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.

Whether you are a researcher, practitioner,

entrepreneur, or simply interested in the world of herbal medicine, this book

is an essential resource for understanding the intricacies of quality control,

standardization, and regulations in the herbal industry.

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.