Even as the winter session of Parliament begins on November 19, a string of Bills related to pharma industry like NBRA Bill, HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill, Central Drug Authority (CDA) Bill, ART Bill, Clinical Establishments Bill, etc, are waiting in the wings for the Parliament's final nod.
The new pharmaceutical policy is also pending for which the government has formed a new Group of Ministers (GoM) under the chairmanship of Union agriculture minister Sharad Pawar. But, the new pharma policy, which has been pending since the year 2002, is unlikely to reach Parliament in this session as the GoM is yet to meet.
Though almost all formalities to present these bills have been completed, the final hiccups may delay the tabling of some of the bills in Parliament in its winter session.
As far as the CDA Bill is concerned, the tabling of the same in this session of Parliament looks difficult as the union health ministry has once again sought 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 during the last session of the last government in March this year, the government shelved the move at the eleventh hour, presumably under pressure from the small scale industry associations and other interest groups.
As for the Clinical Establishments Bill, the government is redrafting the bill in place of the already lapsed Clinical Establishments (registration and regulation) Bill 2007, to introduce mandatory registration of all healthcare establishments and is likely to be tabled in the winter session. The new Healthcare Establishments (registration and regulation) Bill will have an expanded purview unlike in the previous bill which sought to cover only clinical establishments. The laboratories, diagnostic services, R&D facilities taking up clinical trials on patients and all systems of medicines will be included for compulsory registration in the new bill.
Another Bill to amend the Transplantation of Human Organs Act, 1994, aiming to impose stringent penalties on the violators of the Act is also likely to be tabled in the winter session of Parliament. By amending the law, the government wanted to plug all the loopholes in the law which were exploited by individuals and even hospitals to engage in unlawful human organ trade activity.
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.
Likewise, the NBRA Bill, aiming to establish a national biotechnology regulatory authority in the country, is also presently stuck in the Law Ministry.
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.