Karnataka denies ban on clinical drug trials

May 4th, 2011 - 10:37 pm ICT by IANS  

Bangalore, May 4 (IANS) Karnataka Chief Minister B.S. Yeddyurappa Wednesday denied a ban on clinical drug trials in government and private hospitals and medical colleges in the state and assured the biotechnology industry of support in carrying out research and development activities.

“No ban imposed on clinical trials, as our government is committed to innovation in biotechnology. I assure you (industry) that the state government will pull all stops to create an investor-friendly environment to attract biotech firms in the state,” he said.

Yeddyurappa was addressing about 800 delegates participating in the 11th edition of Bangalore India Bio trade expo here.

State Medical Education Minister S.A Ramdas told the media Tuesday here that his department would temporarily ban clinical trial and research projects in all government hospitals and colleges.

The statement caused a flutter at the inaugural session of the three-day annual biotech event.

Denying this, Yeddyurappa said the government would allow the trials to be conducted in accordance with the law and guidelines laid down by the central health ministry.

“There will be no compromise on ethical issues involved in clinical drug trials. Research and development organisations and biotech firms conducting clinical trials have to abide by the regulations and ensure there was no exploitation of patients volunteering for the trials,” Yeddyurappa clarified.

Noting that the trend of treating patients like guinea pigs was increasingly alarming due to laxity in following the guidelines during the trials, Ramdas had said the medical education department would set up a two-member committee to study and frame guidelines to regulate the trials in all hospitals and medical colleges.

“The ban will be in effect till the panel submits its report in the next three months and the government takes decision on its recommendations,” Ramdas had told reporters.

According to the medical education department, of the 1,500 clinical research trials being carried out in the state, about 70 percent are conducted in this tech hub.

“Until proper guidelines are framed, all clinical trials will be suspended. Doctors in both government and private hospitals were found signing confidentiality agreements with multinational pharmaceutical firms for conducting trials in lieu of sponsored junkets to foreign countries,” Ramdas asserted.

Playing down the controversy, state biotech vision group and Biocon chairperson Kiran Mazumdar-Shaw said the state had a very enabling environment for R&D; in biotechnology, including clinical trials.

“The chief minister said the news reports about ban on clinical trials were incorrect. He has clarified the minister’s remarks and asserted that the industry would be allowed to carry on the trials,” Shaw told reporters on the margins of the event.

Ramdas was, however, not available for comment as he was away in Mysore on official tour.

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