Regulatory Documents
Biosafety & Biosecurity Related
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
- 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 National Environment Policy
- 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 Notification of Rules, 1989 - September 13, 1993
- Genetic Engineering Approval Committee renamed as Genetic Engineering Appraisal Committee - July 16, 2010 GE Approval Committee renamed as GE Appraisal Committee, July, 2010
Guidelines and Protocols
NATIONAL
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List of infective Microorganisms corresponding to different Risk Groups, 2021" vide DBT OM dated 09.12.2021 Download here
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Minimum qualification of Biosafety Officer, vide DBT OM dated 12.08.2021 Download here
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Submission of Documents for Compliance on IBKP vide DBT OM dated 11.08.2021, Download here
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SOPs for exchange of infectious biosamples/biospecimen from Biorepsitory, 2021 vide DBT OM dated 07.06.2021 Download here
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Generic PCT protocol for assessing toxicity of recombinant DNA derived products in animal models. Download here
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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
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Online IBSC meetings conditions, vide DBT OM dated 22.12.2020 Download here
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Handbook for Institutional Biosafety Committees (IBSCs), Third Revised Edition, September 2020 Download here
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Streamlining of the Regulation Procedure of Biopharma Drug Development, vide DBT OM dated 06.08.2020 Download here
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Rapid Response Regulatory Framework for COVID-19 Vaccine Development vide DBT OM dated 26.05.2020- Checklist recombinant vaccine Covid 19
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OM for Rapid Response Regulatory Framework for COVID-19 vide DBT OM dated 20.03.2020 Rapid Response Regulatory Framework for COVID-19
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Checklist for information requirements in the Applications and Reports on Preclinical toxicity study of similar Biologics, Download here
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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 Revised Simplified Procedures/Guidelines on Import, Export and Exchange
- 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; Monitoring Confined Field Trials of GE Plants- A monitoring Manual
- Monitoring Confined Field Trials of Genetically Engineered Plants- A Tool for trainers; Monitoring Confined Field Trial of GE Plants -Tools for Trainers
- Confined Field Trials of GE Plants, 2015; Confined Field Trials of GE Plants, 2015