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India to create new agency to raise clinical trial standards
By agencies
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Tuesday, 06 September 2005, 19:30 IST
BANGALORE:India plans to create a new agency it hopes will ensure clinical drug trials conducted in the country meet the standards of U.S. and other international regulators.
Numerous multinational drug companies have been conducting trials in India because the cost can be cut in half, said Kapil Sibal, India's science and technology minister.
Sibal said that sometimes the studies require further work to meet U.S. standards, and the new agency will follow world-class protocols that would be acceptable to the U.S. Food and Drug Administration and other national authorities.
The FDA, however, always conducts its own assessment of clinical trials done in other countries when those studies are part of an application to have a drug approved in the United States.
"There is no automatic acceptance," Murray Lumpkin, deputy commissioner for International and Special Programs at the FDA said.
Still, Lumpkin said that over the summer the head of the FDA met with India's health minister to discuss how the United States might be able to help with the new initiative.
"Now we are trying to work through what kind of technical assistance would be helpful and feasible," said Lumpkin. "We also have to look at what our own resources are."
Lumpkin said the agency is frequently asked for this type of help.
He added that the new agency might help raise India's profile as many countries around the world are competing to host clinical trials.
The pact covers areas like health care, biotechnology and nanotechnology and will be inked with Sibal visits Washington D.C.
U.S. companies had been reluctant to invest in India out of concerns local laws did not sufficiently protect patents and copyrights.
India patent laws became much stricter earlier this year, paving the way for the collaboration agreement.