1st Edition

Life Sciences Research to Product Development Regulatory Requirement Transforming, Volume 1

    270 Pages 10 B/W Illustrations
    by CRC Press

    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.

    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


    Dr. Pronobesh Chattopadhyay, M.E (Biomedical Engg.), M.Pharm., Ph.D. is a pharmaceutical scientist in DRDO. His working areas are chemical pharmacology, toxicological interaction on expression, chemical target to TRPV, AdipoR1, AdipoR2, c-Jun kinase pathway in lungs and eyes, and these resulted in exploration to development of many defense products. He was instrumental in developing many defense products which are successfully used by India’s armed forces. A notable technology like the “chili grenade” developed from Bhot Jolakia (one of the hottest chilies in the world) has been transferred (transfer of technology) to three industries and are presently used successfully by many law enforcing agencies in India. He also developed protective gear for ultra-violet protection which are stable at −20oC. He is a Fellow of the National Academy of Sciences India (NASI) and Fellow of Indian Chemical Society (FICS). He has published more than 170 research papers and five book chapters and filed 15 patents while three patents are granted. He has received many awards, including the Gandhi Young Technology Innovation Awards under Biotechnology Industry Research Assistance Council (BIRAC), Laboratory Scientist Awards, Technology Awards, etc. He is a regular reviewer of ethnopharmacology, toxicology, and biochemical pharmacology, and Elsevier publishing house recognized him as a potential reviewer. Twelve Ph.D. degrees and three post doctorate degrees have been awarded under his supervision, and 25 postgraduate students completed their dissertations.

    Dr. Danswrang Goyary graduated in Biotechnology and did his M.Sc. and Ph.D. degrees in Biochemistry from Northeastern Hill University (NEHU), Shillong, India. He qualified NETJRF (UG-CSIR) in 2002 and received a fellowship for his doctoral degree. He started his professional career at the Defence Institute of Bio-Energy Research, Haldwani, Uttarakhand as a scientist in the year 2005 and extensively contributed to the fields of life sciences and biopharmaceuticals of defense importance as a biochemist. He is presently working in Defence Research Laboratory, DRDO, Tezpur (Assam). He is actively involved in studying the mechanism of different kind of wound healing, hemostasis and associated with the development of defense products viz. chili grenades, snake repellent, high-SPF sunscreen, impregnated fabrics for disease vector and insect control, etc. He has contributed more than 50 publications in peer reviewed journals, secured two patents, supervised three Ph.D. students, and guided more than 15 post-graduate students. He has received laboratory awards such as Technology Group awards, Science Day oration award, Technology Day oration award, etc. He is a member of many committees such as institutional animal ethical committees (IAEC) and institutional biosafety committees (IBSC), etc.