health

1. BTC 122V Biosafety and Bioethics 2hrs/wk
Preamble
To learn about biohazards, biosafety levels, Biosafety guidelines Government of India, GMP &
GLP and to impart information about IPR and bioethics in biotechnology
Upon successful completion of the course, students will be able to
COs Outcome
CO1 Describe about biohazards, Biological Safety Cabinets and Biosafety Levels
CO2
Explain about role of Biosafety guidelines Government of India and Risk analysis,
assessment, management and communication
CO3
Exert the principles of Good Manufacturing Practices (GMP), Good Laboratory Practices
(GLP) and Test system
CO4 Deliver information on IPR , Agreement and Treaties
CO5
Bring acquaintance about Principles of bioethics and ethical implications of
biotechnological products
UNIT-I
Biosafety- hazardous materials used in biotechnology — handling and disposal- Waste
Categories- Chemical waste- Radioactive waste- Biohazardous waste- Sharp material;
Instructions for Hazardous Waste Disposal- Introduction to Biological Safety Cabinets; Primary
Containment for Biohazards; Biosafety Levels; Biosafety Levels of Specific Microorganisms;
Recommended Biosafety Levels for Infectious Agents and Infected Animals;
UNIT-II
Biosafety guidelines Government of India- Roles of Institutional Biosafety Committee, RCGM,
GEAC etc. for GMO applications in food and agriculture; Environmental release of GMOs; Risk
Analysis; Risk Assessment; Risk management and communication; National Regulations and
relevant International Agreements including; Cartegana Protocol
UNIT-III
Good Manufacturing Practices (GMP)- Good Laboratory Practices (GLP)- GLP Principle-Test
Facility Organisation and Personnel- At minimum it should- Facilities- Apparatus, Material, and
Reagents- Test Systems- Test and Reference Substances- Standard Operating Procedures-
Performance of the Study- Storage and Retention of Records and Material
UNIT-IV

2. Intellectual Property: Types of IP: Patents, Trademarks, Copyright & Related Rights, Industrial
Design, Traditional Knowledge, Geographical Indications; Agreement and Treaties - GATT &
TRIPS Agreement; WIPO Treaties, Budapest Treaty and Patent Cooperation Treaty
UNIT-V
Bioethics: Principles of bioethics: Legality, morality and ethics, autonomy, human rights,
beneficence, privacy, justice, equity- Ethical implications of biotechnological products and
techniques. Social and ethicalImplications of biological weapons.
Text Books
1. Bareact, Indian Patent Act 1970 Acts & Rules. 2007. Universal Law Publishing Co.
Pvt.Ltd.,
2. Sateesh MK.Bioethics and Biosafety. 2010. I. K. International Pvt Ltd.
Reference Books
1. Kankanala C., Genetic Patent Law & Strategy. 2007. 1st Edition,
ManupatraInformationSolution Pvt. Ltd.,
2. Sree Krishna V Bioethics and Biosafety in Biotechnology. .2007.New age
internationalpublishers