble Learning

   6 Hours

   Overview of the following ML models with emphasis on intuitive and conceptual understanding.

   Decision Trees (structure and splitting criteria), interpretation of decision paths and feature importance

   Random Forest, overview of ensemble concept

   Advantages and limitations of tree-based models

   Demonstration of these models for pharmaceutical and clinical applications such as ADR risk stratification, Patient classification, Predicting treatment outcomes etc.

5. Unit V: Unsupervised Learning & Practical Case Studies

   6 Hours

   Overview of the unsupervised learning with emphasis on intuitive and conceptual understanding of pattern recognition and clustering, and their applications in pharmaceutical sciences.

   Concept of unsupervised learning

   Clustering overview, K-means clustering, choosing number of clusters, Interpreting cluster outputs

   Mini-case study integrating regression, classification, or clustering on healthcare datasets to demonstrate Patient segmentation, and drug grouping based on properties.

Suggested Readings

• James, G., Witten, D., Hastie, T. and Tibshirani, R. An Introduction to Statistical Learning with Applications in Python. Springer. Available at: statlearning.com.
• Simon, G. J. and Aliferis, C. Artificial Intelligence and Machine Learning in Health Care and Medical Sciences: Best Practices and Pitfalls. Springer.
• Brown, N. Artificial Intelligence in Drug Discovery. Royal Society of Chemistry.
• Walters, S. J., Campbell, M. J. and Machin, D. Medical Statistics: A Textbook for the Health Sciences. Wiley-Blackwell.
• Géron, A. Hands-On Machine Learning with Scikit-Learn, Keras and TensorFlow. O’Reilly Media.

Course Objectives

• Explain the environmental challenges and disaster risks relevant to human health and pharmaceutical activities.
• Demonstrate knowledge of waste management protocols and legal guidelines for pharmaceutical and biomedical waste handling.
• Apply technical understanding of effluent and sewage treatment technologies used in the pharmaceutical sector.
• Assess the ecological impact of APIs and recommend mitigation strategies for pollution control.
• Explain sustainable practices and energy-efficient operations within pharmaceutical industries.

Course Content

1. Unit I: Environmental Pollution

   3 Hours

   Definition, scope, and importance of environmental studies

   Types, causes, effects, and control measures of Air, water, soil, noise, and nuclear pollution

   Solid waste and hazardous waste management in pharmaceuticals

   Role of pharmacists in conservation and sustainable use of resources

2. Unit II: Pharmaceutical Waste and Effluent Management

   3 Hours

   Types of pharmaceutical waste: chemical, expired drugs, packaging, biomedical waste

   Biomedical Waste Management Rules (2016) and CPCB guidelines

   Effluent Treatment Plant (ETP) design and functioning

   Water purification methods in pharmaceutical settings (RO, UV, distillation, filtration)

3. Unit III: Environmental Impact of the Pharmaceutical Industry

   3 Hours

   Sources of pollution in pharmaceutical manufacturing

   Types of pharmaceutical waste: solid, liquid, and gaseous

   Environmental risks of active pharmaceutical ingredients (APIs) and its dosage forms.

   Impact of pharmaceutical residues on ecosystems and human health

4. Unit IV: Sustainability in the Pharmaceutical Sector

   3 Hours

   Principles of sustainable development in pharma

   Principles and Practices of Green pharmacy

   Energy conservation and resource optimization.

5. Unit V: Government Policies, Compliance, and Practical Exposure

   3 Hours

   Environmental laws: Environment (Protection) Act, 1986; Water (Prevention and Control of Pollution) Act

   National Green Tribunal (NGT) and regulatory bodies (CPCB, SPCB)

   Government initiatives: Swachh Bharat Abhiyan; River rejuvenation program- Namami Gange Programme; Jal Jeevan Mission

   ISO-14000

Suggested Readings

• Bharucha, E. Environmental Studies. University Grants Commission, New Delhi.
• Rajagopalan, R. Environmental Studies. Oxford University Press.
• Joseph, B. Environmental Studies. Tata McGraw Hill.

Course Objectives

• Understand the concept, definition, scope, and need of Value Education in personal, social, and professional life.
• Develop self-exploration, positive attitude, confidence, and ethical sensitivity as foundations of value-based living.
• Comprehend the co-existence of Self (I) and Body and establish harmony between physical and psychological aspects.
• Analyze the importance of family, society, and relationships in promoting mutual respect, trust, and cooperation.
• Appreciate the concept of harmony in nature and existence, leading to sustainable and responsible human conduct.

Course Content

1. Unit I: Introduction to Value Education

   3 Hours

   Concept, definition, and need for value education.

   Content and process of value education.

   Application of human values in everyday life.

2. Unit II: Self-Exploration and Human Aspirations

   3 Hours

   Self-exploration as a means of value education.

   Development of positive attitude and self-confidence.

   Right understanding of happiness and prosperity.

3. Unit III: Harmony in the Human Being

   3 Hours

   Human being as more than just the physical body.

   Harmony between the Self (‘I’) and the Body.

   Understanding the coexistence of the Self and the Body.

4. Unit IV: Harmony in the Individual and Society

   3 Hours

   Understanding the needs of the Self and the needs of the Body.

   Activities of the Self and activities of the Body.

   Family as the basic unit of human interaction and the role of values in relationships.

   Foundations of respect in relationships: affection, kindness, guidance, reverence, glory, gratitude, and love.

5. Unit V: Harmony in Society and Nature

   3 Hours

   Comprehensive human goal: the five dimensions of human endeavour.

   Harmony in nature and the four orders in nature.

   Holistic perception of harmony in existence.

Suggested Readings

• Tripathi, A. N. Human Values. New Age International Publishers, New Delhi.
• Gaur, R. R., Asthana, R. and Bagaria, G. P. A Foundation Course in Human Values and Professional Ethics. Excel Books, New Delhi.
• Gaur, R. R., Asthana, R. and Bagaria, G. P. Teachers’ Manual for A Foundation Course in Human Values and Professional Ethics. Excel Books, New Delhi.
• Raghavan, V. Universal Human Values. Excel Books.
• Gaur, R. R., Sangal, R. and Bagaria, G. P. Human Values and Professional Ethics. Excel Books.
• Govindarajan, M., Natarajan, S. and Senthil Kumar, V. S. Engineering Ethics. Prentice Hall India.
• Velasquez, M. G. Business Ethics: Concepts and Cases. Pearson Education.

Course Objectives

• To provide a foundational understanding of the history of pharmacology, focusing on the evolution of drug discovery and development.
• Introducing the concepts of pharmacodynamics and pharmacokinetics, helping students understand the mechanisms of drug action, absorption, distribution, metabolism, and excretion.
• To familiarize students with the principles behind new drug development, including preclinical testing, drug screening methods, and safety pharmacology.
• To enable students to learn about toxicity testing, ensuring they understand different methods of evaluating drug safety and the regulatory guidelines involved in toxicity assessment.
• To prepare students for understanding the pharmacology of different therapeutic drug classes, by applying basic pharmacological knowledge to current trends in drug development and screening.

Course Content

1. Unit I: Introduction to Pharmacology

   8 Hours

   Definition, historical perspectives, branches of pharmacology and their scope, drug, nature and sources of drugs, International Classification of Diseases (ICD) and International Non-proprietary Names (INN) for drugs

   Concept of generic medicines, essential drugs and rational drug use (RDU). Indian Government’s initiatives to promote these concepts.

   Routes of drug administration along with their advantages and disadvantages.

2. Unit II: Pharmacokinetics

   7 Hours

   Drug absorption, mechanisms of drug absorption, membrane transporters, bioavailability, bioequivalence, factors affecting drug absorption.

   Drug distribution in different compartments, volume of distribution, storage sites, plasma protein binding and its therapeutic importance.

   Drug biotransformation, microsomal, non-microsomal metabolism and cytochrome P450 enzyme system, phase I and II reactions, first-pass metabolism, entero-hepatic cycling, concept of prodrugs.

   Drug excretion and its kinetics.

3. Unit III: Pharmacodynamics

   10 Hours

   Types drug action and mechanisms of drug action, dose response relationship.

   Receptor theories, structure of receptors, classification and regulation of receptors, spare receptors. Concept of agonist, inverse agonist, partial agonist and antagonist.

   Signal transduction mechanisms of receptors.

   Factors modifying drug action including the concepts of tachyphylaxis, idiosyncrasy, drug tolerance, dependence, addiction, and the combined effect of drugs (Additive effect & Synergism).

   Adverse drug reactions (ADR) and types of ADRs.

   Drug interaction, types, pharmacokinetic and pharmacodynamic drug-drug interactions.

4. Unit IV: Overview of drug discovery and evaluation of new drug

   12 Hours

   Brief discussion on drug discovery and preclinical evaluation of new drugs.

   Human relevant screening techniques: Reconstructed human epidermis, organ-on-Chip model, skin irritancy test by reconstructed corneal epithelium, skin corrosivity testing by Direct Peptide Reactivity Assay.

   Advantages and disadvantages of in vitro and in silico Pharmacological screening and evaluation

   Recent trends in pharmacology

   Chronopharmacology: Introduction, biological clock, types of rhythms, hormones, diseases and drugs affected by circadian rhythm. Introduction to chrono kinetics and importance of chronotherapeutic and future scope.

   Introduction, general principles, applications and scope of Pharmacogenomics, Gene therapy, Biosimilars and Precision medicine.

5. Unit V: Toxicology

   8 Hours

   Introduction to toxicology and its branches. Classification of poisons based on actions and lethal doses, types of antidotes.

   General principles of treatment of acute poisoning include heavy metal poisoning. Management of poisoning.

   Definition and basic knowledge of preclinical toxicity testing-acute toxicity, sub-acute toxicity, combined chronic and carcinogenicity testing as per OECD norms.

   Basic understanding of principles of genotoxicity and teratogenicity as per OECD guidelines.

   Definition and concepts of safety pharmacology as per ICH and OECD guidelines.

Suggested Readings

• Brunton, L., Hilal-Dandan, R. and Knollmann, B. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. McGraw-Hill Education.
• Rang, H. P., Dale, M. M., Ritter, J. M., Flower, R. J. and Henderson, G. Rang and Dale’s Pharmacology. Elsevier.
• Katzung, B. G. and Trevor, A. J. Basic and Clinical Pharmacology. McGraw-Hill Education.
• Whalen, K. and Finkel, R. Lippincott’s Illustrated Reviews: Pharmacology. Wolters Kluwer.
• Tripathi, K. D. Essentials of Medical Pharmacology. Jaypee Brothers Medical Publishers.

Course Objectives

• Understand Chemistry of Carboxylic acids, Phenols, Amines and Polynuclear Aromatic hydrocarbons
• Explain the concepts of optical isomerism and their pharmaceutical significance.
• Explain the concepts of Geometrical isomerism and their pharmaceutical significance
• Know about IUPAC nomenclature and Chemistry of heterocycles
• Equip students with knowledge of organic reaction mechanisms and their applications in drug synthesis.

Course Content

1. Unit I: Chemistry of Carboxylic acids, Phenols, Amines and Polynuclear Aromatic hydrocarbons

   15 Hours

   Aliphatic and aromatic carboxylic acids

   Methods to prepare carboxylic acids (Oxidation of alcohols, carbonation of Grignard reagent, Kolbe-Schmidt reaction)

   Study of acidity of carboxylic acids and effect of substituents on acidity

   Study of chemical reactions of carboxylic acids [Mechanism of nucleophilic acyl substitution, Decarboxylation and Hell-Volhard-Zelinsky reaction]. Pharmaceutical applications of aromatic carboxylic acids (Benzoic acid, Salicylic acid, Acetyl Salicylic acid)

   Aliphatic and aromatic amines

   Methods to prepare amines (Reduction of nitro compound, reduction of nitriles and Hofmann degradation of amides)

   Study of basicity of amines and effect of substituents on basicity

   Study of mechanism and synthetic applications of diazonium salts including Sandmeyer’s and azo-dye coupling reaction

   Alcohols and Phenols

   Classification of alcohols, methods to prepare alcohols (oxymercuration-demercuration, reduction of carbonyl compounds)

   Acidity of alcohols and Phenols including effect of substituent on acidity

   Definition of phenols, method to prepare phenols by cumene process. Comparison of the acidity of phenol vs alcohol

   Study of mechanism of chemical reactions of phenols (Reimer-Tiemann reaction, halogenation and nitration of phenols). Pharmaceutical applications of alcohols and phenols (Glycerine, Thymol, Paracetamol)

   Chemistry of polynuclear hydrocarbons

   Definition, and classification of polynuclear aromatic hydrocarbons, Study of synthesis (Haworth synthesis) and mechanism of electrophilic aromatic substitution reactions of naphthalene, phenanthrene and anthracene and medicinal uses of drugs containing Naphthalene (Propranolol, Naphazoline) and Phenanthrene (Morphine, Codeine).

2. Unit II: Optical isomerism

   7 Hours

   Definition of stereoisomerism and types of stereoisomerism with examples

   Definition with examples for optical activity, origin of chirality, elements of symmetry, chiral and achiral molecules, enantiomerism, diastereoisomerism and meso compounds

   Study of configuration including D & L system, sequence rules, R & S system. Medicinal importance of optical isomers with examples

   Racemic mixture and resolution of racemic mixtures

3. Unit III: Geometrical isomerism

   6 Hours

   Nomenclature of geometrical isomers (Cis & Trans, E & Z, Syn & Anti system)

   Conformational isomerism and its analysis in ethane, butane and cyclohexane

   Stereo isomerism in biphenyl compounds (Atropisomerism) and conditions for optical activity in biphenyl compounds

4. Unit IV: Chemistry of five membered heterocycles

   10 Hours

   IUPAC nomenclature and classification of heterocyclic compounds as per the Hansch-Widman system

   Relative aromaticity and reactivity of pyrrole, furan and thiophene

   Study of synthesis of pyrrole (Paal–Knorr synthesis), furan (Feist-Bénary reaction), thiophene (Hinsberg synthesis) and Mechanism of Electrophilic substitution reactions of pyrrole, furan and thiophene

   Medicinal uses of drugs containing pyrrole (Ethosuximide, procyclidine), furan (Furosemide, Nitrofurazone) and thiophene (Cephaloridine, Clopidogrel)

5. Unit V: Chemistry of other heterocycles

   7 Hours

   Study of nomenclature of fused heterocyclic compounds, synthesis for pyrazole (Knorr synthesis), imidazole (Debus-Radziszewski reaction), pyridine (The Hantzsch synthesis), quinoline (The Skraup synthesis) and Electrophilic aromatic substitution reactions of pyrazole and imidazole

   Chemical structures of Indole, pyrimidine, benzimidazole, purine, azepine, pyrazole, oxazole, Phenothiazine, benzotriazole, quinoxaline

   Basicity of imidazole, pyridine and quinolone

   Medicinal uses of any two drugs containing pyrazole (Sildenafil, Celecoxib), imidazole (Metronidazole, Pilocarpine), pyridine (Isoniazid, Chlorpheniramine), quinoline (Chloroquine, Ciprofloxacin), indole (Indomethacin, Reserpine), benzimidazole (Albendazole, Mebendazole) pyrimidine (Fluorouracil, Sulphadiazine), purine (Mercaptopurine, Thioguanine), azepine (Diazepam, Loxapine) heterocycles

Suggested Readings

• Finar, I. L. Organic Chemistry, Vol. 1. Pearson Education.
• Finar, I. L. Organic Chemistry: Stereochemistry and Natural Products, Vol. 2. Pearson Education.
• Smith, M. B. and March, J. March’s Advanced Organic Chemistry: Reactions, Mechanisms and Structure. Wiley.
• Bahl, B. S. and Bahl, A. Textbook of Organic Chemistry. S. Chand.
• Nadendla, R. R. Pharmaceutical Organic Chemistry: Heterocyclic and Natural Products. Vallabh Prakashan.
• Gilchrist, T. L. Heterocyclic Chemistry. Prentice Hall.
• Eliel, E. L. and Wilen, S. H. Stereochemistry of Organic Compounds. Wiley.

Course Objectives

• Understand the fundamentals of dosage form development, including pre-formulation studies, drug–excipient compatibility, and stability considerations as per ICH guidelines.
• Acquire knowledge of formulation and manufacturing of compressed solid dosage forms, including tablets and coated tablets, along with quality control and packaging.
• Develop competence in the formulation and evaluation of finely divided and filled solid dosage forms, such as powders, granules, and hard and soft gelatin capsules.
• Understand the principles and formulation strategies of modified-release solid dosage forms, including sustained-release and controlled-release systems.
• Gain knowledge of microencapsulation techniques, their applications, advantages, limitations, and evaluation of microcapsules in pharmaceutical products.

Course Content

1. Unit I: Fundamentals of Dosage Form Development

   7 Hours

   Pre-formulation studies: concept, need, and parameters including solubility, pKa, physical nature (amorphous and crystalline), polymorphism, particle size and shape, and powder flow parameters.

   Drug–excipient compatibility studies.

   Packaging selection for various dosage forms.

   Drug product and container-closure interaction.

   Introduction to stability guidelines of new drug substances and products (ICH Q1).

2. Unit II: Compressed Solids

   12 Hours

   Tablets: Excipients (roles and examples); tooling (types and specifications); manufacturing methods and equipment; tablet defects and remedies; in-process quality control (IPQC); finished-product tests; packaging.

