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B.Pharm Elective Courses Appendix | New PCI B.Pharm Syllabus 2026

This page gives the complete syllabi of the elective courses (SEC, AEC and VAC) exactly as printed in Appendix I of the new B.Pharm syllabus from the Pharmacy Council of India (NEP-2020). Each semester page of this section links here for the elective options of that semester. Only 1 elective course shall be selected from each elective slot, as printed in the official syllabus.

SEC means Skill Enhancement Course, AEC means Ability Enhancement Course, and VAC means Value Added Course, as expanded in the official document.

Source: Pharmacy Council of India, Syllabus, Bachelor of Pharmacy (B. Pharm) (2026), As per NEP 2020, Appendix I. The syllabus text below is reproduced word for word from the official document.

Semester 2 Electives (BP212P SEC)

BP212P SEC1 Communication Skills (Practical)

Course Objectives: The objectives of this course are to:

1. Enhance verbal and non-verbal communication skills in academic, clinical, and professional pharmacy settings.
2. Develop competence in patient counselling, prescription communication, and interprofessional dialogue.
3. Promote empathetic and ethical communication in diverse cultural and patient contexts.
4. Use digital tools and professional formats (e.g., email, reports, posters) for effective communication.
5. Foster confidence, active listening, and clarity in pharmacy-related presentations and conversations.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Demonstrate effective verbal and non-verbal communication in clinical, retail, and academic pharmacy contexts.
2. Perform patient counselling and handle real-world pharmacy interactions using role-play and case scenarios.
3. Draft professional emails, prepare patient information leaflets, and create drug labels with clarity and accuracy.
4. Deliver confident oral presentations and communicate complex medical information in a simplified, patient-friendly manner.
5. Apply principles of ethical and culturally sensitive communication in handling patients and professional peers.

List of Practical (Perform any 12 Experiments):

1. Introduction to Communication in Pharmacy • Types of communication: verbal, non-verbal, written • Importance in clinical, academic, and retail pharmacy
2. Listening and Observation Skills Workshop • Active listening techniques, barriers to listening • Observation of cues: patient posture, tone, compliance
3. Role-play: Communicating with a Patient for Dispensing a Prescription • Explanation of dosage, frequency, side effects, and precautions
4. Role-play: Handling Difficult Conversations (e.g., Angry Patient or Confused Elderly) • Empathy, patience, tone modulation, de-escalation techniques
5. Written Communication I: Professional Email Writing & Documentation • Writing emails to doctors, suppliers, institutions • Structure, etiquette, and clarity in pharmacy communications
6. Written Communication II: Preparing Patient Information Leaflets and Drug Labels • Use of simple language, drug facts, precautions, icons • Creating flyers for common conditions (e.g., diabetes, asthma)
7. Non-verbal Communication Skills • Body language, eye contact, gestures, tone of voice • Cross-cultural sensitivity in pharmacy communication
8. Presentation Skills I – Basic Techniques • Voice projection, clarity, use of visuals • Individual practice with simple pharmacy topics
9. Presentation Skills II – Group Presentations • Topics: health awareness campaigns, drug education, OTC safety • Peer and faculty feedback
10. Patient Counseling Practice (Case-Based) • Counseling for chronic illness (e.g., hypertension, diabetes) • Role-playing real-life counseling situations
11. Communicating with Healthcare Professionals • Case handoff, drug information request, referral writing • Using SBAR (Situation, Background, Assessment, Recommendation) format
12. Mock Interview / Group Discussion Practice • Industry/clinical job interview scenarios • GD on topics like "Generic vs Branded Medicines"
13. Digital Communication Skills for Pharmacists • Creating a simple health blog, social media awareness post • Basics of teleconsultation and ePharmacy chat support
14. Ethics and Professionalism in Communication • Confidentiality, patient rights, informed consent • Role-play ethical dilemmas in pharmacy
15. Assessment & Reflection • Final presentation or counseling demo • Feedback, self-evaluation, and faculty observation

BP212P SEC2 Mental Well-Being, Stress and Conflict Management (Practical)

Course Objectives: The objectives of this course are to:

1. Introduce students to the concepts of mental well-being and stress.
2. Equip students with techniques to manage stress, anxiety, and emotional well-being.
3. Develop conflict resolution skills for personal and professional life.
4. Encourage emotional intelligence and interpersonal communication.
5. Promote resilience and positive mindset development.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Identify sources and effects of stress in personal and professional life.
2. Apply stress management techniques such as mindfulness, journaling, and relaxation exercises.
3. Utilize conflict management strategies to resolve interpersonal and workplace conflicts.
4. Demonstrate improved emotional intelligence and resilience.
5. Develop effective communication skills for personal and professional growth.

List of Practical (Perform any 12 Experiments):

1. Self-assessment of stress levels using Perceived Stress Scale (PSS)
2. Journaling activity: Maintain a 7-day emotional diary
3. Mindfulness breathing exercise and reflection
4. Guided meditation session and feedback form
5. Time management activity using Eisenhower Matrix
6. Role-play exercise on workplace conflict resolution
7. SWOT analysis of personal behavior and coping mechanisms
8. Cognitive restructuring worksheet for negative thoughts
9. Group discussion: "How do you respond to stress?"
10. Conflict styles self-test (Thomas-Kilmann Conflict Mode Instrument)
11. Visualization technique to reduce anxiety
12. Progressive muscle relaxation practice
13. Team activity: Building trust through icebreakers and communication
14. Reflection report after practicing gratitude for 5 days
15. Case study analysis: Conflict scenario in a healthcare/pharma setup

BP212P SEC3 Fundamentals of Computer Operations (Practical)

Course Objectives: The objectives of this course are to:

1. Provide foundational knowledge of computer systems, operating environments, and digital tools used in academic and professional settings.
2. Develop practical skills in digital documentation, data handling, and presentation using commonly available office productivity tools.
3. Familiarize students with file management practices and digital communication methods used in professional environments.
4. Enhance the ability to access, search, and retrieve scientific and academic information from online resources.
5. Prepare students to utilize computer-based tools for managing pharmaceutical data, documentation, and basic professional tasks.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Demonstrate the ability to operate computer systems and perform basic system and file management functions.
2. Prepare and format digital documents and spreadsheets for academic and pharmaceutical applications.
3. Develop presentations and use digital communication tools for effective professional communication.
4. Access and retrieve scientific information using online databases and academic search platforms.
5. Apply basic computer skills for organizing, analyzing, and managing pharmaceutical data and documentation.

List of Practical (Perform any 12 Experiments):

General Instruction on Digital Tools: Open-source digital tools are preferred for teaching and learning purposes. However, institutions may choose appropriate software platforms, applications, or online services depending on availability, institutional policy, and infrastructure. The selected tools should enable students to perform the required digital and documentation tasks effectively. The specific software may vary, but the skills and competencies listed below must be achieved using suitable tools.

Practical Components:

1. Basic operation and navigation of a computer operating system, including system settings and file explorer functions.
2. Creating, renaming, organizing, moving, and deleting files and folders within a computer system.
3. Preparing a structured academic or pharmacy-related report using a word-processing application with appropriate formatting, tables, headers, and page layout.
4. Inserting equations, images, and formatted elements while preparing documents such as reports, notices, or certificates using document editing tools.
5. Creating spreadsheets for pharmacy-related calculations such as dose calculations, inventory records, or sales data using spreadsheet applications.
6. Applying basic spreadsheet formulas and functions such as summation, averaging, conditional calculations, and counting operations.
7. Generating graphs, charts, and data visualizations from experimental or pharmaceutical data using spreadsheet tools.
8. Preparing a short academic presentation (approximately five slides) using presentation software with text, images, and basic design elements.
9. Performing effective internet browsing and academic search techniques using online scientific literature databases and search platforms.
10. Writing and sending professional emails including file attachments, proper subject lines, and appropriate use of CC and BCC with correct communication etiquette.
11. Introduction to digital systems used in pharmacy practice such as billing, inventory management, or prescription management through demonstration or simulation.
12. Using cloud-based storage platforms for saving, organizing, and sharing academic or pharmacy-related files and data.
13. Exploring digital health technologies such as pharmacy-related mobile applications or electronic health tools used in healthcare practice.
14. Accessing and utilizing online learning platforms for professional education and course materials.
15. Preparing and submitting digital assignments using word-processing, spreadsheet, or presentation tools.

Semester 3 Electives (BP312P AEC)

BP312P AEC1 Nutraceuticals and Functional Foods (Practical)

Course Objectives: The objectives of this course are to:

1. Introduce the concept and classification of nutraceuticals and functional foods.
2. Explore the role of bioactive components in health promotion and disease prevention.
3. Familiarize students with the formulation, labelling, and quality control of nutraceuticals.
4. Understand the regulatory aspects governing nutraceuticals and dietary supplements.
5. Develop practical skills in extraction, analysis, and preparation of functional foods.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Classify and explain the functions of various nutraceuticals and functional foods.
2. Identify sources of important phytochemicals and dietary bioactives.
3. Perform basic laboratory techniques for nutraceutical product development.
4. Analyze labels and evaluate quality and efficacy of marketed supplements.
5. Understand regulatory frameworks (FSSAI, FDA, EFSA) and apply them in practice.

List of Practical (Perform any 12 Experiments):

1. Identification and classification of nutraceuticals and functional foods from marketed products
2. Preparation of a probiotic drink or yogurt using lactic acid bacteria
3. Extraction of phytochemicals (flavonoids, alkaloids) from plant material
4. Estimation of antioxidant activity using DPPH method
5. Formulation of a herbal supplement capsule or powder
6. Demonstration of dietary fiber content from cereals or vegetables
7. Assessment of total polyphenol content using Folin–Ciocalteu reagent
8. Label analysis of functional foods and dietary supplements (FSSAI standards)
9. Case study presentation: Role of omega-3 fatty acids in cardiovascular health
10. Demonstration of stability testing of a nutraceutical formulation
11. Preparation of fortified food product (e.g., iron-fortified juice)
12. Visit to a food testing laboratory or nutraceutical industry (or virtual tour)
13. Evaluation of glycemic index of selected carbohydrate-rich foods (conceptual)
14. Regulatory comparison of nutraceutical guidelines (FSSAI vs. FDA vs. EFSA)
15. Preparation of a functional food label with nutrition facts and claims

BP312P AEC2 Food Analysis (Practical)

Course Objectives: The primary objectives of this course are:

1. Understand to perform proximate analysis.
2. Know to operate, maintain, interpret and evaluate the data of instruments.
3. Understand and apply quality control principles.
4. Know to detect and analyze Food adulteration.
5. Knew to nutritional and quality aspects of food products

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Gain knowledge on nutritional and quality aspects of food products.
2. Understand troubleshoot common issues of instruments.
3. Execute and apply theoretical knowledge of food chemistry.
4. Understand the various analytical techniques for qualitative and quantitative analysis.
5. Understand the significance and application of food analysis in ensuring safety and quality.

