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From approval to appraisal

The government’s subtle, but significant, move to divest the Genetic Engineering Approval Committee (GEAC) of its job of approving the genetically modified (GM) products and convert it into merely a GM appraisal body has taken the biotechnology sector by surprise. The Gazette notification to this effect replaces the word “approval” in the committee’s nomenclature with “appraisal”, thus making it the “Genetic Engineering Appraisal Committee”. One obvious reason for doing so could be to justify, with retrospective effect, the environment ministry’s controversial action in February last to overrule the GEAC’s decision to clear the launch of the country’s first GM edible product, Bt brinjal. Even if it is so, the usurping of authority of clearing products of a sophisticated science like molecular biotechnology by the political bosses is bound to raise questions.

Misgivings over the motive behind this move arise also because it has come at a time when the Biotechnology Regulatory Authority of India (BRAI) Bill, 2010, is awaiting introduction in Parliament. Once the BRAI comes into being as the country’s apex and scientifically competent biotechnology regulator, the GEAC would automatically become redundant. Besides, unlike the GEAC, whose competence to regulate GM products has been widely challenged for being inappropriately controlled by the ministry of environment, rather than that of agriculture, health or science and technology, and for being headed by a civic official (read Babu), instead of a scientist, the proposed BRAI may have better acceptability. For, the proposed Bill envisages the BRAI to be a three-member (all scientists) body, assisted by three divisions looking after issues related to agriculture and allied fields, human and animal health, and industry and environment. Reservations expressed by some activists about the BRAI Bill on the grounds of likely political interference have been addressed.

The immediate concern really is the uncertainty this move has created over the fate of a large number of gene-altered products evolved at substantial cost and scientific effort which are either awaiting clearance or are in advanced stages of trials. While the GEAC has been virtually debarred from approving new GM products, the new regulator, the BRAI, is unlikely to start functioning in the near future as enactment of the statute and framing of rules under it may take years. At stake also is the future of the Indian biotechnology industry, which is presently estimated at over '5,000 crore. Besides, large investments have also been made in the public sector biotech research centres by the Indian Council of Agricultural Research (ICAR), state agricultural universities, the department of biotechnology and other publicly funded bodies. Over a dozen of transgenic and non-transgenic but gene-altered seeds of different crops evolved by these centres are said to be in advanced stages of evaluation and may be ready to seek approval soon. India is already way behind many other countries in gainfully harnessing the limitless potential of the amazing science of biotechnology in vital sectors like agriculture, pharmaceuticals and others. An ill-timed policy and needless administrative interventions can push the country further back in this field. India needs a competent and professionally independent regulator for this sector.