Data Monitoring, OOMF, DBT Annual Report and Monthly Reporting

Overview

 In India, the manufacture, import, research and release of Genetically Engineered Organisms (GEOs), as well as products made by the use of such organisms are governed by The Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered Organisms or Cells, (“Rules 1989”) notified by the Ministry of Environment, Forest and Climate Change (MoEF&CC), on December 5, 1989, under the Environment (Protection) Act 1986. The Rules 1989 are broad in scope and covers the area of research as well as large-scale handling of hazardous microorganisms, GE organisms or cells and products thereof. The Rules, 1989 delegated the Department to administer the functioning of i) Institutional Biosafety Committees (IBSCs) which operate directly from the premises of the institutions and ensures on-site assessment and monitoring of adherence to the biosafety guidelines with overall oversight of the regulatory process, at the institutional level and ii) Review Committee on Genetic Manipulation (RCGM) which monitors & reviews all ongoing research projects involving high risk category and confined field experiments to ensure the compliance of biosafety rules & regulations.

Mandate:

In accordance with Rules, 1989 of the Environment Protection Act, 1986, RCGM shall function from the Department of Biotechnology to monitor the safety related aspect in respect of on-going research projects or activities involving hazardous microorganisms, GE organisms and cells and products thereof. RCGM shall bring out Manuals of guidelines specifying procedure for regulatory process with respect to activities involving  GE organisms in research use as well as industrial & environmental applications with a view to ensure human health and environmental safety. All ongoing research projects involving hazardous microorganisms, GE organisms or cells and products thereof shall be reviewed to ensure that adequate precautions and containment conditions are being met.RCGM shall lay down procedures restricting or prohibiting production, sale, importation and use of such hazardous microorganisms, GE organisms or cells.

Major Programs and initiatives (Include Mission Programmes):

• The Department has initiated organizing Interactive sessions for IBSCs/Researchers on fortnight basis to create awareness on biosafety related issues among the researchers.
• Guidelines on Certification of BSL-3 facilities have been issued.

Achievements:

• Indian Biosafety Knowledge Portal (IBKP): In line with Government of India’s ease of doing business and digital India, an online web portal namely Indian Biosafety Knowledge Portal (IBKP), has been launched by DBT that not only maintains the transparency, accountability but also enabled uninterrupted submission as well as review of applications during the COVID-19 crisis.
• Reduced timelines for approval process: The timelines for review process of applications submitted have been drastically reduced to one third duration with support of an internal assessment unit and experts. For this, RCGM meetings are now being conducted every fortnightly as compared to earlier cycle of 45 days thereby enabling to dispose applications on import/export/transfer within 7-10 days.
• Rapid response to emerging situations: To fast track approval process of applications for development of vaccines, diagnostics, prophylactics and therapeutics within 7 to 10 days, Rapid Response Regulatory Framework for COVID-19 have been framed in association with DBT-CDSCO. Additionally, to facilitate research and development activities on COVID-19 following Documents have been issued: i) Rapid Response Regulatory Framework for COVID 19 in March, 2020 ii) Regulations and Guidelines for recombinant DNA Research &Biocontainment- Interim Guidelines of laboratory biosafety to handle COVID 19 specimen for R & D purpose, April, 2020. iii) Rapid Response Regulatory Framework for COVID-19 Vaccine development, May, 2020.
• Facilitation of Online IBSC meetings, due to prevailing COVID-19 situation:In order to facilitate seamless research on recombinant DNA technology in various research institutions and industry, DBT allowed IBSCs to conduct their meetings through video conferencing while ensuring the safety of laboratory personnel and the environment (DBT order for conducting online IBSC meetings by IBSCs registered on IBKP portal 22 December 2020).
• Simplified procedure for Import/Export and exchange of materials: Towards cutting down on regulatory steps without compromising biosafety, a revised notification on “Simplified Procedures & Guidelines on Exchange, Import & Export of GE organisms & Products thereof for R&D purpose” was issued by DBT on 17th January2020 empowering IBSC (that functions within institutional premises) to accord approval for import, export, and exchange without any requirement of approval from RCGM.
• Streamlining in Biopharma product development and its approval: To facilitate the product development and streamline the approval process,  a notification was issued by DBT on 06.08.2020 on Regulation procedure of Biopharma Drug Development wherein several reforms were notified including: a) Two times approval time points from RCGM has been reduced to one time submission; b) For PCT protocol approval the time lines have been fixed to 15 days; c) Earlier for any IND molecule, the number of consistency batch requirement was 05 which has now been reduced to 03 (like Similar Biologics).
• Handbook for Institutional Biosafety Committees (IBSCs), 2020: Handbook has been revised and the third revised edition has been notified on September 02, 2020 to update IBSCs’ regarding recent reforms including decentralized regulatory powers to IBSC and implementation of a use-friendly online mechanism of regulatory process through IBKP.
• Online Interactive sessions for creating awareness for IBSCs/Researchers: Towards informing and mobilising IBSCs/Researchers regarding several reforms in Indian biotechnology regulation to facilitate use of biotechnology, its promotion, adoption, and popularization without compromising safety and security concerns, several interactive sessions (34) for IBSCs registered on IBKP have been arranged so far. The interactive session was attended by more than 1200 representatives from Universities, Institute and Private organizations and researchers working in biological sciences.

