The Hindu : Opinion / Editorials : REGULATING BIOTECHNOLOGY

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Friday, May 28, 2004

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REGULATING BIOTECHNOLOGY

THE RAPID ADVANCES in biology have created a whole new industry — biotechnology. Now scientists are able to probe and decipher life's myriad processes at the level of genes, biological molecules, and associated chemical pathways. Such knowledge has led to ways of tinkering with and modifying those biological processes. Modern biology and biotechnology are seen on the one hand as the bold new scientific frontier that will revolutionise agriculture and health. On the other hand, they have also been depicted as the latest example of man's scientific hubris, arousing fears that life forms might be created which are harmful to human and animal health and the environment, or which raise important ethical issues. The biotechnology industry therefore requires a strong regulatory system that is able to keep watch over its growth and gain the confidence of both the industry and the general public. On assuming office as Union Minister of State for Science and Technology, Kapil Sibal announced that steps would be taken to simplify the regulatory procedures in biotechnology. The Government is indeed well-placed to make good on this promise as two committees that are looking into regulatory issues are expected to submit their reports shortly. The task force headed by Professor M.S. Swaminathan, the architect of India's Green Revolution, has examined the use of biotechnology in agriculture. The other chaired by R.A. Mashelkar, Director-General of the Council of Scientific and Industrial Research, is studying regulatory procedures for biotechnology in pharmaceutical applications.

India currently has a three-tier structure for regulating laboratory research and industrial application involving hazardous micro-organisms or genetic engineering. Each institution involved in such work must have a biosafety committee that provides the first level of monitoring. Then a Review Committee on Genetic Modification (RCGM), functioning in the Department of Biotechnology, is expected to maintain oversight of all research activities in the country. Finally, any large-scale use must be cleared by the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests. GEAC is headed by an Additional Secretary in the Ministry and many of its members have positions ex officio. There have been widespread complaints that GEAC is too bureaucratic, its chairman changes every time the official concerned is transferred, and it lacks technical expertise. The purpose of streamlining regulatory procedures without compromising oversight requirements would be served by establishing a statutory and autonomous national authority. Given the pace of scientific advance in biology and biotechnology, it is important that such a regulatory body be led by a respected scientist and its members be specialists in fields relevant to biotechnology.

The national regulatory authority would need two wings, one to deal with agriculture and the related field of food biotechnology, and the other with medical and pharmaceutical biotechnology. The widespread sale of spurious Bt cotton seeds in Gujarat highlights the importance of State-level coordination, monitoring and enforcement, especially because agriculture is a State subject. One suggestion is that State advisory boards be established under the proposed national regulatory authority for this purpose. In the case of medical and pharmaceutical biotechnology, where clinical trials are also involved, oversight procedures need to be streamlined and appropriately divided between the regulatory authority and the Drug Controller of India. Given public concerns about the impact of biotechnology, national regulators must release information about the basis on which they have taken decisions, for example when they allow the release of a genetically modified crop variety. In the end, the biotechnology authority has to find ways of balancing industry demands for simplified procedures with larger societal requirements for adequate scrutiny. That is not an easy balance to strike but without it the biotechnology industry cannot thrive.

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