The Biotechnology Regulatory Authority of India Bill, 2010 (NBRA Bill) and the Assisted Reproductive Technology (Regulation) Bill are among a string of Bills related to pharma and health sectors which are waiting for the Parliament nod as the winter session of Parliament begins on November 9.
Two major Bills which are almost sure to be introduced in this session are Biotechnology Regulatory Authority of India Bill, 2010 (NBRA Bill) and the Assisted Reproductive Technology (Regulation) Bill.
But for the indifferent attitude of the Department of Biotechnology (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. Now, the introduction of NBRA Bill looks a certainty during this winter session as the DBT has already completed all the formalities.
Another Bill that is also almost certain to be introduced in this session is the ART Bill, which has been finalised by the Indian Council for Medical Research (ICMR). ART Bill is being introduced in the country to regulate thousands of infertility clinics that have mushroomed in the country over the past several years.
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 in the winter session included HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill and Central Drug Authority (CDA) Bill.
Yet another Bill, which has been waiting for Parliament nod is the HIV/AIDS Bill that aims to end discrimination to the HIV patients and ensuring access to treatment to them. The Bill 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 tabling of the CDA Bill is concerned, the chances are remote as the union health ministry is seeking the state governments' opinion on it. Though the Bill proposing to make amendments in the Drugs and Cosmetics Act, 1940, to facilitate the creation of CDA was to be introduced in Parliament long ago, the government shelved the move, presumably under pressure from the small scale industry associations and other interest groups.