(BT05076) BIOETHICS, BIO SAFETY AND INTELLECTUAL

Unit I: B
Introduction to Bioethics. Social and ethical issues in Biotechnology
Unit II: Biosafety I
Definition of Biosafety. Biosafety for human health and environment. Social and
ethical issues.
Unit III: Biosafety II
Use of genetically modified organisms and their release in to the environment.
Special procedures for r-DNA based products
Unit IV: Regulatory Affairs
Regulatory requirements for drugs and Biologics. GLP. GMP
Unit V: Intellectual Property Rights I
Intellectual property rights, and Intellectual Property protection, patents and
methods of application of patents,
Unit VI: Intellectual Property Rights II
Trade Secrets copyrights, Trade Marks, legal implications, farmers rights, plant
breeder’s rights.
Unit VII: Intellectual Property Rights III
International and National conventions on biotechnology and related areas.
Unit VIII
WTO guidelines
TEXT BOOKS:
1. Sasson A, Biotechnologies and Development, UNESCO Publications, 1988.
2. Sasson A. Biotechnologies in developing countries present and future,
UNESCO publishers, 1993.
REFERENCE:
1. Singh K. Intellectual Property Rights on Biotechnology, BCll, New Delhi.