   Tablet Coating: Types of coating (sugar, film, compression, enteric); need, advantages, and limitations; polymers, process specifications, and equipment; coating defects; quality control of coated tablets.

3. Unit III: Finely Divided and Filled Solids

   12 Hours

   Medicated powders and granules: formulation considerations, manufacturing processes (mixing, granulation), quality control, and packaging.

   Gelatin and non-gelatin shells: composition, empty shell manufacturing, quality control, and capsule sizes.

   Hard gelatin capsules: formulation design; filling methods (manual, semi-automatic, automatic); IPQC and finished-product tests; packaging.

   Soft gelatin capsules: shell composition and plasticizers; fill materials; manufacturing methods (rotary die and others); defects; quality control and stability.

4. Unit IV: Modified-Release Solids

   7 Hours

   Types of tablets: sustained-release and controlled-release tablets.

   Concept, need, advantages, and disadvantages.

   Formulation design and drug-release mechanisms.

   Polymers used for sustained and controlled release.

   Evaluation of modified-release dosage forms.

5. Unit V: Microencapsulation

   7 Hours

   Concept, need, advantages, and disadvantages.

   Methods of microencapsulation: spray drying, spray congealing, extrusion and spheronisation, fluidized bed coating, and phase-separation coacervation.

   Evaluation of microcapsules.

Suggested Readings

• Allen, L. V., Popovich, N. G. and Ansel, H. C. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Lippincott Williams & Wilkins.
• Aulton, M. E. and Taylor, K. M. G. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. Elsevier.
• Lachman, L., Lieberman, H. A. and Kanig, J. L. The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors.
• Troy, D. B. and Beringer, P. Remington: The Science and Practice of Pharmacy. Pharmaceutical Press.
• Robinson, J. R. and Lee, V. H. L. Controlled Drug Delivery: Fundamentals and Applications. CRC Press.
• Sinko, P. J. Martin’s Physical Pharmacy and Pharmaceutical Sciences. Lippincott Williams & Wilkins.
• Indian Pharmacopoeia. Indian Pharmacopoeia Commission.
• United States Pharmacopeia. United States Pharmacopeial Convention.
• British Pharmacopoeia. British Pharmacopoeia Commission.

Course Objectives

• Provide fundamental knowledge of pharmaceutical engineering principles and common unit operations involved in solid and liquid pharmaceutical manufacturing.
• Develop an understanding of thermal operations such as drying, evaporation, distillation, and heat transfer used in pharmaceutical processing.
• Introduce material handling systems, corrosion control, and waste management practices relevant to pharmaceutical plants.
• Explain the principles of fluid flow and flow measurement used in pharmaceutical process equipment.
• Develop knowledge of the design, construction, working principles, and pharmaceutical applications of engineering equipment used in the pharmaceutical industry.

Course Content

1. Unit I: Unit operations associated with solids

   12 Hours

   Principle, construction, working, advantages and disadvantages and Pharmaceutical applications of size reduction, size separation and mixing equipment

2. Unit II: Unit operations associated with liquids

   12 Hours

   Principle, construction, working, advantages and disadvantages and Pharmaceutical applications of filtration, crystallization and centrifugation equipment

3. Unit III: Unit operations associated with heat transfer

   12 Hours

   Principle, construction, working, advantages and disadvantages and Pharmaceutical applications of evaporation, drying, distillation and Heat transfer equipment

4. Unit IV: Materials and material handling

   5 Hours

   Introduction to material handling equipment and techniques, Conveyors, hoists, and automated guided vehicles (AGVs), Storage systems: bins, silos in warehouses, Safety considerations in material handling and waste management. Types of corrosion and their impact on pharmaceutical processes and environment

5. Unit V: Flow of fluids

   4 Hours

   Types and measurement of flow, manometers, Reynolds number and its significance, Bernoulli’s theorem and its applications, Orifice meter, Venturimeter, Pitot tube and Rotometer.

Suggested Readings

• Banker, G. S. Pharmaceutical Engineering. Marcel Dekker.
• Sambamurthy, K. Introduction to Pharmaceutical Engineering. New Age International.
• Kennedy, T. F. Good Design Practices for GMP Pharmaceutical Facilities. CRC Press.
• Banker, G. S. and Rhodes, C. T. Modern Pharmaceutics. CRC Press.
• Hickey, A. J. Pharmaceutical Process Engineering. CRC Press.
• Cole, G. C. Pharmaceutical Facilities: Design, Layouts and Validation. CRC Press.
• Bertch, F. J. Fundamentals of Modern Pharmaceutical Process Engineering. Academic Press.
• Chase, A. G. Environmental Management in the Pharmaceutical Industry. Springer.
• Bunn, G. Pharmaceutical Production Facilities: Design and Applications. CRC Press.

Course Objectives

• Introduce the fundamental concepts of microbiology and its relevance to pharmaceutical sciences.
• Provide insights into the industrial application of microorganisms in the manufacture of pharmaceutical products.
• Provide knowledge Good Manufacturing Practices (GMP) related to microbial contamination control.
• Provide understanding in microbial evaluation techniques such as sterility testing, microbial limit tests, and microbial assay.
• Familiarize students with sterilization technologies, microbial spoilage control, and in vitro cell culture techniques for pharmaceutical research and quality assurance.

Course Content

1. Unit I: Introduction and role of microorganisms in pharmaceutical industry

   9 Hours

   Fundamentals of microbiology: Microorganisms and medicines, Introduction to various microorganisms, Microbial cultivation, isolation and enumeration. Pharmaceutical importance of microorganisms.

   Introduction to Microscope (Compound and Electron Microscope)

   Identification of bacteria using staining techniques (simple, Gram‘s & Acid-fast staining) and biochemical tests (IMViC).

   Antibiotics produced by microbiology (Production and uses streptomycin, cephalosporin)

2. Unit II: Evaluation of microbiological contamination

   9 Hours

   Sources and types of microbial contaminant

   Control of microbial contamination during manufacture of Nonsterile dosage forms and sterile dosage forms (including Aseptic area), control of Atmosphere, Water, Raw material, Facility, Packaging, Equipment

   Microbiological spoilage of pharmaceuticals, Factors affecting microbial spoilage of pharmaceuticals.

   Introduction to Fermentation, types and fermenters.

3. Unit III: Microbial control and evaluation

   9 Hours

   Designing of aseptic area. Laminar flow equipment’s, clean area classification, Biological Safety Level categories. Methods of prevention.

   Disinfectants, antiseptics, and preservatives, and their evaluation, Factors affecting the antimicrobial activity of disinfectants

4. Unit IV: Sterilization procedures, assurance and evaluation

   9 Hours

   Physical, chemical, gaseous, radiation and mechanical methods of sterilization, Advances sterilization technologies, Evaluation of efficiency of sterilization; Validation of sterilization procedures and Sterility indicators.

   Sterility assurance, Bioburden determination, Modelling in predicting microbial growth and death, Test for bacteriostatic, bactericidal activity

5. Unit V: Microbiological quality control

   9 Hours

   Microbial limit tests and Microbial assay (antibiotics, vitamins and amino acids)

   Sterility testing of products according to IP, BP and USP

   Methods for monitoring Water and Air Quality

   In vitro cell cultures, general procedure for cell culture, Application of cell cultures in pharmaceutical industry and research

Suggested Readings

• Pelczar, M. J., Chan, E. C. S. and Krieg, N. R. Microbiology: Concepts and Applications. McGraw-Hill.
• Prescott, L. M., Harley, J. P. and Klein, D. A. Microbiology. McGraw-Hill.
• Hugo, W. B. and Russell, A. D. Pharmaceutical Microbiology. Blackwell Science.
• Waites, M. J., Morgan, N. L., Rockey, J. S. and Higton, G. Industrial Microbiology: An Introduction. Blackwell Science.
• Denyer, S. P., Hodges, N. A. and Gorman, S. P. Hugo and Russell’s Pharmaceutical Microbiology. Wiley-Blackwell.
• Atlas, R. M. Handbook of Microbiological Media. CRC Press.
• Sandle, T. Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control. Elsevier.
• Sutton, S. V. W. Microbiology in Pharmaceutical Manufacturing. PDA/DHI Publishing.

Course Objectives

• Understand the historical and foundational aspects of experimental pharmacology
• Develop knowledge and practical awareness of ethical and regulatory standards in laboratory animal care and use, as outlined in CCSEA guidelines
• Acquire skills in pharmacological data acquisition and analysis
• Interpret and construct dose-response curves (DRCs) and calculate and interpret pharmacological indices such as LD50, threshold and ceiling dose, slope of DRC, and PD₂,
• Calculate the pharmacokinetic parameters and analyse the roles of pharmacokinetic parameters in the drug effects, and dosing schedule.

Practical / Lab Exercises

1. To describe the contributions of renowned pharmacologists and their discoveries based on pharmacological experiments (Any 5 Noble Laureates whose research contributed to the development of Pharmacology).
2. To study various laboratory safety precautions, hazards, personal hygiene, commonly used tools, devices and instruments in experimental pharmacology.
3. To study common experimental animals including transgenic animals along with their applications in the pharmacological experiments in current drug discovery paradigm.
4. To study concept of 6Rs along with the maintenance and experimentation on laboratory animals as per the CCSEA guidelines.
5. To demonstrate collection/isolation of DNA and RNA using computer simulations and audiovisual aids.
6. To study important anaesthetics and euthanasia procedures for experimental animals.
7. To demonstrate different routes drug administration using computer simulation and understand the significance of each route along with the maximum administrable dose.
8. To study preparation of different types of physiological salt solutions (PSS), cell culture media and to understand the role of each ingredient used in PSS preparation.
9. To study the instrumentation used for isolated tissue experiments (students organ bath assembly) and recent development in recording of the responses of isolated tissues.
10. To record the dose response curve of any two agonists on suitable isolated tissue preparation using computer simulation experiment.
11. To study the potentiating effect of physostigmine on DRC of acetyl choline through interactive computer simulation.
12. To study antagonizing effect of d-tubocurarine on the DRCs of acetylcholine through interactive computer simulation.
13. To determine of PD2 of given agonists using isolated tissue preparation using computer simulation experiment.
14. To study and determine various pharmacokinetic parameters (Cmax, Tmax, Ke, t½, Vd, Clt, AUC, AUMC) from given hypothetical data.
15. To estimate LD₅₀ using hypothetical data through computer-simulated experimentation (as per OECD 425 guideline) using software.
16. Software based quantification of micronucleus test and chromosomal aberration test
17. Software based prediction of teratogenicity.
18. Use of UV-Spectrophotometer for studying drug-protein interactions.

Suggested Readings

• Ghosh, M. N. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.
• Vogel, H. G. Drug Discovery and Evaluation: Pharmacological Assays. Springer.
• Hofmann, F. B. Handbook of Experimental Pharmacology (HEP Series). Springer Nature.
• Organisation for Economic Co-operation and Development. OECD Guidelines for the Testing of Chemicals.
• International Council for Harmonisation. ICH Guideline S7A: Safety Pharmacology Studies for Human Pharmaceuticals.
• International Council for Harmonisation. ICH Guideline S7B: Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization.

Course Objectives

• Understand basic laboratory safety rules and learn how to handle chemicals and glassware properly.
• Gain hands-on experience in preparing, purifying, and identifying organic compounds.
• Learn practical techniques to separate components of binary organic mixtures.
• Learn digital tools for drawing chemical structures and Chemical Reactions.
• Determine molecular properties of aromatic organic and heterocyclic compounds

Practical / Lab Exercises

1. Prepare, purify and characterize melting point, recrystallization following organic compounds (Minimum of 04 aromatic and any two heterocyclic compounds with different chemical reactions)
2. a. Benzanilide/phenyl benzoate/acetanilide from aniline/ phenol by acetylation/acylation reaction.
3. b. 2,4,6-Tribromo aniline from aniline/para bromo acetanilide from Acetanilide by halogenation (Bromination) reaction.
4. c. 5-Nitro salicylic acid from salicylic acid / meta di-nitro benzene from nitro benzene by nitration reaction.
5. d. Benzoic acid/ Salicylic acid from alkyl benzoate/ alkyl salicylate by hydrolysis reaction.
6. e. 1-Phenyl-azo-2-napthol from aniline by diazotization and coupling reactions.
7. f. Synthesis of 2,4,6-trinitrophenol by nitration reaction
8. g. Synthesis of 3,5-dimethyl pyrazole from acetylacetone.
9. h. Synthesis of benzimidazole from ortho phenylene diamine
10. i. Preparation of benzophenone oxime.
11. Qualitative analysis of binary mixture of organic compounds (any two) (Acid + Neutral and Base + Neutral).
12. To draw and visualize 3D structures, calculate molecular properties and to draw Chemical reactions using software tools

Suggested Readings

• Furniss, B. S., Hannaford, A. J., Smith, P. W. G. and Tatchell, A. R. Vogel’s Textbook of Practical Organic Chemistry. Pearson Education.
• Mann, F. G. and Saunders, B. C. Practical Organic Chemistry. Pearson Education.
• Pavia, D. L., Lampman, G. M. and Kriz, G. S. Introduction to Organic Laboratory Techniques: A Small Scale Approach. Brooks/Cole.

Course Objectives

• Provide understanding on preformulation principles and evaluation of key parameters for drugs, excipients, and dosage forms.
• Provide understanding of drug–excipient compatibility testing during formulation development.
• Provide hands-on experience in manufacturing processes and evaluation for solid dosage forms.
• Provide hands-on experience in manufacturing processes and evaluation for sustained/controlled-release dosage forms and microcapsules.
• Provide fundamentals of packaging material evaluation.

Practical / Lab Exercises

1. Preformulation study of any drug/excipient as per pharmacopoeia.
2. Evaluation of powder flow properties for tablet blends.
3. Evaluation of effect of lubricating agents on powder flow properties.
4. Preparation and evaluation of tablets by direct compression.
5. Preparation and evaluation of tablets by dry granulation.
6. Preparation and evaluation of tablets by wet granulation.
7. Quality control of marketed tablets (IR, coated, enteric-coated).
8. Preparation and evaluation of coated tablets.
9. Comparison of dissolution profiles of marketed preparations.
10. Preparation and evaluation of hard-/non-gelatin capsules (fill weight, disintegration).
11. Virtual demonstration: hard-gelatin shell and soft-gel manufacturing (with overview of aseptic line/isolator).
12. Evaluation of packaging materials: primary and secondary/tertiary.
13. Preparation and evaluation of sustained-release tablets.
14. Preparation and evaluation of enteric-coated tablets.

Suggested Readings

• Aulton, M. E. Aulton’s Pharmaceutics: The Science of Dosage Form Design. Elsevier.
• Lachman, L., Lieberman, H. A. and Kanig, J. L. The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors.
• Troy, D. B. and Beringer, P. Remington: The Science and Practice of Pharmacy. Pharmaceutical Press.
• Gibson, M. Pharmaceutical Preformulation and Formulation. CRC Press.
• Robinson, J. R. and Lee, V. H. L. Controlled Drug Delivery: Fundamentals and Applications. CRC Press.
• Indian Pharmacopoeia. Indian Pharmacopoeia Commission.

Course Objectives

• Understand and apply plant tissue culture techniques and related approaches for biomass and secondary metabolite production.
• Introduce biomanufacturing concepts in herbal drug technology, including plant-based production systems and edible vaccines.
• Develop skills in the preparation and optimization of standardized herbal extracts using metabolite analysis and TLC fingerprinting.
• Study the formulation of herbal products using standardized extracts in conventional and novel dosage forms.
• Understand quality control, standardization, regulatory guidelines, and interaction studies for safe herbal drug development.

