The new capabilities to manipulate the genetic material present tremendous potential and find use in many novel experiments and applications. These developments have generated a sense of concern among scientists working in biological areas and others to find ways how safely the research in the field should be carried out and means to regulate work involving pathogenic microorganisms and genes of virulence. Several countries have formulated safety guidelines and regulations for research in the field of recombinant DNA, large scale use of them in production process and their applications in the environment. Considering the possible incremental risks associated with the use of new techniques in laboratory research with pathogenic microorganisms, the National Biotechnology Board issued a set of safety guidelines for India in 1983 to ensure the safety of workers in the laboratory environment. While framing the guidelines, the Committee took into account the local factors such as resistance to infection (immunity), host parasite burden in the community, laboratory environment and chances of survival and growth of altered organisms under the tropical conditions.
Remarkable developments have ensured in the last few years in the field of genetic manipulation and the scenario has shifted from the laboratories to the market place elsewhere. In India there is a growing awareness of the commercial potential of Biotechnology and efforts are being made to promote large scale use of indigenously relevant biotechnologies. A large number of research institutions in Government, Universities and private R&D labs have active biotech programmes where research is being done in both in basic and applied fronts utilising microorganisms plant and animals, tissue culture and cell lines and on development of vaccines towards communicable diseases of both men and animals. A good deal of effort is being made in the areas of diagnostics, biofertilizers, biocides, fertility control, tissue culture of high value crops to develop technologies and useful products. The successes in indigenous research efforts would soon be translated into commercially viable technologies through clearing houses with major R&D Centres, University shops with academic institutions and by the industry itself.
The Biotechnology Safety Guidelines could never be one time exercise as knowledge is ever expanding and the Department of Biotechnology which has the mandate in this area, set up the rDNA Committee to prepare a modified draft on the basis of current scientific information and from the experience gained locally and outside the country on the use of the new technique in the area of research, possible manufacture and applications.
The guidelines cover areas of research involving genetically engineered organism. It also deals with genetic transformation of green plants, rDNA technology in vaccine development and on large scale production and dekliberate/ accidental release of organisms, plants, animals and products derived by rDNA technology into the environment. The issues relating to Genetic Engineering of human embryos, use of embryos and foetuses in research and human germ line gene therapy are excluded from the scope of the guidelines.
While preparing the revised guidelines the Committee and its sub-groups have met 4 times and have taken note of the guidelines currently in use in other countries. The evolution of the guidelines and updation have gone through the process of consultation with experts, academies, agencies and industry and the concerned Ministries with a view to gain general acceptance and broad consensus.
The guidelines are in respect of safety measures for the research activities, large scale use and also the environmental impact during field applications of genetically altered material products.
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