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Legislation soon to address `patient safety' in research

P.T. Jyothi Datta

Mumbai, Oct. 27

WITH an accent on "patient safety", the Government is set to bring in a legislation to protect the "welfare of a subject" taking part in research of any sort.

The Biomedical Research on Human Subjects (Regulation, Control and Safeguards) Bill 2004 has been cleared by the Health Ministry and is currently being whetted by the Law Ministry. And if the going is smooth, the Centre hopes to introduce the Bill in the forthcoming winter session of Parliament, according to Dr Vasantha Muthuswamy, Senior Deputy Director-General, Indian Council of Medical Research (ICMR).

Speaking to Business Line, she said that the Bill would look at all issues related to patient-safety, when a human subject is used in research of any form.

"Ethics committees would be made mandatory in organisations undertaking research on human subjects, be it for a herbal drug or an allopathic drug. The Bill also includes steps for prosecution, if the law is breached," she said.

Admitting that any law is only as good as it's implementation, she said, "It does not mean that a patient will be protected 200 per cent. But now, patients would be able to take a legal recourse for research gone awry."

Underlining the significance of having a legislation to protect a human being from becoming the proverbial "guinea pig" in research, she said: "Globally, there are at least 400-odd individual guidelines, position papers and regional guidelines on the issue. But in India, subjects could be induced into allowing medicines to be researched on them because of their poverty. Patients are promised payment and compensation. Later, accessibility to these drugs becomes an issue, because subjects don't often get these medicines. Patient safety is of paramount importance in such circumstances," she said.

The Bill has already been through three Union Health Ministers - Dr C.P. Thakur, Ms Sushma Swaraj and the incumbent, Dr Anbumani Ramdoss, she said.

Meanwhile, given the "galloping speed" at which the definition of "ethics" was changing, she said that the ICMR guidelines of 2000 on research are also being revised to include new areas in science.

"The new draft guidelines are out on ethical and patient safety issues in segments such as genetically modified drugs, HIV/AIDS medicines, stem-cell research. Also, the intellectual property rights aspect will have to be incorporated. These guidelines are expected to be revised by 2005," she told a gathering here in Mumbai.

The proposed new Act has provisions for further amendments. The revised ICMR guidelines, when finalised, will get incorporated into the proposed legislation, she said.

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