Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Reuters NewMedia - November 19, 2004
Stephanie Nebehay
It was the third time since June that an Indian company has removed anti-AIDS drugs following WHO inspections which revealed faulty bioequivalence tests meant to show the drugs have the same effect as the original patented brands.
There are still 48 antiretrovirals on WHO's list of so-called "prequalified" life-extending drugs, both generic and patented, a key weapon in the fight against the global epidemic. It was set up two years ago to guide procurement by aid agencies in Africa and Asia, who say availability of approved low-cost generics is key to extending treatment.
"All six drugs on WHO's prequalified list have been withdrawn by them (Hetero)," WHO spokesman Iain Simpson said.
"There are certainly major concerns about the lab testing, about the quality of it, about the situation that has been found by these (WHO) inspections," he added.
Hetero, which is based in Hyderabad, will redo the studies and hoped to resubmit the results for consideration early next year, according to the WHO spokesman.
In a statement, the WHO said that Hetero had acknowledged "deficiencies in the data submitted" and had pledged to hire different contract research organizations (CROs) to carry out fresh testing.
"The irregularities found during the CRO inspections do not undermine the proven pharmaceutical quality of the medicines -- including their purity and stability ...," the WHO said.
INSPECTIONS
Earlier this month Ranbaxy of India pulled its AIDS drugs off the WHO's list after also finding discrepancies in the equivalency tests. It followed the removal by India's Cipla of two HIV/AIDS drugs in June for similar problems.
After shortcomings came to light, the United Nations agency last August began routine inspections of contract research organizations, independent labs which do bioequivalence testing, the last stage of the lengthy process of approving a product.
"It goes back to inspections not being done routinely in the first place. With perfect hindsight perhaps that should have been done," Simpson said.
"But we were following practices of the drug regulatory agencies including the U.S. Food and Drug Administration and the European Drug Regulatory Agency in doing spot checks on CROs."
The three Indian drug makers were using different laboratories, according to the WHO spokesman.
Lembit Rago, coordinator of quality, safety and efficacy of medicines at WHO, said that the withdrawals showed the need for the inspections so as to ensure better quality treatment.
The WHO has launched a campaign to get antiretorivrals to three million people in the developing world by the end of 2005. Only 440,000 of the six million AIDS patients are getting them.
The WHO also reiterated that countries should suspend the use of de-listed medicines and switch to other prequalified products. But if these were difficult to obtain immediately, it was recommended patients continue the use of de-listed products.
"The risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven but which have demonstrated quality and safety," the WHO said.
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