BIOTECHNOLOGY AND SOCIETY
Introduction to science, technology and society, issues of access-Case studies/experiences from developing and developed countries. Ownership, monopoly, traditional knowledge, biodiversity, benefit sharing, environmental sustainability, public vs. private funding, biotechnology in international relations, globalization and development divide. Public acceptance issues for biotechnology: Biotechnology and hunger: Challenges for the Indian Biotechnological research and industries.
LEGAL ISSUES & BIOETHICS
The legal, institutional and socioeconomic impacts of biotechnology; biotechnology and social responsibility, Public education to increase the awareness of bioethics with regard to generating new forms of life for informed decision making – with case studies. Principles of bioethics: Legality, morality and ethics, autonomy, human rights, beneficence, privacy, justice, equity etc. The expanding scope of ethics from biomedical practice to biotechnology, bioethics vs. business ethics, ethical dimensions of IPR, technology transfer and other global biotech issues.
BIOSAFETY CONCEPTS
Ethical conflicts in biotechnology - interference with nature, fear of unknown, unequal distribution of risks and benefits of biotechnology, Rational vs. subjective perceptions of risks and benefits, relationship between risk, hazard, exposure and safeguards, Biotechnology and biosafety concerns at the level of individuals, institutions, society, region, country and the world. The Cartagena protocol on biosafety. Biosafety management. Ethical implications of biotechnological products and techniques Laboratory associated infections and other hazards, assessment of biological hazards and levels of biosafety, prudent biosafety practices in the laboratory/ institution. Experimental protocol approvals, levels of containment.
REGULATIONS
Biosafety assessment procedures in India and abroad. International dimensions in biosafety, bioterrorism and convention on biological weapons. Social and ethical implications of biological weapons. Biosafety regulations and national and international guidelines with regard to recombinant DNA technology. Guidelines for research in transgenic plants. Good manufacturing practice and Good lab practices (GMP and GLP). National and international regulations for food and pharma products.
OTHER SECTORS:
The GM-food debate and biosafety assessment procedures for biotech foods & related products, including transgenic food crops, case studies of relevance. Key to the environmentally responsible use of biotechnology. Environmental aspects of biotech applications. Use of genetically modified organisms and their release in environment. Discussions on recombinant organisms and transgenic crops, with case studies of relevance. Plant breeder’s rights. Legal implications, Biodiversity and farmers rights. Biosafety assessment of pharmaceutical products such as drugs/vaccines etc. Biosafety issues in Clinical Trials.
Course outcomes:
After studying this course, students will be able to:
• Demonstrate strong basics in principles of biosafety issues and good laboratory practices
Question paper pattern:
The SEE question paper will be set for 100 marks and the marks scored will be proportionately reduced to 60.
• The question paper will have ten full questions carrying equal marks.
• Each full question is for 20 marks.
• There will be two full questions (with a maximum of four sub questions) from each module.
• Each full question will have sub question covering all the topics under a module.
• The students will have to answer five full questions, selecting one full question from each module.
Textbook/ Textbooks
Reference Books
1 Bioethics &Biosaftey Sateesh MK IK Publishers 2008
2 Biotechnologies and development Sasson A UNESCO Publications 1988
3 Biotechnologies in developing countries Sasson A UNESCO Publications 1988