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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 IBSCs on 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 of IBSCs 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-cum-Evaluation Committee (MEC). About 320 IBSCs 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