Overview
In India, the manufacture, import, research and release of Genetically Engineered (GE) Organisms, as well as products made by the use of such organisms are governed by The Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered Organisms or Cells, (“The Rules, 1989”) notified by the Ministry of Environment, Forest and Climate Change (MoEF&CC), on December 5, 1989, under the Environment (Protection) Act 1986. The Rules, 1989 are broad in scope and cover the area of research as well as large-scale handling of hazardous microorganisms, GE organisms or cells and products thereof. In accordance with The Rules, 1989,
- Recombinant DNA Advisory Committee (RDAC) is mandated to review developments in Biotechnology at national and international levels and recommend suitable and appropriate safety regulations for India in recombinant research, use and applications from time to time
- Review Committee on Genetic Manipulation (RCGM) is mandated to monitor & review all ongoing research projects involving high-risk category and confined field experiments and ensure the compliance of biosafety rules & regulations. Framing and implementation of safety measures and guidelines, while conducting research on high-risk group microorganisms and GE organisms have also been entrusted upon RCGM and
- Institutional Biosafety Committees (IBSCs) are mandated to operate directly from the premises of the institutions and ensure on-site assessment and monitoring of adherence to the biosafety guidelines with overall oversight of the regulatory process, at the institutional level. Further, RCGM also certifies BSL-3 facilities through a mechanism involving critical review of mandatory documents by an Inter-ministerial committee.
Mandate
Review Committee on Genetic Manipulation (RCGM) functions from the Department of Biotechnology to monitor the safety-related aspect with respect to ongoing research projects or activities involving hazardous microorganisms, GE organisms and cells and products thereof. RCGM brings out Manuals of guidelines specifying procedures for regulatory processes with respect to activities involving GE organisms in research use as well as industrial & environmental applications with a view to ensuring human health and environmental safety. All ongoing research projects involving hazardous microorganisms, GE organisms or cells and products thereof, are reviewed to ensure that adequate precautions and containment conditions are being met. RCGM lays down procedures restricting or prohibiting production, sale, importation and use of such hazardous microorganisms, GE organisms or cells.
Key Activities
- RCGM lays down procedures restricting or prohibiting the production, sale, importation and use of GE organisms or products thereof for research and applications as mentioned in the schedule of Rules, 1989. RCGM brings out manuals and guidelines specifying procedures for regulatory processes with respect to activities involving GE organisms in research, use and application, including industry, with a view to ensure biosafety and these regulatory documents are regularly updated on the Indian Biosafety Knowledge Portal (https://ibkp.dbtindia.gov.in/). The RCGM recommends NoC for import or exchange of genes, DNA fragments, vectors, plasmids, cosmids, etiologic agents and transgenic organisms or germplasm(s) including transformed calli, seeds, plants and plant parts for research use only. RCGM monitors the safety-related aspects of ongoing recombinant DNA (rDNA) projects and activities involving GE organisms/ hazardous microorganisms. All ongoing projects including high risk category and confined field experiments are reviewed by RCGM to ensure that adequate precautions and containment conditions are complied with as per the Guidelines and Standard Operating Procedures (SOPs) issued by DBT. Further, through increased frequency of RCGM meetings (fortnightly), approval time has been significantly reduced.
- In line with the Government of India’s ease of doing business and digital India, all applications are received, and recommendations are communicated through the an online web portal, namely Indian Biosafety Knowledge Portal (IBKP, https://ibkp.dbtindia.gov.in/).The Portal facilitates registration of IBSC, and maintains the transparency and accountability of regulatory approval process. All the regulatory guidelines, manuals, protocols, SOPs and other documents are notifying on the Indian Biosafety Knowledge Portal.
- RCGM certifies BSL-3 facilities through a mechanism involving critical review of mandatory documents by an Inter-ministerial committee, followed by approval by RCGM. BSL-3 facilities are also inspected to understand the design, procedures and engineering controls to provide recommendations in case of any deficiency or non-compliance. So far, 47 facilities have been recommended by the Inter-ministerial committee for certification of BSL-3 facility and approved by RCGM.
- RCGM secretariat facilitates training of IBSCs/Researchers by conducting online interactive sessions for awareness regarding biosafety-related reforms in Indian Biotechnology Regulation. These sessions were attended by the representatives from Universities, Institutes and Private organizations and researchers working in biological sciences.
- Biological Research Regulatory Approval Portal (BioRRAP, https://biorrap.gov.in/) has been launched by DBT to track the regulatory approvals for a research proposal on a single portal. BioRRAP provides a single route to direct the applicant to regulatory agencies providing requisite approval relevant to the biological research.
