The department of biotechnology (DBT) has shown exemplary commitment and sagacity in bringing out the draft of the National Biotechnology Regulatory Authority (NBRA) Bill and the Draft Establishment Plan. The speed with which it has recently concluded a national consultation with the stakeholders across the country, is again an expression of its commitment to the cause.

The evolutionary process started with the enactment of the Environment Protection Act in 1986, followed by rules framed in 1989, to create the Genetic Engineering Approval Committee (GEAC). The string of other regulatory bodies will be culminating now in the creation of a one window clearance system for living modified organisms (LMO), the National Biotechnology Regulatory Authority.

An international parallel can be seen in the Australian Statutory Office of the Gene Technology Regulator (OGTR), established under an Act in 2000. It takes all decisions in dealings with genetically modified organisms (GMOs), including research, manufacture, production, experimental trials, commercial release and importation. The regulator has extensive powers to monitor and enforce the law.

While the Bill and the Establishment Plan have been ably crafted, some valid amendments would be in order. As with the Cartagena Protocol on Biosafety, to which India is a signatory, the NBRA should create an enabling environment. There should be sound application of biotechnology to make it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimising the possible risks to the environment and to human health. A scientific assessment of the risks involved is necessarily limited by the extent of available credible scientific knowledge, and hence only reasonable safety, as in all other fields of human endeavour, can be ensured. The aims and objectives of the Bill would need to be suitably amended to reflect these concepts in a credible and transparent manner.

The composition of the authority appears to be unwieldy for any meaningful decision-making process. Ideally, there should be a smaller core group constituting the NBRA responsible for taking all decisions on the development and regulation of products of modern biotechnology, with an expanded group of scientific and other advisors reflecting all the stakeholders. The Bill, however, has conceived a bigger and expanded NBRA with the Product Rulings Committee as the decision-making body. Relations between the NBRA and the Product Rulings Committee need to be clearly defined in order to avoid unnecessary litigation.

The integrity and autonomy of the body taking the decision should be upheld in the interest of speedy disposal of pending matters. This would mean that as a statutory authority, NBRA should be fully autonomous and be responsible for all science-based decisions that it takes, without any fear or favour from any organisation, including the Central and state governments.

However, matters of domestic and international policies and cooperation would continue to be in the realm of the Central government.

GEAC has played and continues to play a pioneering role in promoting and effectively regulating products of modern biotechnology, while ensuring safety of the environment and human and animal health. It has been ably supported in this effort by the department of biotechnology and other agencies connected with the regulatory regime.

As a sequel to the evolutionary process, NBRA would be replacing GEAC as the one window clearance centre. One only hopes that the rigorous scientific and technological framework for risk assessment and approvals put in place by DBT and GEAC, are carried forward by NBRA in the light of new scientific and technological advances.

The writer is executive director, All India Crop Biotechnology Association