The government needs to act urgently on the reports of the expert committees on the regulatory structure for the biotech industry. The delay is hampering the growth of this new sunrise industry in the Indian economy.
The case for regulating biotechnology industry is a strong one, even in open societies committed to a free economy. Rapid advances in biology have enabled scientists 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 aroused 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.
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, in the Ministry of Science and Technology, is expected to oversee all research activities in the country. Evaluation of product safety, efficacy, clinical trials, market authorisation and post-market surveillance is the mandate of the Drug Controller General of India, under the Ministry of Health. Finally, any large-scale use must be cleared by the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests.
The regulatory apparatus is thus spread across three ministries. Of these, 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. GEAC has been on the defensive all too often on genetic-modification issues, caught in the web of inter-ministerial ego clashes and criticised by scientists for lording over what it does not understand.
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. Subsequently, two official committees on streamlining the regulatory structure have suggested setting up of a single National Biotech Regulatory Authority. The committees have differed on the structure of the authority they have suggested.
The committee on recombinant pharmaceuticals, headed by Dr. R A Mashelkar, Director General of Council for Scientific and Industrial Research, has suggested that the authority should have four separate wings for transgenic crops, recombinant drugs and other industrial products, genetically modified food and feed and transgenic animals and aquaculture. These wings should consist of experts in the field. The committee has assigned distinct roles GEAC, RCGM, DGCI, Indian Council of Agricultural Research and Indian Council of Medical Research. It has said that Genetic Engineering Approval Committee (GEAC) will have no say if the final product does not involve living modified organisms (LMOs) and that its role will be limited to approving containment facilities of above 20 litre fermentation capacity for the use of LMOs.
According to the Committee, the in-house institutional biosafety committee (IBSC) of companies will approve experiments utilising organism and genetic elements from risk I & II categories up to laboratory fermentation of 20 litre capacity. IBSC should intimate the review committee on genetic modification (RCGM). RCGM should inform and recommend to GEAC about containment facilities at R&D and production sites. If its recommendations are accepted, ninety per cent of biotech drug approvals that are currently going through the scrutiny of the GEAC could be directly approved by DCGI.
On the other hand, the M S Swaminathan Committee on applications of biotechnology in agriculture has proposed setting up of an autonomous National Biotechnology Regulatory Authority (NBRA) with two wings, one for food and agriculture sector and the other for pharmaceutical and industrial applications.
The Swaminathan Committee has suggested that pending the setting up of an autonomous Agricultural Biotechnology Regulatory Authority (ABRA), the release of transgenic crops for commercial cultivation should be done by the Indian Council of Agricultural Research (ICAR) and the Union agriculture ministry. The panel has limited the powers of the GEAC to "only environmental clearance".
Whatever be the final structure of the 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. 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 General 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.