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The regulations classify activities involving GMOs into
four risk categories, provide lists of bacterial, fungal,
parasitic and viral agents that fall into each category, and
specify the roles of the institution and the company, the IBSC
and the RCGM vis à vis the risk categories:
Category I comprises routine recombinant
DNA experiments conducted inside a laboratory;
Category II consists of both laboratory and greenhouse
experiments involving transgenes that combat biotic stresses
through resistance to herbicides and pesticides;
Categories III and IV comprise experiments and field trials
where the escape of transgenic traits into the open
environment could cause significant alterations in the
ecosystem.
Through the biosafety regulations, Government of India
established a three-tier regulatory structure at the central
level in
New Delhi
comprising three committees:
The Review Committee on Genetic Manipulation (RCGM)
under the Ministry of Science and Technology (MoST);
The Genetic Engineering Approval Committee (GEAC)
under the Ministry of Environment and Forestry (MoEF);
The Monitoring and Evaluation Committee (MEC)
under DBT/MoST;
DBT provides the secretariat for RCGM and MEC, and the MoEF
for GEAC. The GoI also issued directives on the setting up a
de-centralised structure consisting of Institutional
Biosafety Committees (IBSCs) and State and District
Level Committees (SBCCs and DLCs). The biosafety
regulations indicate in broad terms the composition and
responsibilities of all these six bodies. DBT is represented
on all of them except the SBCCs and DLCs. IBSCs have been
established in all institutions (public and private) that deal
with GMOs. But, even as late as of 2004, only three states
(out of a total of twenty-five states and several ‘union
territories’ that make up the Indian Union) had created SBCCs,
while DLCs have not been set up anywhere. RCGM’s mandate is to
assess and decide on the applications submitted by
institutions and companies for conducting R&D work, greenhouse
tests and contained field tests on plots of less than one
acre in size (0.4 hectare).

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