The Regulations and guidelines on biosafety of recombinant DNA research & biocontainment, 2017 were released by Secretary, DBT, Prof. K VijayRaghavan during 2017-Meeting of States Parties of the Biological Weapons Convention (BWC) at Geneva, Switzerland on 5th December, 2017.
In view of the recent developments in the field of biotechnology, biosafety & biosecurity, and experience gained while implementing the biosafety frameworks within the country, a new guideline on ‘Regulations and guidelines on biosafety of recombinant DNA research and biocontainment, 2017’ has been prepared by Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology, New Delhi. The guidelines has been prepared after due incorporation of views from researchers, experts, academicians, concerned Ministries/departments and other stakeholders. The document specifies practices for handling hazardous biological material, recombinant nucleic acid molecules and cells, organisms and viruses containing such molecules, in order to ensure an optimal protection of public health and of the environment. It provides clarity on competent authorities, biosafety requirements, recommendations for laboratory facilities such as facility design, biosafety equipment, personal protective equipment, risk assessment & management strategies, good laboratory practices & techniques, provisions for transboundary exchange of regulated materials, waste management etc. in ~190 pages.
Expressing his delight at the finalization and release of the guidelines, Prof. VijayRaghavan mentioned that the regulations have been formulated through an elaborate process of consultation and is compatible with world standards. Underlining how Recombinant DNA has undergone changes over the years through gene editing, he added that they would go a long way preventing unregulated handling, exchange and conduct of research & development with regard to risk-inherent microorganisms, genetically engineered organisms or cells and products.
Adoption of this guideline shall be binding for all public and private organizations involved in research, development and handling of GE organisms (microorganisms, animals, plants, arthropods, aquatic animals, etc.) and non-GE hazardous microorganisms and products produced through exploration of such organisms.