The Biotechnology Regulatory Authority of India Bill (NBRA Bill) is the only Bill in the health and pharma sectors which has found a place in the tentative list for transaction of business during the ongoing budget session of Parliament which has started on March 12.

The introduction of the NBRA Bill during the ongoing budget session is almost certain as the Bill was almost introduced during the last winter session of Parliament but was held back due to some technical lacunae. Now the introduction is just a formality during this session as all technical hindrances have been removed for the introduction of the Bill. In the tentative list of 31 new bills listed to be introduced during this session, NBRA Bill is the only Bill in the health and pharma sectors.

The NBRA Bill 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.

The Bill is being introduced to establish Biotechnology Regulatory Authority of India to regulate research, import, transport, use of organism and product produced from modern biotechnology. It 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 in the country. Once in place, the Authority will have overriding powers on matters related to the development and deployment of biotechnology products and processes in the country.

The Bill has been drafted by the Department of Biotechnology (DBT). After issuing the draft bill, in order to garner the views of all stakeholders across the country, the DBT had organised deliberations with the experts in major cities like Delhi, Bangalore, Hyderabad, Chennai, Mumbai and Kolkata.

Other important Bills, belonging to the health and pharma sectors, which have been waiting for introduction in Parliament include ART Bill, HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill, Central Drug Authority (CDA) Bill, etc.