As biotechnology continues to transform agriculture, healthcare, and industry, understanding its legal, ethical, and safety implications has become essential. The book offers a comprehensive exploration of the key frameworks that govern innovation and safety in the biotech sector. Structured into four interconnected parts, this book equips students, researchers, policymakers, and professionals with the foundational knowledge and practical insights needed to navigate this evolving landscape.

Part I focuses on Intellectual Property Rights (IPR), introducing the fundamental types of IP, including patents, copyrights, and plant variety protection. It also explains the patent application process, international treaties, and the role of IPR in global biotechnology trade.

Part II delves into biosafety principles and regulations, covering biohazard containment, biosafety risk assessment, and the legal instruments that shape national and international biosafety policies.

Part III addresses the risk and safety assessment of transgenic organisms, particularly GM crops and plants. It explores environmental and food safety concerns, detection methods, and long-term monitoring of genetically modified organisms (GMOs).

Part IV examines the bioethical and societal dimensions of biotechnology, highlighting field trial protocols, ethical considerations, and challenges such as biopiracy and the misappropriation of genetic resources.

With clear explanations, regulatory context, and case-based perspectives, this book serves as a valuable academic resource and a practical guide for responsible innovation in biotechnology. It promotes informed decision-making and ethical conduct in scientific research, development, and commercialization.

Sankar Kr Acharya,presently,Dean, Post Graduate Studies ;former Head, Dept. of Agril Extension and Director, Extension Education, Bidhan Chandra KrishiViswavidyalaya, Mohanpur, WB, born on 6th October, 1960, started his career as Assistant Professor at BCKV in 1988 and has been in teaching, research and extension more than  36years. An erudite teacher as well as an elegant speaker, is internationally acclaimed for his unique research domain of Social Entropy and Energy Metabolism, Social Ecology and Environmental Sociology, Enterprise Ecology Framework, Conservation Stewardships: Research Publication: 251 in National and International Journals. Book Publication: 119 books authored.  So far, he has delivered 49 keynote addresses and chaired 57 sessions in National  and International congresses.

Expert Member, Agriculture Commission; Marketing and Extension Sub Committee, Govt. of West Bengal; Expert member WWF projects in BTR (Buxa Tiger Reserve Project); Expert member; DFID project on Primary Education (DPEP); Rapid Environment Impact Analysis.Co-PI of ICAR, NAHEP and World Bank funded project on Conservation Agriculture. So, far he has successfully guided 23 Ph D scholars and 97 M Sc scholars,. He is the Fellow of ISEE, IARI, New Delhi, Fellow, BIOVED, Allahabad; Fellow, Society of community mobilization, IARI, New Delhi. He is now acting as editor, reviewer of several national and international journals Awards and Distinctions: Distinguish Scholar Award, Krishisanskriti, New Delhi; Certificate of Merit for standing First class first at M Sc(Ag) in Agricultural Extension, 1986; ;Honorary Appointment to the Research Board of Advisors, The American Biographic Institute, USA (2003) ;He has been honored to be selected as the Convener of Panel (PE-32) entitled the hunger, poverty and silence, of World Congress, IUAES, University of Manchester, UK, 2013 ;He has been honoured to be selected as the Convener of Panel (P-102) entitled ,’ Uncertainties, Unpredictability and Marginalization: The impact and mitigation for survival of agriculture and humanity, of the 19th  World Congress, IUAES-WAU, 14-20 October, 2023, New Delhi, India, 2023 ;Honoured to be nominated as Expert Member, Working group on Agricultural Extension, West Bengal State Agriculture Commission (2007) ;Honoured to be nominated by the Hon’ble Vice-Chancellor, BCKV to Act as an Expert Member, DPEP, A DFID, UK, project for planning and revamping primary education through POA of GOVT of India.(1995)Expert Member, Buxa Tiger Reserve Project funded by WWF(World Wide Wild Life Funding), 1998 ;Dr Daulat Singh Memorial Award, Society of Extension Education, Dr. M.S. Swaminathan Award, Brainware University and CRIJAF, ICAR; Distinguished Professor and Academician Award, Research Education Solution (RES), M S Swaminathan School of Agriculture, Centurion University(2022); Eminent Scientist Award, EIABT, Citwan Nepal. He is also the Expert Member, Research Council, Vidyasagar University, WB.

Prof Acharya is the Achievers of German patent (Utility model no.20202310273) :Novel LOT based inventory management system with radio controlled pallet racking for storage solution. He is the Fellow, West Bengal Academy of Science and Technology (WAST), 2024. He is also the fellow of ISEE, New Delhi, Fellow, BIOVED, Allahabad, Fellow, Mobilization, New Delhi. On academic missions, he visited Italy, France, Germany, China, Sri Lanka, Vietnam, Bangladesh, He has a rich profile of editorial and reviewers’ contributions a different national and international Journals. Now, he has been invited to Zurich, Switzerland to deliver the Keynote address in International conference on Conservation Agriculture, June 22-23, 2025.

N. Mandal, Professor & Head, Department of Agricultural Biotechnology, Faculty of Agriculture Bidhan Chandra KrishiViswavidyalaya (BCKV), Mohanpur – 741252, West Bengal, India

Part I: Intellectual Property Rights and Legal Framework

Chapter 1. Introduction to Intellectual Property Rights (IPR)

Chapter 2. Types of Intellectual Property Rights

Chapter 3. Patents in Biotechnology

Chapter 4. Patent Application Procedure and Treaties

Chapter 5. Plant Variety Protection and Copyright in Biotechnology

Chapter 6. Global Trade and IPR

Part II: Biosafety and Regulatory Frameworks

Chapter 7. Fundamentals of Biosafety and Biohazards

Chapter 8. Biosafety Risk Assessment and Containment Strategies

Chapter 9. Biosafety Policies and Legal Instruments

Part III: Risk and Safety Assessment of Transgenics

Chapter 10. Transgenic Plants: Environmental and Food Safety Concerns

Chapter 11. Risk Assessment and Safety Evaluation of GM Crops

Chapter 12. Detection and Monitoring of Transgenics

Part IV: Bioethics and Societal Issues in Biotechnology

Chapter 13. Field Trials and Standard Operating Procedures

Chapter 14. Bioethics in Biotechnology

Chapter 15. Biopiracy and Ethical Misappropriation