Course Content

1. Unit I: Plant Tissue Culture and Standardized Extracts

   10 Hours

   Plant tissue culture as an alternative source of medicine:

   Historical development

   Types of cultures

   Nutritional requirements

   Growth and maintenance of callus and suspension culture

   Role of elicitation, genetic transformation, biotransformation, precursor feeding, and somaclonal variation in biomass and secondary metabolite production

   Introduction to biomanufacturing:

   Medicinal plant–based biomanufacturing

   Utilising plant factories in obtaining valuable ingredients for food, pharmaceutical, and cosmetic industries

   Examples: Shikonin and Paclitaxel

   Oral vaccines in healthcare

   Optimization and production of standardized extracts of medicinal plants:

   Strategies for preparation of desired quality extracts by optimizing and adjusting bioactives ensuring quality using analysis of metabolites and TLC fingerprints of the following:

   Aqueous and hydro-alcoholic extracts of Ashwagandha, Shatavari, Licorice, Neem, and Haritaki

   Flavonoid-rich fraction of Sweet lime peel

   Terpenoid-rich fraction of Bacopa

   Phenol-rich fraction of Green Tea

   Steroid-rich fraction of Tribulus

   Alkaloid-rich fraction of Vasaka

2. Unit II: Herbal Formulations, Excipients and Cosmetics

   10 Hours

   Herbal formulations:

   Conventional herbal formulations: syrups, mixtures, powders, capsules, tablets, creams, ointments

   Novel dosage forms: phytosomes (phytocomplexes), liposomes, nanoformulations

   Composition, preparation, and characterization using standardized extracts and bioactives

   Herbal cosmetics:

   Sources and description of raw materials of herbal origin as active agents in skincare, hair care, and oral hygiene products

   Applications in skincare, hair care, and oral hygiene products such as:

   Sunscreen-lotion/gel

   Hair oil, shampoo, herbal dye

   Herbal mouthwash, chewing gums, candies, gargles

   Face serums and herbal face packs

   Excipients of Natural origin

   Colorants, sweeteners, binders, diluents

   Viscosity builders, disintegrants

   Flavors and perfumes

   Protective agents, waxes, bleaching agents and antioxidants

3. Unit III: Quality Control and Standardisation of Herbal Medicines

   7 Hours

   WHO, AYUSH, and EU guidelines on quality control, stability, and shelf life studies of herbal medicines

   Approaches for standardisation and quality control of botanicals and formulations

   Testing methods and regulatory considerations

   Role of DNA fingerprint and molecular markers such as rbcL, matK, and SCAR in quality control

   Forensic pharmacognosy: Role in identification of illicit herbal drugs (e.g., Cannabis, Opium)

4. Unit IV: Herb–Drug / Food / Herb Interactions

   10 Hours

   General introduction to interactions and role of ADME, Cytochrome P450, and P-gp

   Herb–drug interactions:

   St. John’s Wort with warfarin

   Ginkgo biloba with aspirin

   Herb–food interactions:

   Licorice with salty foods

   Turmeric with fats

   Green tea with iron-rich foods

   Herb–herb interactions:

   Ephedra with Ginseng

   Chamomile with Valerian

   Adverse reactions related to plants and foods such as allergy, intolerance, and toxicity

5. Unit V: Regulatory Requirements of Herbal Drugs and Botanicals

   8 Hours

   Regulatory framework in India for Herbal and ASU medicines:

   a) Role of regulatory bodies

   b) ASU DTAB (Ayurveda, Siddha, and Unani Drugs Technical Advisory Board)

   c) ASU DCC (Drugs Consultative Committee for ASU drugs)

   d) Schedule T – GMP requirements for ASU drugs

   e) Schedule E1 – Poisonous drugs listed under AYUSH

   f) Drugs and Cosmetics Act – Regulatory provisions relevant to herbal/ASU medicines, procedures for registration, trade, and export

   g) Concept of Phytopharmaceuticals and Ayush Aahara in bridging Indian traditional knowledge with modern science.

Suggested Readings

• Waldesch, F. G. Herbal Medicinal Products. CRC Press.
• Indian Herbal Pharmacopoeia. Indian Drug Manufacturers’ Association.
• World Health Organization. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants.
• Drugs and Cosmetics Act and Rules (India). Government of India.

Course Objectives

• Develop a comprehensive understanding of the fundamental principles of medicinal chemistry, including physicochemical properties, drug metabolism, and prodrug concepts.
• Classify and describe the chemical structures, therapeutic uses, and structure–activity relationships of drugs acting on the autonomic and cardiovascular systems.
• Apply the principles of structure–activity relationships (SAR) to explain and predict the pharmacological activity.
• Understand the synthetic pathways of drugs, emphasizing important reaction steps and chemical transformations.
• Analyze the relationship between drug structure and pharmacological activity in relation to therapeutic efficacy and safety.

Course Content

1. Study of the development of the following classes of drugs, Chemical Classification, Structure, uses of drugs mentioned in the course, Structure activity relationship of selective class of drugs as specified in the course and Synthesis of selected drugs as superscripted (*)

2. Unit I: Fundamentals of Medicinal Chemistry

   7 Hours

   Introduction: History and scope of medicinal chemistry

   Physicochemical properties in relation to biological action: Ionization, solubility, partition coefficient, hydrogen bonding, Chelation, Bioisosterism and protein binding

   Drug metabolism: Phase I & II reactions

3. Unit II: Drugs Acting on the Autonomic Nervous System

   15 Hours

   Adrenergic or Sympathomimetic agents: Nor-epinephrine, Epinephrine, Phenylephrine*, Dopamine, Methyldopa, Clonidine, Dobutamine, Isoproterenol, Terbutaline, Salbutamol*, Bitolterol, Naphazoline, Oxymetazoline and Xylometazoline, Hydroxyamphetamine, Pseudoephedrine, Propylhexedrine, Metaraminol.

   Anti-adrenergic or Sympatholytic agents: Tolazoline*, Phentolamine, Phenoxybenzamine, Prazosin, Dihydroergotamine, Propranolol*, Metibranolol, Atenolol, Betazolol, Bisoprolol, Esmolol, Metoprolol, Labetalol, Carvedilol. SAR of beta adrenergic blockers.

   Cholinergic or Parasympathomimetic agents: Acetylcholine, Carbachol*, Bethanechol, Methacholine, Pilocarpine, Physostigmine, Neostigmine, Pyridostigmine, Edrophonium chloride, Tacrine hydrochloride, Ambenonium chloride, Isofluorphate, Echothiophate iodide, Parathione, Malathion. Pralidoxime chloride.

   Anti-Cholinergic or Parasympatholytic agents: Atropine, Hyoscyamine, Scopolamine, Homatropine, Ipratropium*, Tropicamide, Cyclopentolate, Clidinium Glycopyrrolate, Dicyclomine*, Methantheline, Propantheline, Benztropine mesylate, Orphenadrine, Biperidine, Procyclidine, Tridihexethyl, Isopropamide, Ethopropazine, SAR of cholinergic blockers.

   Local anesthetic agents: Cocaine, Hexylcaine, Meprylcaine, Cyclomethycaine, Piperocaine. Benzocaine, Butamben, Procaine*, Butacaine, Propoxycaine, Tetracaine, Benoxinate, Lignocaine, Mepivacaine, Prilocaine, Etidocaine, Phenacaine, Diperodon, Dibucaine.* SAR of Local anesthetics.

4. Unit III: Drugs Acting on the Cardiovascular System

   9 Hours

   Anti-anginals: Amyl nitrite, Nitroglycerin, Pentaerythritol, Isosorbide dinitrite*, Dipyridamole, Verapamil, Bepridil hydrochloride, Diltiazem, Nifedipine, Amlodipine, Felodipine, Nicardipine, Nimodipine.

   Anti-hypertensives: Timolol, Captopril, Lisinopril, Enalapril, Benazepril, Quinapril, Methyldopate,* Clonidine, Guanethidine, Guanabenz, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine, Hydralazine.

   Drugs to treat Congestive Heart Failure (CHF): Digoxin, Digitoxin, Nesiritide, Bosentan, Tezosentan.

   Anti-arrhythmics (Class I–IV): Quinidine sulphate, Procainamide, Disopyramide*, Phenytoin, Lidocaine, Tocainide, Mexiletine, Lorcainide, Amiodarone, Sotalol.

5. Unit IV: Drugs acting on blood and Renal System

   6 Hours

   Antihyperlipidemic Agents: Fenofibrate*, Lovastatin, Cholesteramine and Cholestipol

   Coagulants and Anti-Coagulants: Menadione, Acetomenadione, Warfarin, Anisindione, clopidogrel.

   Diuretics: Acetazolamide*, Methazolamide, Dichlorphenamide, Chlorthiazide, Hydrochlorothiazide, Hydroflumethiazide, Cyclothiazide, Furosemide*, Bumetanide, Ethacrynic acid, Spironolactone, Triamterene, Amiloride. Mannitol. SAR of Thiazides.

6. Unit V: Autacoids and related drugs

   8 Hours

   Antihistamines

   a. H1–antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate, Doxylamines, Clemastine, Diphenylphyraline, Tripelenamine, Chlorcyclizine, Meclizine, Buclizine, Chlorpheniramine, Triprolidine, Phenindamine, Promethazine*, Trimeprazine, Cyproheptadine, Azatidine, Astemizole, Loratadine, Cetirizine, Levocetrizine Cromolyn.

   b. H2-antagonists: Cimetidine*, Famotidine, Ranitidine.

   Gastric Proton pump inhibitors: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole

   Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Antipyretics: Sodium salicylate, Aspirin, Diflunisal, Mefenamic acid*, Niflumic acid, Meclofenamate, Indomethacin, Sulindac, Tolmetin, Zomepirac, Diclofenac, Ketorolac, Ibuprofen*, Naproxen, Piroxicam, Phenacetin, Acetaminophen, Antipyrine, Phenylbutazone, Celecoxib, Etoricoxib, SAR of representative agents by class.

Suggested Readings

• Lemke, T. L., Williams, D. A. and Roche, V. F. Foye’s Principles of Medicinal Chemistry. Lippincott Williams & Wilkins.
• Beale, J. M., Thomas, J. T. and Duckett, M. H. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry. Lippincott Williams & Wilkins.
• Abraham, D. J. and Griffin, J. L. Burger’s Medicinal Chemistry and Drug Discovery. Wiley.
• Patrick, G. L. An Introduction to Medicinal Chemistry. Oxford University Press.
• Lednicer, D. The Organic Chemistry of Drug Synthesis. Wiley.
• Furniss, B. S., Hannaford, A. J., Smith, P. W. G. and Tatchell, A. R. Vogel’s Textbook of Practical Organic Chemistry. Pearson Education.
• Brunton, L., Hilal-Dandan, R. and Knollmann, B. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. McGraw-Hill Education.
• Williams, D. A. Foye’s Principles of Medicinal Chemistry. Lippincott Williams & Wilkins.

Course Objectives

• Understand and apply plant tissue culture techniques and related approaches for biomass and secondary metabolite production.
• Introduce biomanufacturing concepts in herbal drug technology, including plant-based production systems and edible vaccines.
• Develop skills in the preparation and optimization of standardized herbal extracts using metabolite analysis and TLC fingerprinting.
• Study the formulation of herbal products using standardized extracts in conventional and novel dosage forms.
• Understand quality control, standardization, regulatory guidelines, and interaction studies for safe herbal drug development.

Course Content

1. Unit I: Introduction to Pharmaceutical Biotechnology

   9 Hours

   Introduction to biotechnology in pharmaceutical sciences; protein therapeutics; analytical characterization of proteins; monoclonal antibodies; antigens; enzyme immobilization; cell culture and immobilization techniques; pharmaceutical applications.

2. Unit II: Genetic Engineering and Recombinant DNA Technology

   9 Hours

   Principles of genetic engineering; recombinant DNA technology; production of interferons, hepatitis-B vaccine, and insulin; polymerase chain reaction (PCR) and its applications; mutations and types of mutants.

3. Unit III: Microbial Biotransformation and Fermentation Technology

   9 Hours

   Microbial biotransformation; fermentation principles and process control; industrial production of alcohol, penicillins, citric acid, and vitamin B₁₂; blood products—collection, processing, and storage.

4. Unit IV: Gene Therapy, Genomics and Personalized Medicine

   9 Hours

   Gene therapy—types and methodologies; delivery systems; ethical concerns and challenges; Human Genome Project; role of bioinformatics and artificial intelligence in personalized medicine.

5. Unit V: Immunology, Vaccines and Sera

   9 Hours

   Basics of immunology; types and generations of vaccines; immunization strategies; vaccine preparation, evaluation, and standardization; regulatory aspects; sera therapy; marketed products; challenges and newer approaches.

Suggested Readings

• Crommelin, D. J. A., Sindelar, R. D. and Meibohm, B. Pharmaceutical Biotechnology: Fundamentals and Applications. Springer.
• Walsh, G. Biopharmaceuticals: Biochemistry and Biotechnology. Wiley-Blackwell.
• Brown, T. A. Gene Cloning and DNA Analysis: An Introduction. Wiley-Blackwell.
• Glick, B. R., Pasternak, J. J. and Patten, C. L. Molecular Biotechnology: Principles and Applications of Recombinant DNA. ASM Press.
• Doran, P. M. Bioprocess Engineering Principles. Academic Press.
• Vogel, H. C. and Todaro, C. L. Fermentation and Biochemical Engineering Handbook. William Andrew.
• Primrose, S. B., Twyman, R. M. and Old, R. W. Principles of Gene Manipulation and Genomics. Wiley-Blackwell.
• Strachan, T. and Read, A. Human Molecular Genetics. Garland Science.
• Plotkin, S. A., Orenstein, W. A., Offit, P. A. and Edwards, K. M. Plotkin’s Vaccines. Elsevier.
• Kindt, T. J., Goldsby, R. A., Osborne, B. A. and Kuby, J. Kuby Immunology. W. H. Freeman.
• Janeway, C. A., Travers, P., Walport, M. and Shlomchik, M. Janeway’s Immunobiology. Garland Science.

Course Objectives

• Understand the concepts of social pharmacy, public health, and their interrelation.
• Identify the social determinants of health and their impact on health outcomes and medication use.
• Recognize the role of pharmacists in public health initiatives, health promotion, and disease prevention.
• To gain knowledge about the Indian healthcare system, national health policies, and important health programs.
• To understand basic epidemiological principles and their application in public health.

Course Content

1. Unit I: Introduction to Social Pharmacy and Public Health

   6 Hours

   a) Social Pharmacy: Definition, scope, historical development, and importance. Social pharmacy as a multidisciplinary field.

   b) Public Health: Definition, concepts, history, core functions, and ethical considerations.

   c) Interplay between Social Pharmacy and Public Health: The evolving role of the pharmacist in the public health arena.

   d) Concept of Health and Disease: WHO definition of health; dimensions of health – physical, mental, social, spiritual, and environmental.

   e) Determinants of Health: Social, economic, environmental, lifestyle, and healthcare service determinants and their impact on population health.

   f) Health Indicators: Indicators used to measure health status and health outcomes in a population.

2. Unit II: Health Systems, Policy, and Pharmacoepidemiology

   6 Hours

   a) Healthcare Delivery Systems: Overview of global healthcare systems.

   b) Indian Healthcare System: Structure, public and private sectors, primary, secondary, and tertiary levels of care.

   c) Health Policy: Introduction to health policy formulation and analysis; objectives of India’s National Health Policy.

   d) National Health Mission (NHM): NRHM and NUHM – goals, strategies, and impact on public health indicators.

   e) Pharmacoepidemiology: Definition, aims, scope, and applications.

   f) Measures of Disease Frequency and Distribution: Incidence, prevalence, endemic, epidemic, pandemic; morbidity and mortality rates, Odds ratio and relative risk.

   g) Introduction to Biostatistics: Role in public health; types of data; basic data presentation methods.

3. Unit III: Preventive Healthcare, Health Promotion, and Communicable Diseases

   6 Hours

   a) Levels of Prevention: Primordial, primary, secondary, and tertiary prevention with examples.

   b) Role of Pharmacists in Disease Prevention and Health Promotion: Immunization services, screening programs, lifestyle counselling.

   c) Health Education: Definition, principles, methods, and importance; development of effective health education materials.

   d) Mother and Child Health (MCH): Antenatal care, postnatal care, breastfeeding, immunization schedules.

   e) Communicable Diseases: Modes of transmission, prevention, and control of tuberculosis, HIV/AIDS, malaria, dengue, typhoid, influenza; pharmacist’s role.

4. Unit IV: Non-Communicable Diseases, Nutrition, Mental Health, and National Programs

   6 Hours

   a) Non-Communicable Diseases (NCDs): Diabetes, hypertension, cardiovascular diseases, chronic respiratory diseases, cancer; prevention and management.

   b) Nutrition and Health: Balanced diet, macro- and micronutrients, malnutrition, nutritional deficiency disorders, food safety, and adulteration.

   c) Mental Health: Common mental disorders, stigma, promotion of mental well-being; pharmacist’s role.

   d) National Health Programs in India: Programs related to MCH, NCDs, communicable diseases, tobacco control, and deafness prevention.

5. Unit V: Pharmacoeconomics, Rational Use of Medicines, Professional Roles, and Future Trends

   6 Hours

   a) Pharmacoeconomics: Introduction, significance; Cost-Benefit Analysis (CBA), Cost-Effectiveness Analysis (CEA), Cost-Utility Analysis (CUA).

   b) Rational Use of Medicines (RUM): Definition, importance, problems of irrational drug use; pharmacist’s role.

   c) Medication Adherence: Factors affecting adherence, consequences of non-adherence, improvement strategies.

   d) Drug Misuse and Abuse: Alcohol, tobacco, opioids, prescription drug abuse; pharmacist’s role.

   e) Professionalism and Ethics in Social Pharmacy: Ethical dilemmas in public health pharmacy.

   f) Disaster Management: Role of pharmacists.

   g) Emerging Trends: Telepharmacy, digital health, personalized medicine, expanding public health responsibilities of pharmacists.

Suggested Readings

• Anderson, S., Dedrick, R. and Tiffany, B. Community Pharmacy Practice for Public Health. McGraw-Hill Education.
• Desselle, S. Public Health and Pharmacy Practice. McGraw-Hill Education.
• Donyai, P. Social and Cognitive Pharmacy: Theory and Case Studies. Pharmaceutical Press.
• Gillam, S., Yates, J. and Badrinath, P. Essential Public Health: Theory and Practice. Cambridge University Press.
• Levin, B. L. and Hanson, A. Essentials of Public Health Pharmacy. Jones & Bartlett Learning.
• Park, K. Park’s Textbook of Preventive and Social Medicine. Banarsidas Bhanot Publishers.
• Schneider, M. J. Introduction to Public Health. Jones & Bartlett Learning.
• Taylor, K. and Harding, G. Pharmacy Practice. CRC Press.
• Wertheimer, A., Ibrahim, M. I. M. and Babar, Z. U. D. Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries. Elsevier.

