The Department of Biotechnology (DBT) has forwarded the draft of the National Biotechnology Regulatory Authority (NBRA) Bill to the Law Ministry which has learnt to have begun the exercise of its vetting.
The DBT held a number of consultations across the country and gathered the inputs of the stakeholders on the proposed legislation and made necessary changes accordingly before passing it on to the Law Ministry. Once the Law Ministry clears the same, the bill is expected to be ready for introduction in the first or second sitting of the next Government, sources said.
The Department organised sittings with experts and other stakeholders in Delhi, Bangalore, Hyderabad, Chennai, Mumbai and Kolkata, in association with the Biotech Consortium India. Sources claimed that the participants had generally welcomed the move to streamline the sunshine sector by giving a right regulatory direction.
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. Apart from the formation of the authority, several aspects of the proposed bill including data exclusivity, sharing of data or information on the field trials and safety testing with public, ensuring full autonomy to the proposed regulatory authority, the role of appellate tribunal vis-à-vis its relation with other civil courts, inter-ministerial cooperation to address overlapping issues with existing laws particularly in case of foods and pharma were also discussed with the stakeholders, sources said.
The stakeholders reportedly stressed the need for a professionalized communication and outreach system and suggested that the same should be inbuilt as part of the new organization to enable smooth flow of information to various stakeholders.
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.