Even though a string of important Bills related to pharma and health sectors are waiting to be introduced in Parliament for its final nod, only one major Bill, the NBRA Bill, finds a place in the tentative list for transaction of business during the winter session of Parliament which has begun on November 9.  A total of 29 new Bills have been listed in the tentative list of government legislative and other business which are expected to be taken up during the sixth session of 15th Lok Sabha which is already underway.  

Besides, The Biotechnology Regulatory Authority of India Bill, 2010 (NBRA Bill), the other two relatively  unimportant Bills that have been listed for introduction in Parliament are the National Institute of Mental Health and Neurosciences, Bangalore Bill, 2010 and the Narcotic Drugs and Psychotropic Substances (Amendment) Bill, 2010. While the former Bill is aimed to declare the institution known as the National Institute of Mental Health and Neurosciences, Bangalore, to be an institution of national importance and to provide for its incorporation and matters connected therewith, the latter is aimed to amend certain provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985).

Surprisingly, some of the important Bills like Assisted Reproductive Technology (Regulation) Bill (ART Bill), being introduced to regulate thousands of infertility clinics that have mushroomed in the country over the past several years, and the Drugs & Cosmetics (Amendment) Bill, aiming to enact a comprehensive legislation to ensure standards, safety, quality and effectiveness of medical devices in the country, could not found a place in the transaction of business for the ongoing session.

The introduction of NBRA Bill looks a certainty during this winter session as the Department of Biotechnology (DBT) has already completed all the formalities in this regard. But for the indifferent attitude of the DBT which could not complete the printing of the report and other minor formalities, the NBRA Bill, in fact, was to be introduced during the last session itself which had sittings from July 26 to September 7.

The introduction of the NBRA Bill is important, especially in the backdrop of the ongoing controversy over the genetically modified crops in the country. 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 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.

Other major bills which have been waiting to be introduced in Parliament for its final nod included HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill, Central Drug Authority (CDA) Bill, Medical Devices Bill and the National Blood Transfusion Authority Bill.