[Ip-health] Reuters: India's Hetero Takes ARVs Off WHO List

[Mike Palmedo]

http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews&storyID=6870735&section=news

India's Hetero Takes AIDS Drugs Off WHO List

Stephanie Nebehay
19 November, 2004

GENEVA (Reuters) - Hetero Drugs has withdrawn all six of its generic
antiretroviral drugs from the WHO's list of approved drugs following
concerns about their laboratory tests, the World Health Organization
(WHO) said Friday.

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"All six drugs on WHO's prequalified list have been withdrawn by them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.