The much awaited Biotechnology Regulatory Authority of India Bill, 2012 (known as NBRA Bill), which has repeatedly been finding a place in the tentative list for transaction of business for the last several sessions of Parliament, may ultimately get through during the ongoing winter session of Parliament that began on November 22. This is the only Bill related to pharma and health sectors which has found a place in the list of new Bills lined up for introduction in Parliament during this session.

There is optimism among the officials that the NBRA Bill may ultimately be introduced in Parliament during this ongoing session as this is one of the 10 Bills which have been earmarked for introduction in Parliament during this session. As the number of new Bills listed for introduction is very less this time, there are chances that all the 10 Bills may be introduced this time. Till the last session, there used to be around 35 to 40 new Bills queuing up for introduction.

Sources said that though there are several Bills related to pharma and health sectors which have been waiting in the wings to be introduced in Parliament for its final nod, only NBRA Bill may be introduced during this session as other major bills are are entangled in various departmental procedures before being introduced in Parliament.

While other bills like ART Bill, HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill, Medical Devices Bill, etc. are pending in different government departments for clearance, the NBRA Bill has already cleared all these technical and bureaucratic hurdles and the introduction of the Bill in during this session, which is scheduled to conclude on December 20, is almost certain, sources said.

The NBRA Bill seeks to establish Biotechnology Regulatory Authority of India to regulate research, import, transport, use of organisms and product produced from modern biotechnology. The Bill, drafted by the Department of Biotechnology (DBT), also seeks to make NBRA as an independent, autonomous, statutory agency to safeguard the health and safety of the people of India and to protect the environment by identifying risks posed by, or as a result of, modern biotechnology, and managing those risks through regulating the safe development and deployment of biotechnology products and processes in the country.