Description
The present volume, Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1, discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (US FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). Many researchers either abandon their work in the middle of the process or find it difficult to follow the rules. Therefore, it is not surprising that any biological researcher associated with drug development should have a thorough understanding of regulatory requirements. This volume incorporates all the requisite regulatory norms and provides the latest information on the mandated regulation of herbal medicines.
The book covers other obligatory regulatory requirements such as:
- The legal method and practice of herbal drug products, the roles of Ayurvedic medicines, and the process to obtain regulatory approval.
- Drug molecules not included in Department of Ayurveda, Yoga, Naturopathy, Unani, Siddha, and homeopathy (AYUSH) but referred to as phytopharmaceuticals are also considered new drugs.
- The boundary line between food and herbal pharmaceuticals is discussed, as well as pre-clinical toxicity testing, clinical trials, and stability studies in accordance with the rules.
The chapter on regulatory implications for the approval process in this book will be the most useful resource for researchers and students, particularly those with backgrounds in pharma, forensic medicine, or regulatory affairs, or those who aspire to succeed in drug research. Additionally, the information contained in this volume of the book could be of great interest to researchers working in the herbal drug industry.
Table of Contents
Chapter 1: Process of Drug Discovery
Chapter 2: History of Drug Regulatory Authorities
Chapter 3: Regulatory of Herbal and Ayurvedic Drug in the context of AYUSH and DCGI
Chapter 4: Traditional medicine (TM)- Regulatory Requirement
Chapter 5: Enforcement of Drug & Cosmetics Act, 1940 to Ayurvedic and Unani Drugs in India
Chapter 6: Ayurvedic Drugs Regulation in India
Chapter 7: Licensing procedure of Indian System of medicine (Ayurveda, Unani, Siddha and Homoeopathy Drugs)
Chapter 8: Regulatory Approval Process of Phytopharmaceuticals, Herbal Drugs or Isolated Compounds from plants or New Claim other than AYUSH Drugs
Chapter 9: Safety and toxicity of Ayurveda, Siddha and Unani (ASU) drugs
Chapter 10: The embarking of Food Safety and Standards Authority of India (FSSAI) and implantation of Food Safety and Standards Act
Chapter-11: Herbal as food vs Drugs: Regulatory framework
Chapter 12: Regulatory Approval and Commercialization process herbal as Insecticide
Chapter 13: Safety studies or pre-clinical toxicity of Modern Medicine
Chapter 14: Clinical trial procedures including the modern medicine and ayurvedic therapies
Chapter 15: Stability Testing of Drugs
Chapter 16: Regulation of Clinical Trial and Role of Institutional Human Ethical Committee
