Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Associated Press - November 19, 2004
SAM CAGE, Associated Press Writer
Hetero decided to withdraw the drugs -- the only prequalified retrovirals it makes -- after a WHO inspection, the agency said Friday.
The company has told WHO that the laboratories it was using to conduct the bioequivalence tests, which should prove that their drugs are the same as the patented medicines, "were not compatible with the current standards" and that there were "deficiencies in the data submitted," the agency said.
WHO spokesman Iain Simpson said the problem was with the testing, not with the drugs.
"It is clear that these are quality medicines; they are not dangerous medicines," Simpson told reporters. "However, the last stage is to show that these products are equivalent in the way they actually work with the original product."
So far the laboratory testing has failed to show that.
"These products may well be bioequivalent," Simpson said. "We just don't know."
The company will review the data from tests designed to prove that the generic versions equivalent to the original medicines, WHO said Friday.
In principle, patients should stop using these medicines and switch to other prequalified products, but if they cannot find alternative products immediately they should continue using the de-listed products, WHO said.
Hetero was not immediately available to comment, but has told WHO that it will contract new laboratories and submit new bioequivalence tests for the six medicines "as soon as possible," WHO said.
The drugs which Hetero is removing from the list are: two different doses of Stavudine; Indinavir; Lamivudine; Zidovudine; and a combination of Lamivudine and Zidovudine.
The withdrawal of the drugs comes in response to a warning letter sent by WHO earlier this year to all manufacturers of HIV/AIDS medicines participating in the prequalification project, urging them to verify the data they had submitted and to check whether the sites they were using for bioequivalence tests were complying with good medical and laboratory practice.
The health agency sent the letter after it removed five other antiretroviral medicines manufactured by other Indian firms, Ranbaxy Laboratories and Cipla, from its list of approved HIV treatments. Bioequivalence tests had failed to prove that these were the same as the patented versions.
Last week, Ranbaxy also withdrew all of its generic versions of antiretroviral drugs from the approved list, again saying it is uncertain they are biologically the same as the patented drugs.
"Our findings, and the companies' admission of responsibility by withdrawing their products, show that (laboratory) inspections are necessary," said Dr. Lembit Rago, coordinator for WHO's quality and safety of medicines division. "Current WHO procedures are ultimately improving medicines monitoring mechanisms which will, in the long term, ensure better quality treatment for patients."
There are now 48 antiretrovirals for the treatment of HIV/AIDS on the WHO prequalified list.
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