[india-drug] Legislation to provide insurance cover for clinical trial

[Sunitha Srinivas <s.srinivas@ru.ac.za>]

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(Source:
http://www.pharmabiz.com/article/detnews.asp?articleid=19816&sectionid=
Thanks?..SS)

Centre plans legislation to provide insurance cover for clinical trial
volunteers
------------------------------------------------------------------------


Friday, January 09, 2004 08:00 IST 
Our Bureau, Bangalore

The Union government is planning to bring in legislation to protect the
interests of the infected volunteers going in for trials of HIV/AIDS
vaccines and drugs that are being developed by various research
institutes in the country. The law is expected to be in place by the
end of 2004. 

With India emerging as a hub for clinical trials, the central
government felt it was important to provide insurance coverage for
volunteers willing to undergo such trials. 

The trials of the retroviral vaccine would begin this year with
informed consent of the infected persons. The HIV vaccine trials would
begin in Pune, Tamil Nadu and North East where the central government
was also permitting trials of the vaccine from other countries, if the
Indian vaccine failed.

Dr NK Ganguly, director, Indian Council for Medical Research (ICMR)
stated this in his keynote address at an Indo-US symposium on
Infectious Diseases Research and Development. ICMR had drafted the
legislation on support systems and insurance coverage for people going
in for trials of HIV/AIDS vaccines. 

The Centre was also considering providing insurance cover for patients
undergoing trials by the pharmaceutical companies. Although most of the
trials are conducted in partnership with drug manufacturing firms, the
insurance coverage was not comprehensive, he stated.

"We have worked on a format with the lawyers' group and have submitted
the draft to the government to provide legislation to those who undergo
trials. They are protected in certain areas with adequate coverage, if
they develop HIV/AIDS," said Dr Ganguly. 

"If the HIV infected person apply for a job outside the country,
especially West Asia they are taken care of by providing a certificate,
so that they are not turned away", he said. 

The ethical guidelines for biomedical research was already in place,
stated the ICMR chief who hoped that the legislation to protect
HIV/AIDS would be in place soon. 

ICMR is also negotiating with the US government to hold joint trials in
vaccines for the human papilloma virus, a major cause of problems in
HIV infected women, which is suspected to lead to cancer. The US
government tied-up with Thailand for HIV vaccine trials two months ago.




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