List of Practical (Perform any 12 Experiments):

1. Determination of the acid value for the given oil/fat
2. Determination of the ester value of the given oil/fat
3. Determination of the saponification value of the given oil/fat
4. Determination of total and free acidity in honey as per FSSAI method.
5. Quantification of caffeine content in soft drinks.
6. Determination of fat content in milk by gravimetric method
7. Detection of starch and urea in milk as per FSSAI method.
8. Assessment of fluoride content in drinking water
9. Assessment of total hardness in drinking water
10. Determination of the rancidity of the oil by UV Visible spectrophotometer
11. Quantification of benzoic acid as preservative in beverages/jam/ jellies by titrimetric/spectrophotometric method.
12. Isolation and identification of synthetic food colours by paper chromatography/Thin layer chromatography.
13. Determination of total curcuminoid content in turmeric by UV visible spectrophotometer.
14. Assessment of the total ash content for spices and condiments.
15. Determination of gluten content in whole wheat/wheat flour.
16. Determination of alcoholic acidity in bread and bread products.
17. Determination of Caloric value of food and nutritional supplements.

BP312P AEC3 Yoga and Life Sciences (Practical)

Course Objectives: The objectives of this course are:

1. To introduce students to the principles of yoga and its scientific basis.
2. To teach the practical aspects of yoga, including asanas (postures), pranayama (breathing exercises), and meditation.
3. To enhance students' understanding of the health benefits of yoga on physical and mental well-being.
4. To explore the role of yoga in the prevention and management of diseases.
5. To encourage a holistic lifestyle by incorporating yoga into daily routines.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Perform basic yoga postures (asanas) and breathing exercises (pranayama).
2. Understand the physiological and psychological benefits of yoga.
3. Apply yoga techniques for stress relief, flexibility, and mental clarity.
4. Recognize the therapeutic potential of yoga in managing chronic health conditions.
5. Integrate yoga into daily life for improved well-being and productivity.

List of Practical (Perform any 12 Experiments):

1. Demonstration and practice of Surya Namaskar (Sun Salutation)
2. Practice of basic asanas: Tadasana, Vrikshasana, Bhujangasana
3. Practice of Pranayama techniques: Nadi Shodhana, Bhramari
4. Meditation session: Focused awareness and breath control
5. Yoga-based stretching and warm-up routine
6. Recording physiological parameters (heart rate, BP) before and after yoga
7. Yoga journal: Track weekly yoga practice and mood changes
8. Poster presentation on "Scientific benefits of yoga on immunity"
9. Yoga for specific health conditions: Back pain, asthma, stress
10. Group chanting of Mantra – observation of mental state
11. Learning the role of yoga in circadian rhythm regulation
12. Visit to a yoga wellness center or attending a virtual session
13. Assessment of flexibility using sit-and-reach test before/after practice
14. Demonstration of Yog Nidra (guided relaxation technique)
15. Case presentation: Impact of yoga on a chronic disease condition

Semester 6 Electives (BP607T AEC, BP610P SEC, BP611P VAC)

BP607T AEC1 Green Chemistry (Theory)

Course Objectives: The objectives of this course are to:

1. Comprehend the foundational principles and overarching scope of green chemistry within pharmaceutical sciences.
2. Analyze and evaluate the environmental impact of traditional pharmaceutical manufacturing processes and the significance of green chemistry metrics.
3. Acquire knowledge of diverse green chemical techniques, including alternative solvents and various catalytic approaches, for sustainable drug synthesis.
4. Recognize the industrial application of green chemistry principles in pharmaceutical manufacturing processes, focusing on waste minimization and pollution control.
5. To articulate the principles of green chemistry.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Articulate the principles of green chemistry and provide relevant pharmaceutical examples for each.
2. Identify and propose suitable green solvents and catalysts,
3. Understand the advanced synthetic methods using Green synthesis using microwave, Ultrasonic for the production of active pharmaceutical ingredients (APIs).
4. Develop strategies for waste minimization and continuous flow reactor in pharmaceutical manufacturing in industries.
5. Articulate the principles of green chemistry and provide relevant pharmaceutical examples for each.

Note: The fifth course outcome printed in the official document repeats the first.

Unit I

Introduction to Green Chemistry in Pharmacy

1. Definition and scope of green chemistry in pharmaceutical sciences
2. Principles of Green Chemistry with pharmaceutical examples

Unit II

Environmental Aspects and Metrics in Green Pharmacy

• Comparison of traditional vs. green chemical approaches in drug synthesis • Environmental impact of pharmaceutical manufacturing • Overview of pharmaceutical pollutants and their life cycle • Metrics: Atom economy, E-factor, Process Mass Intensity (PMI)

Unit III

Green Techniques in Pharmaceutical Synthesis – I

1. Green Solvents and use of green solvents (e.g. water, supercritical fluids, ionic liquids) in drug synthesis
2. Solvent-free reactions in pharmaceutical synthesis
3. Green Catalysis and Reaction Enhancement in pharmaceutical green chemistry – Overview of catalysis in pharmaceutical green chemistry, Photochemical Transformations, Phase Transfer Catalysis

Unit IV

Green Techniques in Pharmaceutical Synthesis – II

1. Microwave assisted reactions: Merit and demerits of its use
2. Mechanism, superheating effects of microwave
3. Effects of solvents in microwave assisted synthesis
4. Microwave technology in process optimization
5. Applications in various organic reactions and heterocycles synthesis

Unit V

Green Chemistry in Industrial and Regulatory Aspects

1. Green chemistry in pharmaceutical manufacturing processes
2. Ultrasound assisted reactions: Types of sonochemical reactions, synthetic applications
3. Continuous flow reactors: Working principle, advantages and synthetic applications
4. Waste minimization and pollution control in formulation industries
5. Role of green chemistry in Good Manufacturing Practices (GMP)

BP607T AEC2 Materiovigilance and Hemovigilance (Theory)

Course Objectives: The objectives of this course are to:

1. Understand the concepts, scope, and importance of materiovigilance and hemovigilance systems in ensuring patient safety in healthcare.
2. Familiarize students with national and international regulatory frameworks, reporting systems, and global initiatives related to vigilance programs.
3. Identify and evaluate adverse events associated with medical devices and blood transfusion practices.
4. Develop competencies in detection, reporting, investigation, and documentation of vigilance-related incidents.
5. Promote awareness of safety culture, quality assurance, and ethical responsibilities in clinical and healthcare practices.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Explain the principles, scope, and significance of materiovigilance and hemovigilance in ensuring patient and public health safety.
2. Describe the structure and functioning of the Materiovigilance Programme of India (MvPI) and the procedures for reporting medical device-related adverse events.
3. Outline the framework of the Hemovigilance Programme of India (HvPI) and classify different types of transfusion-related adverse reactions.
4. Compare national and international vigilance systems and apply basic methods of risk assessment, signal detection, and root cause analysis.
5. Demonstrate appropriate documentation and reporting practices and recognize the role of healthcare professionals in promoting vigilance and patient safety.

Unit I

Introduction to Vigilance Systems

• Overview of Materiovigilance, Hemovigilance and other vigilance system in Healthcare • Importance of post-marketing surveillance in patient safety • Scope and objectives of materiovigilance and hemovigilance programs • Basic concepts of adverse event reporting and safety monitoring • Historical evolution and global relevance of Materiovigilance, Hemovigilance practices

Unit II

Materiovigilance – Principles and Practices

• Introduction to Materiovigilance Programme of India (MvPI) • Roles of NCC-MvPI and technical collaborators (e.g., Sree Chitra Tirunal Institute) • Classification of medical devices (Class A to D) based on risk • Identification and documentation of Medical Device Adverse Events (MDAEs) • Medical device reporting forms, process flow, and responsibilities • Causality assessment of Medical Device Adverse Events

Unit III

Hemovigilance – Principles and Practices

• Overview of Hemovigilance Programme of India (HvPI) • Organizational structure: NIB, NBTC, hospital-based hemovigilance • Adverse Transfusion Reactions (ATRs): Types and clinical manifestations • Use of TRRF (Transfusion Reaction Reporting Form) and HaemoVigil software • Responsibilities of blood banks, transfusion officers, and healthcare providers • Case examples along with Causality assessment of Hemolytic reactions, TRALI, TACO, allergic responses.

Unit IV

Global Regulations, Risk Assessment & Root Cause Analysis

• International frameworks: US FDA (MAUDE), EU MDR, SHOT (UK), French Hemovigilance • Comparison of Indian and global materiovigilance/hemovigilance practices • Signal detection and evaluation of adverse events • Root cause analysis (RCA) and implementation of corrective & preventive actions (CAPA) • Risk communication and role of healthcare teams in mitigation

Unit V

Reporting Systems, Quality Assurance, and Professional Role

Demonstration: Reporting of MDAEs and ATRs using mock forms • Practical exercises in form-filling and event documentation • Integration of vigilance into hospital quality systems (e.g., NABH, ISO) • Strategies to enhance adverse event reporting culture • Ethical considerations and communication with patients/families • Role of pharmacists, nurses, clinicians, biomedical engineers in vigilance programs

BP607T AEC3 Scientific Writing (Theory)

Course Objectives: The objectives of this course are to:

1. Develop the ability to write clearly, concisely, and effectively for scientific audiences.
2. Understand the structure and components of scientific documents such as research papers, proposals, and literature reviews.
3. Learn the principles of scientific style, tone, and formatting in academic writing.
4. Apply correct citation practices and reference management techniques.
5. Recognize and address ethical issues in scientific communication, including plagiarism and data integrity.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Understand the principles of scientific writing
2. Develop clear and concise scientific writing skills
3. Use effective scientific citation techniques
4. Understand and apply the ethical principles of scientific writing
5. Develop the ability to critically evaluate scientific literature

Unit I

Introduction to Scientific Writing

• Overview of the course • Principles of scientific writing • Overview of scientific research • Introduction to Microsoft tools and its application

Unit II

Writing Literature Reviews and Scientific Papers

• Structure and format of literature reviews • Conducting a literature review • Analyzing literature and developing themes • Writing a compelling introduction • Developing a clear methodology • Results and analysis

Unit III

Communicating Results and Data

• Understanding data presentation • Developing tables and figures • Using effective graphic design

Unit IV

Scientific Citation and Referencing

• Understanding citation styles • Citation and plagiarism • Referencing in scientific writing

Unit V

Ethical Issues in Scientific Writing and Peer Review and Revision

• Ethical principles in scientific writing • Misconduct and fraud in scientific writing • Peer review and publication ethics • Providing Constructive feedback • Responding to feedback

BP607T AEC4 Drug Store and Business Management (Theory)

Course Objectives: The objectives of this course are to:

1. Understand the principles of trade, commerce, and different types of business organizations.
2. Gain knowledge on effective drug store layout, procurement, and inventory control.
3. Apply basic accounting and financial principles for pharmacy business operations.
4. Explore marketing and sales strategies applicable to pharmaceutical products.
5. Develop entrepreneurial skills and understand legal aspects of drug store management.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Describe different business models and their relevance to pharmaceutical trade.
2. Manage drug store operations, including procurement, storage, and customer service.
3. Maintain basic accounting records and interpret financial statements.
4. Implement inventory control techniques and pricing policies.
5. Apply marketing principles and legal guidelines for establishing a retail pharmacy.