Success Storiesfor Last Five Years:

Facilities Established: Not Applicable

Products/Processes Developed: Not Applicable

Technologies Developed/Transferred: Not Applicable

Year wise List of publications for Last Five Years:

• National Guidelines for Stem Cell Research (Department of Biotechnology and Indian Council of Medical Research), 2017.
• Regulations & Guidelines for Recombinant DNA Research and Biocontainment. Department of Biotechnology, 2017.  
• Checklist for information requirements in the Applications and Reports on Preclinical toxicity study of similar Biologics. Department of Biotechnology, August 31, 2018.
• National Guidelines for Gene Therapy Product Development and Clinical Trials (Department of Biotechnology and Indian Council of Medical Research), 2019
• Revised Simplified Procedures/ Guidelines on Import, Export and Exchange of GE organisms and products thereof for R&D purpose. Department of Biotechnology, 2020.
• Rapid response regulatory framework for COVID-19 to deal with applications for development of vaccines, diagnostics, prophylactic and therapeutics. Department of Biotechnology and Central Drugs Standard Control Organization, 2020.
• Interim guidance document on laboratory biosafety to handle COVID-19 specimens for R&D purpose. Department of Biotechnology, 2020.
• Rapid Response Regulatory Framework for COVID-19 Vaccine development; Checklist for application to conduct pre-clinical toxicity (PCT) studies for recombinant vaccine for COVID-19. Department of Biotechnology, 2020.
• Streamlining of the Regulation procedure of Biopharma Drug Development. Department of Biotechnology, 2020.
• Handbook for Institutional Biosafety Committees (IBSCs). Department of Biotechnology, 2020.
• Guidelines for the Establishment of containment facilities: Biosafety Level 2 (BSL-2) & 3 (BSL-3) and certification of BSL 3 facility, 2020.
• Standard Operating Procedures (SOPs) for Exchange of Infectious Biosamples/Biospecimens from Biorepository, 2021.
• Risk group updation: The “List of Infective Microorganisms corresponding to different Risk Groups” superseded the Annexure I of “The Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017” notified by the Department of Biotechnology vide OM No. BT/BS/17/635/2015-PID, dated 01st April 2018, and was notified on Dec 09, 2021. 

List of Patents Applied/Granted/Commercialized:Not Applicable

The following amendment needs to be done under section Biosafety data Links

Application Formats

Checklist for information requirements in Form C3 and C5 to RCGM- PCT application and PCT Report on Similar Biologics

Minutes of the RCGM Meetings

Guidelines for Biosafety

• Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008 
• Guidelines for the monitoring of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008  
• Guidelines for the conduct of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008  Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008 
• Protocol for Food and Feed Safety Assessment of GE crops, 2008
• Guidelines on Similar Biologics, 2016 
• Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants, 2016 
• Environmental Risk Assessment of Genetically Engineered Plants: A Guide for Stakeholders, 2016  
• Regulations & Guidelines for Recombinant DNA Research and Biocontainment. Department of Biotechnology, 2017.  
• Checklist for information requirements in the Applications and Reports on Preclinical toxicity study of similar Biologics. Department of Biotechnology, 2018.
• National Guidelines for Gene Therapy Product Development and Clinical Trials (Department of Biotechnology and Indian Council of Medical Research), 2019
• Revised Simplified Procedures/ Guidelines on Import, Export and Exchange of GE organisms and products thereof for R&D purpose. Department of Biotechnology, 2020.
• Rapid response regulatory framework for COVID-19 to deal with applications for development of vaccines, diagnostics, prophylactic and therapeutics. Department of Biotechnology and Central Drugs Standard Control Organization, 2020.
• Interim guidance document on laboratory biosafety to handle COVID-19 specimens for R&D purpose. Department of Biotechnology, 2020.
• Rapid Response Regulatory Framework for COVID-19 Vaccine development; Checklist for application to conduct pre-clinical toxicity (PCT) studies for recombinant vaccine for COVID-19. Department of Biotechnology, 2020.
• Streamlining of the Regulation procedure of Biopharma Drug Development. Department of Biotechnology, 2020.
• Handbook for Institutional Biosafety Committees (IBSCs). Department of Biotechnology, 2020.
• Guidelines for the Establishment of containment facilities: Biosafety Level 2 (BSL-2) & 3 (BSL-3) and certification of BSL 3 facility, 2020.
• Standard Operating Procedures (SOPs) for Exchange of Infectious Biosamples/Biospecimens from Biorepository, 2021.
• Risk group updation: The “List of Infective Microorganisms corresponding to different Risk Groups” superseded the Annexure I of “The Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017” notified by the Department of Biotechnology vide OM No. BT/BS/17/635/2015-PID, dated 01st April 2018, and was notified on Dec 09, 2021.

Notifications

For more information, please visit: https://ibkp.dbtindia.gov.in/

Contacts Concerned Officer for more Information