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

Notifications
Guidelines and Protocols

NATIONAL

  • 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- Checklist recombinant vaccine Covid 19
  • OM for Rapid Response Regulatory Framework for COVID-19 vide DBT OM dated 20.03.2020 Rapid Response Regulatory Framework for COVID-19
  • 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 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