Life Sciences Research to Product Development

ISBN-13: 9781032504261 / Twarda / 2024 / 264 str.

India) Goyary Danswrang (Defence Research Laboratory

Opis

This volume-1 book incorporates all the requisite regulatory norms and provides the latest information on the mandated regulation of herbal medicines.

Spis treści

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

O autorze

Dr. Pronobesh Chattopadhyay is working as scientist in Defence Research Laboratory, DRDO, Tezpur. His working area are chemical pharmacology, toxicological interaction on expression, chemical target to TRPV, AdipoR1, AdipoR2, c-Jun kinase pathway in lungs, eye and these resulted in exploration to development of many defence products.  He is instrumental for developing many defence products which are successfully used by India forces. A notable technology like ‘Chilli Grenade’ developed from Bhot Jolakia (One of the hottest Chilli in the world) has been transferred (Transfer Of Technology) to three industries and are presently used successfully by 15 state Police, RAF including J & K Police. He also developed protective gears for Ultra-violet protection which are stable -50oC for Armed Forces deployed in Siachen Glacier. Besides, he has also contributed in development of many products for protection of the armed forces deployed in Jungle warfare.  He is a Fellow of the National Academy of Sciences India (NASI) and Fellow of Indian Chemical Society (FICS). He published more than 170 research papers, 05 book chapters and filed 15 patents where 3 patents are granted.  He got many awards including the Gandhi Young Technology Innovation Awards under Biotechnology Industry Research Assistance Council (BIRAC), Laboratory Scientist Awards, Technology Awards by Defence Research Laboratory, DRDO and Dr. S.N Dubey best publication awards etc. He is regular reviewer of Ethnopharmacology, Toxicology, Biochemical Pharmacology and Elsevier publishing house recognised a potential reviewer.   A 12 Ph.D.  and 3 post doctorate awarded under his supervision and 25 post-graduate students completed their dissertation.  

Dr. Danswrang Goyary graduated in Biotechnology, Completed M.Sc. and Ph.D. in Biochemistry from North Eastern Hill University (NEHU), Shillong, India. He qualified NET-JRF (UG-CSIR) in 2002 and received Fellowship for his doctoral degree. He started his professional career at Defence Institute of Bio-Energy Research (then Defence Agricultural Research Laboratory), Haldwani (Uttarakhand) as Scientist in the year 2005 and extensively contributed in the field of life sciences and bio-pharmaceuticals of defence importance as a Biochemist. Dr. Danswrang Goyary is presently working in Defence Research Laboratory, DRDO, Tezpur (Assam). He is actively involved in studying the mechanism of different kind of wound healing, haemostasis and associated with the development of defence products viz. Chilli grenade, 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, 02 patents, supervised 03 Ph.D. students, and guided more than 15 post graduate students. He received laboratory awards such as Technology Group awards, Science Day oration award, Technology Day Oration award etc. He is member for many committees such as institutional animal ethical committees (IAEC) and institutional biosafety committees (IBSC) etc.