Course Objectives

• Develop a comprehensive understanding of neurohumoral transmission, neurotransmitters, and the organization and function of the autonomic nervous system.
• Provide knowledge of the classification, mechanisms of action, and pharmacological effects of various classes of drugs.
• Explain the pharmacology of drugs acting on the peripheral nervous system, cardiovascular system, and urinary system.
• Describe the physiological roles of autacoids and the pharmacology of drugs used in the management of pulmonary diseases and related disorders.
• Familiarize students with the pharmacology of drugs acting on the immune system, hematopoietic system, and blood, and relate pharmacological principles to clinical conditions through case-based learning.

Course Content

1. Unit I: Pharmacology of drugs acting on the peripheral nervous system

   10 Hours

   a) Organization and functions of PNS.

   b) Neurohumoral transmission, co-transmission. Neurotransmitters and their receptors, including non-adrenergic and non-cholinergic (NANC) neurotransmitters.

   c) Parasympathomimetic and Parasympatholytic drugs.

   d) Sympathomimetic and sympatholytic drugs.

   e) Skeletal muscle relaxants (peripheral and central).

   f) Drugs used in the treatment of myasthenia gravis and glaucoma

2. Unit II: Pharmacology of drugs acting on the cardiovascular system

   10 Hours

   a) Introduction to cardiovascular hemodynamic and cardiac electrophysiology.

   b) Drugs used in congestive cardiac failure.

   c) Anti-arrhythmic drugs.

   d) Anti-anginal and newer anti-ischemic drugs.

   e) Anti-hypertensive drugs.

   f) Shock, types of shocks and drugs used in their management.

   g) Stroke, types of strokes and drugs used in their management

3. Unit III: Pharmacology of drugs acting on blood and kidney

   10 Hours

   1. Pharmacology of drugs acting on blood

   a) Anti-platelet agents

   b) Coagulants and anticoagulants.

   c) Fibrinolytics and Plasma expanders.

   d) Haematinics.

   e) Anti-hyperlipidaemic drugs.

   2. Pharmacology of drugs acting on kidney

   a) Diuretics.

   b) Anti-diuretics.

4. Unit IV: Pharmacology of autacoids and related drugs

   9 Hours

   a) Introduction to autacoids and their classification. Therapeutic significance of important agonists and antagonists of prostaglandins, thromboxane, leukotrienes, angiotensin, bradykinin and substance P.

   b) Histamine and antihistamines.

   c) 5-HT, its agonists and antagonists, drugs used in migraine.

   d) Non-steroidal anti-inflammatory drugs, antipyretics and analgesics.

   e) Anti-gout and Antirheumatic drugs including Disease Modifying Antirheumatic Drugs (DMARDs).

5. Unit V: Pharmacology of Drugs acting on respiratory system; Pharmacology of Drugs acting on immune system

   6 Hours

   i) Pharmacology of Drugs acting on respiratory system

   a) Drugs used in the treatment of bronchial asthma and COPD.

   b) Definitions, classification and therapeutic uses of nasal decongestants, mucolytics, expectorants and antitussives.

   c) Respiratory stimulants.

   ii) Pharmacology of Drugs acting on immune system

   Mechanism of action, adverse effects and therapeutic uses of important classes of immune stimulants and immunosuppressants.

Suggested Readings

• Brunton, L., Hilal-Dandan, R. and Knollmann, B. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. McGraw-Hill Education.
• Craig, C. R. and Stitzel, R. E. Modern Pharmacology with Clinical Applications. Lippincott Williams & Wilkins.
• DiPiro, J. T., Talbert, R. L., Yee, G. C. and Matzke, G. R. Pharmacotherapy: A Pathophysiologic Approach. McGraw-Hill Education.
• Katzung, B. G. and Trevor, A. J. Basic and Clinical Pharmacology. McGraw-Hill Education.
• Rang, H. P., Dale, M. M., Ritter, J. M., Flower, R. J. and Henderson, G. Rang and Dale’s Pharmacology. Elsevier.
• Tripathi, K. D. Essentials of Medical Pharmacology. Jaypee Brothers Medical Publishers.

Course Objectives

• To apply seed germination and plant tissue culture techniques for medicinal plants.
• To prepare and standardize herbal extracts and phytoconstituent-enriched fractions as per Pharmacopoeial procedures.
• To evaluate natural excipients and standardized herbal extracts for formulation development.
• To develop and evaluate herbal cosmetic, pharmaceutical, and novel delivery systems using standardized extracts.
• To assess the quality of marketed herbal formulations and extracts through experiential learning and surveys.

Practical / Lab Exercises

1. (Minimum 12 experiments must be performed)
2. To establish seed germination and plant tissue culture of a medicinal plant.
3. Preparation and standardization of extracts of Phenol-rich fraction of Green Tea.
4. Preparation and standardisation of Aqueous and hydro-alcoholic extracts of Ashwagandha or Haritaki (as per IP procedure)
5. Preparation and standardization of Flavonoid-enriched fraction of Sweet lime peel
6. Preparation and standardization of Terpenoid-rich fraction of Bacopa.
7. Preparation and standardization of Steroid-rich fraction of Tribulus
8. Preparation and standardization of Alkaloid-rich fraction of Vasaka
9. Evaluation of excipients of natural origin.
10. To develop and evaluate herbal cosmetics in form of gel, cream, lotion using standardized herbal extract.
11. To develop and evaluate herbal shampoo using standardized herbal extract.
12. To develop herbal formulations in form of syrups and mixtures using standardized herbal extract and their evaluation as per Pharmacopoeial guidelines.
13. To develop herbal tablets using standardized herbal extract and their evaluation as per Pharmacopoeial guidelines.
14. Preparation of botanicals-based new herbal medicinal product delivery systems (phytosomes).
15. Experiential learning-based experiments involving collection of herbal formulations/ extracts from the market and their quality evaluation as per Pharmacopoeial guidelines.
16. Survey on different commercialized marketed herbal cosmetics.
17. Survey on different commercialized marketed herbal medicine.

Suggested Readings

• Evans, W. C. Trease and Evans’ Pharmacognosy. Elsevier.
• Harborne, J. B. Phytochemical Methods: A Guide to Modern Techniques of Plant Analysis. Springer.
• Houghton, P. J. and Raman, A. Laboratory Handbook for the Fractionation of Natural Extracts. Chapman & Hall.
• Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Indian Pharmacopoeia Commission.
• Mukherjee, P. K. Quality Control and Evaluation of Herbal Drugs. Elsevier.
• Sarker, S. D., Latif, Z. and Gray, A. I. Natural Products Isolation. Humana Press.
• World Health Organization. WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants.
• World Health Organization. WHO Quality Control Methods for Herbal Materials.

Course Objectives

• Comprehend the fundamental principles of drug synthesis, assay, and monograph analysis.
• Acquire practical skills in the synthesis of selected drug molecules and intermediates.
• Develop proficiency in performing qualitative and quantitative assays of drugs.
• Understand the requirements and procedures involved in drug monograph analysis.
• Apply appropriate techniques and methodologies for the preparation, assay, and monograph analysis of various drugs.

Practical / Lab Exercises

1. (Minimum 12 experiments must be performed)
2. Preparation of Drugs / Intermediates: a. Aspirin; b. Benzotriazole; c. Benzocaine; d. Phenytoin; e. Dibenzalacetone; f. Paracetamol
3. Assay of Drugs (Any 3): a. Aspirin; b. Ibuprofen; c. Furosemide; d. Paracetamol
4. Monograph Analysis (Any 3): a. Paracetamol; b. Aspirin; c. Phenobarbital; d. Diclofenac; e. Phenytoin

Suggested Readings

• Abraham, D. J. and Rotella, D. P. Burger’s Medicinal Chemistry, Drug Discovery and Development. John Wiley & Sons.
• Beckett, A. H. and Stenlake, J. B. Practical Pharmaceutical Chemistry. CBS Publishers & Distributors.
• Furniss, B. S., Hannaford, A. J., Smith, P. W. G. and Tatchell, A. R. Vogel’s Textbook of Practical Organic Chemistry. Pearson Education.
• Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Indian Pharmacopoeia Commission.
• Kar, A. Advanced Practical Medicinal Chemistry. New Age International Publishers.
• Lednicer, D. The Organic Chemistry of Drug Synthesis. John Wiley & Sons.
• Moffat, A. C., Osselton, M. D. and Widdop, B. Clarke’s Analysis of Drugs and Poisons. Pharmaceutical Press.
• United States Pharmacopeial Convention. United States Pharmacopeia–National Formulary (USP–NF). United States Pharmacopeial Convention.
• Vogel, A. I. Vogel’s Textbook of Quantitative Chemical Analysis. Longman Scientific & Technical.

Course Objectives

• Provide fundamental knowledge of biotechnology concepts, including protein therapeutics, monoclonal antibodies, enzyme immobilization, and their pharmaceutical applications.
• Explain the principles and applications of genetic engineering and recombinant DNA technology in pharmaceutical sciences.
• Develop understanding of microbial biotransformation, fermentation processes, and large-scale production of pharmaceutical products such as alcohol, antibiotics, vaccines, and blood products.
• Describe the principles, methodologies, delivery systems, and ethical considerations associated with gene therapy and modern vaccine technologies.
• Introduce the regulatory requirements and standardization procedures for vaccines, sera, and other biopharmaceutical products.

Practical / Lab Exercises

1. (Minimum 12 experiments must be performed)
2. Understanding Good microbiological laboratory practices while working in Microbiology laboratory aseptic handling in microbiology lab: growth and isolation of microbes using streaking, spreading and subculturing techniques: microbial staining, study of various equipments such as loop, straight wire, spreader, forceps, pipette, test tube, petridish, burner etc and apparatus used in microbiology lab - BOD incubator, laminar flow, aseptic hood, autoclave, hot air sterilizer, deep freezer and microscopes.
3. Handling of biological spill, decontamination procedures and hygiene while handling microorganisms and disposal
4. Sterilization and evaluation of glassware and apparatus using hot air oven
5. Preparation and sterilization of solid and liquid culture medium using different techniques
6. Determination of microbiological efficacy of disinfectant/ preservative efficacy test
7. Tests for sterility of ophthalmic or parenteral marketed formulation according to IP.
8. Analysis of Biotechnological product (Protein, nucleic acid materials) by UV Vis and FTIR spectrophotometer
9. Production of alcohol using Fermentation process
10. Practice Whole cell immobilization technique (any one)
11. Practice Enzyme immobilization technique and its kinetics
12. Isolation and estimation of DNA and RNA
13. Isolation of plasmids and expression of protein
14. Agarose gel electrophoresis of DNA/ RNA
15. SDS – polyacrylamide gel electrophoresis for proteins.
16. Microbiological assay of antibiotics.

Suggested Readings

• Baltz, R. H., Davies, J. E. and Demain, A. L. Manual of Industrial Microbiology and Biotechnology. ASM Press.
• Carter, S. J. Cooper and Gunn’s Tutorial Pharmacy. CBS Publishers & Distributors.
• Chou, S. L. M. Practical Biotechnology: A Guide to Biochemical Engineering. Springer.
• Denyer, S. P., Hodges, N. A. and Gorman, S. P. Hugo and Russell’s Pharmaceutical Microbiology. Wiley-Blackwell.
• Glick, B. R., Pasternak, J. J. and Patten, C. L. Molecular Biotechnology: Principles and Applications of Recombinant DNA. ASM Press.
• Lachman, L., Lieberman, H. A., Kanig, J. L. and Khar, R. K. The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors.
• Pelczar, M. J., Chan, E. C. S. and Krieg, N. R. Microbiology. McGraw-Hill.

Course Objectives

• Understand and apply basic health assessment techniques (blood pressure, BMI, and blood glucose levels), and perform essential first aid skills.
• Gain skills in the development of health education tools and communication strategies to promote prevention and control of communicable diseases and encourage healthy lifestyle modifications.
• Familiarize with mental health assessment tools and improve clinical communication skills through simulated role-play exercises focused on patient screening.
• Acquire practical knowledge of immunization practices and demonstrate correct vaccine administration techniques using simulation models.
• Understand the principles of epidemiology and designing preventive strategies for common communicable diseases. Develop foundational knowledge of Pharmacoeconomics and its applications. Evaluate health interventions, while identifying irrational drug use practices.

Practical / Lab Exercises

1. (Minimum 12 Experiments must be performed; * Mandatory experiments)
2. Training on health screening services (Blood pressure, body mass index (BMI), blood glucose levels, heart rate (pulse rate), respiratory rate, body temperature, oxygen saturation (SpO₂), hemoglobin levels (basic anemia screening)).
3. Develop health promotion material for the prevention of communicable diseases.
4. Role play- usage of different mental scales in patient screening.
5. Case study on calculation of prevalence; incidence, odds ratio and relative risk.
6. Design and demonstrate preventive strategies for major communicable diseases (group activity)
7. Present a case study highlighting cost-benefit analysis in healthcare.
8. Perform cost-effectiveness analysis for selected health interventions.
9. Conduct cost-utility analysis to assess health program efficiency.
10. Perform basic first aid techniques.
11. Design informational leaflet on lifestyle modifications for disease prevention.
12. Identify and illustrate irrational drug use with a real-world example.
13. Prepare an immunization chart, interpret the vaccination schedule and perform patient counselling for vaccination*.
14. Hand wash and hand sanitizing techniques*.
15. Demonstration and practice of wound dressing in first aid and basic suturing techniques*.
16. Practical training on routes of drug administration-oral, and other non-parenteral routes*.
17. Practical training on routes of drug administration- parenteral routes*.
18. Training on basic life support (BLS)*.

Suggested Readings

• Drummond, M. F., Sculpher, M. J., Claxton, K., Stoddart, G. L. and Torrance, G. W. Methods for the Economic Evaluation of Health Care Programmes. Oxford University Press.
• Harding, G. and Taylor, K. Social Pharmacy. Pharmaceutical Press.
• Park, K. Park’s Textbook of Preventive and Social Medicine. Banarsidas Bhanot Publishers.

Course Objectives

• Provide understanding of the theoretical and practical aspects of different pharmacological experiments using virtual simulations and video demonstrations.
• Develop skills to assess drug effects on various systems such as cardiovascular, respiratory, skeletal muscle, and gastrointestinal tract using simulation models.
• Familiarize the learners with experimental methodologies such as Langendorff’s heart preparation, spasmogen and spasmolytic effects, and PA2 value determination using Schild plot.
• Provide knowledge of modern techniques for drug evaluation.
• Explore clinical pharmacology aspects through case studies on drug interactions, management of cardiovascular and respiratory diseases, and plasma volume expanders.

Practical / Lab Exercises

1. (Minimum 12 Experiments must be performed)
2. To demonstrate Langendorff’s heart assembly and its applications in pharmacology (only video demonstration/or charts and illustrations).
3. Recording of the effects of different electrolytes, agonists and antagonists on the isolated and perfused frog heart preparation using interactive computer simulation experiment.
4. To study the effect of various drugs on blood pressure and heart rate anaesthetized dog using interactive computer simulation experiment.
5. Demonstration of the estimation of intraocular pressure on rabbit eye and human eye by using conventional Schiotz tonometer and non-contact tonometer.
6. To evaluate the muscle relaxant activity of drugs on Rota-rod apparatus using interactive computer simulation experiment.
7. Demonstration of the effect of spasmogens and spasmolytic using rabbit jejunum using interactive computer simulation experiment.
8. Determination of PA2 value of Atropine using a suitable isolated tissue preparation by Schild plot method with the help of hypothetical data using interactive computer simulation experiment.
9. Determination of PA2 value of Prazosin using a suitable isolated tissue preparation by Schild plot method with the help of hypothetical data using interactive computer simulation experiment.
10. To study the antiallergic effects of drugs using mast cell degranulation assay using interactive computer simulated experiment.
11. Evaluation of diuretic activity of drugs in rats using metabolic cages (simulation) and estimation of electrolytes in the urine samples/serum using flame photometer/commercially available kits.
12. Evaluation of effects of antihistaminic drugs on the histamine-induced bronchospasm in guinea pigs using interactive simulated experiment.
13. To study and analyse drug-drug interaction/ rational drug management of asthma with the help of Case Study/ hypothetical data/ any clinical report.
14. To study clinical pharmacology of the plasma volume expanders and their importance (using charts/open sources videos).
15. Demonstration of evaluation of anti-inflammatory activity in paw oedema model using plethysmometer using simulations.
16. Concept of Biobanking and its significance in drug screening.
17. Isolation of Polymorphonuclear cells from blood and evaluation of endotoxin-induced oxidative stress in them using Nitrobluetetrazolium dye method by colourimetry.
18. Determination of viability of cells (using isolated polymorphonuclear cells) by Trypan blue dye exclusion assay to determine cell viability using microscopy method.
19. Determination of anti-inflammatory activity of durgs in vitro using RBC membrane stabilization assay
20. Determination of protein concentrations using Bradford reagent and plotting of standard curve of bovine serum albumin.
21. Estimation of anticholinesterase inhibitory activity of drugs using Ellman’s reagent (DTNB)
22. Determination and and plotting of standard curve for LPO, Nitric oxide and GSH.
23. *PCI recommended software’s shall be used for performing experiments.

Suggested Readings

• Ghosh, M. N. Fundamentals of Experimental Pharmacology. Hilton & Company.
• Hofmann, F. B. Handbook of Experimental Pharmacology (HEP Series). Springer Nature.
• Computer Assisted Learning (CAL) software packages for experimental pharmacology simulations.

