About the Book:

"Quality Control of herbal Drugs: Standardisation and Regulations" offers a comprehensive guide to navigating the complexities of this industry.

This book answers a multitude of important questions, such as: What are the different categories of herbal products? How do traditional AYUSH products differ from modern herbal products? What are the guidelines and regulations concerning the quality, safety, toxicity, and efficacy of AYUSH products, herbal drugs, and derived products?

Furthermore, the book explores the process of standardizing herbal products, outlining the requirements for establishing a successful herbal industry. It also delves into the necessity of conducting preclinical and clinical studies for herbal products, shedding light on the importance of evidence-based practices.

"Quality Control of herbal Drugs: Standardisation and Regulations" provide practical insights into herbal entrepreneurship, but it also explores how herbal products are regulated in various countries. With the inclusion of QR codes after each chapter, readers can easily access additional supportive knowledge to enrich their understanding of the subject.

Contents:

Section 1: Herbal Products and Regulations

1.  Overview on Herbal Product Regulations: Challenges and Solution

Section 2: Herbs and Derived Products

2.  Extraction, Purification, Preliminary Phytochemical Screening and Structural Elucidation of Natural Products 3.  Herbal Formulations: Traditional, Conventional and NDDS 4.  Herbal Cosmetics and Regulations 5.  Nutraceuticals and Regulations 6.  Labeling and Packaging of Herbal Products

Section 3: Traditional Medicines Regulations

7.  Indian Systems of Medicines, Regulations and Related Guidelines 8.  WHO - General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine 2000 9.  Drug & Cosmetic Act, 1940-Schedule T Good Manufacturing Practice of Indian Systems of Medicine

Section 4: Quality Control, Standardisation, Regulations for Herbal Products

10. WHO Good Agricultural and Collection Practices [GAP, GCP, GACP] 2003 11. NMPB Guidelines and Standard for Good Field Collection Practices for Medicinal Plants 2009 12. WHO Guidelines on Good Herbal Processing Practice for Herbal Medicine 2018 13. WHO Guidelines on Good Storage and Distribution Practices 2019 14. Herbal Monograph, Pharmacopoeias, Markers 15. WHO Guidelines for Selecting Marker Substances of Herbal Origin for Quality Control of Herbal Medicines 2017 16. WHO and ICH Guidelines for Quality Control of Herbal Materials 17. Stability Testing and Shelf Life Determination of Herbal Medicines

Section 5: Pre-clinical and Toxicity Regulations for Herbal Products

18. CPCSEA and OECD Guidelines for Animal Experimentation 19. Human Dose Calculation Guidelines 20. WHO Guidelines for Assessment, Evaluation of Toxicity, Safety and Efficacy of Herbal Medicines 2000 21. AYUSH General Guidelines for Safety/Toxicity Evaluation of Ayurvedic Formulations 2018

Section 6: Pharmacovigilance and Clinical Trial Regulations for Herbal Products 22. WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems 2004 23. Fundamentals of Clinical Trails and Phases of Trials 24. AYUSH Guidelines of Good Clinical Practices 2018 25. CDSCO  Guidelines of Good Clinical Practices 2013 26. Ethical Principles for Clinical Trials 27. ICH Guidelines for Good Clinical Practices 2016

Section 7: Herbal Industry, IPR and Regulatory Affairs

28. Herbal Industry: Infrastructure, Formulation, Production and Pilot Plant Scale-Up Management of Herbal Products 29. Herbal Entrepreneurship 30.      Herbal Raw Material Trade 31. GMP, GLP, TQM and ISO for Herbal Medicines 32. Intellectual Property Rights and Herbal Products 33. Geographical Indications of Goods (Registration and Protection) Act, 1999 34. New Drug Application: NDA, INDA, ANDA, BLA, OTC 35. Master Formula, SMF-Site Master File, DMF-Drug Master File, Dossier and CTD, Chemistry Manufacturing & Controls (CMC) Dossier

About the Author:

S. L. Deore has completed her B. Pharm from A. R.A. College of Pharmacy, Dhule, Maharashtra. She is Gold Medalist in B.Pharm from North Maharashtra University in 2004. She has completed M.Pharm from Govt. College of Pharmacy, Amravati in 2006. She has awarded PhD in pharmaceutical sciences by SGB Amravati University in May 2011. She has isolated and elucidated two new saponins in her PhD work. She has completed PG Diploma in Patent's Law from Nalsar university of Law, Hyderabad in 2016.

She has authored 03 reference books, 03 B.Pharm Semester (Theory and Practical) books and one textbook. Her books were included in Pharmacy syllabus of many universities from Kerala, Maharashtra and Andhra Pradesh. She has also contributed book chapters in CRC Press and Springer Published books.

She has organized many national workshops, seminars, webinars and competitions. She has published many research papers in various national- international journals about the medicinal plants and herbal drugs.  She has guided 45 M.Pharm students and 05 Ph.D students. She has filed 05 Indian patents in herbal drug technology. She has been granted 01 Indian patent. She has transferred technology of taste masking for one of popular mushroom nutraceutical marketed product.

She has fetched different project grants related t medicinal plants of worth about INR 97 lakh from AICTE-Delhi, RGSTC- Mumbai, NMPB (Ministry of AYUSH, Govt. of India) and DST, Delhi. She has been awarded AICTE`s National Technical Teachers' Award (NTTA) of Year 2022 on National Teacher's Day 5 Sept. 2022 by Ministry of Education, Govt. of India.  She has developed SWAYAM MOOC Self-paced Course “Indian Traditional Medicinal and Aromatic Plants” approved by AICTE, Delhi.

         Her areas of research are intellectual property rights and traditional medicine, isolation and structural elucidation of phytochemicals, nutraceutical development, and traditional medicine screening, chromatographic and phytochemical analysis of extracts, development of microemulsion, and oral films of phytochemicals. Presently she is working with Govt. College of Pharmacy, Amravati (Maharashtra) as an Associate Professor.