Since 2002, researchers have conducted several additional laboratory safety tests on RISUG.
"When we first began using RISUG in volunteers more than 15 years ago, we didn't have access to the more sophisticated toxicity tests available today," says Dr. H. C. Das, one of the lead investigators. "Last year we sent RISUG to an FDA-registered laboratory in the United States for more tests, and the results came back clean. We've also done more studies at the Industrial Toxicology Research Centre in Lucknow, India with the latest equipment. We're glad to be able to provide men this additional reassurance."
Dr. R. S. Sharma, deputy director general of the Indian Council of Medical Research (ICMR), concurs that the safety results were "very satisfactory." The ICMR is working to arrange study sites throughout India, beginning with Jaipur, Ludhiana, Udhampur, and India's capital New Delhi. Three data monitoring committees will watch for any safety concerns.
But Lissner cautions that progress will be slow without sufficient political will. "A reversibility study in men is key," she stresses. "And we're hoping that the Indian government is committed enough to this research to get the next batch of RISUG made to the FDA's latest Good Manufacturing Practice standards. If it is, the results will carry more weight internationally. Then men in other countries -- such as the US -- can hope for faster government approval."
Currently, RISUG's developers are arranging a collaboration with US researchers. Lissner says that to gain FDA approval, US researchers will have to begin with animal tests, so studies in North American men would not start for several years. Still, she notes that "We shouldn't be discouraged. We already know that RISUG works, which is half the battle in drug development. Men in studies in India have been using it for more than a decade. Now we just have to finish our homework."
Source:Male Contraception Information Project