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Rules, Acts & Guidelines

Acts,  Rules, Regulations

 NATIONAL

  •         The Environment (Protection) Act, 1986 Download here
  •         Rules for the manufacture, use, import, export & storage of hazardous microorganisms, GE organisms or cells,1989 Download here
  •         Drugs and Cosmetics Rules - 1988 (eight amendment)  Download here
  •         Schedule–Y of Drugs and Cosmetics Act  Download here
  •         Protection of Plant Varieties and Farmers’ Rights Act, 2001 Download here
  •         Biological Diversity Act, 2002 Download here
  •         Food Safety and Standards Act 2006 Download here
  •         Plant Quarantine Order, 2003 Download here

INTERNATIONAL

  •        Convention on Biological Diversity (1992) Download here
  •        Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000) Download here
  •        Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (CPB) Download here

Policies


Notifications

  • Foreign Trade Policy for import of GM Products, 2006  Download here
  • Exemption of recombinant pharmaceutical falling in specific category for Rules 7 to 10 of Rules 1989 Download here
  • Exemption of processed food derived from living modified organism Download here
  • Notifications empowering Seed inspectors, Seed Analyst and Laboratories notified under seed Act, 1966 and Seed Control Order, 1983 under Environment (Protection) Act, 1986 Download here
  • Authorizing ICAR for approval of Bt cotton Download here
  • Notification for LMO/GMO detection National Referral Laboratories Download here
  • Notification empowering CICR to detect presence Cry1AC gene in Cotton seeds Download here

Guidelines and Protocols

NATIONAL

  • Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017  Download here
  • Environmental Risk Assessment of Genetically Engineered Plants: A Guide for Stakeholders, 2016  Download here
  • Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants, 2016 Download here
  • Risk Analysis Framework, 2016   Download here     
  • Guidelines on Similar Biologics, 2016 Download here
  • Guidelines and Handbook for Institutional Biosafety Committees (IBSCs), 2011 Download here
  • Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008 Download here
  • Guidelines for the monitoring of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008  Download here
  • Guidelines for the conduct of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008 Download here
  • Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008 Download here
  • Protocol for Food and Feed Safety Assessment of GE crops, 2008 Download here
  • Export control system of SCOMET items, 2018 Download here