Unit I

Introduction to Trade and Industry

• Objectives and scope of business • Classification of business activities – industry, commerce, trade • Forms of business organization: sole proprietorship, partnership, cooperatives, corporations • Features and merits/demerits of each form Pharmacy business and its legal considerations

Unit II

Drug Store Management

• Selection of site, space, and layout of a drug store • Types of drug stores – hospital pharmacy, community pharmacy, chain pharmacy • Procurement of drugs and inventory control • Storage conditions and stock maintenance (cold storage, poisonous drugs, etc.) • Records and registers to be maintained

Unit III

Inventory Control and Sales Promotion

• Introduction to inventory control: need and methods • Economic Order Quantity (EOQ), Reorder Level (ROL), Lead time • FIFO and LIFO methods • Sales promotion techniques: advertising, displays, discounts • Customer relationship management (CRM) in pharmacy

Unit IV

Financial Management and Bookkeeping

• Basics of accounting: journal, ledger, trial balance • Introduction to financial statements: profit and loss account, balance sheet • Pricing policies: markup, markdown, break-even analysis • Bank transactions: types of accounts, cheques, drafts • Taxation basics: GST, income tax (as applicable to pharmacies)

Unit V

Pharmaceutical Marketing and Entrepreneurships

• Definition and scope of pharmaceutical marketing • Elements of marketing mix (4Ps) for pharmacy • Drug distribution channels: wholesale and retail • Entrepreneurship development in pharmacy • Regulatory aspects of retail drug licensing (Drug and Cosmetics Act overview)

BP607T AEC5 Career Building in Cultivation of Medicinal Plants (Theory)

Course Objectives: The objectives of this course are to:

1. Explain the significance, historical background, and therapeutic importance of medicinal plants.
2. Examine the structure, scope, and economic potential of the medicinal plant industry.
3. Identify and describe important medicinal plants of India and their applications.
4. Develop knowledge of sustainable, organic, and scientific cultivation practices for medicinal plants.
5. Explore entrepreneurship opportunities and value chain development in the medicinal plant sector.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Explain the importance and historical development of medicinal plants in traditional and modern healthcare systems.
2. Describe the structure and functioning of the medicinal plant industry and its economic significance.
3. Identify major medicinal plants of India and explain their uses and sources.
4. Apply principles of sustainable and organic cultivation practices for medicinal plants.
5. Analyze entrepreneurship opportunities and value chain development in the medicinal plant sector.

Unit I

Introduction and Industry Overview

• Definition, importance, and cultural background (Ayurveda & ethnobotany) • Global and Indian demand, healthcare and pharma role • Key stakeholders: farmers, traders, processors, exporters • Value chain, supply-demand, government/private initiatives (NMPB, AYUSH, NABARD)

Unit II

Key Medicinal Plants and Cultivation Basics

• Botanical characteristics and uses of major plants: Ashwagandha, Tulsi, Aloe vera, Shatavari, Brahmi, etc. • Regional suitability and agro-climatic zones • Factors affecting Cultivation: Soil, propagation, irrigation, pest control, organic inputs • Harvesting, post-harvest management and storage

Unit III

Organic Farming and Market Linkages

• Organic certification and sustainable farming practices • Biodiversity conservation and agroforestry integration • Processing, drying, packaging, branding • Market linkages: pharma, cooperatives, online platforms, export guidelines

Unit IV

Policy, Entrepreneurship and Digital Tools

• Government schemes and legal frameworks (NMPB, AYUSH, forest laws, GACP) • Entrepreneurship: starting herbal farms, franchises, consulting, contract farming • Digital tools: farm management software, GIS, mobile apps, ecommerce marketing

Unit V

Practical Exposure and Project Presentation

• Virtual/shortened farm/nursery visit or guest lecture (can be online) • Group/individual project: business plan or herbal enterprise pitch presentation

BP607T AEC6 Active Pharmaceutical Ingredients and Excipient Sciences (Theory)

Course Objectives: The objectives of this course are to:

1. Understand the fundamental concepts of Active Pharmaceutical Ingredients (APIs) and excipients in dosage form development.
2. Analyse the physicochemical properties influencing API–excipient compatibility and formulation performance.
3. Develop knowledge of industrial methodologies for characterization and quality control.
4. Understand GMP protocols and regulatory frameworks governing API and excipient manufacturing.
5. Explore emerging industrial trends including green chemistry and bio-based excipients.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. To explain the classification, properties and functional roles of APIs and excipients.
2. To apply analytical and preformulation methodologies for compatibility and stability evaluation.
3. To understand manufacturing, scale-up and quality control procedures used in industry.
4. To evaluate regulatory documentation and compliance requirements for API and excipient approval.
5. To develop awareness of current industrial practices and innovation trends.

Unit I

Introduction to APIs and Excipients

• Definitions, classifications, and sources (synthetic, natural, biotech APIs; functional excipients). • Physicochemical properties: Solubility, polymorphism, hygroscopicity, particle characteristics. • Roles in formulations: Bioavailability enhancement, stability, manufacturability. • Industry overview: Global market trends, common examples (e.g., paracetamol API, HPMC excipient).

Unit II

Methodologies for Selection and Pre-formulation

• Excipient selection criteria: Functionality-related characteristics (FRC). • Compatibility studies: Binary mixtures via DSC, FTIR, XRD. • Analytical methodologies: HPLC/GC for purity, Karl Fischer titration, laser diffraction for PSD. • QbD approach: Risk assessment for API-excipient interactions.

Unit III

Manufacturing Protocols

• API processes: Synthesis routes, crystallization, drying, milling; labto-pilot scale-up. • Excipient handling: Sieving, blending, lubrication protocols. • GMP essentials: Equipment qualification, process validation. • Unit operations: Wet/dry granulation, direct compression.

Unit IV

Quality Control and Stability Protocols

• QC tests: Assay, dissolution, content uniformity (IP/USP methods). • Stability studies: ICH Q1A zones, accelerated/forced degradation. • Impurity profiling: Genotoxic impurities (ICH M7), residual solvents. • In-process controls: Blend uniformity, weight variation.

Unit V

Regulatory Compliance and Industry Practices

• ICH Q7 guidelines for APIs • USP-NF excipient monographs and Schedule M requirements • Drug Master File (DMF) for APIs • Certificate of Suitability (COS) for excipients • Process and cleaning validation protocols • Regulatory inspections (USFDA 483, EMA expectations) • Emerging trends: green chemistry and bio-based excipients

BP610P SEC1 Computer Aided Drug Design (Practical)

Course Objectives: The objectives of this course are to:

1. Familiarize students with target identification and protein preparation using biological databases and molecular visualization tools.
2. Develop skills in ligand design, optimization, and 3D conformer generation using computational chemistry software.
3. Provide practical understanding of molecular docking and interaction analysis for structure-based drug design.
4. Introduce pharmacophore modelling and QSAR techniques for virtual screening and predictive modelling.
5. Train students in ADMET prediction and molecular dynamics simulations for evaluating drug-likeness and stability of drug–target complexes.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Retrieve and prepare biological targets from protein databases and analyze active sites using molecular modelling tools.
2. Design and optimize ligand structures and generate energetically stable conformers for computational drug design studies.
3. Perform molecular docking and analyze drug–target interactions to evaluate ligand binding affinity and stability.
4. Apply pharmacophore modelling and QSAR methods for virtual screening and prediction of biological activity.
5. Evaluate drug candidates using ADMET prediction tools and molecular dynamics simulations to assess drug-likeness and complex stability.

List of Practical:

General Instruction on Computational Tools: Open-source computational tools are preferred for teaching and learning purposes. However, institutions may select appropriate software platforms or online resources based on availability, institutional policy, and technical feasibility. The choice of software should enable students to perform the required computational tasks effectively. The specific software used may vary, but the learning outcomes and computational procedures described below must be achieved using suitable tools.

1. Target Identification and Preparation: Retrieve protein sequence or structural information from publicly available biological databases. Prepare the target protein by removing unwanted molecules, correcting structural issues, and adding necessary atoms or charges using appropriate molecular visualization or preparation tools. Identify potential binding or active sites using computational methods that analyze structural pockets and cavities.
2. Ligand Design and Optimization: Design or sketch candidate molecules using suitable molecular drawing tools. Convert structures into three-dimensional form and optimize their geometry using computational chemistry methods. Generate multiple conformations of the molecule and perform energy minimization to obtain stable structures.
3. Molecular Docking: Perform docking simulations using computational docking platforms to predict the interaction between ligands and the target protein. Examine binding orientations and molecular interactions using visualization tools. Rank compounds based on predicted binding affinity and interaction quality.
4. Pharmacophore Modeling: Identify essential molecular features responsible for biological activity such as hydrogen bond donors/acceptors, hydrophobic regions, and aromatic centers. Construct pharmacophore models representing these key features. Use these models to screen compound libraries for molecules that match the required feature pattern.
5. QSAR Modeling: Calculate molecular descriptors that represent structural and physicochemical properties of compounds. Develop predictive statistical or machine learning models that relate these descriptors to biological activity. Validate models using appropriate validation techniques such as cross-validation and external datasets.
6. ADMET Prediction: Evaluate pharmacokinetic and toxicity properties computationally, including: Absorption, Distribution, Metabolism, Excretion, Toxicity. Use predictive computational models and online resources to assess druglikeness and safety profiles.
7. Molecular Dynamics Simulations: Conduct simulations to study the dynamic behavior of the protein–ligand complex over time. Analyze parameters such as structural stability, atomic fluctuations, hydrogen bonding, and interaction persistence. Visualize simulation trajectories to understand conformational changes and binding stability.

