QUALITY CONTROL AND STANDARDIZATION OF PHYTOMEDICINES – For BPharm and MPharm | Dr. Sunil S Jalalpure, Dr. Bhaskar K Kurangi | Nirali Prakashan

About the Book :

The present textbook on “Quality Control and Standardization of Phytomedicines” covers various aspects related regulatory requirements in quality control and standardization of herbal medicines along with its analytical, biological, toxicological and evidence based validation. The proposed textbook covers major curriculum and syllabus from Pharmacy and Ayurveda science. This book provides guidance and solutions on quality assessment and standardization of phytomedicines to the research scientist, research scholar, faculty, undergraduate and post graduate students of Pharmacy as well as Ayurveda stream. The book also covers most of the curriculum from different subjects of M. Pharm. Program of Pharmacognosy and also covered curriculum from B. Pharm. VIII Semester subject of Quality Control and Standardization of Herbals.

This book is written with an intention to incorporate all the information with regards to various quality and regulatory aspects of phytomedicines. According to the knowledge of authors, it is first and single textbook which provides all the relevant information on analytical, biological, toxicological as well as evidence based validation and quality assessment of phytomedicines which include, herbs, parts of medicinal plant, extracts, raw materials, along with finished herbal formulations. It also covers knowledge related to drug discovery and development from natural source. Various scientific databases published by government councils have been covered in this book. The present textbook composed of eighteen chapters and at the end of each chapter we have also incorporated important questions.

The first chapter covers the information related to herbal medicine along with different types of Traditional Systems of Medicine and its role in healthcare management. The second
chapter of book covers various aspects and information related to drug discovery and development from natural source. This chapter also covers the process of drug development from natural source. The third chapter deals with laws pertaining to Ayurvedic drugs. The fourth chapter incorporated with lot of information on regulatory requirement, guidelines
and quality assurance in herbal medicines. The fifth chapter covers the perspectives on regulatory affairs in phytomedicines at national and international level. The sixth chapter deals with infrastructure requirement for herbal industry along with challenges in herbal manufacturing and pilot plant Scale-up technique. The seventh chapter covers Schedule-T which highlights on good manufacturing practices to be followed in Ayurveda, Siddha and Unani Medicines. The eighth chapter covers the concept and types of standardization methodology used for crude drugs, extracts and finished herbal preparations. The ninth chapter mainly deals with stability testing of phytomedicines along with regulatory requirements. The tenth chapter provides valuable information related to in-vivo and in-vitro screening methodology for herbal drugs and extracts. The eleventh chapter deals with novel approaches used in evaluation of phytomedicines. The twelveth chapter covers informative aspects of evidence based validation of phytomedicines. The thirteenth chapter covers the regulations and guidance on toxicity assessment along with safety and efficacy of phytomedicines. The fourteenth chapter deals with the science of pharmacovigilance in phytomedicines. The fifteenth chapter covers types and role of different modern analytical and instrumentation techniques for analysis of phytomedicines. The sixteenth chapter covers role of markers in quality control and standardization of phytomedicines. The seventeenth chapter deals with challenges, constraints and opportunities in quality evaluation of phytomedicines. The eighteenth chapter deals with introduction and information on various scientific research databases published by Indian government councils.

Contents :

1. Traditional Systems of Medicine in Healthcare,
2. Drug Discovery and Development from Traditional Medicines,
3. Laws Governing Ayurvedic Drugs,
4. Regulatory Requirement and Quality Assurance in Herbal Medicines,
5. Regulatory Affairs in Phytomedicines: National and International Perspectives,
6. Herbal Drug Industry,
7. Schedule T: Good Manufacturing Practices for Ayurveda, Siddha and Unani Medicines,
8. Herbal Drug Standardization,
9. Stability Testing of Phytomedicines,
10. Biological Screening of Herbal Drugs and Extracts,
11. Novel Approaches in Evaluation of Herbal Drugs,
12. Evidence Based Validation of Phytomedicines,
13. Toxicity Regulations in Phytomedicines,
14. Pharmacovigilance of Phytomedicines,
15. Modern Instrumentation Techniques for Analysis of Phytomedicines,
16. Role of Markers in Quality Control and Standardization of Phytomedicines,
17. Quality Evaluation of Phytomedicines: Challenges, Constraints and Opportunities,
18. Introduction to Medicinal Plant Databases,

Bibliography,
Annexures