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Regulations in India
In India, through the Ministry of Environment and Forests (MOEF), the Central Government had enacted environment protection laws under the Environment Protection Act (EPA). Among these laws the rules and regulations for handling (production, import, use, research and release) the genetically modified organisms (GMOs) including transgenic plants were laid down in December 1989. These laws also covered the products made by the use of such organisms.
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The Department of Biotechnology (DBT) of the Ministry of Science and Technology implements the R & D experiments utilizing GMOs and recombinant DNA products, while MOEF implements the large scale commercial use and deployment of these GMOs including transgenic plants. The DBT prepared biosafety guidelines in 1990 and subsequently revised them in 1994. Under these guidelines, every organization involved in R & D using GMOs is required to set up its Institutional Biosafety Committee (IBSC)with a nominee from DBT. This committee is the nodal point for interaction with the Government through a national committee called the Review Committee for Genetic Manipulation (RCGM), which functions under the charge of DBT. RCGM reviews all approvals of ongoing R & D projects on GMOs, undertakes field visits of experiments and issues clearance for import/export of etiologic agents, vectors, germplasm, organelles, etc., needed for experimental work, training and research. On the recommendation of RCGM, trial permits are issued by DBT.
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Experiments are monitored by the RCGM besides the IBSC. In addition to these two nodal agencies, State Biotechnology Co-ordination Committee (SBCC) of each state and the District Level Committee (DLC) ofeach district are also required to be involved in the inspection and monitoring of the experiments at the field sites. However, none of the states have established SBCC and DLC so far, even in the state, where field trials are already being conducted.
For any large scale use of GMOs, MOEF has constituted an interministerial committee called Genetic Engineering Approval Committee (GEAC), which reviews applications and accords approvals for large scale trials. On the basis of such approval, MOEF will issue authorization for large scale use of GMOs. GEAC will consult concerned ministries or other regulatory authorities before according the approval. For instance, the Directorate General of Health Services is consulted when drugs and pharmaceuticals are involved in the GMOs.
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Although, there are biosafety guidelines, and several committees as above are available to enforce them, there is criticism and doubts about their adequacy. There is sometimes lack of expertise and at other times lack of co-ordination, so that the decision making in the past has been inefficient, and is still evolving. At times this has also led to controversies between DBT and the industries. For instance, in one case, DBT had to allow an isolation distances of only 70m instead of 100m prescribed earlier under regulations. NGOs like Gene Campaign (Suman Sahai, Convenor) and the Research Foundation for Science, Technology and Ecology or RFSTE (Vandana Shiva, Director) also criticise biosafety policy for ignoring Indian needs and environmental conditions. In view of these and other aspects of biosafety regulations, doubts have also been expressed about India's preparedness to meet the potential risks arising from GMOs. For instance, perhaps India does not have yet an effective system to monitor imports of agricultural commodities/plant materials and their subsequent use in field trials, plant breeding and commercial use.
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In view of the above, DBT plans to conduct training programmes and foreign visits of scientists to improve its database on biosafety issues at international fora. Parts of the guidelines prepared by the Organization for Economic and Cooperative Development (OECD) have also been included in Indian guidelines. The United Nation Environment Programme (UNEP) and World Health Organisation (WHO) have also issued guidelines for safe use of GMOs. India needs to take notice of these guidelines. At UNEP, the 'Protocol on Biosafety' is being formulated under the Convention on Biological Diversity (CBD). This protocol has yet to be adopted in Indian Policy.
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