BP610P SEC2 Analytical Method Development and Validation (Practical)

Course Objectives: The objectives of this course are to:

1. Provide practical exposure to analytical method development using spectrophotometric, chromatographic, and titrimetric techniques for pharmaceutical analysis.
2. Introduce principles of optimization of analytical parameters such as wavelength, mobile phase composition, column selection, flow rate, temperature, and pH for reliable analysis.
3. Familiarize students with validation requirements of analytical methods as per regulatory guidelines, including assessment of sensitivity, linearity, and specificity.
4. Expose students to advanced chromatographic applications such as dissolution testing, impurity profiling, forced degradation studies, and residual solvent analysis.
5. Bridge analytical theory with industrial and regulatory practices relevant to quality control and quality assurance of pharmaceutical products.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Develop and optimize analytical methods using UV–Visible spectrophotometry, HPLC, GC, and titrimetric techniques for pharmaceutical substances.
2. Construct calibration curves and perform quantitative estimation of APIs and formulations with appropriate analytical validation.
3. Select and optimize chromatographic conditions including column type, mobile phase composition, flow rate, temperature, and detection wavelength.
4. Apply analytical method validation parameters such as LOD, LOQ, and robustness to ensure reliability and regulatory compliance.
5. Conduct stability-indicating and impurity-related studies, including forced degradation, dissolution testing, and residual solvent analysis.

List of Practical (Perform any 12 Experiments):

1. Development of a UV-Visible spectrophotometric method for the assay of paracetamol API. Construction of calibration curve for a model API using UV-Visible spectrophotometry.
2. Determination of solid dosage form by using dissolution method.
3. Analytical method development and validation of Atenolol/metformin by using HPLC.
4. Investigation of different columns for HPLC separation of a Multi-component Drug Mixture.
5. Optimization of mobile Phase composition for HPLC analysis of a selected drug.
6. Optimization of Flow rate and temperature in HPLC for paracetamol/ caffeine.
7. Selection of wavelength for spectrophotometric analysis by HPLC of Marketed drugs.
8. Determination of λmax and calibration curve for qualitative analysis of paracetamol.
9. Determination of effect of pH on Retention time in RP-HPLC.
10. Validation of HPLC method : Determination of LOD and LOQ for paracetamol by HPLC
11. Preliminary Investigation of forced Degradation studies on Ibuprofen by HPLC.
12. Method development for related substances of a drug substance using HPLC.
13. Determination of residual solvent analysis for ethanol/acetone in API by using Gas Chromatography.
14. Development of titrimetric method for the assay of marketed drugs(Ascorbic acid/sodium bicarbonate).

BP610P SEC3 Principles of Preclinical Studies (Practical)

Course Objectives: The objectives of this course are to:

1. Introduce the role and importance of preclinical studies in the drug discovery and development process.
2. Familiarize students with laboratory animal handling, ethical considerations, and experimental protocols used in preclinical research.
3. Explain the principles of pharmacokinetics and toxicology as applied to animal models.
4. Describe the regulatory guidelines and standards governing preclinical research and animal experimentation.
5. Develop skills in analyzing and interpreting preclinical data to support decision-making for clinical trials.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Explain the role and significance of preclinical studies in drug discovery and development.
2. Demonstrate appropriate laboratory animal handling practices in accordance with ethical and regulatory guidelines.
3. Analyze pharmacokinetic parameters obtained from preclinical animal studies.
4. Design and interpret basic toxicological studies to evaluate drug safety.
5. Apply preclinical data in assessing drug candidates for progression to clinical trials.

List of Practical (Perform any 12 Experiments):

1. Handling, restraining, and sex differentiation of laboratory animals (demo/video)
2. Calculation of dose for animals based on body surface area
3. Routes of administration: oral, intraperitoneal, subcutaneous (simulation)
4. Observation of behavioral effects using actophotometer/rotarod (if available)
5. Determination of acute toxicity (LD50 concept) – case-based calculation
6. Planning a 28-day sub-acute toxicity study protocol
7. Pharmacokinetic study: Cmax, Tmax, AUC calculation (sample dataset)
8. Observation of histopathological slides from toxicity studies
9. Demonstration of sampling methods – blood, urine (case or video)
10. Writing an animal study protocol using CPCSEA format
11. Identification of organs for toxicity evaluation – liver, kidney, brain
12. Visit to CPCSEA-approved animal house/laboratory
13. Observation of animal behavior – grooming, nesting (case-based)
14. Simulated ethics committee approval process (IAEC)
15. Group activity: Design of a preclinical study for a hypothetical drug

*PCI recommended software's shall be used for performing experiments.

BP611P VAC1 Professional Skills (Practical)

Course Objectives: The objectives of this course are to:

1. Develop effective verbal and interpersonal communication skills required for professional environments.
2. Train students in workplace etiquette, interview preparation, and team collaboration.
3. Enhance problem-solving, time management, and critical thinking abilities relevant to professional settings.
4. Promote personal grooming, digital professionalism, and responsible social media etiquette.
5. Prepare students to face professional challenges through experiential learning, role play, and interactive activities.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Demonstrate professional communication skills in interviews, emails, presentations, and workplace meetings.
2. Prepare and present an industry-standard résumé and professional online profile.
3. Exhibit confidence and clarity during group discussions, presentations, and interviews.
4. Apply time management, decision-making, and conflict resolution strategies in professional situations.
5. Maintain workplace ethics, etiquette, and a professional demeanor in both physical and digital environments.

List of Practical (Perform any 12 Experiments):

1. Self-introduction exercise – verbal and written presentation
2. Resume/CV writing – using current industry formats
3. Mock job interview – panel-based or peer-reviewed
4. Group discussion (GD) – on current healthcare or industry topics
5. Public speaking practice – impromptu and prepared speeches
6. Email etiquette and writing professional emails
7. Time management matrix creation (Eisenhower box)
8. Body language analysis – observe and present feedback
9. Conflict resolution role play – team-based activity
10. Creating a LinkedIn profile and optimizing it professionally
11. Debate session – critical thinking and communication
12. Listening skills test – audio-based task with Q&A
13. Workplace scenario simulation – ethics, teamwork, communication
14. Presentation skills – create and deliver PowerPoint presentations
15. Goal-setting and career mapping – using SMART goals

BP611P VAC2 Process Analytical Technology (PAT) and QbD in Formulation Science (Practical)

Course Objectives: The objectives of this course are to:

1. Introduce PAT concepts so students grasp how in-line sensors monitor critical quality attributes (CQAs).
2. Explain QbD thinking for defining design space, critical process parameters (CPPs), and risk-based control strategies.
3. Teach basic PAT tools: near-infrared (NIR) probes, focused-beam reflectance (FBRM), and multivariate models.
4. Demonstrate mini-DoE methods that link process variables to CQAs and support realtime release testing (RTRT).
5. Instil risk-analysis skills using Ishikawa diagrams and FMEA to prioritise and mitigate formulation hazards.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Describe the role of PAT and QbD in ensuring consistent product quality throughout a formulation process.
2. Identify and justify key CQAs, CPPs, and potential failure modes for a solid-dosage product.
3. Collect and interpret real-time data from an NIR or FBRM sensor and decide when a blend or granulation meets targets.
4. Design and analyse a small factorial experiment that optimises at least one CQA within a defined design space.
5. Prepare a brief risk-control plan showing ranked RPN values and proposed PAT-based monitoring to enable RTRT.

List of Practical:

1. Identify Critical Quality Attributes (CQAs) – Brainstorm and list five tablet CQAs (hardness, dissolution, etc.) and link each to patient safety or efficacy.
2. Ishikawa (Fish-Bone) Diagram – Draw a cause-and-effect diagram for poor tablet dissolution, categorising factors into Materials, Methods, Machines and Manpower.
3. Blend-Uniformity by NIR Probe – Collect in-line near-infrared spectra during 10 min of blender operation and plot real-time API concentration trends.
4. Moisture Tracking with NIR – Use a portable NIR gun to measure LOD in wet granules every 2 min, stopping when the plot hits the 3 % target.
5. Mini DoE for Granulation – Run a 2² design varying impeller speed and granulation time; measure granule mean size and create main-effects plots.
6. Real-Time Release Test (RTRT) – Set up an at-line NIR hardness prediction model, test 20 tablets, and compare predicted vs. actual hardness.
7. Control Chart of Particle Size (FBRM) – Stream Focused Beam Reflectance data during milling; plot X̄ and R for d₅₀ and decide if the process is in control.
8. Multivariate Calibration Model – Build a partial-least-squares (PLS) model correlating NIR spectra to drug content; report R² and RMSEP.
9. FMEA Risk-Priority Number – Score severity, occurrence and detectability for three high-risk process variables; rank them by RPN and suggest mitigation.
10. PAT Model Verification Batch – Run the optimised process, capture PAT data, and confirm that all CQAs meet specification without end-product testing.

Semester 7 Electives (BP708T AEC)

BP708T AEC1 cGMP (Theory)

Course Objectives: The objectives of this course are to:

1. Explain the structure, purpose, and implementation of Standard Operating Procedures (SOPs) in pharmaceutical operations.
2. Develop understanding of training and development systems, including training needs assessment and evaluation methods used in the pharmaceutical industry.
3. Describe the principles of current Good Manufacturing Practices (cGMP) and key regulatory guidelines relevant to pharmaceutical quality assurance.
4. Examine core pharmaceutical quality systems such as Quality Management Systems (QMS), CAPA, deviation management, and non-conformance handling.
5. Understand procedures for managing customer complaints, investigating quality issues, and ensuring product safety and regulatory compliance.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Understand the structure of SOPs, its writing and approval system, Importance of training, development, training needs identification and evaluation.
2. Understand the major FDA guidelines (regulated and semi regulated markets) and its understanding.
3. Impart knowledge on manufacturing assurance, analytical assurance, engineering assurance etc, and handling systems for non-conformances.
4. Procedures used to investigate market complaints and its closure.
5. Impart knowledge on preparing for the regulatory audits, reports handling and drafting of compliance report, with certain understanding of Do's and Don'ts during the audits.

Unit I

Standard Operating Procedures (SOP), Systems for Training & Development in Pharmaceuticals

• Introduction to SOPs, SOP on SOP, Contents of a standard SOP, Writing a good SOP, Distribution and control of SOPs. • Introduction to Training and development, Training needs identification, Training and evaluation.

Unit II

A comprehensive review of cGMP and various important FDA guidelines

• List of major guidelines referred in pharmaceuticals • Effectively reading and understanding the guidelines

Unit III

Important Quality Assurance and cGMP systems adopted in Pharmaceuticals

• Introduction to Quality Management Systems (QMS), Manufacturing Assurance, Analytical Assurance, Developments Quality Assurance, Engineering Assurance. • Concepts of corrective and preventive actions (CAPA), Deviations and Incidents handling.