Course Objectives

• Provide comprehensive knowledge of drugs acting on the central nervous system, including anesthetics, sedatives, antipsychotics, and anticonvulsants, with emphasis on their chemical classification and structure–activity relationships (SAR).
• Familiarize students with anti-infective chemotherapeutic agents used against tuberculosis, malaria, protozoal, viral, fungal, helminthic, and urinary tract infections, including their chemical structures and SAR.
• Impart understanding of antibiotics and sulfa drugs, focusing on their chemical classes, mechanisms, therapeutic relevance, and structure–activity relationships.
• Introduce antineoplastic agents and endocrine drugs, highlighting their chemical nature, classification, therapeutic applications, and structure–activity correlations.
• Develop knowledge of antidiabetic agents and narcotic analgesics, including opioid antagonists, with emphasis on medicinal chemistry principles and SAR of key drug classes.

Course Content

1. Unit I: Drugs Acting on the Central Nervous System

   10 Hours

   Study of the development of the following classes of drugs includes chemical classification, structure, uses, SAR of selective drug classes, and synthesis of selected drugs as superscripted*

   General Anesthetics: Halothane, Methoxyflurane, Enflurane, Sevoflurane, Isoflurane, Desflurane, Methohexital, Thiamylal, Thiopental, Ketamine*, Ramelteon, Remimazolam, Fospropofol, Dexmedetomidine

   Sedatives and Hypnotics: Barbital, Phenobarbital*, Mephobarbital, Amobarbital, Butabarbital, Pentobarbital, Secobarbital, Chlordiazepoxide, Diazepam*, Oxazepam, Chlorazepate, Lorazepam, Alprazolam, Zolpidem, Glutethimide, Meprobamate, Ethchlorvynol, Triclofos, Paraldehyde

   SAR of Barbiturates and Benzodiazepines

   Antipsychotics: Promazine, Chlorpromazine*, Triflupromazine, Thioridazine, Piperacetazine, Prochlorperazine, Trifluoperazine, Chlorprothixene, Thiothixene, Loxapine, Clozapine, Haloperidol, Droperidol, Risperidone, Molindone, Sulpiride, Brexpiprazole, Lumateperone, Pimavanserin, Samidorphan

   SAR of Phenothiazines

   Anticonvulsants: Phenobarbitone, Methabarbital, Phenytoin*, Mephenytoin, Ethotoin

   Oxazolidinediones: Trimethadione, Paramethadione

   Succinimides: Phensuximide, Methsuximide, Ethosuximide

   Phenacemide, Carbamazepine*, Clonazepam, Primidone, Valproic acid, Gabapentin, Felbamate, Perampanel, Lacosamide, Retigabine

   SAR of Anticonvulsants

2. Unit II: Anti-Infective Chemotherapeutic Agents

   12 Hours

   Antitubercular Agents: Isoniazid*, Ethionamide, Ethambutol, Pyrazinamide, Para-amino salicylic acid*, Rifampicin, Rifabutin, Cycloserine, Streptomycin, Capreomycin, Pretomanid, Clofazimine, Levofloxacin, Bedaquiline, Linezolid, Delamanid

   Antimalarials: Quinine, Chloroquine*, Amodiaquine, Primaquine, Pamaquine, Quinacrine, Mefloquine, Cycloguanil pamoate, Proguanil, Pyrimethamine, Artesunate, Artemether, Atovaquone

   SAR of Quinoline derivatives

   Antiprotozoals: Metronidazole*, Tinidazole, Ornidazole, Diloxanide, Iodoquinol, Pentamidine isethionate, Atovaquone, Eflornithine, Paromomycin, Nitazoxanide

   Antivirals: Amantadine, Rimantadine, Idoxuridine, Acyclovir*, Ganciclovir, Zidovudine, Didanosine, Zalcitabine, Lamivudine, Loviride, Delavirdine, Ribavirin, Saquinavir, Indinavir, Ritonavir, Valganciclovir, Peramivir, Lenacapavir

   Antifungals: Amphotericin-B, Nystatin, Natamycin, Griseofulvin, Clotrimazole, Econazole, Butoconazole, Oxiconazole, Tioconazole, Miconazole, Ketoconazole*, Terconazole, Itraconazole, Fluconazole, Naftifine, Tolnaftate, Posaconazole, Isavuconazole

   Anthelmintics: Diethylcarbamazine, Thiabendazole, Mebendazole, Albendazole*, Niclosamide, Oxamniquine, Praziquantel, Ivermectin

   Urinary Tract Anti-infective Agents: Nalidixic acid, Norfloxacin, Enoxacin, Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin, Furazolidone, Nitrofurantoin, Methenamine, Moxifloxacin

   SAR of Quinolones

3. Unit III: Antibiotics and Sulfa Drugs

   8 Hours

   Antibiotics: Penicillins, Cephalosporins, β-Lactamase inhibitors, Monobactams

   Aminoglycosides: Streptomycin, Neomycin, Kanamycin, Tetracyclines: Tetracycline, Oxytetracycline, Minocycline, Doxycycline, Macrolides: Erythromycin, Clarithromycin, Azithromycin Chloramphenicol*, Clindamycin, Clavulanic acid

   SAR of Penicillins, Tetracyclines, and Cephalosporins

   Sulfa Drugs: Sulphamethizole, Sulfisoxazole, Sulphapyridine, Sulphathiazole, Sulfacetamide, Sulphamethoxazole, Sulphadiazine, Mefenide, Sulfasalazine, Trimethoprim, Cotrimoxazole, Dapsone*

   SAR of Sulfonamides

4. Unit IV: Antineoplastic Agents

   6 Hours

   Mechlorethamine, Cyclophosphamide, Melphalan, Chlorambucil, Busulfan, Thiotepa, Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine, Cytarabine, Methotrexate*, Azathioprine, Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin, Etoposide, Vinblastine, Vincristine, Paclitaxel, Camptothecin, Cisplatin, Mitotane, Carboplatin

5. Unit V: Endocrine Drugs, Antidiabetic Agents and Narcotic Analgesics

   9 Hours

   Endocrine Drugs

   Sex hormones: Testosterone, Nandrolone, Progesterone, Oestriol, Oestradiol, Oestrone, Diethylstilbestrol

   Drugs for erectile dysfunction: Sildenafil, Tadalafil

   Oral contraceptives: Mifepristone, Norgestrel, Levonorgestrel

   Corticosteroids: Cortisone, Hydrocortisone, Prednisolone, Betamethasone, Dexamethasone

   Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine, Propylthiouracil, Methimazole

   Antidiabetic Agents: Insulin and preparations, Tolbutamide*, Chlorpropamide, Glipizide, Glimepiride

   Biguanides: Metformin

   Thiazolidinediones: Pioglitazone, Rosiglitazone

   Repaglinide, Nateglinide, Acarbose, Voglibose

   Narcotic Analgesics: Morphine, Codeine, Meperidine, Anilerdine, Diphenoxylate, Loperamide, Fentanyl*, Methadone, Propoxyphene, Pentazocine, Levorphanol

   Nalorphine, Levallorphan, Naloxone

   SAR of Morphine analogues

Suggested Readings

• Abraham, D. J. and Griffin, J. L. Burger’s Medicinal Chemistry and Drug Discovery. Wiley.
• Brunton, L., Hilal-Dandan, R. and Knollmann, B. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. McGraw-Hill Education.
• Kar, Ashuthosh. Medicinal Chemistry. New Age International.
• Lednicer, D. The Organic Chemistry of Drug Synthesis. Wiley.
• Li, J. J. Modern Drug Synthesis. Wiley.
• Patrick, G. L. An Introduction to Medicinal Chemistry. Oxford University Press.
• Vogel, A. I. Vogel’s Textbook of Practical Organic Chemistry. Pearson Education.
• Williams, D. A., Lemke, T. L. and Roche, V. F. Foye’s Principles of Medicinal Chemistry. Lippincott Williams & Wilkins.
• Wilson, C. O., Beale, J. M. and Block, J. H. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry. Lippincott Williams & Wilkins.

Course Objectives

• Introduce students to the industrial, commercial, and economic aspects of herbal drugs in national and global markets.
• Knowledge of commercial production, quality assurance, and standardization of herbal extracts, volatile oils, and traditional AYUSH formulations
• Train students in modern analytical techniques for the identification, characterization, and quality evaluation of plant-based drugs and herbal products
• Develop skills in isolation, characterization, commercial production, and analysis of bioactive phytoconstituents.
• Familiarize students with national and international regulatory frameworks, pharmacopoeial standards, and safety, efficacy, and pharmacovigilance requirements governing herbal medicinal products.

Course Content

1. Unit I: General Introduction to Herbal Industries, institutions and trade status of herbals

   8 Hours

   (a) Role of medicinal and aromatic plants trade in national economy of a country and introduction of Current trade status and potential of some commercially important medicinal plants/natural products like Ashwagandha, Turmeric, Ginseng, Amla and essential oils.

   (b) A brief account of bioeconomy, biodiversity hot spots and plant-based industries and institutions involved in research work on medicinal and aromatic plants in India.

   (c) Emerging therapeutic categories of Herbal Medicinal Products available in market, their composition with rationale for Aphrodisiac, Antistress, anti-diabetics, antihyperlipidemic, immunomodulator, hepatoprotective and kidney disorders

   (d) Emerging Herbal cosmeceuticals: Anti-Aging, Depigmenting, anti-acne, sunscreen, detoxifying, anti-irritant, nutricosmetics.

2. Unit II: Commercial Production and Standardization of botanicals

   10 Hours

   Significance of AYUSH/ WHO-GMP, GLP and USFDA compliant facility in production of quality herbal products.

   Commercial production of standardized herbal extracts with clinical relevance: Coleus, Amla, Turmeric, Ashwagandha and Senna.

   Commercial production and standardization of volatile oils: Eucalyptus oils, Lavender oil and Peppermint oil, Rosemary oil

   Preparation and standardization of Ayush formulations viz Aristas and Asawas, Ghutika/Habb, Churna/ Shafoof Arq, Sharbat, Tincture and Bhasma.

3. Unit III: Modern methods of analysis of Plants and Plant-based products

   12 Hours

   Basic principles and applications in analysis of botanicals:

   Spectroscopic methods: UV-Visible spectroscopy, IR Spectroscopy, NMR spectroscopy and Mass spectroscopy, Atomic Absorption Scpectroscopy

   Chromatographic methods: HPTLC, HPLC, UPLC, GC,

4. Unit IV: Isolation, Characterization, Commercial Production and analysis of bioactive phytoconstituents

   8 Hours

   Isolation, characterization with commercial production, identification and analysis of bioactive phytoconstituents: Artemisinin, Sennosides, Withanolids, Boswellic acid, Atropine, and Lycopene.

5. Unit V: International Regulatory Perspectives

   7 Hours

   (a) Overview of global regulations for herbal products (e.g., World Health Organization, United States Food and Drug Administration – Dietary Supplement Health and Education Act, European Medicines Agency, TGA-ARG Therapeutic Goods Administration – Australian Regulatory Guidelines for Complementary Medicines, Natural Health Products (Canada)

   (b) Harmonization challenges and mutual recognition of traditional medicine

   (c) Importance of safety, efficacy and pharmacovigilance in herbal product regulation

   (d) Study of Monographs on herbal drugs and botanicals related to Indian Pharmacopoeia, United States Pharmacopoeia Herbal Medicine and Dietary Supplement, Ayurvedic Pharmacopoeia of India and Unani Pharmacopoeia of India.

Suggested Readings

• Ayurvedic Pharmacopoeia Committee. Ayurvedic Pharmacopoeia of India. Government of India, Ministry of AYUSH.
• European Medicines Agency. Herbal Monographs and Regulatory Guidelines.
• Indian Drug Manufacturers’ Association. Indian Herbal Pharmacopoeia.
• Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Government of India.
• International Council for Harmonisation. ICH Guidelines on Quality, Safety, Efficacy and Multidisciplinary Topics.
• Natural Health Products Directorate. Regulatory Framework for Natural Health Products.
• Unani Pharmacopoeia Committee. Unani Pharmacopoeia of India. Government of India, Ministry of AYUSH.
• United States Pharmacopeial Convention. United States Pharmacopeia.
• World Health Organization. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants.
• Drugs and Cosmetics Act and Rules (India). Government of India.

Course Objectives

• Introduce students to the fundamental concepts, principles, and significance of innovation and entrepreneurship in contemporary economic and social contexts.
• Familiarize students with the structure, components, and key stakeholders of the startup and innovation ecosystem.
• Provide students with an understanding of the startup lifecycle, including ideation, opportunity analysis, product development, validation, and scaling.
• Equip students with practical tools and techniques for problem identification, opportunity recognition, business model development, and idea validation.
• Foster an entrepreneurial mindset by encouraging active participation in innovation-related events, stakeholder interactions, and experiential learning activities.

Course Content

1. Unit I: Introduction to Innovation and Entrepreneurship

   6 Hours

   Defining Innovation and Entrepreneurship: What is Innovation?; Types of Innovation: Product, Process, Business Model, Social; What is Entrepreneurship?; Characteristics of an Entrepreneur

   Invention vs Innovation: Distinction between Invention and Innovation; Importance of Innovation in the 21st Century (Economic growth and job creation; Solving societal problems); Disruptive technologies and their impact

   Case Studies: Innovative companies (e.g., Apple, Google, Tesla)

   Introduction to the Startup Ecosystem: Key components (Entrepreneurs; Incubators/Accelerators; Mentors; Investors; Government; Academia; Support Services); Role of each component in fostering innovation

   Practical Aspect: Participation in National Innovation Day and National Startup Day

2. Unit II: Ideation and Opportunity Identification

   6 Hours

   Identifying Problems and Market Gaps: Problem-solving approach to entrepreneurship; Techniques for problem identification (Observation; Empathy mapping; User interviews); Market research basics (Understanding customer needs and pain points)

   Generating Innovative Ideas: Brainstorming techniques (SCAMPER; Mind Mapping; Design Thinking principles for ideation); Lateral thinking and divergent thinking; From problem to solution: developing initial concepts

   Opportunity Analysis and Feasibility: Market sizing and potential; Competitive analysis; SWOT analysis for new ventures

   Practical Aspect: Participation in Ideation Challenges or Hackathons (e.g., Smart India Hackathon or IIC internal ideation competitions)

3. Unit III: Building a Minimum Viable Product (MVP) and Validation

   6 Hours

   Lean Startup Methodology: Introduction to Lean Startup principles; Build–Measure–Learn feedback loop; Concept of MVP (Importance; Scope and objectives)

   Designing and Developing an MVP: Different types of MVPs; Tools and resources for rapid prototyping; User experience basics for MVPs

   Validation: Customer interviews and feedback collection; A/B testing and split testing; Pivoting vs Persevering

   Practical Aspect: Participation in sessions/workshops on Prototype, MVP, and Product Development

4. Unit IV: Business Models and Startup Operations

   6 Hours

   Business Model Canvas (BMC): Introduction to the 9 building blocks of BMC; Developing a BMC for a new venture; Value Proposition Design

   Legal and Financial Aspects for Startups: Legal structures (Sole Proprietorship; Partnership; Private Limited Company); Intellectual Property Rights (IPR) (Patents; Trademarks; Copyrights); Startup funding (Bootstrapping; Angel investors; Venture capital)

   Team Building and Mentorship: Importance of a strong founding team; Roles and responsibilities in a startup; Value of mentors and advisors

   Practical Aspect: Participation in IPR awareness programs or startup funding sessions

5. Unit V: Scaling, Ecosystem Engagement, and Future Trends

   6 Hours

   Growth Strategies and Scaling Up: Marketing and sales for startups; User acquisition and retention; Challenges of scaling and solutions; Exit strategies (Acquisition; IPO)

   Engaging with the Startup Ecosystem: Networking with investors, mentors, and entrepreneurs; Participation in startup competitions and pitch events; Leveraging incubators and accelerators

   Future Trends in Innovation and Entrepreneurship: Emerging technologies (Artificial Intelligence; Blockchain; Internet of Things (IoT); Sustainable Technologies); Social entrepreneurship and impact investing; Global startup trends

   Practical Aspect: Participation in National Innovation Day and student engagement activities to prepare and deliver a concise pitch for their developed idea, simulating a startup pitch event.

Suggested Readings

• Eric Ries. The Lean Startup: How Today’s Entrepreneurs Use Continuous Innovation to Create Radically Successful Businesses. Crown Business.
• Thiel, P. and Masters, B. Zero to One: Notes on Startups, or How to Build the Future. Crown Business.
• Bansal, R. Stay Hungry Stay Foolish. Westland.
• Dalal, M. Big Billion Startup: The Untold Flipkart Story. Pan Macmillan India.
• Ivaturi, V. K. The Manual for Indian Start-Ups: Tools to Start and Scale-Up Your New Venture. Notion Press.
• Mishra, S., Patjoshi, P. K. and Patnaik, S. K. Innovation and Entrepreneurship. Pearson India.
• Sardar, R. and Waghmare, G. Startup Ecosystem in India: Text and Cases. Himalaya Publishing House.

Course Objectives

• Understand the principles of formulation and development of monophasic liquid dosage forms, including solvent selection and solubility enhancement techniques.
• Acquire knowledge of biphasic liquid dosage forms, including physicochemical principles, formulation strategies, manufacturing processes, and stability considerations.
• Develop competence in pressurised dosage forms such as aerosols, metered-dose inhalers, and dry powder inhalers, with emphasis on formulation design, device components, manufacturing, and quality evaluation.
• Understand the formulation, manufacturing, and evaluation of semisolid dosage forms, with emphasis on drug permeation through the skin and factors affecting topical drug delivery.
• Gain exposure to advanced drug delivery systems such as nanosuspensions, nanoemulsions, SMEDDS/SNEDDS, xerogels, and emulgels for improved therapeutic performance.

