The bill seeking to establish the National Biotechnology Regulatory Authority (NBRA) will soon go to the Cabinet for approval and may be introduced during the next session of the Parliament as the final draft is ready.

The draft National Biotechnology Regulatory Bill, 2008, aimed at setting up the authority, has been cleared by the concerned departments and will be submitted to the Cabinet soon. The Department of Biotechnology is keen to see that the bill is going to the Parliament during the next session as the current budget session, concluding on August 7, cannot take it up, sources said.

An Interdisciplinary and Inter-ministerial Advisory Committee had been constituted to oversee and advise on all matters related to drafting, reviewing the comments of experts and stakeholders as well as preparing final documents. "The governmental process of inter-ministerial consultation has been completed for obtaining necessary approvals for the NBR Bill by the Cabinet," sources said.

Before forwarding the bill for vetting by the Law Ministry, the DBT had held a number of consultations across the country and gathered inputs from the stakeholders. The Department organised sittings with experts and other stakeholders in Delhi, Bangalore, Hyderabad, Chennai, Mumbai and Kolkata, in association with the Biotech Consortium India. "The stakeholders had welcomed the bill aimed at streamlining the sector. Hence, only minor changes were needed to be included in the final draft," a senior official said.

The Bill seeks to set up the NBRA as an independent, autonomous, statutory agency to safeguard the health and safety of the people and to regulate the safe development and deployment of biotechnology products and processes.

Elements of biotechnology regulation are currently spread over multiple acts and some of these would be amended to establish and operationalize the NBRA. The new legislation is expected to provide an opportunity to consolidate and enhance the efficiency and effectiveness of biotechnology regulation, increase collaboration with state governments in this area, promote public confidence in the regulatory system, and facilitate international trade.