Unit IV

Handling of non-conforming materials

Handling of Customer Complaints

• Introduction to complaints, Types of complaints • Understanding Manufacturing defects and Quality issues • Handling and investigation of customer complaints

Unit V

Regulatory Audits

• Introduction to audits and Types of audits. • Preparation for a successful audit, Audit teams and internal audits. • Handling of FDA inspections: FDA observations, Compliance and replying to an audit report.

BP708T AEC2 Pharmaceutical Automation (Theory)

Course Objectives: The objectives of this course are to:

1. Introduce the fundamental concepts of automation technologies used in the pharmaceutical industry.
2. Explain the application of automated systems in pharmaceutical manufacturing, quality control, and packaging operations.
3. Describe the principles of process instrumentation, SCADA, PLC, and robotics in pharmaceutical production environments.
4. Develop understanding of laboratory automation systems including LIMS and Process Analytical Technology (PAT).
5. Examine regulatory considerations and emerging trends in pharmaceutical automation and digital manufacturing.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Explain the principles and advantages of automation in pharmaceutical processes.
2. Identify and describe various automated systems used in production and quality control.
3. Apply knowledge of instrumentation and control systems like SCADA and PLC in pharma environments.
4. Analyze the role of automation in enhancing data integrity, regulatory compliance, and productivity.
5. Evaluate new trends like Industry 4.0, IoT, and AI applications in pharmaceutical automation.

Unit I

Introduction to Automation in Pharmaceuticals

• Definition and scope of automation in pharmaceutical industry • Importance and benefits: accuracy, efficiency, cost-effectiveness, compliance • Types of automation: fixed, programmable, flexible • Application areas: production, packaging, quality control, warehousing • Challenges and limitations of automation

Unit II

Automated Manufacturing Systems

• Principles of automated tablet compression, capsule filling, liquid filling, and coating machines • PLC-based machinery in granulation and drying • Robotics in sterile product manufacturing (isolators, RABS) • Continuous manufacturing vs. batch processing • Automation in aseptic processing and lyophilization

Unit III

Process Control and Instrumentation

• Sensors and transducers: temperature, pressure, flow, pH, conductivity • Introduction to SCADA (Supervisory Control and Data Acquisition) systems • Distributed Control Systems (DCS) in pharma • Process Analytical Technology (PAT) – definition and applications • Basics of automation programming (ladder diagrams, logic gates – overview only)

Unit IV

Quality Control and Laboratory Automation

• Automation in analytical laboratories: HPLC, UV, FTIR, dissolution testers • Laboratory Information Management System (LIMS) • Integration of instruments with software and data loggers • Automated sampling and testing methods • Role of AI/ML in predictive quality assurance

Unit V

Regulatory Aspects and Emerging Trends

• Regulatory expectations: USFDA, WHO, EMA on automation & electronic systems • 21 CFR Part 11 – electronic records and signatures • Data integrity and ALCOA • Emerging trends: IoT, Industry 4.0, cloud-based manufacturing, AI in pharma • Case studies: automated systems in top pharma companies

BP708T AEC3 Modern Techniques in Cellular Biology (Theory)

Course Objectives: The objectives of this course are to:

1. Learn the basics of five key cell-biology tools: CRISPR editing, flow cytometry, livecell imaging, single-cell RNA-seq, and advanced fluorescence microscopy.
2. Plan good experiments by picking the right reagents, controls, and settings for each technique.
3. Get hands-on practice using at least one workflow from every unit.
4. Read and understand the data these methods produce: plots, images, and geneexpression maps.
5. Apply the methods responsibly by considering safety, ethics, and real-world biomedical uses.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Explain key principles of CRISPR editing, flow cytometry/FACS, live-cell imaging, single-cell RNA-seq, and advanced fluorescence microscopy.
2. Design and carry out one basic protocol for each technique (e.g., gRNA design, fourcolour FACS run, 12-h time-lapse capture, scRNA-seq data import, confocal Z-stack acquisition).
3. Interpret the resulting data by creating clear plots, images, or cluster maps and extracting at least one biological conclusion from each.
4. Choose the right technique for a given cellular-biology question and justify the choice with brief technical and practical reasoning.
5. Apply essential safety, ethical, and data-quality guidelines while performing and reporting every experiment.

Unit I: CRISPR & Genome Editing

CRISPR-Cas9 mechanics, guide-RNA design and DNA repair outcomes, contrasts knock-outs, knock-ins and base-editing, and shows how dCas9 fusions enable gene activation or repression. Students compare delivery routes: plasmid, ribonucleoprotein, viral and lipid-nanoparticle, then evaluate off-target detection strategies before a mini-lab in which they design a gRNA and screen predicted off-targets.

Unit II: Flow Cytometry & Cell Sorting

Learners review flow-cytometer fluidics, optics and fluorochrome chemistry, interpret forward/side scatter plots for cell size and granularity, and build multi-colour antibody panels with compensation. They perform cell-cycle, apoptosis and immunophenotyping assays, study FACS sorting logic and viability checks, and finish with a hands-on run of a four-colour immunophenotyping panel.

Unit III: Live-Cell Imaging

This unit covers phase-contrast, DIC and fluorescence time-lapse microscopy, stressing environmental control through on-stage incubators and microfluidic perfusion. Students deploy fluorescent reporters such as GFP fusions and calcium biosensors to track motility, division and signalling, learn to minimise phototoxicity and manage large image datasets, then conduct a 12-hour GFP-cell time-lapse demo.

Unit IV: Single-Cell RNA-Seq & Multi-Omics

Participants examine single-cell isolation by droplets, microwells or FACS, walk through barcoding, library preparation and sequencing, and run a basic bioinformatics pipeline for quality control, normalisation, clustering and UMAP/t-SNE visualisation. They identify cell types, trajectories and rare populations, glimpse CITE-seq and spatial transcriptomics, and explore a public scRNA-seq dataset in R/Python during a workshop.

Unit V: Advanced Fluorescence & Super-Resolution Microscopy

Confocal and two-photon fundamentals, followed by super-resolution strategies (STED, SIM and PALM/STORM), plus functional techniques such as FRET, FRAP and FLIM for probing protein interactions and dynamics. Learners plan multiplexed staining with spectral imaging, discuss clinical applications including FISH and diagnostic immunofluorescence, and acquire and process a confocal z-stack in a practical sessions.

BP708T AEC4 Medical Devices (Theory)

Course Objectives: The objectives of this course are to:

1. Understand the Evolution and Regulatory Landscape: Gain insights into the history, market trends, and regulatory frameworks governing medical devices in India and globally.
2. Master Design and Biocompatibility Principles: Learn the principles of medical device design, selection of materials, and the importance of biocompatibility in device development.
3. Implement Quality Systems in Manufacturing: Understand the application of Good Manufacturing Practices (GMP), quality assurance, and risk management in medical device production.
4. Navigate Regulatory Affairs for Global Market Access: Acquire knowledge of regulatory requirements and strategies for medical device approval and post-market surveillance in various regions.
5. Explore Emerging Technologies in Biomedical Engineering: Investigate the integration of electronics, sensors, and software in medical devices, and address ethical considerations in their development and use.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Analyze Market Trends and Regulatory Policies: Assess the evolution of the medical device industry and the impact of regulatory frameworks on market dynamics across regions.
2. Design Safe, Effective, and Compliant Medical Devices: Apply design principles, emerging technologies (sensors, electronics, software), and appropriate biomaterials to develop medical devices that ensure safety, efficacy, biocompatibility, and functionality.
3. Implement Quality and Risk Management Systems: Apply ISO 13485 standards, risk management processes, and ethical principles to ensure quality, safety, and responsible device development.
4. Navigate Global Regulatory Pathways: Understand and apply regulatory approval processes for medical devices in India, the US, the EU, and other regions.
5. Develop Post-Market Surveillance Strategies: Design and implement strategies to monitor performance, safety, and compliance of medical devices after market launch.

Unit I

Introduction to Medical Devices: History and Overview of Medical Device Industry and evolving market Trends

1. (India + WW)
2. GOI's initiatives and National Medical Device Policy.
3. Regulatory frameworks (CDSCO; State FDA; USFDA; EU-CE, etc.)
4. Medical device design and development process
5. Definition and Classification of Medical Devices (India; US; EU)

Unit II

Medical Device Design, Biomaterials and Biocompatibility:

1. Medical Device Design principles and methodologies, safety analysis
2. Properties and selection of materials & biomaterials for devices
3. Tissue engineering and regenerative medicine
4. Biocompatibility Testing and Standards (ISO 10993)

Unit III

Manufacturing and Quality Systems: (based on ISO 13485 Fifth Sch of IMDR 2017)

1. Good Manufacturing Practices (GMP) & Infrastructure requirements
2. Quality assurance and quality control in Medical Devices
3. Supply chain management (warehousing distribution)
4. Risk Management (ISO 14971)

Unit IV

Regulatory Affairs, Regulatory strategies for global market access

1. Medical device regulations and standards (IMDR 2017)
2. Understanding Regional Differences in Regulatory Pathways
3. Regulatory submissions and approvals (India)
4. Post-market surveillance and vigilance (India)
5. Global Regulatory Requirements (USFDA, CE Mark, etc.)
6. Case Studies of Global Regulatory Challenges

Unit V

Biomedical Engineering; Instrumentation: Emerging Technologies

1. Principles of biomedical sensors and transducers
2. Medical imaging techniques (X-ray, CT, MRI, ultrasound)
3. Telemedicine and remote monitoring
4. Integration of Electronics and Software in Medical Devices
5. Wearable Devices and Remote Monitoring
6. Ethical issues in device development and use

BP708T AEC5 Transformation of Food Waste into Medicinal Products (Theory)

Course Objectives: The objectives of this course are to:

1. Explain the sources, environmental impacts, and regulatory aspects of food waste.
2. Describe sustainable principles and technologies used in food waste management.
3. Explore methods for converting food waste into value-added products.
4. Discuss the recovery of bioactive compounds from food waste and their potential applications.
5. Introduce the use of artificial intelligence and digital technologies in food waste management and resource optimization.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Identify types, sources, impacts, and regulations related to food waste.
2. Apply principles and sustainable technologies for effective food waste management.
3. Explain the conversion of food waste into biofuels, biopolymers, and other valueadded products.
4. Assess bioactive compounds derived from food waste and their industrial and health applications.
5. Understand the role of AI, IoT, and blockchain in smart food waste management systems.

