| Description |
1 online resource (271 p.) |
| Contents |
Cover -- Half Title -- Title -- Copyright -- Contents -- Author Biographies -- Acknowledgments -- Preface -- Disclaimer -- Chapter 1 Process of Drug Discovery -- 1.1 Introduction -- 1.2 Drug Discovery Process -- 1.2.1 Screening Large Compounds and Natural Compounds -- 1.2.2 Modifying the Chemical Structures of Existing Molecules -- 1.2.3 Studying Disease Pathogenesis -- 1.2.4 Modern Techniques of Drug Discovery -- 1.2.5 Clinical Steps of Drug Discovery -- 1.2.6 Post Approval Studies -- 1.3 Clinical Trials Registry of India (CTRI) -- 1.4 Investigational New Drug Application (INDA) |
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1.5 New Drug Application (NDA) -- 1.6 Over-the-Counter (OTC) Drugs -- 1.7 Abbreviated New Drug Application (ANDA) -- 1.8 Generic Drug Product -- 1.9 Fixed-Dose Combinations (FDCs) -- 1.10 USFDA -- 1.10.1 Drug Discovery Process: Code of Federal Regulations (CFR) -- Bibliography -- Chapter 2 History of Drug Regulatory Authorities -- 2.1 Introduction -- 2.2 History of the United States Food and Drug Administration (USFDA) -- 2.3 Creation of the European Medicines Agency (EMA) -- 2.4 The Emergence of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) |
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2.5 Central Drugs Standard Control Organization (CDSCO), and the Office of Its Controller, the Drugs Controller General (India) (DCGI) -- 2.5.1 The Functional Bodies of Drug Regulatory Authority in India -- Bibliography -- Chapter 3 Regulation of Herbal and Ayurvedic Drugs in the Context of AYUSH and DCGI -- 3.1 Introduction -- 3.2 Safety Category -- 3.3 Classification of Herbal Medicine Concerning Regulatory Authorities -- 3.3.1 Category 1: Indigenous Herbal Medicines -- 3.3.2 Category 2: Herbal Medicines in Systems -- 3.3.3 Category 3: Modified Herbal Medicines |
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3.3.4 Category 4: Imported Products with a Herbal Medicine Base -- 3.4 DCGI's Approval -- 3.5 Relaxation of Regulations regarding Herbal Medicine -- Bibliography -- Chapter 4 Traditional Medicine (TM) Regulatory Requirements -- 4.1 Introduction -- 4.2 Beijing Declaration (8th November 2008) -- 4.3 Challenges of Herbal Medicine -- 4.4 Regulatory and Legislative Quality Control of Herbal Products -- 4.5 Requirement of Licensing of Herbal Medicine -- 4.6 Approaches for Approval of Herbal Medicine in Indian Concern -- 4.7 Clinical Trial of Traditional Medicine: A Concept Proof |
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4.8 Toxic Contaminants of Traditional Medicine -- 4.8.1 Microbial Contamination -- 4.8.2 Heavy Metals -- 4.8.3 Radioactive Contamination -- 4.8.4 Pesticide Residue -- 4.8.5 Plant Materials -- 4.9 Quality Control of Traditional Medicine -- Bibliography -- Chapter 5 Enforcement of Drugs and Cosmetics Act, 1940 to Ayurvedic, Siddha, and Unani Drugs in India -- 5.1 Introduction -- 5.2 Chapter IVA of Drugs and Cosmetics Act, 1940 -- 5.3 Chairman Appointed by Central Government from the Board Member -- 5.3.1 Functioning of the Board Members |
| Summary |
This volume-1 book incorporates all the requisite regulatory norms and provides the latest information on the mandated regulation of herbal medicines |
| Notes |
Description based upon print version of record |
|
5.4 The Ayurveda Siddha and Unani Drugs Consultative Committee (Section 33D) |
| Form |
Electronic book
|
| Author |
Goyary, Danswrang
|
| ISBN |
9781003848097 |
|
1003848095 |
|
