The National Biotechnology Regulatory Authority Bill, which was listed among the 62 new bills to be introduced in the ongoing session of Parliament, cannot be introduced during this session also, thanks to the inter-ministerial procedural delay to finalise the draft bill.

According to sources, the introduction of the much awaited NBRA bill, aiming to set up the National Biotechnology Regulatory Authority (NBRA) in the country, is well nigh impossible in this ongoing session of Parliament which is coming to an end on December 21. The introduction of the NBRA bill is not possible in this session as the inputs from at least three government departments are yet to come. After getting the inputs from all the concerned government departments, the bill has to get the sanction of the union cabinet before its entry in Parliament for its final nod. With just two days of business left in this session, all this is not possible, sources said.

However, department of biotechnology (DBT) sources said that the delay is only due to administrative problems and there is no technical issues involved in the delay of finalising the draft. The bill will definitely be introduced in the budget session of Parliament, sources added.

Though a number of bills related to pharma and health were waiting to be introduced in Parliament for quite some time and were at different stages of legislative process, only a few of them had made it to the final list of bills to be presented during the ongoing winter session of Parliament. The Biotechnology Regulatory Authority of India Bill, 2009, the Transplantation of Human Organs (Amendment) Bill, 2009 and the Clinical Establishment (Registration & Regulation) Bill, 2009 were among them.

The NBRA 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.