1. Biotechnology Regulation
Legal Aspects &
Intellectual property rights
By
Shruti Gupta
II Sem M.tech Marine Biotechnology
NCAAH

2. What is Biotechnology?
Biotechnology = bios (life) + logos (study of or essence)
– Literally ‗the study of tools from living things‘
"any technique that uses living organisms (or parts
of living organisms) to make or modify products or
to improve plants or animals, for beneficial use"

3. Biotechnology & the Law
Branches in Biotechnology
40
30
20
10

4. Legal aspects of Biotechnology
Agriculture Biotechnology
Regulatory Frame work in India
Some of the key steps taken by the State Governments includes:
 announcing separate Biotechnology Policy for their States.
 setting up of Task Forces with experts to guide them on policy issues.
 setting up of exclusive Biotechnology Parks with agriculture.
 health biotechnology as key areas.
Department of Biotechnology [DBT]
Genetic Engineering and Approval Committee[GEAC]

5. The MOST important committees
 The Institutional Biosafety Committees (IBSC), responsible for the local
implementation of guidelines.
 Review Committee on Genetic Manipulations (RCGM) responsible for
issuing permits.
 GEAC responsible for monitoring the large scale and commercial use of
transgenic materials.
research activities involving genetic manipulation of
microorganisms.
All research carried out by the applicant company shall
designate a Principal Investigator [PI].
IBSC

6. PI is required to intimate to the IBSC
PI shall seek permission of IBSC before starting the experiment.
IBSC shall intimate its decision to the RCGM before execution
of the experiments and RCGM shall put the information on
record.
The risk involved in the experiments are considered to be of
higher magnitude having the potential of polluting/endangering
the environment, the biosphere, the eco system, the animals and
the human beings could be conducted only after obtaining
clearance from RCGM and upon being notified by the DBT.
Stage I
Exp.
Stage II
Exp.
Stage
III Exp.

7. It comprises representatives of
a) DBT
b) Indian Council for Medical Research
c) Indian Council for Agricultural Research
d) Council for Scientific and Industrial
Research
RCGM
After reviewing the application from IBSC it recommend
the application to Monitoring cum Evaluation
Committee [MEC] of the DBT for agronomic benefits
and evaluation.

8. GEAC
In case of large scale field trials, deregulation and commercialization, in
addition to the DBT approval process, permission of GEAC constituted
under the MoEF is also required.
Approval of the GEAC is required from the environmental angle on:
i. Import, export, transport, manufacture, process, selling of any
microorganisms or genetically engineered substances or cells
including food stuffs and additives that contain products derived by
gene therapy.
ii. Discharge of genetically engineered/classified organisms/cells
from Laboratory, hospitals and related areas into environment.
iii. Large scale use of genetically engineered organisms/classified
microorganisms in industrial production and applications.
iv. Deliberate release of genetically engineered organisms.

9. Pharmaceutical Biotechnology
Industrial licensing under the Industrial [Development & Regulation]
Act, 1951 is compulsory for:
• bulk drugs produced by the use of recombinant DNA technology
• bulk drugs requiring in-vivo use of nucleic acids
• specific cell/tissue targeted formulations
Procedure
Research & Development
Manufacture
Imports

10. The Regulation of Biotechnology
The U.S Department has created a new unit within the Animal and Plant
Health Inspection service called Biotechnology regulatory services
(BRS).
APHIS regulations for certain genetically engineered (GE) organisms that
may pose a risk to plant health.
 The Coordinated Framework for the Regulation of Biotechnology
established in 1986, describes the federal system for evaluating products
developed using modern biotechnology.
 The three main federal agencies responsible for regulating the safe use of
genetically engineered organisms are:
• APHIS (The Animal and Plant Health Inspection Service)
• U.S. Environmental Protection Agency (EPA)
• U.S. Department of Health and Human Services' Food and Drug
Administration (FDA)

11. The Status of Biotechnology in India
The Government of India has prepared a draft for public 'Biotechnology
Regulatory Authority of India (BRAI)
Bio Agri
6.95%
Bio-IT
2.09 %
Bio Industrial
6.74%
Bio Services
8.95%
Bio Pharma
75.24 %

13. Intellectual property rights
 Intellectual property (IP) is the creation of the
human mind—the intangible intellect that can
translate into tangible products.
 Intellectual property rights (IPR) protect the use
of these human creations.
 The major elements or forms of intellectual
property rights today include patents, utility
models, industrial designs, trademarks and service
marks, geographical indications and layout of
integrated circuits, copyright, and plant breeder‘
rights.

14. There are currently two main systems of protection for biotechnology:
 rights in plant varieties
 patents:
―The right to exclusively produce, use and/or market a
• Product
• Process
• Application‖
 Today, IPR plays an important role in every sector and has become an
important aspect of research for Pharma and research oriented industries.
The continuous efforts of the government in policy establishment, IT
protection, infrastructure, IPR search portals and manpower made this
Industry a step ahead.

15. Categories of Intellectual Property
• Industrial property, which includes inventions
(patents), trademarks, industrial designs, and geographic indications of
source.
• Copyright, which includes artistic works such as novels, poems and
plays, films, musical works, dance, artistic works such as
drawings, paintings, photographs , sculptures, and architectural designs.
• Rights related to copyright include those of performing artists in their
performances, producers of phonograms in their recordings, and those of
broadcasters in their radio and television programs.

16. References:
• Keith E. Maskus, Benefiting from Intellectual Property Protection;
Development Trade and the WTO, the World Bank Handbook (2002).
• Manfield E. Intellectual property Protection, foreign direct
investment, Washington DC, International Finance Corporation, Discussion
Paper No.19.
• Sara Boettiger, Gregory D. Graff, Philip G. Pardey, Eric Van Dusen
and Br ian D . W right (2004), Intellectual Property Rights for Plant
Biotechnology: International Aspects.
• Simpson RD, Sedjo RA, Reid JW (1996). Valuing biodiversity for use in
pharmaceutical research. J Pol Economy 104: 163–185.
• UPOV Geneva (2001), International Convention for the Protection of New
Varieties of Plants of December 2, 1961 as last revised on March 19, 1991.