June 28 :Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India has been entrusted with the responsibility of setting up of National Biotechnology Regulatory Authority (NBRA). The NBRA would be set up as an independent, autonomous and professionally led body to provide a single window mechanism for biosafety clearance of genetically modified products and processes.
Setting up of NBRA will require the promulgation of new legislation, namely the “National Biotechnology Regulatory Act” or the NBR Act. Draft establishment plan and draft legislation have been prepared by a Consultative Committee of experts. Copies of both the draft documents have been placed at http://dbtindia.nic.in and http://dbtbiosafety.nic.in
DBT has initiated the consultative process with all the stakeholders for discussing the establishment plan and draft Bill for the above. As part of the above process, a consultation with senior media representatives was held under the chairmanship of Prof. M.S. Swaminathan on June 28, 2008 at New Delhi.
Representatives from leading news organizations participated in the consultation. Several aspects of the proposed bill including data exclusivity, sharing of data/information on the field trials and safety testing with public, ensuring full autonomy to the proposed regulatory authority, the role of appellate tribunal vis-à-vis its relation with other civil courts, inter-ministerial cooperation to address overlapping issues with existing laws particularly in case of foods and pharma were discussed. Several representatives stressed the need for a professionalized communication and outreach system and suggested that the same should be inbuilt as part of the new organization to enable smooth flow of information to various stakeholders. Dr. M.K. Bhan, Secretary, DBT clarified that the Department is only a facilitator in establishment of this Authority and would have no role in its functioning and operations once it is established. He reiterated that NBRA will be a fully autonomous and professional body with comparable global standards and public feedback systems for ensuring science based regulations.
Chairing the meeting, Prof. M.S. Swaminathan indicated that consultation with all stakeholders and taking into account their concerns would ensure adequate public confidence in the establishment of NBRA.
DBT officials informed that the date for seeking feedback from various stakeholders has been extended upto July 31, 2008 and all responses can be sent at nbra.dbt@nic.in.