Unit I

Introduction to Food Waste

Food waste: Definition, Types, Sources, Causes, Problems, Impacts Advantages, Challenges, Solutions and Future directions. Indian and International regulations for food waste management

Unit II

Sustainable Management of Food Waste

Principles of Food waste Management. Technologies and Processes: Thermo-chemical Processes, Biological Processes, Green extraction, Pyrolytic and Enzymatic techniques

Unit III

Byproducts from Food Waste

Production of Biohydrogen, Biogas, Organic acids, Vermicompost, and Biopolymers

Unit IV

Bioactive Compounds from Food Waste

Antimicrobial, Antioxidants, Anti-inflammatory agents, Antibiotics, Prebiotics, Nutritional Supplements, Cosmetics and Biopolymers

Unit V

3D printed medicines: Customized dosages and Scaffolds

Role of AI in Food waste management

Machine learning, Internet of Things (IoT) and Blockchain

BP708T AEC6 Bio-similars, Vaccines and Macromolecule Sciences (Theory)

Course Objectives: The objectives of this course are to:

1. Introduce the fundamental concepts of biological macromolecules, biosimilars, and modern vaccine technologies used in pharmaceutical biotechnology.
2. Explain the physicochemical and functional characterization methods used for the analysis and comparability assessment of biologics and biosimilars.
3. Develop understanding of upstream and downstream manufacturing processes involved in the production of biopharmaceuticals and vaccines.
4. Describe quality control, stability testing, and immunogenicity assessment procedures applied to biologics and vaccine products.
5. Familiarize students with regulatory frameworks and approval pathways governing biosimilars and vaccines in India and global markets.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Describe the structure and therapeutic roles of biological macromolecules, biosimilars and vaccines.
2. Apply analytical methodologies for characterization and bioequivalence assessment.
3. Understand upstream and downstream processing and formulation protocols.
4. Understand quality control, stability testing, and immunogenicity assessment methods used for ensuring the safety and efficacy of biologics and vaccines.
5. Assess regulatory compliance requirements across the product lifecycle.

Unit I

Introduction to Biosimilars, Vaccines and Macromolecules

• Classes: Monoclonal antibodies (mAbs), cytokines, insulin, growth factors; primary/secondary/tertiary structures. • Biosimilars: Definition, rationale, types (e.g., erythropoietin, filgrastim). • Vaccines: Generations (live, subunit, viral vector, mRNA); adjuvants and delivery systems. • Industry landscape: Blockbuster biologics (Humira, Keytruda), Indian biosimilar market.

Unit II

Characterization Methodologies

• Physicochemical: SDS-PAGE, SEC-HPLC, peptide mapping, mass spectrometry. • Glycosylation analysis: N-linked glycans (HILIC, lectin arrays). • Functional assays: Cell-based potency, binding ELISA, ADCC. • Comparability for biosimilars: Fingerprinting (ICH Q5E).

Unit III

Manufacturing Protocols

• Upstream: Cell line development (CHO, HEK), bioreactors, media optimization. • Downstream: Harvesting, chromatography (affinity, ion-exchange), viral clearance. • Fill-finish: Lyophilization, aseptic processing, cold chain. • Process analytical technology (PAT) in biologics.

Unit IV

Quality Control and Stability Protocols

• Release testing: Host cell proteins (HCP), DNA, sterility, endotoxin (LAL). • Stability: ICH Q5C for biologics; subvisible particles, aggregation. • Immunogenicity assessment: ADA assays, neutralizing antibodies. • Vaccine QC: Potency, identity, safety (animal models).

Unit V

Regulatory Compliances and Case Studies

• Global: USFDA 351(k) biosimilar pathway, EMA guidelines, WHO prequalification. • India: CDSCO Biosimilar Guidelines 2021, DCGI vaccine approvals. • Documentation: BLA/CMC modules, PK/PD comparability studies. • Case studies: COVID-19 mRNA vaccines (Pfizer), Indian trastuzumab biosimilars.

BP708T AEC7 Precision Medicine (Theory)

Course Objectives: The objectives of this course are to:

1. Introduce the fundamental concepts, scope, and evolution of precision medicine and its relevance to modern pharmacy practice.
2. Provide an understanding of pharmacogenomics and the role of genetic variability in drug response, safety, and efficacy.
3. Explain the importance of biomarkers, targeted therapies, and companion diagnostics in personalized treatment strategies.
4. Introduce the emerging technologies such as artificial intelligence, big data analytics, and electronic health records in precision medicine.
5. Develop awareness of regulatory frameworks, ethical considerations, and clinical implementation challenges associated with genomic-based therapies.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Define precision medicine and explain its evolution from conventional therapy to personalized healthcare approaches, highlighting the role of pharmacists and interdisciplinary collaboration.
2. Describe basic human genetics and pharmacogenomic principles, and interpret genotype–phenotype relationships affecting drug response and adverse drug reactions.
3. Analyze the role of genetic polymorphisms (e.g., CYP450 enzymes) and utilize pharmacogenomic resources and databases such as PharmGKB and CPIC in clinical decision-making.
4. Classify biomarkers and evaluate their role in targeted therapies and companion diagnostics, with reference to real-world clinical case studies as targeted nanocarriers, antibody–drug conjugates, and smart delivery systems
5. Define precision medicine and explain its evolution from conventional therapy to personalized healthcare approaches, highlighting the role of pharmacists and interdisciplinary collaboration.

Note: The fifth course outcome printed in the official document repeats the first.

Unit I

Introduction to Precision Medicine and Its Relevance to Pharmacy

Definition and scope of precision medicine. Evolution from "one-size-fits-all" to personalized approaches. Key components: genomics, epigenetics, environmental factors, lifestyle. Role of pharmacists in precision medicine. Interdisciplinary nature (clinicians, bioinformaticians, pharmacologists)

Unit II

Pharmacogenomics in Drug Response and Safety

Basic human genetics relevant to pharmacy. Genotype-phenotype relationships. Genetic polymorphisms: CYP450 enzymes (CYP2D6, CYP2C9, etc.). FDA drug labelling and pharmacogenomic biomarkers. Tools/databases: AlphaGenome, PharmGKB, CPIC, SNPedia

Unit III

Biomarkers, Targeted Therapy, and Companion Diagnostics

Types of biomarkers: predictive, prognostic, diagnostic. Role of biomarkers in targeted therapy. Companion diagnostics: regulatory approval and clinical application. Case study: Trastuzumab and HER2 testing in breast cancer. Lab-on-chip and biosensor technologies. Targeted nano-delivery in oncology. Antibody-drug conjugates (ADCs). Smart delivery systems (stimuli-responsive biosensors)

Unit IV

Technology, AI, and Big Data in Precision Medicine

Role of AI, machine learning, and data analytics in precision medicine. Electronic Health Records (EHRs), clinical decision support systems. Integration of genomic data with patient profiles. Examples of AI-driven drug discovery. Data security and interoperability

Unit V

Regulatory, Ethical, and Clinical Implementation

Regulatory guidelines (US FDA, EMA, CDSCO) for genomic-based therapies. Clinical trial design for precision drugs. Cost-effectiveness and access in low-resource settings. Ethical issues: genetic testing, informed consent, data ownership. Future of pharmacy practice in the precision medicine era

Semester 8 Electives (BP806T AEC, BP809P VAC)

BP806T AEC1 Pharmaceutical Packaging (Theory)

Course Objectives: The objectives of this course are:

1. Provide students with a comprehensive understanding of pharmaceutical packaging, its principles, materials, processes, and regulatory aspects.
2. Equip students with knowledge of the selection, design, and development of packaging materials for various dosage forms.
3. Educate students on the interaction between packaging and formulation, quality control, and advances in pharmaceutical packaging.
4. Train students in assessing packaging materials for pharmaceutical products in compliance with regulatory guidelines.
5. Prepare students for future roles in pharmaceutical manufacturing, quality assurance, and packaging development.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Understand the purpose and function of packaging in pharmaceuticals, including primary, secondary, and tertiary packaging.
2. Identify and evaluate the materials used in pharmaceutical packaging and their interactions with dosage forms.
3. Design and select appropriate packaging materials during product development.
4. Apply quality control and regulatory principles to packaging processes.
5. Recognize advancements in packaging technology, including child-resistant packaging, tamper-evident packaging, and automation.

Unit I

General Information on Packaging

1. Introduction: Purpose of packaging, selection of the ideal package (primary, secondary and tertiary), hazards encountered by the package, various types of inner and outer packages, selection of a suitable package.
2. Packaging materials: Detailed study with regard to composition packaging characteristics, advantages, economics and limitations of various packaging materials with special emphasis on glass, plastics, metals and rubber.
3. Child resistant package, Tamper Evident Packaging, AntiCounterfeit Packaging, Environmental considerations of packaging (Recycling).

Unit II

Pharmaceutical Packaging – Design and Development

1. Selection and Design of Packaging during Product Development Process (Parameters).
2. Packaging Process: Significance of Strip, Blister, Pouch Packaging, advantages, economics and limitation, Packing machinery and recent advances, films employed in Packing (Video based learning).

Unit III

Formulation Packaging Interaction

1. Polymer Chemistry Science and Stability Aspects
2. Extractable and Leachables
3. Methods to study formulation packaging interaction
4. Suitability considerations for pharmaceutical packaging

Unit IV

Quality Assurance, Control and Regulatory Aspects

1. Total Quality management, Good Manufacturing Practice, Quality Risk Management related to Packaging Department, Specification Testing and Shelf-life testing as per Pharmacopoeial Guidelines for Packaging Material in-process and finished Package Products.
2. Standard Operating Procedures (SOPs)/Documentation for Solid/SemiSolid/Liquid/Parenteral Formulation Packaging. Packaging waste and Waste policies for packaging materials,

Unit V

Advances in Pharmaceutical Packaging

1. Labelling- Types of label (including Bar code, Hologram, RF, structured program, inmould and decorative labelling) – Use of Software, Legal requirements of Labelling, packaging inserts and outserts. Adhesives and Machinery Employed for Labelling - Pharmacy Accessory Label Printers (PALP), Concept of paperless labelling
2. Logistics Packaging - Block Chain Technology in Supply Traceability, Transparency and Credibility. Review on Automated Packaging System for Oral Solids (Auto-Print), Oral Liquid (Fluidose), and overwrapping (PABS).

BP806T AEC2 Supply Chain Management (Theory)

Course Objectives: The objectives of this course are to:

1. Understand and apply key SCM concepts and frameworks.
2. Analyze and optimize supply chain processes using industry-standard models.
3. Evaluate the impact of digital technologies and sustainability on supply chains.
4. Develop strategies for risk management and resilience in supply chains.
5. Implement best practices for procurement, logistics, and inventory management.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Analyze and design efficient supply chains.
2. Implement effective procurement and supplier management strategies.
3. Optimize logistics and distribution networks
4. Leverage technology for supply chain innovation.
5. Develop sustainable and resilient supply chain practices and importance of cold chain management.