Course Content

1. Unit I: Monophasic Liquids & Pressurised Dosage Forms

   6 Hours

   Foundations: Need, advantages/limitations; monophasic vs biphasic; solubility-enhancement techniques.

   Vehicles & solvents: Pharmaceutical waters (types; manufacturing & Quality Control of Purified/Distilled); classes of solvents as per toxicity.

   Formulation & manufacturing: Raw-material considerations and additives; processing; Quality Control of solutions/syrups/elixirs; powders for reconstitution as solutions.

   Measuring, filling & packaging: Techniques; container–closure integrity; automation in liquid manufacturing.

2. Unit II: Biphasic Liquids - Suspensions

   6 Hours

   Formulation & manufacturing: Additives; classification of suspending agents; IPQC & Quality Control; instabilities and packaging.

   Advances: Nanosuspensions; dry powder for reconstitution as suspensions; raft-forming systems.

3. Unit III: Biphasic Liquids - Emulsions

   6 Hours

   Formulation & manufacturing: Additives; classification of emulsifying agents; IPQC & Quality Control; instabilities and packaging.

   Advances: Nano-emulsions, micro-emulsions, SMEDDS/SNEDDS (overview, applications).

4. Unit IV: Pressurized dosage forms (Aerosols/MDIs)

   6 Hours

   Concepts; propellant classification/selection; valves & containers; formulation, manufacturing, and Quality Control (leak, spray pattern, delivered dose, particle-size/aerodynamic performance).

   Dry Powder Inhalers: valves & containers; formulation, manufacturing, and Quality Control

5. Unit V: Semisolid Dosage Form

   6 Hours

   Theory of Semisolid Dosage Forms: Definition & Purpose, Drug Permeation Pathways through skin, Factors affecting Permeation, Permeation enhancers: Physical and Chemical.

   Types of semisolid dosage form:

   Ointments: Base Selection, Formulation, Manufacturing and Evaluation

   Creams: Formulation, Manufacturing and Evaluation

   Gels/Jellies: Formulation, Manufacturing and Evaluation.

   Pastes: Formulation, Manufacturing and Evaluation

   Suppositories and Pessaries: Formulation, Manufacturing and Evaluation

   Advances: Xerogels, emulgels (overview, applications).

Suggested Readings

• Aulton, M. E. Aulton’s Pharmaceutics: The Science of Dosage Form Design. Elsevier.
• Gibson, M. Pharmaceutical Preformulation and Formulation. CRC Press.
• Lachman, L., Lieberman, H. A. and Kanig, J. L. The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors.
• Robinson, J. R. and Lee, V. H. L. Controlled Drug Delivery: Fundamentals and Applications. CRC Press.
• Troy, D. B. and Beringer, P. Remington: The Science and Practice of Pharmacy. Pharmaceutical Press.
• Indian Pharmacopoeia. Indian Pharmacopoeia Commission.

Course Objectives

• Introduce the concepts and systems of pharmaceutical quality management
• Provide an overview of regulatory frameworks governing pharmaceutical quality.
• Familiarize students with organizational, infrastructural, and operational requirements of pharmaceutical manufacturing and quality control.
• Explain quality control testing of pharmaceutical products
• Understand the documentation, validation, calibration, and data integrity essential for regulatory compliance.

Course Content

1. Unit I: Quality Assurance and Quality Management Systems

   10 Hours

   Quality Assurance and Quality Management concepts: Definition and concepts of Quality Control, Quality Assurance, and GMP

   Total Quality Management (TQM): Definition, elements, and philosophies

   ICH Guidelines: Purpose, process of harmonization, overview of QSEM with special emphasis on Q-series guidelines

   Quality by Design (QbD): Definition, overview, elements of QbD program, and tools

   ISO 9000 and ISO 14000: Overview, benefits, elements, and steps for registration

   NABL Accreditation: Principles and procedures

2. Unit II: Organization, Personnel, Premises, and Materials Management

   10 Hours

   Organization and Personnel: Responsibilities, training, hygiene, and personal records

   Premises: Design, construction, plant layout, maintenance, sanitation, environmental control, utilities, and control of contamination

   Equipment and Raw Materials: Equipment selection, User Requirement Specifications (URS), handling and maintenance of raw materials

   Warehousing: Good warehousing practices and materials management

3. Unit III: Quality Control and Good Laboratory Practices

   10 Hours

   Quality Control Tests for Formulations: In-process and finished product quality control tests for tablets, capsules, ointments, creams, ophthalmic and parenteral preparations

   Quality Control of Raw Materials and Packaging Materials: Tests for raw materials, containers, rubber closures, and secondary packing materials

   Good Laboratory Practices (GLP): General provisions, organization and personnel, facilities and equipment, ALCOA principles, reference standards, testing facility operations, records and reports, and disqualification of testing facilities

4. Unit IV: Documentation, Complaints, and Product Recall

   8 Hours

   Documentation in the Pharmaceutical Industry: Batch Formula Record, Master Formula Record, Drug Master File, SOPs, quality audits, preparation, handling, archival, and distribution of records

   Complaints and Product Recall: Handling of complaints, evaluation of complaints, returned goods, recalls, and waste disposal

5. Unit V: Calibration and Validation

   7 Hours

   Calibration and Validation: Introduction, definitions, importance, and general principles

   Calibration of weights and measures, pH meter

   Qualification of UV-Visible spectrophotometer, electronic balance, IR spectrophotometer, and HPLC

   Analytical Method Validation: General principles of analytical method validation as per ICH Q2 guidelines

Suggested Readings

• Godfrey, A. B. and Juran, J. M. Juran’s Quality Handbook. McGraw-Hill Education.
• Organisation of Pharmaceutical Producers of India. Quality Assurance Guide. OPPI.
• Weinberg, S. Good Laboratory Practice Regulations. Marcel Dekker.
• World Health Organization. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. World Health Organization.

Course Objectives

• Understand the neurohumoral transmission in the central nervous system and the role of neurotransmitters and their modulators in CNS disorders.
• Learn the pharmacology of drugs used in pathological conditions of CNS, GIT, and endocrine system.
• Familiarize learners with concepts of drug abuse, addiction, dependence, tolerance, and their management.
• Impart comprehensive knowledge of chemotherapeutic agents including anticancer drugs.
• Introduce the principles of rational use of chemotherapeutic agents.

Course Content

1. Unit I: Pharmacology of Drugs Acting on Central Nervous System

   10 Hours

   Neurohumoral transmission in the CNS; physiological roles of GABA, glutamate, glycine, serotonin, and dopamine.

   a. General anesthetics, pre-anaesthetic medications, and local anaesthetic agents

   b. Sedative–hypnotics

   c. Alcohol and disulfiram

   d. Opioids, opiate analgesics, and antagonists

   e. Drugs used in epilepsy

   f. Drugs used in Parkinson’s and Alzheimer’s diseases

2. Unit II: Pharmacology of Drugs Used in Psychiatry

   7 Hours

   a. Antipsychotics, antidepressants, anti-anxiety drugs, mood stabilizers, CNS stimulants, and hallucinogens

   b. Substance abuse, drug addiction, and general principles of de-addiction

3. Unit III: Chemotherapy

   14 Hours

   i) Introduction

   a. Definitions of chemotherapy, chemotherapeutic index, antibiotics, and antimicrobial agents

   b. Concept of selective targeting in chemotherapy

   c. Classification of antimicrobial agents based on mechanism of action

   d. Concept of superinfection, chemoprophylaxis, and combined use of antibiotics

   e. Antimicrobial resistance: causes, mechanisms, and preventive measures

   ii) Antimicrobial Agents: Classification, mechanism of action, adverse drug reactions, and therapeutic uses of: Sulphonamides and cotrimoxazole; Fluoroquinolones; Penicillins and cephalosporins; Macrolides and tetracyclines; Linezolid; Carbapenems and monobactams; Chloramphenicol and aminoglycosides

   iii) Chemotherapy of Diseases: Drugs used in the treatment of: Fungal infections; Viral infections; Helminthiasis; Urinary tract infections; Tuberculosis; Leprosy; Malaria; Amoebiasis; Neoplastic diseases

4. Unit IV: Pharmacology of Drugs Acting on Endocrine System

   10 Hours

   a. Introduction to basic concepts of endocrinology

   b. Thyroid and antithyroid agents

   c. Parathormone, calcitonin, and vitamin D

   d. Insulin and oral hypoglycaemic agents

   e. ACTH and corticosteroids

   f. Oral contraceptives

   g. Drugs acting on the uterus

   h. PCOD

5. Unit V: Drugs Acting on Gastrointestinal Tract

   4 Hours

   a. Drugs used in peptic ulcer

   b. Drugs used for constipation and diarrhoea

   c. Emetics and anti-emetics

   d. Digestants, carminatives, appetizers, and anorectics – definitions and examples

Suggested Readings

• Brunton, L., Hilal-Dandan, R. and Knollmann, B. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. McGraw-Hill Education.
• Craig, C. R. and Stitzel, R. E. Modern Pharmacology with Clinical Applications. Lippincott Williams & Wilkins.
• DiPiro, J. T., Talbert, R. L., Yee, G. C. and Matzke, G. R. Pharmacotherapy: A Pathophysiologic Approach. McGraw-Hill Education.
• Katzung, B. G. and Trevor, A. J. Basic and Clinical Pharmacology. McGraw-Hill Education.
• Rang, H. P., Dale, M. M., Ritter, J. M., Flower, R. J. and Henderson, G. Rang and Dale’s Pharmacology. Elsevier.
• Tripathi, K. D. Essentials of Medical Pharmacology. Jaypee Brothers Medical Publishers.

Course Objectives

• Comprehend the fundamental principles of drug synthesis and apply them to the preparation of selected drug molecules and intermediates.
• Develop practical skills in performing laboratory techniques for the synthesis of organic compounds, including the use of microwave irradiation.
• Understand and apply the principles of drug assay to quantitatively analyze the purity and concentration of given drug samples.
• Learn and utilize computational tools to predict physicochemical and ADME properties of drug molecules.
• Apply molecular docking techniques to predict drug-target interactions.

Practical / Lab Exercises

1. Preparation of Drugs / Intermediates (Any 4): 7-Hydroxy-4-methyl coumarin; Thiobarbituric acid; 2,3-Diphenylquinoxaline; Sulphanilamide; Triphenyl imidazole; Perform synthesis of intermediate/drug using microwave irradiation or green chemistry techniques.
2. Assay of Drugs (Any 4): Sulpha drugs; Metronidazole; Isoniazid; Phenobarbitone; Benzyl penicillin; Chloroquine
3. Drug Design & Computational Tools (Any 4): Calculate physicochemical and ADME properties using Swiss ADME (e.g. logP, molecular weight, H-bond donors/acceptors); Perform basic molecular docking studies using any of open-source academic tools.

Suggested Readings

• Abraham, D. J. and Griffin, J. L. Burger’s Medicinal Chemistry and Drug Discovery. Wiley.
• Finar, I. L. Organic Chemistry. Pearson Education.
• Furniss, B. S., Hannaford, A. J., Smith, P. W. G. and Tatchell, A. R. Vogel’s Textbook of Practical Organic Chemistry. Pearson Education.
• Lednicer, D. The Organic Chemistry of Drug Synthesis. Wiley.
• Patrick, G. L. An Introduction to Medicinal Chemistry. Oxford University Press.
• Remington. The Science and Practice of Pharmacy. Pharmaceutical Press.
• Williams, D. A., Lemke, T. L. and Roche, V. F. Foye’s Principles of Medicinal Chemistry. Lippincott Williams & Wilkins.
• Wilson, C. O., Beale, J. M. and Block, J. H. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry. Lippincott Williams & Wilkins.
• Indian Pharmacopoeia. Indian Pharmacopoeia Commission.
• Brown, N. Artificial Intelligence in Drug Discovery. Cambridge: Royal Society of Chemistry.

Course Objectives

• Apply knowledge of chromatographic and spectroscopic techniques for the separation, isolation, and analysis of phytoconstituents.
• Learn isolation and characterization of major secondary metabolites and volatile oil constituents using standard laboratory methods.
• Perform chemoprofiling, purification, and quantitative estimation of herbal and Ayurvedic formulations.
• Prepare and document herbal drug monographs and traditional formulations as per IP, API, and IHP guidelines.
• Integrate experiential learning and community-based studies for understanding the use, quality, and awareness of traditional medicines.

Practical / Lab Exercises

1. (Minimum 12 experiments must be performed)
2. To perform column chromatography for isolation of phytochemicals.
3. Preparative TLC of curcuminoids.
4. Isolation and identification of Piperine.
5. Isolation and identification of Sennoside.
6. Isolation and identification of Withanolide.
7. Isolation and identification of Lycopene.
8. Acid – base purification process for the separation of alkaloids.
9. Chemoprofiling of purified alkaloidal fraction.
10. Separation of amino acid by paper chromatography.
11. TLC/HPTLC/HPLC of herbal extracts/ botanicals.
12. Isolation and determination of total aldehyde content in volatile oil.
13. Preparation of monographs on herbal drugs wrt IP, API, IHP.
14. Determination of the alcohol content of Asava and Arista.
15. Standardization of any two Ayurvedic formulations using UV-spectroscopy.
16. Preparation and evaluation of Ayurvedic churna.
17. Experiential learning-based experiments focused on the preparation and practical applications of folkloric or region-specific traditional formulations within the community.
18. Case studies analyzing community awareness and usage patterns of various traditional formulations.

Suggested Readings

• Mukherjee, P. K. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons.
• Sinha, D., Mukherjee, S. and Chowdhury, S. Methods of Extraction of Phytochemicals. IGI Global.
• Zhang, J., Wen, C., Zhang, H., Duan, Y. and Ma, H. Extraction of Bioactive Compounds with Subcritical Water. Elsevier.

Course Objectives

• Understand various solubility enhancement techniques.
• Provide hands-on experience in manufacturing processes and evaluation of monophasic and biphasic liquid dosage forms.
• Provide hands-on experience in manufacturing processes and evaluation of semisolid dosage forms.
• Learn manufacturing processes and evaluation of pressurised dosage forms.
• Understand the effects of formulation parameters on the performance of biphasic and semisolid dosage forms.

Practical / Lab Exercises

1. (Minimum 12 experiments must be performed)
2. To enhance the solubility of a BCS Class II drug by solid dispersion technique.
3. To enhance the solubility of a BCS Class II drug by cyclodextrin complexation.
4. Preparation and evaluation of medicated syrups using simple and artificial syrup bases.
5. Preparation and evaluation of different types of pharmaceutical emulsions.
6. Preparation and evaluation of an emulsion with a small-dose oily active (e.g., calciferol).
7. Preparation and evaluation of an oral suspension.
8. To study the effect of different suspending agents/concentrations on sedimentation volume.
9. Preparation and evaluation of a dry powder for reconstitution as a suspension.
10. Preparation and evaluation of pharmaceutical creams.
11. Preparation and evaluation of pharmaceutical gels.
12. To study the effect of different gelling agents/concentrations on viscosity of gels.
13. Preparation and evaluation of medicated suppositories.
14. Preparation and evaluation of medicated pessaries.
15. Preparation and evaluation of in-situ gels.
16. Preparation and evaluation of emulgels.

Suggested Readings

• Aulton, M. E. Aulton’s Pharmaceutics: The Science of Dosage Form Design. Elsevier.
• Gibson, M. Pharmaceutical Preformulation and Formulation. CRC Press.
• Lachman, L., Lieberman, H. A. and Kanig, J. L. The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors.
• Robinson, J. R. and Lee, V. H. L. Controlled Drug Delivery: Fundamentals and Applications. CRC Press.
• Troy, D. B. and Beringer, P. Remington: The Science and Practice of Pharmacy. Pharmaceutical Press.
• Indian Pharmacopoeia. Indian Pharmacopoeia Commission.

Course Objectives

• Provide understanding of the theoretical and practical aspects of different pharmacological experiments using virtual simulations and video demonstrations.
• Develop skills to assess drug effects on various systems such as cardiovascular, respiratory, skeletal muscle, and gastrointestinal using simulation models.
• Familiarize the learners with experimental methodologies such as Langendorff’s heart preparation, spasmogenic and spasmolytic effects, and PA2 value determination using Schild plot.
• Provide knowledge of the modern techniques for drug evaluation, such as intraocular pressure measurement, nitric oxide estimation, neutrophil function tests and spirometry.
• Explore clinical pharmacology aspects through case studies on drug interactions, management of cardiovascular and respiratory diseases, and plasma volume expanders.

