India Biotechnology Regulations implemented under Rules, 1989 of the Environment Protection Act, 1986 are dynamic and complementing with emerging technology used for research, product development and progress in science of risk assessment. Government of India has undertaken several reforms in biotechnology regulatory system. To assist Review Committee on Genetic Manipulation (RCGM), the project “Establishment of Biosafety Support Unit (BSU)” with trained and skilled scientists with specialization in relevant scientific discipline has been funded by the Department of Biotechnology, Govt. of India and is being implemented at Regional Centre for Biotechnology.

BSU supports the current regulatory framework at RCGM, DBT in regards to biosafety issues. BSU has been assisting in scrutiny of Biopharma and Agricultural biotechnology based applications received for risk assessment for conducting research, Preparation of reports to facilitate decision making by the competent bodies, Drafting/revision of guidelines/guidance documents/SOPs for generating biosafety data including to address the challenges raised by the emerging new areas of Biotechnology such as Genome Editing, Development of policy documents on emerging pandemic situation such as COVID-19, Development and maintenance of IBKP Portal, Conducting awareness generation cum Interactive Sessions for IBSCs and Researchers and developing e-learning modules for stakeholders working in the regulatory science, Providing support to RCGM Secretariat in organizing scheduled meetings of the RCGM, various sub-committees and monitoring teams, etc. and (any) other task assigned by RCGM, DBT, from time to time.

BSU facilitated different working groups in drafting/revising the guidelines/guidance documents/SOPs notified by RCGM-DBT, which can be accessed at https://ibkp.dbtindia.gov.in/Content/Rules