Only two Bills among a string of bills related to pharma and health sectors will be introduced in the ongoing Budget session of Parliament. In the tentative list of business for this session, though there are a total of 65 new bills which are expected to be taken up during this session, only two bills are related to health sector, the Biotechnology Regulatory Authority of India Bill, 2010 and the Clinical Establishments (Registration & Regulation) Bill, 2010.

In fact, the Biotechnology Regulatory Authority Bill (NBRA) Bill and the Clinical Establishment (Registration & Regulation) Bill, along with the Transplantation of Human Organs (Amendment) Bill, were listed among the 62 new bills to be introduced in the winter session of Parliament which concluded on December 21. While the Transplantation of Human Organs (Amendment) Bill was introduced in the winter session of Parliament, the other two Bills could not be introduced in Parliament due to several procedural delays.

Though still in the tentative list, the entry of the NBRA Bill in Parliament is almost certain, 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.

The introduction of the Clinical Establishments Bill in Parliament is also almost certain as it has already been ratified by the union cabinet. The bill aims to bring in uniformity in the healthcare delivery sector by making the registration of all clinical establishments mandatory and prescribing enhanced penalty for the defaulters.

Other major Bills which were not listed in the tentative list for transaction of business in the one-and-a-half month long session included HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill, Central Drug Authority (CDA) Bill and ART Bill. The Budget session of Parliament which began on February 22 will conclude on May 7.