Flawed moves for a National Biotechnology Regulatory Authority

The proposal to create a National Biotechnology Regulatory Authority (NBRA), for which a draft bill is now in circulation, is being moved in an unprofessional manner by the Government of India.

The bill is driven by the Department of Biotechnology. The DBT ought to know that biotechnology covers some 30 areas, of which many need to be regulated. These areas include stem cells, nanobiotechnology, biological warfare, vaccines, bioinformatics, organ transplantation, new drug delivery systems, new materials such as spider silk and bacterial ropes, plant-based traditional drug formulations, and assisted reproductive technologies. But the proposed bill is confined to Genetically Manipulated Organisms (GMOs) and their products. Should it not, therefore, have been called a National GMO Regulatory Authority instead of an NBRA? Biotechnology cannot be equated with genetic engineering. If the DBT really thinks so, it ought to change its own name to “Department of Genetic Engineering.”

The bill has a range of other problems as well.

The objective of any proposed bill should be to fill a defined void. There is already a regulatory procedure in place for GMOs and their products, involving the Review Committee on Genetic Manipulation (RCGM) of the DBT and the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests. Therefore, it should first be determined if anything is wrong with the present system. Then an attempt should be made to correct the existing system. Only if this is not possible should a new bill be considered. The authorities concerned should state what part of the existing procedures is undesirable and how the proposed bill will correct it. For example, the present system does not prescribe any penalty for contamination of a non-GMO farm by GMOs in an adjoining farm. The proposed bill is silent on such problems.

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