Guidelines and Protocols
Series of guidelines and protocols have been issued by Department of Biotechnology and Ministry of Environment and Forests relating to GMOs and product thereof as under:
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Recombinant DNA Safety Guidelines, 1990
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Revised Guidelines for Research in Transgenic Plants, 1998
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Guidelines for Generating Pre-clinical and Clinical Data for r-DNA based Vaccines, Diagnostics and other Biologicals, 1999
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Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008
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Guidelines for Confined Filed Trials of Regulated Genetically Engineered (GE) Plants
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Guidelines for the monitoring of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008
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Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008
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Protocol for Food and Feed Safety Assessment of GE crops, 2008
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Guidelines and Handbook for Institutional Biosafety Committees (IBSCs), 2011
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Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012
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Environmental Risk Assessment of Genetically Engineered Plants:A Guide for Stakeholders, 2016
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Guidelines for the Enviromental Risk Assessment of Genetically Engineered Plants, 2016
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Risk Analysis Framework, 2016