Welcome to RCGM Secretariat Department of Biotechnology, MoST, GoI

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

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

Entry of Tomato Leaf Curl New Delhi Virus in “List of Infective Microorganisms corresponding to different Risk Groups, 2021" superseding the Annexure I of "Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017". Download here
Entry of Pseudorabies virus in “List of Infective Microorganisms corresponding to different Risk Groups, 2021" superseding the Annexure I of "Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017 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- 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