a-rapid-response-regulatory-for-covid-19-summary

Context: The Department of Biotechnology has taken several proactive measures to streamline the biosafety regulation and to facilitate researchers and industries which are undertaking research and development in Recombinant DNA Technology and Hazardous Microorganisms.

Initiatives taken: 

  1. Operationalization of Indian Biosafety Knowledge Portal: The Indian Knowledge Biosafety Portal launched in 2019 was made fully operationalized and now the Department is receiving all new applications through online portal only. This has made the whole process transparent and time bound.
  2. Revised Simplified Guidelines on Import, Export and Exchange of Genetically Engineered(GE) Organisms and Product thereof for R&D Purpose.
  3. Facilitation of Research and Development on COVID-19: Considering the emerging situations of spread of Coronavirus and with the understanding on requirement of rapid research and development for COVI-19, the Department has proactively taken several steps to facilitate researchers and industries involved in research on COVID19. DBT has issued following guidelines, orders and checklist on COVID 19:
    1. Rapid Response Regulatory Framework for COVID-19 to deal with application for development of vaccines, diagnostics, prophylactics and therapeutics.
    2.  DBT notified “Interim Guidance Document on Laboratory Biosafety to Handle COVID-19 Specimens”.
    3. Rapid response regulatory framework for development of recombinant DNA COVID 19 vaccine.

Indian Biosafety Knowledge Portal (IBKP) 

  1. It is a web based portal, with a major thrust to reach out to researchers, industry and other stakeholders to  provide latest scientific information and regulatory guidance related to authorization of  GMOs/LMOs and products thereof.
  2. IBKP is an interactive online web portal  for transactions in dealing  with Review Committee on Genetic Manipulation (RCGM) serviced by Department of Biotechnology, Ministry of Science and Technology, Government of India under the Rules for Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/ Genetically Engineered Organisms or Cells, 1989 (Rules 1989) of Environment (Protection) Act 1986.
  3. The IBKP provides information on:
    1. Relevant  Acts and Rules related to Biosafety of GMOs/LMOs in India
    2. Biosafety, Biocontainment guidelines, Check lists, etc.
    3. Database on various ongoing research activities on GMOs/LMOs and products thereof in the country including scientific Risk Assessment and Risk Management Plans (RARMPs)
    4. Linkages to international developments and scientific information.
    5. IBSC registrations/renewals and annual compliance records
  4. The portal facilitates online submission of Forms for Import/Export/Research & development projects, Pre-clinical toxicity of recombinant DNA derived Biosimilars and Investigational New Drug (IND), event selection trials, Biosafety Research Level 1 trial, etc. including online tracking of the application status.

 

Recombinant DNA Technology

  • The recombinant DNA technology emerged with the discovery of restriction enzymes in the year 1968 by Swiss microbiologist Werner Arber.
  • Recombinant DNA technology is the joining together of DNA molecules from two different species. 
  • The recombinant DNA molecule or artificial DNA is inserted into a host organism to produce new genetic combinations that are of value to science, medicine, agriculture, and industry.
  • This technology is popularly known as genetic engineering
  • Inserting the desired gene into the genome of the host involves the selection of the desired gene for administration into the host followed by a selection of the perfect vector with which the gene has to be integrated and recombinant DNA formed.
  • Thus the recombinant DNA has to be maintained in the host and carried forward to the offspring.
Image source:Express Pharma