Module 1
Chapter 1: Basic Tests for Drugs
1.1. Basic Tests for Drugs
1.2. Basic Tests for Pharmaceutical Substances
1.2.1. Amikacin Sulphate
1.2.2. Bacitracin Zinc
1.2.3. Captopril
1.2.4. Chloramphenicol Sodium Succinate
1.2.5. Cisplatin
1.2.6. Coal Tar
1.2.7. Doxorubicin Hydrochloride
1.2.8. Fluphenazine Decanoate
1.2.9. Hydrocortisone Sodium Succinate
1.2.10. Ketamine Hydrochloride
1.2.11. Levamisole
1.2.12. Magnesium Sulfate
1.2.13. Prednisolone Sodium Phosphate
1.2.14. Tamoxifen Citrate
1.2.15. Vinblastine Sulphate
1.3. Basic Tests for Medicinal Plant Materials
1.3.1. Ipecacuanha Root
1.3.2. Podophyllum Resin
1.3.3. Senna Fruit
1.3.4. Senna Leaf
1.4. Basic Tests for Medicinal Plant Dosage Forms
1.4.1. Allopurinol Tablets
1.4.2. Barium Sulphate Powder for Suspension
1.4.3. Beclometasone Dipropionate Inhalation (Aerosol)
1.4.4. Calcium Gluconate Injection
1.4.5. Dextran 70 Injection
1.4.6. Doxycycline Hyclate Tablets
1.4.7. Epinephrine Hydrogen Tartrate Injection
1.4.8. Flucytosine Tablets
1.4.9. Gentamicin Sulfate Injection
1.4.10. Hydralazine Hydrochloride Tablets
1.4.11. Hydrocortisone Ointment
1.4.12. Indometacin Tablets
1.4.13. Ketamine Hydrochloride Injection
1.4.14. Levothyroxine Sodium Tablets
1.4.15. Metronidazole Suppositories
1.4.16. Miconazole Nitrate Cream
1.4.17. Niclosamide Tablets
1.4.18. Oral Rehydration Salts (Composition A)
1.4.19. Oral Rehydration Salts (Composition B)
1.4.20. Paracetamol Suppositories
1.4.21. Piperazine Citrate Syrup
1.4.22. Reserpine Injection
1.4.23. Sodium Lactate Injection
1.4.24. Sodium Cromoglicate Capsules for Inhalation
1.4.25. Verapamil Hydrochloride Injection
1.4.26. Warfarin Sodium Tablets
1.5. Summary
1.6. Exercise
Chapter 2: WHO Guidelines for Quality Control of Herbal Drugs
2.1. WHO Guidelines for Quality Control of Herbal Drugs
2.2. Parameters for Quality Control of Herbal Drugs
2.2.1. Botanical Parameters
2.2.2. Physicochemical Properties
2.2.3. Pharmacological Parameters
2.2.4. Toxicological Parameters
2.3. Summary
2.4. Exercise
Chapter 3: Evaluation of Commercial Crude Drugs
3.1. Evaluation of Commercial Crude Drugs Intended for Use
3.1.1. Introduction
3.1.2. Organoleptic or Morphological Evaluation
3.1.3. Microscopic Evaluation
3.1.4. Physical Evaluation
3.1.5. Chemical Evaluation
3.1.6. Biological Evaluation
3.2. Summary
3.3. Exercise
Module 2
Chapter 4: Quality Assurance in the Herbal Drug Industry
4.1. Quality Assurance in the Herbal Drug Industry
4.1.1. CGMP
4.1.2. GAP
4.1.3. GMP
4.1.4. GLP
4.2. WHO Guidelines on Current Good Manufacturing Practices (cGMP) for Herbal Medicines
4.2.1. Some Definitions
4.2.2. Quality Assurance in the Manufacture of Herbal Medicines
4.2.3. Good Manufacturing Practice for Herbal Medicines
4.2.4. Sanitation and Hygiene
4.2.5. Qualification and Validation
4.2.6. Complaints
4.2.7. Product Recalls
4.2.8. Contract Production and Analysis
4.29. Self-inspection
4.2.10. Personnel
4.2.12. Personal Hygiene
4.2.11. Training
4.2.13. Premises
4.2.14. Equipment
4.2.15. Materials
4.2.16. Documentation
4.2.17. Good Practices in Production
4.2.18. Good Practices in Quality Control
4.3. Summary
4.4. Exercise
