Even as the monsoon session of Parliament begins on August 1, a number of Bills related to pharma and health sectors are waiting in the wings to be introduced in Parliament for its final nod. One major Bill which is most likely to be introduced in this session is the National Biotechnology Regulatory Authority (NBRA) Bill.

Though there are several other important Bills related to these sectors which are waiting to be introduced in Parliament for its final nod, the chances of them making into the Parliament during the monsoon session are bleak as there are also several important Bills related to other ministries waiting to to introduced during the session.

However, the introduction of NBRA Bill during this session is almost a certainty as the Bill has been waiting in the wings for a long time. The much awaited NBRA 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.

In fact, the NBRA Bill was scheduled to be introduced during the last budget session, but the Bill could not make it to Parliament because of the prolonged stalemate in the House. Now, according to officials in the DBT, the remaining formalities for introducing the bill have been completed and necessary approvals have been given for the bill to be introduced in Parliament.

Though there are several Bills pending in these sectors, major Bills which are also likely to be included in the tentative list for transaction of business of the session included HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill, Central Drug Authority (CDA) Bill and ART Bill.

The HIV/AIDS Bill that aims to end discrimination to the HIV patients and ensuring access to treatment to them is mired in controversy and is presently stuck in the union law ministry. The prospect of its entry into Parliament in this session looks bleak as even if the law ministry clears it early, it has then to go to the union cabinet.

The tabling of Ethical Guidelines for Biomedical Research on Human Subjects Bill in this session is also difficult as the Indian Council of Medical Research (ICMR) is reviewing the Bill to make the punishment part of the Bill more severe as a deterrent.

As far as the Assisted Reproductive Technology (Regulation) Bill (ART Bill) is concerned, the Bill is also pending with the law ministry. Once the Bill is cleared by the law ministry, it will go to the union cabinet before its way to Parliament. The chances of the Bill, which aims to regulate thousands of infertility clinics that have mushroomed in the country over the past several years, tabling in this session also looks dim.

Another Bill, which has also been pending for its introduction in Parliament, is the Drugs & Cosmetics (Amendment) Bill, aiming to enact a comprehensive legislation to ensure standards, safety, quality and effectiveness of medical devices in the country.