9/10/2014

Biotechnology: Biosafety Issues - Science and Technology - Sectors: National Portal of India

Biosafety Issues
Under Biosafety programme main emphasis has been given to facilitate and implement biosafety procedures and
guidelines for ensuring safety from the use of Genetically Modified Organisms (GMOs) and products thereof in
research and application to the users as well as to the environment. The institutions and industries involved in
recombinant DNA work are carrying out their activities with the approval from Institutional Biosafety Committees
(IBSCs), Monitoring-cum-Evaluation Committee (MEC) and Review Committee on Genetic Manipulation (RCGM) and
other institutional structures. The Department had reconstituted the Review Committee on Genetic Manipulation
(RCGM) to monitor the safety related aspects in respect of ongoing r-DNA projects & activities involving Genetically
Engineered Organisms/Hazardous organisms and controlled field experiments of transgenic crops, in compliance with
the Rules-1989 of Environment (Protection) Act, 1986 (EPA-1986). The RCGM was actively involved in clearing and
guiding public and private institutions in the development of transgenic crops and RDNA therapeutics.
Apart from considering the applications submitted by various organizations involved in the r-DNA
technology, RCGM has taken several policy decisions such as standardization of protocol for conduct of multi-location
field trials, data collection parameters, nomenclature of transgenic crop/gene/event, and new monitoring mechanism
for Bt. cotton. In the area of recombinant pharma sector, the Department actively participated in finalization of report
for the Task Force on "Recombinant Pharma Sector" constituted by the Ministry of Environment & Forests. The
recommendations of the Department on protocols for different kind of r-DNA pharma products based on indigenous
development and marketing, import and marketing, purified materials from Genetically Modified Organisms (GMOs)
as products for commercialization and GMOs as products were included in the final report. The Department had
actively provided inputs on rationalization of biosafety regulatory procedures on transgenic crops and recombinant
DNA therapeutics to several committees set up by Government of India M/s Bitoech Consortium India Ltd. New Delhi
has been supported by the Department to organize workshops on National Consultation on Biosafety aspects related
to Genetically Modified Organisms' to apprise the members of the IBSCson biosafety Rules, Regulations & Procedures.
For making available transgenic crops and recombinant DNA therapeutics to the society at the earliest and at the
same time not compromising on the safety of the products, the rationalized Biosafety guidelines and procedures were
followed. A dedicated dynamic & interactive website on Biosafety reflecting National and International Guidelines,
National Rules & Procedures with dynamic interaction with Institutional Biosafety Committees (IBSC) has been
developed and launched. Another website on "Indian GMO Research Information System (IGMORIS)" aimed to
provide information on research work going on in Indian laboratories, has also been launched. A handbook for
members ofIBSCs was prepared by the Department and distributed to all IBSCs. The Department had played an
active role for the environmental release of four Bt. Cotton events expressing cry1Ac (Mon 531 event); cry1Ac &
cry2Ab (Mon 15985 event) and GFM cry1A and cry1Ac (event No. 1) genes by different seed companies/industries
based on the recommendations of Review Committee on Genetic Manipulation (RCGM) and Monitoring-cumEvaluation Committee (MEC). About 320IBSCs have been constituted so far at various public funded institutions,
universities, private R&D institutions and industries. Keeping in view the recent Orders of the Hon. Supreme Court,
the Department has been making efforts to ensure that the conditions laid out in the Orders are adhered to, while
taking any decision on the applications for various research field trials.
Source: National Portal Content Management Team, Reviewed on: 09-02-2011

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