Institutional Biosafety Committee(IBSC) - Assam University

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2 Concept of Biosafety In India, GMOs and products thereof are regulated as per the “Rules for the manufacture, use/import/export and storage of hazardous microorganisms/ genetically engineered organisms or cells, 1989” (commonly referred as Rules, 1989) notified by the Ministry of Environment and Forests (MoEF), Government of India under the Environment (Protection) Act (1986). These rules are implemented by MoEF, the Department of Biotechnology (DBT), Ministry of Science and Technology and the State Governments through the six competent authorities notified under the Rules which are as follows: • Recombinant DNA Advisory Committee (RDAC) • Institutional Biosafety Committee (IBSC) • Review Committee on Genetic Manipulation (RCGM) • Genetic Engineering Appraisal Committee (GEAC) • State Biotechnology Coordination Committee (SBCC) • District Level Committee (DLC). DBT has taken several initiatives to strengthen the functioning of the IBSCs ( Box 1). Pursuant to issuing various guidelines in 1990 and 1998, DBT in association with Biotech Consortium India Limited (BCIL) organised a series of national consultations at six locations for the IBSC members and the DBT nominees with an objective to apprise them about their roles in greater depth and detail. A detailed background document was prepared and circulated in the meetings. The interaction between the faculty and IBSC members helped in clarifying the roles and responsibilities of IBSC members in general and the DBT nominees in particular. Initiatives by DBT for regulatory ry compliance by IBSCs
3 Guidelines for IBSCs The following is the text of guidelines for IBSCs as adopted by Review Committee on Genetic Mainpulation (RCGM): 1. Purpose/Objectives The purpose of these guidelines is to provide guidance to organisations that have Institutional Biosafety Committees (IBSCs) or intend to set up an IBSC in compliance with “Rules for the manufacture, use/import/export and storage of hazardous microorganisms/ genetically engineered organisms or cells, 1989” (hereinafter referred as Rules, 1989) notified by the Ministry of Environment and Forests (MoEF), Government of India under the Environment (Protection) Act, 1986. As a statutory committee that operates from the premises of an organisation, IBSC is in a position to conduct onsite evaluation, assessment and monitoring of adherence to the biosafety guidelines with overall oversight of the regulatory process, at the institutional level. The decisions taken by the next higher committee i.e., Review Committee on Genetic Manipulation (RCGM), which operates from the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India are based on the applications submitted by the investigators with the approval of IBSC. Therefore,it is pertinent that IBSCs have expertise in evaluation, assessment and monitoring of projects and ensure compliance with the Rules, 1989, Recombinant DNA (rDNA) Safety Guidelines,1990 and other guidelines issued by DBT from time to time.
Page 4 and 5: 4 2. Scope These guidelines describ
Page 6 and 7: 6 • Three or more scientists enga
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Page 10 and 11: 10 GEAC, State Biotechnology Coordi
Page 12 and 13: 12 9.6 DBT nominee The duty of the
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Page 16: 16 Check List for IBSCs
Page 20 and 21: 20 Minutes of the 3 IBSC meeting he
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Page 26 and 27: 26 4.2 Description of the target ge
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Institutional Biosafety Committee(IBSC) - Assam University

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