Regulatory Bodies for Biotechnology

India's biotechnology regulation runs through several linked bodies with distinct roles. At the apex is the proposed Biotechnology Regulatory Authority of India (BRAI), envisaged as an autonomous statutory agency regulating the research, transport, import and manufacture of biotechnology products and organisms; if the enabling bill passes, day-to-day approval work would shift to an Environmental Appraisal Panel under BRAI, supported by an inter-ministerial governing body and a National Biotechnology Advisory Council of stakeholders. Until then, the Genetic Engineering Approval Committee (GEAC), under the Ministry of Environment, Forests and Climate Change, is the body responsible for approving genetically engineered products in India and for monitoring their large-scale, commercial use. GEAC in turn is assisted by the State Biotechnology Coordination Committee (SBCC) and District Level Committees (DLC), while two further national committees do the groundwork beneath it: the Institutional Biosafety Committee (IBSC) handles local implementation of biosafety guidelines at the institution level, and the Review Committee on Genetic Manipulation (RCGM) — which draws representatives from the Department of Biotechnology (DBT), the Indian Council of Medical Research, the Indian Council of Agricultural Research and the Council of Scientific and Industrial Research — is responsible for issuing research permits. The whole system traces back to the DBT's 'Recombinant DNA Safety Guidelines, 1990' (revised in 1994), and bulk drugs made using recombinant DNA technology additionally require industrial licensin …