The document outlines India's biosafety guidelines for research and development activities involving genetically modified organisms (GMOs). It discusses the four biosafety levels established by the Department of Biotechnology (DBT) and the containment facilities recommended for each level. It also categorizes experiments into three categories - Category I experiments which are exempt from approval, Category II experiments which require institutional biosafety committee intimation, and Category III experiments which require prior approval from competent authorities. The document provides examples of experiments that fall under each category and discusses the roles of different committees like IBSC, RCGM, GEAC that oversee and regulate GMO research in India.

1. Asst. Prof. SD Tidke
Modern College, Pune

2.  DBT had formulated rDNA guidelines in 1990
which were revised in 1994
 It include guidelines for R&D activities on GMOs,
transgenic plants, animals and products into the
environment
 Four different biosafety levels have been
recognized and containment facilities for each
level are recommended which have already been
explain.

3. Category I
Category II
Category III

4. Which are exempt for the purpose of intimation and
approval of competent authority.
 The experiments involving self cloning, using strains and
also inter-species cloning belonging to organism in the
same exchanger group.
 Organelle DNA including those from chloroplasts and
mitochondria.
 Host-vector systems consisting of cells in culture and
vectors, either non-viral or viral containing defective viral
genomes.

5. It includes:
 Routing cloning of defined genes, defined non-coding
stretches of DNA and open reading frames in defined
genes in E. coli or other bacterial host which are
generally considered safe to human, animals and
plants.
 Transfer of defined clones genes into agrobacterium.
 Use of defined reporter genes to study transient
expression in plant cells and to study genetic
transformation conditions.

6. It also includes:
 Molecular analysis of transgenic plants grown in
vitro.
 The experiments need intimation to IBSC
(Institutional Biosafety Committee) in the
prescribed proforma.

7. Those requiring prior intimation of competent authority.
 Experiments falling under containment levels II, III
and IV.
 It include experiment carried out in the lab and
greenhouse using defined DNA fragments non
pathogenic to human and animals for genetic
transformation of plants, both model species and crop
species and the plant grow in green house for
molecular and phenotypic evaluation.

8.  Large scale use of recombinants made by self cloning
in systems belonging to exempt category (e.g. E.coli,
Saccharomyces, and B. subtilis)
 Experiment where in DNA or RNA molecules derived
from any source except for eukaryotic viral genome
may be transferred to any non-human vertebrate or any
invertebrate organisms and propagated under
conditions of physical containment PC1 and
appropriate to organism under study.

9.  Experiments involving non pathogen DNA vector
systems and regeneration from single cells.
 Permission to perform experiments will be
provided by IBSC.
 It would be intimated to RCGM (Review
Committee On Genetic Manipulation) before
execution of experiments

10. Those requiring review and approval of competent authority
before commencement.
 It includes experiments having high risk where the escape of
transgenic traits into the open environment could cause
significant alteration in the biosphears, the ecosystem, plants
and animals by dispersing new genetic traits the effects of
which cannot e judged precisely.
 Further this is also includes experiment conducted in
greenhouse and open field condition not belonging to the
above category II types. Such experiments could be
conducted only after clearance from RCGM and DBT.

11.  It also includes experiments on toxic genes for vaccine
production etc…
 The controlled release of GMOs should be done under
appropriate containment facilities to ensure safety and
to prevent unwanted release in the environment.
 Pre-release tests of GMOs in agriculture should include
elucidation of requirements for vegetative growth and
persistence and stability in small plots and
experimental fields.

12.  Experiments involving the use of infectious animal and
plant viruses in tissue culture systems.
 Experiments involving gene transfer to whole plants and
animals.
 Introduction into cultured human cells of recombinant DNA
molecules containing complete genes of potentially
oncogenic viruses or transformed cellular genes.
 Introduction into animal cells of unidentified DNA
molecules derived from cancer cells or in vitro transformed
cells.

13.  Experiments requiring field testing and release of
rDNA engineered microorganisms and plants.
 Experiments involving engineered microbes with
deletions and certain rearrangements.

15. ‘BIOSAFETY’: Protecting human and animal health and
biodiversity from the possible adverse effects of the
products of modern biotechnology
 Biosafety Regulatory System essential for biotechnology
programme
 Indian Biosafety Regulatory System
 Combination of existing and new legislations
 Mix with non-statutory guidelines
 Shared responsibility
 Scope to evolve

16. …1989 Rules: MoEF
A technique by
which heritable
material generated
outside and inserted
into a cell or
organism. Includes
combinations/ deletions
of parts of genetic
material.
GENETIC ENGINEERING
Import
Export
Transport Hazardous
Manufacture MO/GEO
Process
Use Substances/
Sell Cells
GEAC APPROVAL

17. Regulatory Mechanism
Ministry of Environment and Forests
Department of Biotechnology
Recombinant DNAAdvisory Committee (RDAC)
Review Committee on Genetic Manipulations (RCGM)
Genetic Engineering Approval Committee (GEAC)
State Biosafety Coordination Committee (SBCC)
District Level Coordination Committee (DLCC)

18. Administrative Mechanism
ADVISORY APPROVALS ENFORCEMENT
RDAC GEAC
RCGM
IBSC
SBCC
DLCC
Serviced by DBT
Reviews biotech
developments
Recommends
safety regulations
Serviced by MoEF
Environmental
clearance
- Large scale use
- Release into
environment
Supervises
implementation
Punitive powers
Powers to inspect,
investigate and
punish statutory
violations
Post release
monitoring
State nodal
agency

19.  RCGM
 Manuals of guideline
 Approvals: RG III &
above research
 Approvals: contained
filed trials
 Approvals: import for
research
 Monitors research
projects safety aspects
 Advisory role
 Link: IBSC: GEAC
Administrative Mechanism
APPROVALS ENFORCEMENT
 DLCC
 Monitors
safety
regulations in
installations
 Post release
monitoring
 Reports:
SBCC, GEAC
 IBSC
 Institute level
 Approval role
 - R G I: Intimation
 - R G II: Approval
 - R G III
 & above: recommen-
dation
 Site emergency plan
 Adherence of guidelines
 Nodal point for
interaction