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Biosafety guidline

Biosafety Guidelines are policies aimed at regulating recombinant DNA research to minimize risks associated with genetically engineered organisms (GEOs) on public health and the environment. In India, these guidelines were proposed by the Department of Biotechnology and are implemented through various committees that oversee research, safety, and approval processes for GEOs. The guidelines emphasize containment measures and require permissions for specific gene manipulation experiments to ensure laboratory safety and environmental protection.

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1 views25 pages

Biosafety guidline

Biosafety Guidelines are policies aimed at regulating recombinant DNA research to minimize risks associated with genetically engineered organisms (GEOs) on public health and the environment. In India, these guidelines were proposed by the Department of Biotechnology and are implemented through various committees that oversee research, safety, and approval processes for GEOs. The guidelines emphasize containment measures and require permissions for specific gene manipulation experiments to ensure laboratory safety and environmental protection.

Uploaded by

ramadevi saravanan
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© © All Rights Reserved
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What is Biosafety Guidelines?

• Policy proposed or adopted by the


Government to avoid the risks of GEOs
on environment and public health.
Aim of Biosafety Guidelines
• Regulating rDNA research with organisms that
have least or no adverse effect.
• Minimizing the possibilities of occasional
release of GEOs from the laboratory
• Banning the release of GEOs if they are
supposed to be causing potential risks in the
environment
The rDNA Biosafety Guidelines Of India
• In India, DBT has proposed “The recombinant
DNA safety guidelines” in 1983 and amended
in 1990.
• These guidelines deals with a set of rules for
production, use, import, export and storage of
hazardous organisms.
In India, the rDNA guidelines has been
implanted through three committees
• Institutional Biosafety Committee (IBSC)-
controls research activities at institutional level.

• Review Committee on Genetic Manipulation (RCGM)-


reviews special situations where research with
hazardous organisms in laboratory and grants
permission to do that research.

• Genetic Engineering Approval Committee(GEAC)-


approves the GEOs for large scale production and use
in India.
To perform certain gene manipulation experiments, the workers
need to acquire permission of review committee and approval
committee before commencement

• Toxin gene cloning


• Cloning of genes for vaccine production
• Cloning of mosquito and tick DNA
• Cloning of antibiotics resistance genes
• Cloning of oncogenes
• Experiments with infectious animal and plant viruses
• Transgenesis experiment in animal cell cultures
• Transfer of toxicity genes into plants
• Gene therapy for hereditary diseases
CONTAINMENTS
• The term "Containment" is used in describing
the safe methods for managing infectious
agents in the laboratory environment where
they are being handled or maintained.
Purpose of containments

• To reduce exposure of laboratory


workers, other persons, and outside
environment
Elements of containments

• Laboratory Practice and Technique


• Safety Equipments (primary barriers)
• Design Facilitys (Secondary Barrier)
Types of containments

• Physical containment
• Biological containment
Physical containment

• The physical methods being adopted inside


the laboratories to prevent escaping the GEOs
to the environment
• It works on the principal of physical barriers
• It helps to keep the dirt in the laboratory itself
The physical containment include
• Air filtration
• Sterilization lights
• Waste disposal
• Protective handling
Biological containment
• The biological principles used in the
laboratories to prevent the escape of GEOs or
microbes
• Biological containment makes the organisms
unable to survive in the outside environment
Implementation of biosafety guidelines

• The rDNA biosafety guidelines are


implemented for the government of India by
four committee
– Recombinant DNA advisory committee (RDAC)
– Institutional biosafety committee (IBSC)
– Review committee on genetic manipulation
(RCGM)
– Genetic engineering approval committee (GEAC)
Recombinant DNA advisory
committee (RDAC)
• Organized by the Department of
Biotechnology (DBT) under the Ministry of
science and technology

• It provides regulatory control to the


implementation committees
The RDAC has been arranging meeting once in
six months or sooner to discuss about the
standards of safety regulations
These meeting helps to
• Evolve long term policy for R/D in rDNA research

• Formulate suitable safety guidelines

• Train the research and technicians about the hazards


and risks of rDNA research techniques
Institutional biosafety committee (IBSC)

• This is a small committee established by every


institution engaged in rDNA research and the
related production activities
• It monitors rDNA research activities at the
institutional level
• This committee is formed of head of
institution, 3 or more scientists, a medical
officer and one DBT nominated person
Role of IBSC
• Sends report to RCGM regarding observance of safety
guidelines on accidents risks and on deviations if any
• Reviews the requirements of guidelines for safety new
projects
• Allows some person to take training on biosafety in
research activities
• Takes emergency plans in urgent situations
• Attempts to provide medical care to persons working in
the laboratory
Review committee on genetic manipulation
(RCGM)
• The RCGM is functioning under DBT
• It is formed of
– Department of biotechnology (DBT)
– Indian council of medical research (ICMR)
– Indian council of agricultural research (ICAR)
– Council of scientific and industrial research (CSIR)
– Department of science and technology (DST)
RCGM functions
• Establishes the procedural guidance manual for
regulatory process with GEOs
• It reviews the risk potentials of GEOs in the
laboratory and field experiments
• It decides which containment have to be followed
for experiments with risky hazardous microbes
• It advices custom authorities on import of GEOs
and other biological materials from other nations
• It provides advice on IPR and patents
Cont..
• It assists the Bureau of India standards (BIS) to
evolve standards of products coming from
rDNA technology
• The monitoring group of RCGM visit
frequently to laboratories where rDNA works
are going on and inspects safety conditions in
those lab
GENETIC ENGINEERING APPROVAL
COMMITTEE (GEAC)
• This is a higher level committee working under
the Department of Environment and Forests.
• It has full power to permit large scale use of
genetically engineered organisms
• rDNA products
• R/D of rDNA technology
• Industrial production of rDNA products
• Release of GEOS in environment and field use
The GEAC gives approval for
• Import, export, transport, production and sale of
GEOs and other organisms
• Release of GEOs from the laboratories to
environment
• Large scale culture and use of GEOs and microbes
in industries
• Use of GEOs in field application and experimental
trials
• Monitoring the risks and accidents due to GEOs

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