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Biotechnology regulation


The controversy around Bt brinjal has served at least one good purpose. The government has fast-tracked the process of setting up a biotechnology regulator. A regulatory authority is to be set up under an Act of Parliament. A longstanding proposal that has been gathering dust in the Department of Biotechnology has seen the light of day. The Union Cabinet is expected to consider this proposal and bring it to Parliament. The draft of the Bill, which is currently in the public domain, seeks to create a three-member National Biotechnology Regulatory Authority (NBRA) to regulate and monitor the application of biotechnology for various purposes. It will oversee biotechnology businesses with separate divisions for agriculture and allied fields; human and animal health; and industry and environment. While the proposed structure of the NBRA has met with general approval, there are some issues that merit further consideration. A tug-of-war has already begun between different ministries on which ministry should exercise administrative control over the mooted authority. What needs to be realised is that biotechnology is essentially a multidisciplinary science which finds application in numerous fields to evolve useful and commercially important products. As such, the discipline cuts across the domains of several ministries, including those of science and technology (which is now piloting the Bill), agriculture, environment, health, and industry. Each one of these ministries can stake their claim over the administrative control of the NBRA and justify it too. However, since it is important to grant full autonomy to the NBRA to enable it to take independent decisions based on well-conceived and transparent procedures, it should be under none of these ministries. Otherwise, it will end up being like the present Genetic Engineering Approval Committee (GEAC) whose verdict over the Bt brinjal was overruled by a concerned minister.

The best option, under the circumstances, would be to make such an authority report directly to the Prime Minister’s Office. A separate appellate tribunal can, of course, be set up for addressing the grievances against the regulator’s decisions. There are some inadequacies in the NBRA Bill which need to be looked into. While the Bill has provisions for amending existing laws, such as the Drugs and Cosmetics Act, 1940, and the Food Safety and Standards Act, 2006, in order to remove any discrepancy between the new law and the existing ones, provisions in this regard should be clear so that there is no multiplicity of supervisory control and regulatory overkill. The GEAC, which is set up under the Seeds Act and the Environment Protection Act, 1986, may become redundant once the NBRA is created. It may have to be liquidated by amending the environment protection law. An important task for the biotechnology regulator would be to lay down in clear terms the evaluation procedures for biotech products, including gene-altered crops and living beings. It will have to spell out the tests and trials to be conducted for different products and the mode of carrying them out satisfactorily, transparently and impartially. The sole aim should be to make sure that the new product is risk-free and safe for the environment and human and animal health. There should ideally be a time limit for approving or rejecting a product so that the developers are not made to wait endlessly.