Syllabus
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Course Code: BT-405 Course Name: Biosafety, Bioethics and IPR Issues |
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| MODULE NO / UNIT | COURSE SYLLABUS CONTENTS OF MODULE | NOTES |
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| 1 | Biosafety: Introduction; Historical background; Biosafety in the laboratory; Laboratory associated infections and other hazards; Biosafety management for environmentally safe use of biotechnology; Biosafety guidelines; Recommended Biosafety Levels for Infectious Agents and Infected Animals; Definition of GMOs & LMOs; Good manufacturing practices (GMP) and Good lab practices( GLP); Overview of National Regulations and relevant International Agreements including Cartagena Protocol; Roles of Institutional Biosafety Committee (IBSC), RCGM, GEAC, MEC, SBCC, DLC and RDAC; Guidelines for research in transgenic sciences and release of GMOs to environment; Bioterrorism and convention on biological weapons |
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| 2 | Bioethics: Ethical issues related to biotechnology research; Ethical issues associated with consumptions of genetically modified foods and other products, Ethical implications of human genome project, Social and ethical implications of biological weapons, Bioremediations and environmental impacts of using GMOs; Ethics of patenting- and its impact on biodiversity rich developing countries; Use of animals for research and testing and Alternatives for Animals in Research. |
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| 3 | Social, economic and legal issues related to biotechnology: Public education of the processes of biotechnology involved in generating new forms of life for informed decision making; Testing of drugs on human volunteers; Human cloning and Gene therapy - ethical and social issues; Organ transplantation- ethical and legal implications; Research focus to address the need of the poor and of environment. Entrepreneurship: Entrepreneurship and principles of entrepreneurial development, Qualities of an entrepreneur, Functions and types of entrepreneur. Project Management: Formulation, Identification and selection based on size, Technological assessment, Project cost and market potential and marketing concepts. Industrial licensing, venture capital, Biotechnological industries in India and potential job opportunities. |
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| 4 | Intellectual Property Rights: Intellectual property rights and IPR protection; Patenting and the procedure involved in the application of patents and granting of a patent; Compulsory licenses; Legislations covering IPR’s in India, Patent search; Patent Cooperation Treaty (PCT); Traditional knowledge commercial exploitation; Farmers rights; Plant breeder’s rights; International and National conventions on Biotechnology and related areas- GATT, TRIPS, Biodiversity convention, etc. |
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