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Laws regulating genetic technology

Understanding ‘Genetic Technology’

Gene technology– also referred to as gene technology, genetic engineering or genetic modification- is a subdivision of biotechnology, and focuses on technologically altering genes, which, in simple terms, are units of heredity that contain information regarding bodily characteristics. Biotechnology has been practiced throughout history, observed in cross-breeding of pets, and in making food items such as bread, cheese, alcoholic beverages, etc. Gene technology is a more recent development in the field of biotechnology, and allows complex procedures such as thorough modification or removal of a gene, or even the transfer of a gene from one species to another. Thus, when a living organism undergoes changes via the use of gene technology, it is subsequently called Genetically Modified Organisms (GMOs).

Uses for GMOs

● To facilitate research for understanding life processes.
● Crops are modified to increase resistance to pests, droughts, herbicide tolerance, improving the nutritional value, etc.
● Microorganisms are modified to produce vaccines or medicines like insulin.
● Developing novel methods to diagnose and treat diseases.
● Producing enzymes to use in food processing, producing paper pulp or biological leaching of minerals.
● Using microorganisms to decompose toxic substances and clean-up industrial sites or environmental accidents

Regulation of GMOs in India

Being one of the early influencers in the development of a biosafety regulatory system for GMOs, India regulates GMOs and the products and byproducts of the same under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989), as required by the Environment (Protection) Act, 1986. These Rules are implemented by the Ministry of Environment, Forest and Climate Change, jointly with the Department of Biotechnology (DBT), Ministry of Science & Technology and state governments. Six Competent Authorities and their composition have been notified under these Rules that includes:

● rDNA Advisory Committee (RDAC)
● Institutional Biosafety Committee (IBSC)
● Review Committee on Genetic Manipulation (RCGM)
● Genetic Engineering Appraisal Committee (GEAC)
● State Biotechnology Coordination committee (SBCC)
● District Level Committee (DLC)

The Rules, 1989 are further supported by a multitude of guidelines regarding field trials, food safety assessment, environmental risk assessment etc.

With the way the term ‘genetic engineering’ is defined in the Rules, 1989, it seems to imply that the more recent of the ‘genome engineering technologies’ such as ‘gene editing’ may be covered under the rules. Additionally, India is a signatory to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (CPB), which is an international agreement aimed at ensuring the safe handling, transport and use of living modified organisms (LMOs) created using modern biotechnology, and which may have adverse effects on biological diversity, taking also into consideration risks to human health. Despite this, the definition of modern biotechnology contained in the CPB is yet to be adopted in the national regulations.

Besides the Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989 issued under EPA, which covers an entire range of activities involving GMOs and products thereof including sale, storage, exportation, importation, production, manufacturing, packaging, etc., India has three other Acts/Rules that regulate GMOs, namely:

Plant Quarantine (Regulation For Import Into India) Order 2003, implemented by the Ministry of Agriculture & Farmers Welfare. It covers the regulation of import of germplasm/ GMOs/transgenic plant material for research purposes.
Biological Diversity Act, 2002, implemented by the National Biodiversity Authority. It regulates the use of biological resources- including genes- that are used for the improvement of crops and livestock via genetic intervention.
The Food Safety and Standards Act, 2006, implemented by the Food Safety and Standards Authority of India. It regulates the manufacture, storage, distribution, sale and import of food, including GM food.

The abovementioned regulatory authorities review, observe and consider the experiences of other countries in dealing with new technologies. Despite this, there is not much clarity as to how the emerging technologies will be wholly regulated in India, in spite of research having been initiated in several leading institutions, for India still lacks a piece of legislature solely addressing the quickly developing and progressing field of biotechnology and its various branches.


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