A Bill too long delayed

Parliament must ensure India gets a biotech regulator

The much-awaited Biotechnology Regulatory Authority of India (BRAI) Bill, which has finally been introduced in the Lok Sabha, has expectedly been warmly hailed by the biotechnology industry even as it has been vehemently disparaged by detractors of genetically modified (GM) products. The Bill, which was in the making for a long time and in a near-complete form for almost three years, received inputs from several committees. In its final form, it seeks to set up a statutory autonomous biotechnology regulator, BRAI, to supervise the rapidly growing biotechnology sector and ensure safe research, manufacture, transport, import and use of GM substances. The BRAI will replace the Genetic Engineering Approval Committee, which currently regulates this sector and approves commercialisation of genetically altered products. This set-up, which is a toothless appendage of the environment ministry, has failed to live up to the task of overseeing the application of the powerful science of molecular biotechnology.

The current system's ineffectiveness hit its nadir when the existing body's verdict on the country's first genetically altered food crop, Bt brinjal, was overturned by the environment ministry on the basis of information gathered through public meetings. The BRAI, on the other hand, is proposed as the final authority on issues related to biotechnology, mandated to take science-based decisions after due deliberations and safety trials of the genetically altered material. Keeping this in view, this body will have an elaborate and well-designed multi-tier structure comprising three divisions, headed by scientists of known reputation, to look after biotechnology applications in agriculture, human and animal healthcare, and industry with an eye on safeguarding the environment. In addition, it will have an inter-ministerial governing board, biotechnology advisory councils at the central and state levels, risk assessment units and an appellate tribunal headed by a former judge of the Supreme Court or a chief justice of a high court. Notably, the Bill also provides for a degree of transparency in the approval procedures; it mandates public notification of all applications for field and clinical trials as well as of the BRAI's decisions.

No Bill, however carefully drafted, is totally free of loopholes. Nor can it satisfy every interest group. It would be ridiculous to expect the BRAI Bill to be an exception to this general rule. But the harsh and wide-ranging misgivings expressed by its critics are excessive. Even some members of Parliament are opposing it - they are arguing that it should be replaced with a biosafety protection Bill. Activists insist it hurts the interests of farmers and the environment. The main contentions of the anti-GM lobby concern basically the perceived procedural inadequacies in long-term safety assessment; transparency of information; and consultations with the public. They also maintain that the proposed law will tend to promote, rather than restrain, biotechnology and undermine the state governments' jurisdiction on issues concerning public health and agriculture.

Most of these complaints, evidently, are incidental, raised largely to thwart the smooth sailing for the Bill. Yet, since the scope for error in decision making on biotechnology-related issues needs to be kept to a minimum, if not eliminated altogether, it may be worthwhile to look at some of the objections again. But blocking the passage of an empowering Bill will prevent India from harnessing technological advances that could help evolve more potent drugs and vaccines as well as create crops capable of withstanding pests, diseases, drought, salinity and the effects of climate change.