Practical / Lab Exercises

1. (Minimum 12 experiments must be performed)
2. Evaluation of analgesic activity of centrally and peripherally acting analgesics using Eddie's hot plate, tail-flick, tail immersion, and acetic acid-induced writhing methods through interactive computer simulation.
3. Evaluation of antiepileptic activity using maximal electroconvulsive shock (MES)-induced seizures through interactive computer simulation.
4. Demonstration of the antiepileptic activity using pentylenetetrazol-induced seizures through interactive computer simulation.
5. Evaluation of antidepressant activity of drugs using the tail suspension test through interactive computer simulation.
6. Demonstration and study of locomotor activity using actophotometer through interactive computer simulation.
7. Evaluation of antianxiety activity using the elevated plus maze or zero maze model through interactive computer simulation.
8. Evaluation of antipsychotic activity of drugs using inhibition of conditioned response on Cook's pole climbing apparatus through interactive computer simulation.
9. Study of the effect of drugs on learning and memory using the Morris water maze test through interactive computer simulation.
10. Study of antiulcer activity using indomethacin-induced or pylorus ligation-induced ulcer models.
11. Estimation of the concentration of oxytocin on isolated rat uterus preparation using a suitable method through interactive computer-based simulation.
12. Estimation of drug concentration by 3-point or 4-point bioassay through interactive computer simulation.
13. Bioassay of histamine using matching, bracketing, or interpolation methods on suitable isolated tissue preparation with the help of interactive computer simulation.
14. Study of cell culture techniques, including types of cell culture, laboratory instruments/equipment, culture media, and growth of cell cultures in laboratory facilities.
15. Study of antibacterial sensitivity testing of urine culture using techniques such as the disc diffusion method (theoretical details/case studies).
16. Demonstration using databases and software packages for predicting drug activity, ADME properties, and toxicity.
17. Study of electrophoresis of protein and DNA samples and gel visualization techniques.
18. Construction of pharmacological networks using predicted drug targets and disease genes with activity prediction databases, disease gene databases, and suitable software.
19. *PCI recommended software’s shall be used for performing experiments.

Suggested Readings

• Ghosh, M. N. Fundamentals of Experimental Pharmacology. Hilton & Company.
• Vogel, H. G. Drug Discovery and Evaluation: Pharmacological Assays. Springer.
• Hofmann, F. B. Handbook of Experimental Pharmacology (HEP Series). Springer Nature.

Course Objectives

• Understand reverse pharmacology and integrative approaches in natural drug discovery.
• Apply metabolomics and systems biology tools for quality control and bioactivity evaluation of herbal medicines.
• Explore modern AI-driven, in-silico, and high-throughput techniques for identification and optimization of natural product leads.
• Study validation, safety, and development pathways of herbal leads including preclinical and clinical evaluation.
• Understand legal, ethical, and patenting frameworks related to bioprospecting, traditional knowledge protection, and natural product innovation.

Course Content

1. Unit I: Reverse Pharmacology and Integrative Approaches

   6 Hours

   Reverse pharmacology and integrative approaches from the AYUSH perspective.

   Ethnopharmacological approach to bioprospecting.

   Traditional medicine databases: AYUSH Research Portal, ICMR Standards on Indian Medicinal Plants, TKDL, NAPRALERT, Super Natural, etc.

   Molecular docking and ADMET screening of bioactives.

   Concept of adjuvant therapy with herbals in metabolic and non-communicable diseases.

2. Unit II: Metabolomics and Systems Biology

   11 Hours

   Introduction to metabolomics and its tools: applications of NMR and HRMS in metabolomics, Metabolomics profiling and dereplication studies, Role of metabolomics in quality control, scientific, validation of traditional claims and pharmacological evaluation, Network pharmacology and systems biology approaches to herbal medicine, Significance of spectral libraries and chemoinformatics databases in drug discovery

3. Unit III: Modern Techniques in Natural Product Discovery

   10 Hours

   Role of artificial intelligence (AI), Machine learning and big data in Drug discovery from natural Products.

   Molecular docking, Virtual Screening and Pharmacophore modelling, Use of Genomic and transcriptomic tools in medicinal plant research, High-throughput screening (HTS) and bioautography.

4. Unit IV: Validation and Development of Herbal Leads

   12 Hours

   Bioactivity Guided Fractionation, characterization/Structure Elucidation, Optimization of lead compounds for better efficacy, safety, and stability through SAR and QSAR modelling for semi-synthetic compounds of Salicin, Artemisinin, Piperine, Papaverine and Andrographolides.

   Preclinical, Clinical Evaluation and New Drug approvals: Testing for toxicity as per OECD guidelines, pharmacokinetics, and bioavailability of herbal products, extracts and lead compounds, assessment of safety and efficacy, clinical trials with or without placebo for clinical endpoints based on assessment of quality of life reporting adverse events if any, filing IND application, NDA submission, Regulatory review and post marketing surveillance.

5. Unit V: Patenting of Natural Products

   6 Hours

   Key Terminologies and Concepts: Definitions and distinctions: Patent, Intellectual Property Rights (IPR) Farmers' Rights and Breeders' Rights, Bioprospecting and Biopiracy

   Patenting Aspects of Natural Products and Traditional Knowledge: Legal frameworks and challenges in patenting natural substances, Traditional Knowledge Digital Library (TKDL) and its role in protecting indigenous knowledge.

   Role of National Biodiversity Authority in patenting natural products and NAGOYA protocol.

   Case Studies: Turmeric – U.S. patent on wound healing and its revocation, Neem – Biopiracy issue and patent cancellation.

Suggested Readings

• Bhat, S. V., Nagasampagi, B. A. and Sivakumar, M. Chemistry of Natural Products. Springer.
• Gräbley, S. and Thiericke, R. Drug Discovery from Nature. Springer.
• Hanessian, S. Natural Products in Medicinal Chemistry. Wiley-VCH.
• Ikan, R. Natural Products: A Laboratory Guide. Academic Press.
• Kemp, W. Spectroscopic Methods in Organic Chemistry. Macmillan.
• Narayanan, P. Intellectual Property Law. Eastern Law House.
• Sarker, S. D., Latif, Z. and Gray, A. I. Natural Products: Isolation, Structure Elucidation and History. Elsevier.

Course Objectives

• Describe fundamental biopharmaceutics and pharmacokinetic principles governing drug absorption, distribution, metabolism, and excretion.
• Analyze the physicochemical and biological factors that determine drug bioavailability, protein binding, and elimination pathways.
• Illustrate compartmental pharmacokinetic models, and their evaluations through application of mathematical equations to calculate key parameters.
• Design, conduct, and interpret bioavailability, bioequivalence, and in vitro–in vivo correlation studies.
• Apply pharmacokinetic principles to optimize dosing regimens—including loading and maintenance doses and steady-state kinetics—and utilize software tools to analyze both linear and non-linear drug kinetics.

Course Content

1. Unit I: Introduction to Biopharmaceutics and pharmacokinetics

   10 Hours

   Introduction to various Pharmacokinetic parameters (using Plasma drug Concentration vs Time curve) and Pharmacodynamic parameters and drug delivery index.

   Absorption; Mechanisms of drug absorption through GIT, Physicochemical, Biological and Dosage form related factors influencing drug absorption though GIT, methods of Assessment of GIT absorption,

   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.

2. Unit II

   10 Hours

   Elimination (Metabolism and Elimination): Drug metabolism and basic understanding of 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, Introduction to BCS and biopharmaceutical drug disposition classification system, methods of measurement of bioavailability (Plasma data, Urinary excretion data), Protocol for assessment of bioavailability and bioequivalence studies. in-vitro drug dissolution methods (test apparatus I-VII), biorelevant dissolution mediums, in-vitro in-vivo correlations: Concept and Applications, Biowaivers, Methods of enhancement of bioavailability.

3. Unit III

   10 Hours

   Pharmacokinetic Models: Compartment Models: Definition, Basis of classification, Properties of compartment, Advantages and disadvantages of compartment modelling. Kinetic considerations of One compartment open model. (a). Intravenous Injection (Bolus/rapid) (b). Intravenous infusion and (c) Extra-vascular administration. (with emphasis on Curve Fitting, Wagner–Nelson, Loo Riegelman)

   Introduction to non-compartment model: Principles, estimation of PK parameters (AUC, AUMC, MRT, MAT statistical moment theory).

4. Unit IV

   9 Hours

   Multicompartment models: Multiple dosage regimen: dosing interval, drug accumulation, loading dose, maintenance dose, PK Parameters Kinetic consideration of two compartment open model (a) Intravenous Injection (Bolus/rapid) and (b) Extra vascular administrations (oral administration). Kinetics of multiple dosing, steady state drug levels, calculation of loading and maintenance doses and their clinical significance. Multiple dosage regimen.

   Introduction to pharmacokinetic consideration of Modified release drug products.

5. Unit V

   6 Hours

   Nonlinear Pharmacokinetics: Introduction, Reasons for Non-linearity, Michaelis-menton method of estimating parameters, Explanation with example of drugs.

   Application of PK software: Introduction of various in-silico methods for calculating various PK parameters.

Suggested Readings

• Shargel, L. and Yu, A. B. C. Applied Biopharmaceutics and Pharmacokinetics. McGraw-Hill Education.
• Gibaldi, M. Biopharmaceutics and Clinical Pharmacokinetics. Lea & Febiger.
• Rowland, M. and Tozer, T. N. Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications. Wolters Kluwer.
• Bonate, P. L. Pharmacokinetic-Pharmacodynamic Modeling and Simulation. Springer.
• Brahmankar, D. M. and Jaiswal, S. B. Biopharmaceutics and Pharmacokinetics: A Treatise. Vallabh Prakashan.
• Eddy, D. M. Modeling and Simulation in the Medical and Health Sciences. Springer.

Course Objectives

• Introduce the fundamental concepts and types of intellectual property (IP) and highlight their importance in the pharmaceutical and healthcare sectors.
• Understand the procedures and legal frameworks related to patent filing, granting, and protection of intellectual property.
• Develop awareness of international and national IP laws and treaties, including the TRIPS agreement and Indian Patent Act, and their implications for the pharmaceutical industry.
• Provide insights into the management and commercialization of IP, including licensing, technology transfer, and joint ventures.
• Familiarize with common IP infringement issues and remedies, using real-world case studies from the pharmaceutical industry to illustrate key principles.

Course Content

1. Unit I: Introduction to Intellectual Property

   6 Hours

   Definition and scope of Intellectual Property (IP), Importance and types of IP: Patents, Trademarks, Copyrights and Trade Secrets, Overview of the origin and progression of intellectual property rights in India and internationally, Role of IP in the pharmaceutical industry

2. Unit II: Patents – Fundamentals and Process

   6 Hours

   Definition and objectives of patents, Criteria for patentability such as Novelty/innovations, Non-obviousness, Utility, Types of patents and non-patentable inventions in India, Procedure for filing a patent in India, Rights of a patent holder and term of patent protection

3. Unit III: Patent Laws and Acts

   6 Hours

   Overview of Indian Patent Act, 1970 (latest amendments and key provisions under the act), TRIPS Agreement and its implications on the Indian pharmaceutical sector, Compulsory licensing, patent opposition, and revocation, Indian pharmaceutical patents: Case studies.

4. Unit IV: Other Forms of Intellectual Property

   6 Hours

   Trademarks, Copyrights, Industrial designs: Definition, importance, registration process, Basics and protection in scientific work, Importance and legal framework, Trade secrets and geographical indications in pharma industry

5. Unit V: IPR Management and Commercialization

   6 Hours

   Valuation and strategies for commercialization of intellectual property; processes of technology transfer, licensing agreements, and collaborative ventures; issues related to IP infringement and available legal remedies; management practices of IPR in the pharmaceutical industry supported by relevant case studies.

Suggested Readings

• World Intellectual Property Organization. Introduction to Intellectual Property. WIPO.
• Indian IPR. https://ipindia.gov.in/
• Ahuja, V. K. Law Relating to Intellectual Property Rights. LexisNexis.
• Bouchoux, D. Intellectual Property. Cengage Learning.
• Ganguli, P. Intellectual Property Rights: Unleashing the Knowledge Economy. Tata McGraw-Hill.
• Narayanan, P. Intellectual Property Law. Eastern Law House.
• Ramakrishna, T. Basic Principles and Acquisition of Intellectual Property Rights. CIPRA.
• Sreenivasulu, N. S. Law Relating to Intellectual Property. Partridge Publishing.
• Vaidhyanathan, S. Intellectual Property: A Very Short Introduction. Oxford University Press.
• Wadehra, B. L. Law Relating to Intellectual Property. Universal Law Publishing.

Course Objectives

• Introduce applications of artificial intelligence and machine learning across major pharmaceutical disciplines.
• Understand the structured data in natural products, medicinal chemistry, formulation science, and manufacturing
• Interpret regression and classification models in drug discovery, product performance, and quality monitoring.
• Build awareness of predictive modeling for pharmaceutical decision-making.
• Understand multivariate analysis in pharmaceutical analytical techniques.

Course Content

1. Unit I: AI in Natural Products & Pharmacognostic Data Modeling

   6 Hours

   Overview of ML applications in natural products:

   Representation of crude drug data (morphological, microscopic, phytochemical, chromatographic features)

   Structuring herbal datasets for predictive modeling

   Classification models for authentication of crude drugs (authentic vs adulterated)

   Regression models for prediction of secondary metabolite yield

   Application of AI in phytochemical screening and prioritization

   Herb-drug interaction prediction using database-driven approaches

   Limitations of predictive modeling in natural products.

2. Unit II: AI in Medicinal & Pharmaceutical Chemistry

   6 Hours

   Overview of the role of AI applications in pharmaceutical chemistry with focus on drug discovery concepts:

   Conversion of molecular structures into numerical descriptors (MW, logP, HBD/HBA, TPSA)

   Structured chemical datasets and QSAR modeling

   Regression and classification models for predicting biological activity (IC₅₀, solubility, ADMET properties), toxicities.

   Virtual screening and lead optimization concepts

   Limitations of ML models and importance of chemical reasoning

3. Unit III: AI in Drug Product Design & Performance Prediction

   6 Hours

   Overview of AI models across formulation development stages, with emphasis on the applications and limitations:

   Overview of dosage form development and formulation variables

   Machine learning in formulation optimization and excipient selection

   Regression modeling for solubility and bioavailability enhancement

   Time-concentration modeling for drug release interpretation

   Stability study design and modeling degradation trends

   Shelf-life estimation using regression-based approaches

   Practical limitations of extrapolation in formulation science

4. Unit IV: AI in Process Monitoring & Production Systems

   6 Hours

   Overview of introduces multivariate analysis in pharmaceutical analytical techniques with focus on the different models and their applications:

   Digital data acquisition in pharmaceutical production

   Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)

   Correlation analysis for identifying process variability

   Logistic regression models for batch pass/fail prediction

   Feature importance in process monitoring, predictive maintenance concepts.

   Ethical and regulatory considerations in automated decision-making, and limitations of predictive models in manufacturing environments.

5. Unit V: AI in Pharmaceutical Analysis & Chemometrics

   6 Hours

   Overview of multivariate analysis in pharmaceutical analytical techniques with focus on the different models and their applications:

   Introduction to chemometrics and multivariate analytical data

   Spectroscopic data modeling (UV/IR interpretation)

   Regression analysis in quantitative pharmaceutical analysis

   Chromatographic peak modeling and interpretation

   Classification models for genuine vs counterfeit detection

   Handling noise and variability in analytical datasets

   Limitations of AI models in analytical decision-making

Suggested Readings

• Bakeev, K. A. Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries. Wiley.
• Brown, N. Artificial Intelligence in Drug Discovery. Royal Society of Chemistry.
• Chavda, V., et al. Bioinformatics Tools for Pharmaceutical Drug Product Development.
• Gibson, M. Pharmaceutical Preformulation and Formulation. CRC Press.
• Hanessian, S. Natural Products in Medicinal Chemistry. Wiley.
• Pais, A., et al. Artificial Intelligence for Drug Product Lifecycle Applications.
• Schlindwein, W. S. and Gibson, M. Pharmaceutical Quality by Design: A Practical Approach. Wiley.
• World Health Organization. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. WHO Press

Course Objectives

• Understand the interaction of matter with electromagnetic radiation and its application in spectroscopic methods for pharmaceutical drug analysis.
• Study the principles, instrumentation, and pharmaceutical applications of electroanalytical techniques such as potentiometry, conductometry, polarography, and amperometry.
• Understand and apply various chromatographic and electrophoretic separation techniques used for qualitative and quantitative analysis of drugs.
• Impart knowledge of instrumental methods used for accurate qualitative and quantitative analysis of pharmaceutical substances.
• Develop the ability to select, optimize, and validate suitable analytical techniques, interpret analytical data.

Course Content

1. Unit I: Electrochemical Methods of analysis

   10 Hours

   Potentiometry: Electrode potential, electrochemical cell, construction and working of reference and indicator electrodes including membrane electrodes, measurement of potential and pH, potentiometric titrations, methods of detecting end point and Karl Fischer titration.

   Conductometry: Introduction, conductivity cell, conductometric titrations and applications.

   Polarography: Introduction, residual current, migration current, diffusion current and limiting current, DME, polarographic wave, Ilkovic’s equation (Statement Only), and applications.

2. Unit II: Spectroscopy

   10 Hours

   Fundamentals of Spectroscopy: Properties of electromagnetic radiation, electromagnetic spectrum.

   UV Visible spectroscopy: Beer and Lambert’s law, Derivation and deviations. Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on absorption spectra, Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectors (Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode). Applications - single and multi component analysis of pharmaceuticals.

   IR spectroscopy: Introduction, fundamental modes of vibrations in poly atomic molecules, factors affecting vibrations, Instrumentation of dispersive Infrared spectrophotometer (including sample handling Techniques) and FTIR. Pharmaceutical applications.