Chapter 5: WHO Guidelines on GACP for Medicinal Plants
5.1. WHO Guidelines on GACP for Medicinal Plants
5.1.1. Introduction
5.1.2. Objectives
5.2. Good Agricultural Practices for Medicinal Plants
5.2.1. Identification/Authentication of Cultivated Medicinal Plants
5.2.2. Seeds and Other Propagation Materials
5.2.3. Cultivation
5.2.4. Harvest
5.2.5. Personnel
5.3. Good Collection Practices for Medicinal Plants
5.3.1. Primary Processing
5.3.2. Permission to Collect
5.3.3. Technical Planning
5.3.4. Selection of Medicinal Plants for Collection
5.3.5. Collection
5.3.6. Personnel
5.4. Common Technical Aspects of Good Agricultural and Collection Practices for Medicinal Plants
5.4.1. Post-harvest Processing
5.4.2. Bulk Packaging and Labeling
5.4.3. Storage and Transportation
5.4.4. Equipment
5.4.5. Quality Assurance
5.4.6. Documentation
5.4.7. Personnel (Growers, Collectors, Producers, Handlers, Processors)
5.4.8. Health, Hygiene, and Sanitation
5.5. Summary
5.6. Exercise
Module 3
Chapter 6: EU and ICH Guidelines for Quality Control of Herbal Drugs
6.1. EU and ICH Guidelines for Quality Control of Herbal Drugs
6.1.1. Introduction
6.1.2. Scope
6.1.3. Definitions
6.1.4. Qualitative and Quantitative Particulars of the Active Substance(s) of a Herbal Medicinal Product
6.1.5. Description of the Preparation Method of Herbal Medicinal Product
6.1.6. Control of Starting Materials
6.1.7. Control Tests Carried Out at an Intermediate Stage of the Manufacturing Process of Herbal Medicinal Product
6.1.8. Control Tests on the Herbal Medicinal Product
6.1.9. Stability Tests
6.2. Summary
6.3. Exercise
Chapter 7: Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
7.1. Research Guidelines for Evaluating the Safety and Efficacy of 7.1. Herbal Drugs
7.1.1. Introduction
7.1.2. Goals
7.1.3. Objectives
7.1.4. Definitions
7.2. General Considerations in Herbal Medicine Research
7.2.1. Legal Considerations
7.2.2. Ethical Considerations
7.2.3. Traditional Knowledge on Herbal Medicine
7.2.4. Regulatory Requirements
7.2.5. Research Purpose
7.2.6. Selection of Research Projects
7.2.7. Research Approaches
7.2.8. Assuring Access to Relevant Databases
7.2.9. Education
7.3. Research Studies
7.3.1. Literature Background
7.3.2. Protocol Preparation
7.3.3. Quality Specifications of Plant Materials and Preparation
7.3.4. Non-clinical Studies
7.3.5. Clinical Trials Using Herbal Medicine
7.3.6. Evaluation of Herbal Medicine Research
7.3.7. Technology Transfer and Education
7.3.8. Using the Guidelines
7.4. Summary
7.5. Exercise
Module 4
Chapter 8: Stability Testing of Herbal Medicines
8.1. Stability Testing of Herbal Medicines
8.1.1. Introduction
8.1.2. Types of Stability Testing
8.1.3. Storage Conditions
8.1.4. Choice of Markers
8.1.5. Choice of Methods
8.1.6. Shelf life
8.1.7. Protocols for Stability Testing
8.1.8. Challenges in Stability Testing
8.2. Summary
8.3. Exercise
Chapter 9: Application of Various Chromatographic Techniques in Standardization of Herbal Products
9.1. Application of Various Chromatographic Techniques in Standardization of Herbal Products
9.1.1. Introduction
9.1.2. Thin Layer Chromatography (TLC)
