A string of important bills related to pharma and health sectors are waiting to be introduced in Parliament for its final nod in the forthcoming monsoon session of Parliament that begins on July 26. Some of the major bills which are most likely to be introduced in the monsoon session are the NBRA Bill and the ART Bill.

In fact, the NBRA Bill along with the Clinical Establishments (Registration & Regulation) Bill was listed for transaction of business in the last budget session of Parliament which concluded on May 7. While Clinical Establishments (Registration & Regulation) Bill was introduced in Parliament, the NBRA Bill could not be introduced due to the prolonged inter-ministerial consultation.

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 more than a month long session 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.

The entry of the NBRA Bill in the coming session 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.

Another bill that is most likely to be introduced in the monsoon session is the Assisted Reproductive Technology (Regulation) Bill (ART Bill), being introduced in the country to regulate thousands of infertility clinics that have mushroomed in the country over the past several years.

Yet another bill that is also most likely to be introduced in this session 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. The main thrust of the Bill is to establish a Medical Devices Regulatory Authority with adequate powers to ensure standards, efficacy, safety and availability of medical devices manufactured or marketed in the country.

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.

Meanwhile, tabling of other bills in this session looks difficult. The tabling of Ethical Guidelines for Biomedical Research on Human Subjects Bill looks unlikely 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.