The slide covers - Biotechnology regulatory processes and agencies, legal aspects of biotechnology, Intellectual property rights,

1. MARINE BIOTECHNOLOGY
INDUSTRY MANAGEMENT
Kumar Kashyap
M. Tech Marine Biotechnology
2nd
Sem
NCAAH
CUSAT

2. INDEX
• Biotechnology Regulatory Processes
• Biotechnology Regulatory Agencies
• Legal Aspects of Biotechnology
• Intellectual Property Rights

3. Biotechnology Regulatory
Processes
• The regulation of genetic engineering concerns approaches taken by
governments to assess and manage the risks associated with the use
of genetic engineering technology, and the development and release of
genetically modified organisms (GMO), including genetically modified
crops and genetically modified fish.
• Biotech crops undergo more testing and oversight before
commercialization than any other agricultural products, including
conventional crops. Before we submit a biotech crop to regulatory agencies
for approval, the research teams have put it through numerous tests to
ensure and prove it’s as safe as its conventional equivalent. Here’s how the
process works:

4. • Characterizing a New Biotech Product
• At this stage in the regulatory process, Monsanto must prove the
gene inserted is safe and the protein produced by the inserted DNA
is also safe.
• This includes:
• Verifying we’ve inserted only one copy of the gene, the copy is
intact and we have not inserted any other portions of DNA.
• And
• Demonstrating the protein produced by the new DNA is safe for
human and animal consumption.
• Once this testing is complete and data has been generated, our
Product Safety Centre takes over for further testing—this time to
conduct safety assessments to determine food and feed safety.
• In some cases RNA interference is used to express a trait. RNAi is a
mechanism used naturally by cells to regulate gene expression. It is
recognized by the U.S. Food and Drug Administration (FDA) as
“Generally Regarded as Safe” (GRAS) and as such, consumption is
not regulated.

5. • Compositional Analysis
• This stage includes a comparative safety assessment. With the comparative
safety assessment, Monsanto seeks to establish substantial equivalence,
meaning we’re testing to see if a biotech product (a soybean, for example)
is compositionally and nutritionally the same as the conventional soybean
(one without any biotech traits).

6. • Animal Performance Assessments
• Even if Monsanto knows the new biotech products are compositionally the
same as their conventional counterparts, we generate additional assurances
that food and feed from these products are as safe as food and feed from
existing conventional products--through animal performance assessments.
• Environmental Safety
• A part of the regulatory process includes environmental safety testing. This
involves a study of the plant’s impact on the environment including
growth, development, interactions with insects, diseases and other stresses.

7. Biotechnology Regulatory
Agencies
• U.S. Food and Drug Administration (FDA)
• Any new product developed through food and plant biotechnology
innovations falls under the approval and review process of the FDA.
• U.S. Department of Agriculture (USDA)
• The USDA Animal and Plant Health Inspection Service (APHIS) regulates
how biotechnology improves new crop varieties.
• U.S. Environmental Protection Agency (EPA)
• EPA works with FDA and USDA to regulate new biotechnology crops to
ensure these crops don't harm the environment, including other plant and
animal species.
• The Biotechnology Regulatory Authority of India (BRAI) is an
proposed regulatory body in India for uses of biotechnology products
including genetically modified organisms(GMOs)

8. Legal aspects of 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]

9.  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.
The MOST important committeesThe MOST important committees
IBSC
research activities involving genetic manipulation of
microorganisms.
All research carried out by the applicant company
shall designate a Principal Investigator [PI].

10. RCGM
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
After reviewing the application from IBSC it
recommend the application to Monitoring cum
Evaluation Committee [MEC] of the DBT for
agronomic benefits and evaluation.
After reviewing the application from IBSC it
recommend the application to Monitoring cum
Evaluation Committee [MEC] of the DBT for
agronomic benefits and evaluation.

11. 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.
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.

12. Pharmaceutical BiotechnologyPharmaceutical 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
ProcedureProcedure
Research & DevelopmentResearch & Development
ImportsImports
ManufactureManufacture

13. Intellectual property rightsIntellectual 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 PropertyCategories 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
• http://www.monsanto.com/products/pages/biotechnology-regulatory-proce
• http://en.wikipedia.org/wiki/Biotechnology#Regulation
• http://en.wikipedia.org/wiki/Biotechnology_Regulatory_Authority_of_India
• http://www2.dupont.com/Biotechnology/en_US/products/product_saf
ety/links.html
• http://en.wikipedia.org/wiki/Compulsory_license
• http://www.nolo.com/legal-encyclopedia/enforcing-patent-faq-29148-
2.html
• http://economie.fgov.be/en/entreprises/Intellectual_property/Patents/
Conditions_of_patentability/#.VPwXGPmUdg0
• http://www.out-law.com/page-5699
• http://www.slideshare.net/shrutigupta439/biotechnology-regulation-
legal-aspects-intellectual-property-rights