[prince karak]

Sathyabama Institute of Science and Technology B.Sc - MicroBiology SBB1615 Bioethics, Biosafety and IPR Syllabus

SATHYABAMA INSITUTE OF SCIENCE AND TECHNOLOGY SCHOOL OF BIO AND CHEMICAL ENGINEERING

SBB1615 BIOETHICS, BIOSAFETY AND IPR
L T P CREDITS TOTAL MARKS
3 0 0 3 100

UNIT 1 INTRODUCTION TO BIOSAFETY 12 Hrs
Definition of ethics and Bioethics, Ethics in Biotechnology(positive and negative effects with classical examples – Rice
with Vitamin A, No-till Agriculture, cotton without insecticide, reduced need for fertilizer, biological pest control , slow
ripening fruits and controlled ripening, fast growing trees and fishes.

UNIT 2 GMO 12 Hrs.
Guidelines for research with transgenic organisms. Environmental impact of genetically modified organisms (beneficial
and hazardous impact), Field trials with GMO, Containment levels. Biosafety protocol, Cartagena Biosafety protocol,
Mechanism of implementation of biosafety guidelines. Biosafety and politics. Biosafety database.

UNIT 3 IMPLICATIONS OF BIOSAFETY 12 Hrs
Awareness education on genetically engineered organism.-Transgene instability, gene flow, resistance/ tolerance of
target organism, increase weedlessness, risks and uncertainty associated with Biotechnology. Containment levels and
their impact on Environment- Containment- definition, types of containment, summary of recommended Biosafety
levels for infectious agents, detail checklist–premises and lab equipment, Animal facilities, environment.

UNIT 4 GLP AND PATENTS 12 Hrs
Gene technology laboratory. GLP and Bioethics- introduction, national Good Laboratory Practices (GLP), the GLP
authority functions, Good Laboratory Practices- necessity, aspiration and responsibility. Procedure to apply patent,
other intellectual properties viz copy rights, Rights, Plant breeder’s rights, trade secrets/ trade symbol etc. WTO, TRIPS,
PCT and GATT. IPR problems and its hindrance.

UNIT 5 ETHICS 12 Hrs.
Ethics in clinical trials and Good Clinical Practices (GCP) – Definition of clinical trials and GCP, general information
about clinical trials, need to conduct clinical trials, faces ofclinical trials, institutional set ups for conducting clinical trials,
ethics in clinical Biotechnology
Max Hours.60

TEXT / REFERENCE BOOKS
1. Safety Assessment by Thomas, J.A., Fuch, R.L. (2002), Academic Press.
2. Biological safety Principles and practices) by Fleming, D.A., Hunt, D.L., (2000). ASMPress.
3. Biotechnology - A comprehensive treatise. Legal economic and ethical dimensions VCH.Bioethics by Ben
Mepham, Oxford University Press, 2005.
4. Bioethics & Biosafety by R Rallapalli & Geetha Bali, APH Publication, 2007
5. Bioethics & Biosaftey By Sateesh Mk (2008), Ik Publishers
6. Biosafety And Bioethics Rajmohan Joshi Publishers

END SEMESTER EXAM QUESTION PAPER PATTERN
Max. Marks : 100 Exam Duration : 3 Hrs.
PART A : 10 Questions of 2 marks each-No choice 20 Marks