Biotechnology Product And Its Safety


Biotechnology Product And Its Safety

Biotechnological discoveries in the areas of pharmaceuticals agriculture and health care have raised many ethical issues for biotech products. Most of the countries have environmental regulations that ban the deliberate release of genetically engineered microorganisms (GMMS). These microorganisms may be responsible to spread the disease in the society or to change the ecological balance in the environment. The International Centre for Genetic Engineering and Biotechnology CGEB) has also played an important role in biosafety. The ICGEB has provided an on-line bibliographic database on biosafety and risk assessment for the environmental release of genetically modified organisms (GMOs). This database is easily accessible through the website of ICGEB and it also provides information on biosafety to its member states. India has instituted the Recombinant DNA Advisory Committee located in the Department of Biotechnology (D6T) under the Government of India. This committee mainly formulates and updates the biosafety guidelines, guides and advises the institutional biosafety committees. The main areas for safety aspects in biotechnology are as follows

  • Highly pathogenic organisms (natural and modified) to infects humans, animals and plants.
  • Development of antibiotic-resistant microorganisms.
  • Transgene instability and unpredictable gene expression.
  • Change in nutritional value and loss of biodiversity in agriculture.
  • Disposal of spent microbial biomass and purification of effluents from biotechnological processes.
  • Transfer of gene and generation of new line viruses by recombination.
  • Contamination, infection or mutation of process strains.

Recombinant DNA technology enables humans to combine DNA sequences from different sources to create functional DNA molecules with novel properties The recombinant DNA techniques initially raised concerns in the scientific community and remain a public concern even today. A living modified organism means any living organisms that contains a novel combination of genetic material obtained through the use of modern biotechnology.

The National Institute of Health (NIH, USA) has developed guidelines for recombinant DNA research with a view to specify the practices for constructing and handling of recombinant DNA molecules. Recombinant DNA experiments are performed after approval from NIH or any other agency.

In India, DBT has evolved ‘the recombinant DNA safety guidelines’ to exercise powers through the Environmental protection Act, 1986 for the manufacture, use, storage, export and import of hazardous microorganisms or genetically engineered organisms. These guidelines are being implemented through the institutional biosafety committees (IBSCS) which monitor the research activity at the institutional level, the review committee on genetic manipulation which allows the risky research activities in the laboratories and the genetic engineering approval committee (GEAC) which permits large scale use of GMOs at commercial level.