Unit I

Introduction to Supply Chain Management

o Introduction to SCM: Definition, scope, Importance of SCM, in global business, Key components and stakeholders, Supply Chain Strategies, Process and barriers of supply chain management. o Supply Chain Models: SCOR Model (Plan, Source, Make, Deliver, Return) o CSCMP Supply Chain Process Standards. o Supply Chain Network Design, Facility location and layout, Transportation planning. o Supply Chain Performance Metrics, Key Performance Indicators (KPIs) o Performance measurement tools o Case Study: SCM in Practice with Real-world examples

Unit II

Procurement and Supplier Management

o Procurement Fundamentals, Role of procurement in SCM, sourcing strategies o Supplier selection criteria, supplier performance evaluation, Collaboration and communication. o Global Sourcing, Challenges and opportunities, Cultural considerations, Legal and ethical issues o E-Procurement, Electronic procurement systems, Benefits and challenges o Case Study: Procurement Excellence, Best practices.

Unit III

Logistics and Distribution Management

o Logistics Fundamentals, Definition and scope, Importance in SCM o Transportation Management, Modes of transportation, Routing and scheduling, Freight cost analysis o Inventory Management of pharmaceuticals, Inventory types and functions, Inventory control techniques, Economic Order Quantity (EOQ) o Introduction to warehouse functions, Management and Distribution channels and distribution strategies for vaccines and biologicals. o Case Study: Logistics and transportation Optimization process, Knowledge and skill sets needed for optimization.

Unit IV

Technology and Innovation in SCM

o Information Technology in SCM, Role of IT in SCM planning and operations management for pharmaceuticals. o Enterprise Resource Planning (ERP) systems, operations system, Supply Chain Management Softwares. o Big Data and Analytics, Importance of data in SCM. o Artificial Intelligence and Machine Learning, AI/ML applications in SCM, smart logistics. o Demand forecasting, Autonomous vehicles o Security and transparency with special emphasis to cybersecurity.

Unit V

Sustainability and Risk Management in SCM

o Sustainable Supply Chain Management, Green logistics, Circular economy Environmental impact assessment. o Ethical Sourcing, Fair trade practices, Labor standards, Supplier audits. o Risk Management in SCM, Risk identification and assessment, Risk mitigation strategies, Crisis management with special emphasis to Pharmaceutical products. o Regulatory Compliance, International trade regulations, Customs and import/export laws, Compliance standards. o Cold chain management, its need, challenges and opportunities in Pharmaceutical products. o Case Study: Risk and Sustainability Challenges

BP806T AEC4 Traditional Healing Practices of India (Theory)

Course Objectives: The objectives of this course are to:

1. Introduce the fundamental concepts and historical background of Indian traditional medicine systems.
2. Explain the core principles and diagnostic approaches of Ayurveda, Siddha, Unani, Naturopathy, and Homeopathy.
3. Examine tribal and folk healing traditions and their role in community healthcare practices.
4. Explore the cultural, spiritual, and religious dimensions associated with traditional healing systems.
5. Promote understanding of the scientific validation and policy-level integration of traditional medical knowledge.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Understand the foundational concepts and history of traditional healing systems in India.
2. Explore the various regional healing practices and their sociocultural relevance.
3. Analyse the integration of traditional and modern healthcare systems.
4. Develop a critical appreciation of indigenous knowledge systems in health and healing.
5. Encourage scientific validation and policy-level integration of traditional health knowledge

Unit I

Introduction to Traditional Medicine

Definition and scope of traditional healing. Historical evolution of traditional medicine in India. Indigenous knowledge systems and oral traditions. Health and disease in Indian philosophical thought. Integrating Traditional Healing with Modern Medicine. What is a traditional healing practice. Traditional healing practice in India. Socio-Scientific Validation and Knowledge Integration. Preservation of Socio-Cultural Health Knowledge. Ethnoveterinary Empowerment and Rural Health Equity

Unit II

Basic principles: Ayurveda, Panchamahabhuta, Tridosha, Dhatu, Mala. Diagnosis and treatment: Pulse diagnosis, Panchakarma, Rasayana, Nadi Parikshan, Marma therapy, Chiropathic treatment. Materia medica (Dravyaguna) and formulation (Rasa Shastra). Current relevance and institutionalization (AYUSH). The study seeks to integrate traditional healing practices into contemporary healthcare systems. Contemporary usage and debates. Fostering Transdisciplinary Collaboration. Economic Viability and Grassroots Entrepreneurship

Unit III

Siddha and Unani Systems

Siddha: Origin, principles, and therapeutic techniques. Unani: Greek-Arabic foundations, four humors, pharmacopoeia. Role in South Indian and Indo-Islamic medical heritage. Role of traditional healing practice in homeopathy and naturopathy. Development and acceptance in India

Unit IV

Folk and Tribal Healing Practices

Holistic approach to the traditional system, natural methods of healing practices, and cultural significance of the traditional system of medicine. Difference between Indian traditional system of medicine and traditional Chinese medicinal system. Regional practices: Snake stones, ritual healing, herbal knowledge. Role of healers: Vaidya, Ojha, Bhopa, Bonesetters, Dai (traditional midwives). Ethnomedicine and ethnobotany: Case studies from North East of India, Chhattisgarh, Himalaya etc. Multidisciplinary longitudinal study to comprehensively document, scientifically validate, and integrate traditional healing systems

Unit V

Spiritual and Religious Healing

Role of Yoga, Pranayama, and meditation. Healing through Mantras, rituals, and astrology. Use of temples and sacred groves in mental health and well-being. Computational studies will complement laboratory investigations by revealing molecular interactions and mechanisms of action, thereby providing scientific rigor to traditional claims. Legal and policy frameworks (AYUSH, WHO recognition). Role of NGOs and community health programs. Challenges in validation, standardization, and commercialization. Case studies of integration in rural/urban healthcare. Protection of Intellectual Property and Cultural Sovereignty. Documentation of Indigenous Knowledge System (IKS). Prevention of the Traditional system of medicine.

BP806T AEC5 Futuristic Pharma Through Augmented Reality and Virtual Reality (AR/VR): Pharma 4.0 (Theory)

Course Objectives: The objectives of this course are to:

1. Introduce the fundamental concepts of Augmented Reality (AR) and Virtual Reality (VR) technologies and their applications in the pharmaceutical sector.
2. Provide hands-on exposure to AR/VR tools used in pharmaceutical manufacturing, training, simulation, and patient education.
3. Develop skills in utilizing immersive technologies for pharmaceutical research, formulation development, and scientific communication.
4. Explore the integration of Pharma 4.0 technologies, including AI, IoT, and AR/VR, in smart pharmaceutical manufacturing and regulatory compliance.
5. Familiarize students with emerging immersive solutions in the pharmaceutical industry that support quality assurance, training, and regulatory standards.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Explain the core principles of Pharma 4.0 and distinguish immersive technologies (AR, VR, MR, XR) and their components relevant to pharmaceutical applications.
2. Demonstrate hands-on proficiency in using AR/VR hardware and software tools to create basic immersive pharmaceutical experiences.
3. Apply AR/VR technologies in drug discovery, molecular modeling, and collaborative virtual research environments.
4. Design AR/VR training simulations and SOP overlays for pharmaceutical manufacturing, GMP practices, and quality control.
5. Develop and present immersive pharma solutions that meet compliance standards, validation protocols, and Pharma 4.0 integration needs.

Unit I

Introduction to AR/VR and Tools

1. Understanding AR and VR: Concepts, Tools, and Devices. Hands-on demo of Google Cardboard, Oculus, or similar headsets. Difference between AR, VR, and Mixed Reality (MR)
2. Exploring AR/VR Platforms for Life Sciences. Overview of software: Unity 3D, Vuforia, WebAR, JigSpace, ARKit. Demo of existing pharma-related AR/VR apps (e.g., Human Anatomy VR)

Unit II

AR/VR in Pharmaceutical Education and Training

Use of apps for visualizing drug-receptor interaction. Virtual dissection and interactive physiology. Simulated tablet compression and coating machines. Training modules on aseptic techniques using VR. Counseling Patients in a Virtual Pharmacy Setup. Use of avatars and scenarios for OTC counseling, prescription explanation. Emphasis on communication and empathy in virtual settings

Unit III

AR/VR in Manufacturing and Pharma 4.0

Digital Twin Concept & Virtual Plant Walkthrough. Create mock layouts of pharma production plants in AR. Navigate a cleanroom and observe equipment placement virtually. Smart Maintenance and SOP Training via AR. Integrating AR with Sensors and QR-based Inventory. Real-world temperature/humidity sensors. Live monitoring of warehousing systems. Pharma 4.0 Compliance and Regulatory Perspectives. Virtual audit readiness. Documentation and equipment validation trails using AR mockups

Unit IV

AR/VR for Patient-Centric Applications

Patient Leaflets and Drug Delivery Tutorials. Creating content showing how to use inhalers, injectables, or devices. Overlay content on medicine boxes or instruction cards. AR/VR for Mental Health, Pain, and Rehabilitation Therapy. Case studies: VR for phobia therapy, chronic pain, relaxation therapy. Digital Adherence Tools with AR Guidance. Real-time AR reminders linked to prescription schedules. AI avatars for personalized patient nudges

Unit V

Project-Based Integration and Evaluation

Mini Project: Create an AR/VR-Based Solution. Example: VR tour of GMP plant, AR-based patient education module. Demo Unity or online tools like CoSpaces / ZapWorks

BP806T AEC6 Herbal Cosmetics for Industry Perspectives (Theory)

Course Objectives: The objectives of this course are to:

1. Introduce the fundamentals of the herbal cosmetics industry and its scope in the global market.
2. Develop an entrepreneurial mindset for innovation and business development in herbal cosmetic products.
3. Build competence in financial planning, business management, and marketing strategies relevant to herbal cosmetic enterprises.
4. Familiarize students with legal and regulatory frameworks governing the manufacture and marketing of herbal cosmetic products.
5. Develop skills in quality assurance, safety evaluation, and standardization of herbal cosmetic formulations.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Know about the materials, capital and infrastructural requirements along with understanding the fundamentals of Entrepreneurship
2. Understand the specifications and importance of adhering to Good Manufacturing Practices (GMP)
3. Know the guidelines and testing requirements for ensuring quality and safety of herbal cosmetics.
4. Acquire knowledge about legal and regulatory requirements for manufacturing and import of herbal cosmetics. Also the labelling requirements and regulations for advertising. With emphasis on the Drugs and Cosmetics Act (1940) and rules (1945) of India. Along with the regulatory approval process and their registration in Indian and international markets.
5. Know about the materials, capital and infrastructural requirements along with understanding the fundamentals of Entrepreneurship

Note: The fifth course outcome printed in the official document repeats the first.

