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 (eighth 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

• Doubling Farmers’ Income: Rationale, Strategy, Prospects and Action plan, NITI Policy Paper No. 1/2017 Download here
• Twelfth Five Year Plan (2012–2017): Economic Sectors, 2013 Download here
• National Biotechnology Development Strategy 2015-2020 Download here
• National Policy for Farmers, 2007 Download here
• National Environment Policy, 2006 Download here
• Drug Policy, 2002 Download here
• National Seeds Policy, 2002 Download here

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
• Notification of Rules, 1989 - September 13, 1993 Download here
• Genetic Engineering Approval Committee renamed as Genetic Engineering Appraisal Committee - July 16, 2010 Download here
• Requirement of BioRRAP ID for submission of Form C1 on IBKP. Download here

Guidelines and Protocols

NATIONAL

• National Guidelines for the establishment and certification of Biosafety Level-3 (BSL-3) Containment Facility, 2024. Download here

• Entry of microorganisms in “List of Infective Microorganisms corresponding to different Risk Groups, 2021" superseding the Annexure I of "Regulations & GuideIines for Recombinant DNA Research and Biocontainment, 2017" vide DBT OM dated 07.05.2024. Download here
• Standard Operating Procedures for Regulatory Review of Genome Edited Plants under SDN-1 and SDN-2 Categories. Download here
• Guidelines for the Safety Assessment of the Genome Edited Plants, 2022 Download here
• List of infective Microorganisms corresponding to different Risk Groups, 2021" vide DBT OM dated 09.12.2021 Download here
• Minimum qualification of Biosafety Officer vide DBT OM dated 12.08.2021 Download here
• Submission of Documents for Compliance on IBKP vide DBT OM dated 11.08.2021 Download here
• SOPs for exchange of infectious biosamples/biospecimen from Biorepsitory, 2021 vide DBT OM dated 07.06.2021 Download here
• Generic PCT protocol for assessing toxicity of recombinant DNA derived products in animal models Download here
• Guidelines for the Establishment of Containment Facilities: BSL2 and BSL3 and Certification of BSL3 facility 2020 vide DBT order dated 18.12.2020 Download here
• Online IBSC meetings conditions, vide DBT OM dated 22.12.2020 Download here
• Handbook for Institutional Biosafety Committees (IBSCs), Third Revised Edition, September 2020 Download here
• Streamlining of the Regulation Procedure of Biopharma Drug Development, vide DBT OM dated 06.08.2020 Download here
• Rapid Response Regulatory Framework for COVID-19 Vaccine Development, vide DBT OM dated 26.05.2020 Download here
• OM for Rapid Response Regulatory Framework for COVID-19, vide DBT OM dated 20.03.2020 Download here
• Checklist for information requirements in the Applications and Reports on Preclinical toxicity study of similar Biologics, Download here
• Revised Simplified Procedures/Guidelines on Import, Export and Exchange of GE organisms and products thereof for R&D purpose, 2020 vide DBT OM dated 17.01.2020 Download here
• 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
• Simplified Procedures/Guidelines on Exchange, Import & Export of GE organisms & Products thereof for R&D purpose, 2015 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
• Monitoring Confined Field Trials of Genetically Engineered Plants- A Monitoring Manual Download here
• Monitoring Confined Field Trials of Genetically Engineered Plants - A Tool for Trainers Download here
• Confined Field Trials of GE Plants, 2015 Download here
• Guidelines and standard operating procedure for Research and Genetically Engineered Insects, 2023 Download here