3. Unit III: Fluorometric Analysis

   7 Hours

   Theory, luminescence, factors affecting fluorescence, quenching. Instrumentation and pharmaceutical applications.

   Flame Photometry and Atomic Absorption Spectrometry: Theory, nebulisation, flame and flame temperature, interferences, instrumentation and pharmaceutical applications.

   Nepheloturbidometry: Principle, instrumentation and applications.

4. Unit IV: Introduction to Chromatographic Techniques

   8 Hours

   Principle, various stationary and mobile phases, diverse development and detection techniques and applications of column, paper and thin layer chromatography.

   Ion-exchange chromatography: Introduction, principles, types of ions exchange resins, factors affecting ion exchange, methodology and applications.

   Gel filtration and affinity chromatography: Principles and applications.

   Electrophoresis: Introduction, factors affecting electrophoretic mobility, Techniques of paper, gel, capillary electrophoresis, applications.

5. Unit V

   10 Hours

   Gas chromatography: Introduction, theory, instrumentation, derivatization, temperature programming, advantages, disadvantages and applications

   High performance liquid chromatography: Introduction, theory, instrumentation, advantages and applications.

   HPTLC: Principle, instrumentation and applications.

Suggested Readings

• Braun, R. D. Analytical Chemistry: A Modern Approach to Analytical Science. McGraw-Hill.
• Dyer, J. R. Applications of Absorption Spectroscopy of Organic Molecules. Prentice Hall.
• Harvey, D. Modern Analytical Chemistry. McGraw-Hill.
• Sharma, Y. R. Organic Spectroscopy. S. Chand.
• Skoog, D. A., Holler, F. J. and Crouch, S. R. Principles of Instrumental Analysis. Cengage Learning.
• Watson, D. G. Pharmaceutical Analysis. Elsevier.

Course Objectives

• Understand the fundamental principles and scope of pharmaceutical legislations governing drug development, manufacture, distribution, and marketing.
• Gain comprehensive knowledge of Indian pharmaceutical Acts and Rules, including Drugs and Cosmetics Act, Pharmacy Act, NDPS Act, and related regulations.
• Learn the roles, responsibilities, and functions of regulatory authorities involved in regulation and control of pharmaceuticals in India.
• Learn the code of pharmaceutical ethics and legal responsibilities in professional pharmacy practice.
• Develop the ability to analyse regulatory frameworks, pricing controls, and emerging regulations, and assess their impact on public health, industry compliance, and patient safety.

Course Content

1. Unit I: Drugs and Cosmetics Act, 1940 and its rules 1945

   10 Hours

   Objectives, Definitions, Legal definitions of schedules to the Act and Rules, CDSCO guidelines for Import & export of Pharmaceuticals

   Manufacture of drugs – Prohibition of manufacture and sale of certain drugs, Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.

2. Unit II: Drugs and Cosmetics Act, 1940 and its rules 1945

   10 Hours

   Detailed study of Schedule G, H, H1, M, N, P, T, U, V, X, Y, Sch F, Part XII B.

   Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties

   Labeling & packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties.

   Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing authorities, controlling authorities, Drugs Inspectors

3. Unit III

   8 Hours

   Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations including ER20, State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties

   Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations, Offences and Penalties.

   Narcotic Drugs and Psychotropic substances Act -1985 and Rules: Objectives, Definitions, Authorities and Officers, Constitution and Functions of narcotic & Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse, Prohibition, Control and Regulation, opium poppy cultivation and production of poppy straw, manufacture, sale and export of opium, Offences and Penalties

4. Unit IV

   8 Hours

   Study of Salient Features of Drugs and Magic Remedies Act and its rules: Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties

   Prevention of Cruelty to animals Act -1960: Objectives, Definitions, Institutional Animal Ethics Committee, CCSEA guidelines for Breeding and Stocking of Animals, Performance of Experiments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties

   National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO) - 2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations, Retail price and ceiling price of scheduled formulations, National List of Essential Medicines (NLEM).

5. Unit V

   9 Hours

   Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee

   Code of Pharmaceutical ethics: Definition, Pharmacist in relation to his job, trade, medical profession and his profession,

   Medical Termination of Pregnancy Act

   Brief Introduction to Right to Information Act

   Introduction New Drugs and Clinical Trials Rules, 2019 and amendments.

   Cosmetic rules 2020

   Regulatory guidelines on similar biologics.

   Overview of Medical Device Regulations, Guidelines on Probiotics, Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016

Suggested Readings

• Government of India. Drugs and Cosmetics Act and Rules. Government of India.
• Government of India. Drugs and Magic Remedies (Objectionable Advertisements) Act. Government of India.
• Government of India. Medicinal and Toilet Preparations (Excise Duties) Act. Government of India.
• Government of India. Narcotic Drugs and Psychotropic Substances Act. Government of India.
• Government of India. New Drugs and Clinical Trials Rules, 2019. Government of India.
• Central Drugs Standard Control Organization and Department of Biotechnology. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India. Government of India.

Course Objectives

• Understand the dissolution profiles of pharmaceutical formulations using various media and conditions.
• Apply in vitro and ex vivo techniques to assess drug absorption, dissolution, and bioavailability.
• Interpret pharmacokinetic parameters using plasma and urinary excretion data.
• Establish in vitro–in vivo correlation (IVIVC) for drug products based on experimental datasets.
• Utilize software tools to simulate and analyze pharmacokinetic and pharmacodynamic data.

Practical / Lab Exercises

1. To calculate MRT from the given data.
2. To assess the effect of protein binding of a drug
3. To report relative bioavailability of given drug product using urinary excretion data
4. To report relative bioavailability of given drug product using plasma data
5. Establish IVIVC from the given in vitro and in vivo data.
6. To calculate pharmacokinetic parameters of a drug using given plasma level data.
7. To report bioequivalence of drug products using given urinary excretion data administered
8. To calculate absorption rate constant, elimination rate constant and elimination half-life of given excretion data by sigma minus method.
9. To calculate absorption rate constant, elimination rate constant and elimination half-life of the given drug data administered by IV bolus injection represented by one compartment model.
10. To calculate the absorption rate constant by using curve fitting method.
11. To calculate various pharmacokinetic parameters using in silico methods.
12. *PCI recommended software’s shall be used for performing experiments.

Suggested Readings

• Bonate, P. L. Pharmacokinetic-Pharmacodynamic Modeling and Simulation. Springer.
• Brahmankar, D. M. and Jaiswal, S. B. Biopharmaceutics and Pharmacokinetics: A Treatise. Vallabh Prakashan.
• Eddy, D. M. Modeling and Simulation in the Medical and Health Sciences. Springer.
• Gibaldi, M. Biopharmaceutics and Clinical Pharmacokinetics. Lea & Febiger.
• Rowland, M. and Tozer, T. N. Clinical Pharmacokinetics and Pharmacodynamics. Wolters Kluwer.
• Shargel, L. and Yu, A. B. C. Applied Biopharmaceutics and Pharmacokinetics. McGraw-Hill Education.

Course Objectives

• Understand the fundamental principles behind various analytical techniques including titrations, spectrophotometry, fluorimetry, flame photometry, and chromatography.
• Develop proficiency in performing quantitative and qualitative analyses of pharmaceutical compounds using classical and instrumental methods.
• Learn to operate and maintain laboratory instruments such as potentiometers, conductometers, spectrophotometers, fluorimeters, flame photometers, and chromatographic systems.
• Apply appropriate analytical techniques for specific analytical challenges and interpretation, including single and multi-component assays, identification of functional groups, and separation of mixtures.
• Learn good laboratory practices and safety protocols in handling chemicals and operating instruments.

Practical / Lab Exercises

1. Minimum 12 experiments must be performed.
2. Determination of the endpoint of a acid base titration by potentiometric method.
3. Determination of end point of acid base titrations by conductometry.
4. Determination of absorption maxima and effect of solvents on absorption maxima of organic compounds
5. Assay of APIs by colorimetry.
6. Assay of single component by UV- Spectrophotometer.
7. Simultaneous estimation of multicomponent formulations by UV spectrophotometer.
8. Identification of various functional groups in official compounds by FTIR as per IP.
9. Assay of quinine sulphate by fluorimetry
10. Determination of quenching effect by fluorimetry
11. Assay of sodium chloride by flame photometry
12. Assay of potassium chloride by flame photometry
13. Determination of chlorides and sulphates by nephelo turbidometry
14. Separation of amino acids by paper chromatography
15. Separation of mixture of components by thin layer chromatography
16. Demonstration experiment on GC
17. Determination of official compounds by HPLC (anyone)
18. Demonstration experiment on HPTLC.

Suggested Readings

• Vogel, A.I., Textbook of Quantitative Chemical Analysis. Longman Scientific & Technical.
• Beckett, A.H., and Stenlake, J.B., Practical Pharmaceutical Chemistry: Part II. Athlone Press.
• Skoog, D.A., Holler, F.J., and Crouch, S.R., Principles of Instrumental Analysis. Cengage Learning.

Course Objectives

• Introduce the fundamental concepts of biostatistics including types of variables, data collection methods, sampling techniques, and descriptive statistical measures used in pharmaceutical and biomedical research.
• Develop understanding of probability theory, probability distributions, and sampling distributions used in the analysis of biological and pharmaceutical data.
• Explain the principles of correlation and regression analysis for studying relationships between variables and predicting outcomes in pharmaceutical and healthcare datasets.
• Provide knowledge of inferential statistical methods including estimation, confidence intervals, hypothesis testing, parametric and non-parametric tests, and analysis of variance.
• Familiarize students with research methodology, experimental design, and scientific reporting practices relevant to pharmaceutical research and data interpretation.

Course Content

1. Unit I: Basic concepts of biostatistics

   9 Hours

   Definition, meaning and type of variables

   Data – Meaning and methods of data collection, data preprocessing and cleaning

   Population and sample, Importance of sampling, Sampling methods

   Probability and non-probability sampling

   Probability sampling - Random, systematic, stratified, cluster sampling

   Non-probability sampling - Convenience sampling, purposive sampling, snowball sampling

   Types of statistics - Descriptive statistics and inferential statistics

   Descriptive statistics – Meaning and types of descriptive statistics

   Frequency distribution, measures of central tendency

   Measures of dispersion – Range, variance and standard deviation.

   Concept of degrees of freedom, quartiles, skewness and kurtosis

   Diagrammatic representation of frequency distribution

2. Unit II: Probability and probability distributions

   9 Hours

   Probability and probability distributions - Classical probability and statistical probability

   Probability of union, intersection and complement of events, conditional probability, marginal probability

   Probability distributions- Meaning of a probability distribution

   Discrete probability distribution- Meaning and examples of discrete probability distribution, meaning of PMF

   Continuous probability distribution – Meaning and examples of normally distributed data, meaning of PDF

   Normal distribution – Meaning and characteristics of a normal distribution, parameters of a normal distribution, equation for PDF of a normal distribution. Pharmaceutical examples of data which can be modelled with Poisson Normal distribution.

   Standard normal distribution, Z transformation, reading the table of Z values

   Problems based on standard normal distribution, binomial and Poisson distributions

   Sampling distributions – Meaning of sampling distributions

   t distribution – the t statistic, equation for calculating t statistic, meaning of t distribution, meaning of degrees of freedom and their relevance to t distribution, reading and interpreting table of t values, applications of t distribution

   F distribution – the F statistic, equation for calculating F statistic, meaning of F distribution, reading and interpreting table of F values

   Chi square distribution – the Chi square statistic, meaning of chi square distribution, reading and interpreting the table of chi square values, applications of chi square distribution.

3. Unit III: Correlation and regression analysis

   9 Hours

   Correlation analysis – Introduction to the concept of correlation between two variables, positive and negative correlation, no correlation, examples of positive, negative and no correlation

   Measurement of correlation -

   Pearson’s Correlation Co-efficient – Definition and formula, assumptions, range of Pearson’s correlation co-efficient, interpretation of sign and magnitude

   Spearman’s Rank Correlation Co-efficient – Concept and when to use, procedure for calculation Spearman’s Rank Correlation Co-efficient.

   Real life applications in pharmaceutical and health sciences

   Problems on calculation of these two types of correlation co-efficient, use of scatter plot

   Multiple correlation – Concept and applications.

   Regression analysis – Concept of regression, dependent and independent variables in regression analysis, simple linear regression, simple linear regression equation (method of least squares), calculation of slope and intercept, co-efficient of determination, interpretation of output of regression analysis, applications of regression analysis. Relationship between regression co-efficient and correlation co-efficient

   Problems on simple linear regression analysis for predicting values of dependent variables (pharmaceutical examples)

   Multiple linear regression-Concept and applications, meaning of overfitting and underfitting.

4. Unit IV: Inferential statistics

   12 Hours

   Statistical estimation – Point estimates and interval estimates of population parameters from sample statistics

   Concept of confidence intervals. Confidence intervals for means using t values. Problems on generating confidence intervals

   Hypothesis testing – Concept, steps involved, type I and type II error, sample size and power of the test, p values, applications of hypothesis testing

   Parametric tests - t- tests (single sample t test, two independent samples t test, paired t test) ANOVA (one way and two way).

   Assumptions, procedure and applications (case studies using t tests and ANOVA)

   Hypothesis testing in regression analysis and correlation

   Non-parametric tests - Mann Whitney U test, Wilcoxon Sign Rank test, Kruskal Wallis test, Friedman test, Chi square tests.

   Assumptions, procedure and applications (problems on non-parametric tests)

5. Unit V: Research methodology

   6 Hours

   Research – Meaning, importance and types.

   Types of research designs

   Research methodology – Based on the research question, selection of research design, defining the population and sample, selecting the sample size and sampling method, method of data collection and data analysis.

   Decision tree approach for selection of statistical tests on the basis of research question and type of data

   Descriptive research design – Examples of application

   Observational research design – Examples of application

   Experimental research design – Examples of application

   Scientific report writing, plagiarism, referencing styles, selection of research journals, abstracting services and databases

   Screening and Optimization – Concept and experimental designs used for screening and optimization including Plackett Burman design, factorial designs, D optimal design, sequential simplex design, central composite design and response surface methodology, blocking and confounding in experimental designs.

Suggested Readings

• Bolton, S. Pharmaceutical Statistics: Practical and Clinical Applications. Marcel Dekker.
• Daniel, W. W. Biostatistics: A Foundation for Analysis in the Health Sciences. Wiley.
• Montgomery, D. C. Design and Analysis of Experiments. Wiley.

Course Objectives

• Recognize the fundamental concepts and classification of cosmetics and cosmeceutical formulations and their packaging and testing.
• Develop knowledge of some common dermatological, hair, and oral care issues and their respective cosmetic products.
• Develop an understanding of herbal cosmetics and their principles of formulation.
• Learn regulatory guidelines, labeling protocols, and packaging regulations for cosmetics and cosmeceuticals.
• Study the recent trends of research in artificial intelligence (AI) in customized skincare and cosmetic innovation.

Course Content

1. Unit I

   6 Hours

   Cosmetics and cosmeceuticals, Classification of Cosmetics (Cosmetics and Cosmeceuticals for Skin Care, Hair Care, Oral Care, foot care, body cavities, Decorative Cosmetics, Cleansing cosmetics, Perfumes and Fragrances.)

   Types of various dosage forms for Cosmetics, Common excipients for cosmetic.

2. Unit II

   6 Hours

   Common skin problems (Dry Skin, Oily skin, Pimples and acne, Pigmentation, Prickly heat and Sun burn) and general composition, method for preparation, packing and evaluation of the skin Cosmetics and cosmeceuticals. Herbal cosmetics for skin.

   Types of soaps, syndet bars, general composition, method for preparation, packing and evaluation of soaps.

   Introduction to Perfumes and toiletries.

3. Unit III

   6 Hours

   Common Hair problems, Hair Cosmetics and cosmeceuticals: Types of shampoos, general composition, method for preparation, packing and evaluation of shampoos.

   Introduction to hair oils, hair serums, conditioners, hair colors, Depilatory and shaving products. Herbal hair care products.

4. Unit IV

   6 Hours

   Various problems of oral cavity, Oral Cosmetics, and cosmeceuticals: general composition, method for preparation, packing and evaluation of mouth wash and toothpaste. Herbal oral care cosmetics.

   Types of Cosmetics for nails, eyes, body odor, lip care and cleansing.

   Intimate hygiene products for males and females.

5. Unit V

   6 Hours

   Role of Regulatory authorities for Cosmetics and cosmeceuticals (CDSCO and FDA). Cosmetics regulations 2020 and role of BIS.

   Role of certifying bodies like ECCERT and COSMOS in herbal cosmetics. Labeling requirement of cosmetics and Packaging of cosmetics.

   Testing as per BIS specification and analytical methods (including sensory test, sensitivity test).

Suggested Readings

• Baki, G. and Alexander, K. S. Introduction to Cosmetic Formulation and Technology. Wiley.
• Barel, A. O., Paye, M. and Maibach, H. I. Handbook of Cosmetic Science and Technology. CRC Press.
• Benson, H. A. E. and Watkinson, A. C. Cosmetic Formulation: Principles and Practice. CRC Press.
• Chisvert, A. and Salvador, A. Cosmetic Formulation of Skin, Hair and Nails. Wiley.
• Dweck, A. C. and Santos, P. F. Formulating Natural Cosmetics. Allured Publishing.
• Matsumoto, M. Cosmetic Science and Technology. Elsevier.
• Rosen, M. R. Harry’s Cosmeticology. Chemical Publishing.