Unit I

Introduction to the requirements for an herbal cosmetics industry

Market trends, worldwide trade and consumer demand for herbal cosmetics. Advantages and challenges of the herbal cosmetics industry. Requirements for factory location, premises, plant layout and infrastructure and materials.

Unit II

Fundamentals of Entrepreneurship

Characteristics and skills of successful entrepreneurs. Types of entrepreneurship: product, process, and quality testing entrepreneurship. Developing Entrepreneurial mind-set. Case studies Success Stories of some successful herbal cosmetic brands (e.g., Forest Essentials, Biotique, Khadi Naturals). Steps involved in setting up a start-up: Identifying gaps in the herbal cosmetics market. Business plan development for a herbal cosmetic product. SWOT analysis for herbal cosmetics start-ups. Technical, financial, and market feasibility study. Planning for scalability and sustainability

Unit III

Financial Management and Marketing Strategies

Budgeting and cost estimation. Sources of finance: loans, grants, angel investors, venture capital. Government schemes (STARTUP INDIA) and support for MSMEs and herbal industries. Overview on branding essentials – positioning and brand identity. Distribution channels: retail, e-commerce, exports. Digital marketing: social media, Search Engine Optimization (SEO) influencer marketing

Unit IV

Legal and Regulatory Framework

Licensing and registration for herbal cosmetics as per the Drugs and Cosmetics Act (1940) and rules (1945) of India. The role of CDSCO, AYUSH ministry, FSSAI, ISO, GMP in the herbal cosmetics industry. Labelling and packaging norms (Schedule S and role of Bureau of Indian Standards –BIS). Advertising regulation for herbal cosmetics. IP rights: patents, trademarks, and protection of herbal knowledge

Unit V

Quality and safety evaluation of herbal cosmetics

Importance of quality assurance in herbal cosmetics. Key safety concerns (contamination, allergens, microbial growth). Quality evaluation of herbal raw material. Product-Specific Quality Parameters - Quality standards for creams, lotions, shampoos, oils, face packs, etc. Specific marker compounds and their quantification in herbal products. Toxicological and Safety Evaluation: In vitro and in vivo safety testing (skin irritation, sensitization, eye irritation). Patch testing, Draize test, and OECD guidelines. Use of alternative non-animal testing methods (3D skin models, in silico models)

BP809P VAC1 Cleaning Validation (Practical)

Course Objectives: The objectives of this course are:

1. To understand the importance of cleaning validation in pharmaceutical manufacturing.
2. To familiarize students with the regulatory requirements for cleaning validation.
3. To teach methods for residue detection and the development of cleaning protocols.
4. To explore different analytical techniques used in cleaning validation.
5. To develop skills in writing cleaning validation reports and ensuring compliance.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Explain the purpose and importance of cleaning validation.
2. Develop cleaning validation protocols and methods for pharmaceutical equipment.
3. Understand and apply residue detection techniques such as HPLC and TOC.
4. Evaluate cleaning effectiveness and compliance with regulatory standards.
5. Prepare detailed cleaning validation reports and perform revalidation when necessary.

List of Practical (Perform any 12 Experiments):

1. Preparation of a cleaning validation protocol for a tablet machine
2. Calculation of MACO (Maximum Allowable Carry Over)
3. Swab sampling technique demonstration using stainless steel surface
4. Rinse sampling technique for equipment residue detection
5. Visual inspection for equipment cleanliness (case photos/videos)
6. Preparation of recovery study protocol using a known contaminant
7. Demonstration of Total Organic Carbon (TOC) analysis (video/simulation)
8. HPLC method development for residue analysis (demo dataset)
9. Interpretation of swab analysis results and comparison with acceptance limits
10. Preparation of cleaning log sheet and checklists
11. Validation of cleaning agents: detergent effectiveness and rinsibility
12. Determining dirty hold time and clean hold time experimentally (conceptual)
13. Designing a matrix approach for multi-product equipment
14. Simulated deviation report and CAPA for cleaning failure
15. Preparation of a final cleaning validation summary report

BP809P VAC2 Basic Training in Aseptic Handling Techniques (Practical)

Course Objectives: The objectives of this course are:

1. Understand aseptic principles that prevent microbial contamination in clean-room work.
2. Learn correct gowning and hand-hygiene steps for ISO-classified areas.
3. Practise safe techniques for setting up laminar-airflow hoods and transferring sterile materials.
4. Carry out routine monitoring of surfaces, air, and personnel to verify sterility.
5. Document procedures accurately to meet GMP and audit requirements.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Explain the key concepts of asepsis, clean-room classifications, and contamination control.
2. Demonstrate full sterile gown-up and hand-wash without contamination spots.
3. Set up and operate a laminar-airflow workstation and perform aseptic liquid transfers with no spills.
4. Complete a mini media-fill that meets sterility acceptance criteria (> 95 % clear vials).
5. Record and interpret environmental and personnel monitoring data, flagging any values above action limits.

List of Practical:

1. Gown-up / Gown-down Drill – correct sequencing of coverall, hood, mask, goggles, gloves, and sterile boots.
2. Hand-washing Verification – surgical scrub with UV lotion; inspect under UV lamp for missed spots.
3. Clean-room Entry & Flow Simulation – air-shower pass, unidirectional walking, and material air-lock transfer.
4. LAF Hood Preparation – wipe-down with sporicidal, set airflow, place sterile tools in first-air zone.
5. Smoke-pattern Test – visualize HEPA downflow with smoke to confirm laminar, turbulence-free air.
6. Aseptic Liquid Transfer – pipette or syringe transfer of TSB between vials without touching non-sterile surfaces.
7. Sterile Filtration & Filter Integrity Check – filter a buffer through 0.22 µm unit and perform bubble-point test.
8. Mini Media-Fill – fill 20 sterile vials with TSB under LAF, incubate, and record turbidity for 14 days.
9. Environmental & Personnel Monitoring – deploy settle/contact plates, take glove-fingertip prints, run an air sampler.
10. Cleaning & ATP Validation – full hood wipe-down, then ATP swab preand post-clean to verify < 200 RLU residue.

BP809P VAC3 Impurity Profiling (Practical)

Course Objectives: The objectives of this course are:

1. To understand the types and sources of impurities in pharmaceutical substances.
2. To learn the techniques used for detection, isolation, and quantification of impurities.
3. To study regulatory guidelines for impurity profiling (ICH, USFDA, EMA).
4. To develop skills in interpreting impurity data and analytical validation.
5. To apply impurity profiling in drug development, stability studies, and quality control.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Explain the principles and significance of impurity profiling in pharmaceutical analysis.
2. Identify methods for detection and quantification of organic, inorganic, and residual impurities.
3. Follow ICH and pharmacopeial guidelines for impurity limits and documentation.
4. Perform impurity analysis using HPLC, GC, UV, and IR techniques.
5. Evaluate and interpret impurity data for regulatory submissions and quality assurance.

List of Practical (Perform any 12 Experiments):

1. Identification of organic impurities in bulk drugs using TLC
2. Quantification of impurities using HPLC
3. Determination of residual solvents by GC (as per ICH Q3C)
4. UV-spectrophotometric analysis of degradation products
5. Preparation of forced degradation samples (acid/base/hydrolytic)
6. Identification of degradation products via IR spectroscopy
7. Extraction and analysis of impurities from finished dosage forms
8. Impurity profiling of marketed paracetamol tablet using HPLC
9. Qualification of impurities as per ICH Q3A/Q3B guidelines
10. Limit test for heavy metals (as per IP)
11. Estimation of elemental impurities by ICP-MS or simulated method
12. Determination of related substances in antibiotics (e.g., cephalosporins)
13. Use of LC-MS data interpretation for impurity identification (demo/simulated)
14. Impurity profiling of herbal products using HPTLC
15. Report preparation on impurity profiling as per regulatory requirements

Source: Syllabus, Bachelor of Pharmacy (B. Pharm) (2026), As per NEP 2020, Pharmacy Council of India. Syllabus text reproduced word for word from the official document.

BP806T AEC3 Industrial Safety and Waste Management (Theory)

Course Objectives: The objectives of this course are to:

1. Explain the principles of industrial safety and accident prevention in pharmaceutical industries.
2. Analyze workplace hazards and apply risk management strategies for ensuring safe industrial operations.
3. Describe the types of industrial waste generated in pharmaceutical industries and their environmental impacts.
4. Familiarize students with waste treatment technologies and regulatory frameworks governing industrial waste management.
5. Promote understanding of sustainable waste management practices in accordance with national and international environmental standards.

Course Outcomes (CO): Upon successful completion of this course, the students will be able to:

1. Identify hazards in industrial settings and apply preventive safety measures.
2. Conduct risk assessments and implement control strategies for workplace safety.
3. Classify and manage different types of industrial waste generated in pharmaceutical sectors.
4. Apply suitable treatment and disposal methods for hazardous and non-hazardous waste.
5. Interpret and follow safety and environmental regulations applicable to industrial practices.

Unit I

Introduction to Industrial Safety

• Importance of industrial safety in pharmaceutical and chemical industries • Types of industrial hazards: physical, chemical, biological, mechanical, electrical • Accident prevention techniques • Safety signs, symbols, and personal protective equipment (PPE) • OSHA guidelines and ISO safety standards

Unit II

Risk Assessment and Hazard Management

• Hazard identification methods (HAZOP, FMEA) • Risk analysis and evaluation • Safety audit and checklist • Fire hazards and fire-fighting systems • Role of safety officer and disaster management planning

Unit III

Waste Management – Fundamentals

• Classification of industrial waste: hazardous, non-hazardous, solid, liquid • Sources of pharmaceutical and chemical waste • Waste minimization strategies • Recycling, reuse, and resource recovery Environmental impact assessment (EIA) basics

Unit IV

Waste Treatment Technologies

• Physical, chemical, and biological methods of waste treatment • Treatment of effluents, emissions, and solid waste • Common Effluent Treatment Plants (CETP) • Biomedical waste disposal and rules (BMW Rules – India) • Guidelines from CPCB, WHO, and MOEFCC

Unit V

Regulatory and Sustainable Practices

• Environmental Protection Act, Factories Act, Hazardous Waste Rules • Good Manufacturing Practices (GMP) related to waste and safety • International guidelines: US EPA, EU regulations, WHO • Sustainable development goals (SDGs) related to waste and health • Case studies of safe and green pharma manufacturing