9.1.3. High-Performance Thin-Layer Chromatography (HPTLC)
9.1.4. High Performance Liquid Chromatography (HPLC)
9.1.5. Ultra-High Performance Liquid Chromatography (UHPLC)
9.1.6. Hydrophilic Interaction Chromatography (HILIC)
9.1.7. Gas Chromatography (GC-MS)
9.1.8. Supercritical Fluid Chromatography (SFC)
9.1.9. Liquid Chromatography - Nuclear Magnetic Resonance (LC-NMR)
9.1.10. Liquid Chromatography-Mass Spectroscopy (LC-MS)
9.2. Summary
9.3. Exercise
Chapter 10: Preparation of Documents for New Drug Application and Export Registrations
10.1. Preparation of Documents for New Drug Application (NDA) and Export Registration
10.1.1. Introduction
10.1.2. NDA Requirements
10.1.3. Export Registration
10.2. Summary
10.3. Exercise
Chapter 11: GMP Requirements and Drugs & Cosmetics Act Provision
11.1. Good Manufacturing Practices
11.1.1. Introduction
11.1.2. Parts in GMP
11.2. Drugs and Cosmetics Act Provisions
11.2.1. Introduction
11.2.2. Schedules to the Act
11.2.3. Schedules to the Rules
11.2.4. Import of Drugs and Cosmetics
11.2.5. Manufacture of Drugs
11.2.6. Sale of Drugs
11.2.7. Labeling of Drugs
11.2.8. Packaging of Drugs
11.3. Summary
11.4. Exercise
Module 5
Chapter 12: Regulatory Requirements for Herbal Medicines
12.1. Regulatory Requirements for Herbal Medicines
12.1.1. Introduction
12.1.2. Standards of Drugs as per Existing Legislature of India
12.1.3. Standards of Ayurvedic Drugs
12.1.4. Standards of Siddha Drugs
12.1.5. Standards of the Unani Tibetan System of Drugs
12.1.6. Schedule T for Good Manufacturing Practice
12.1.7. Standards of Homeopathic Medicines
12.1.8. Steps to Be Taken to Improve the Existing Efforts of Standardization
12.1.9. Factors to be Considered for Registration of Herbal Medicine Across the Globe
12.2. Summary
12.3. Exercise
Chapter 13: WHO Guidelines on Safety Monitoring of Herbal Medicine in Pharmacovigilance System
13.1. WHO Guidelines on Safety Monitoring of Herbal Medicine in Pharmacovigilance System
13.1.1. Introduction
13.1.2. Objectives
13.2. Pharmacovigilance
13.2.1. The WHO International Drug Monitoring Program
13.2.2. Functions of National Pharmacovigilance Centers
13.2.3. Functions of UMC
13.3. Challenges in Monitoring the Safety of Herbal Medicines
13.3.1. Regulation
13.3.2. Quality Assurance and Control
13.3.3. National/Regional Pharmacopoeias
13.3.4. AppropriateUse
13.4. Safety Monitoring of Herbal Medicines
13.4.1. Sources of Reports
13.4.2. Herbal Products Targeted for Safety Monitoring
13.4.3. Reporting of Suspected Adverse Reactions
13.4.4. Assessment of Case Reports
13.4.5. Data Management
13.5. Communication
13.6. Summary
13.7. Exercise
Chapter 14: Comparison of Various Herbal Pharmacopoeias
14.1. Comparison of Various Herbal Pharmacopoeias
14.1.1. Introduction
14.1.2. Various Herbal Pharmacopoeias
14.2. Summary
14.3. Exercise
Chapter 15: Role of Chemical and Biological Markers in Standardization of Herbal Products
15.1. Role of Chemical and Biological Markers in Standardization of 15.1. Herbal Products
15.1.1. Introduction
15.1.2. Types of Markers
15.1.3. Advantages of DNA Markers over Chemical Markers
15.2. Summary
15.3. Exercise
