WHO pulls out 2 Cipla HIV drugs from its list

The WHO has pulled two generic antiretroviral drugs from its list of approved HIV drugs used in poor countries, saying a routine check found...

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The WHO has pulled two generic antiretroviral drugs from its list of approved HIV drugs used in poor countries, saying a routine check found the manufacturer had not proved them to be biologically equivalent to patented drugs.

It is the first time WHO has removed any HIV drug from its list, Lembit Rago, a WHO official, said on Tuesday. Rago said the problem was detected in routine tests WHO conducts among drugs it finds acceptable for procurement by UN agencies. But, he said, the problem is not expected to interfere with WHO’s initiative to treat 3 million HIV-infected people, mostly in Africa, by next year.

Cipla, an Indian company that has been in the forefront of getting generic drugs approved for use, made the two generic drugs, lamivudine, also known as 3TC, and zidovudine, known as AZT.

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The move comes after the Bush administration’s announcement of a shift in its AIDS policy to allow the purchase of cheaper generic drugs for Africa and the Caribbean. Cipla said the situation was ‘‘on the mend’’ and expected its drugs to be back on the list within weeks.

The problem was detected during an inspection of an independent laboratory Cipla had hired to conduct bioequivalence studies among volunteers whose blood had been tested after they took the generic drugs. Rago did not name the company that did the testing.

A review found that the company’s documents did not meet the standards known as good clinical and laboratory practice. Despite the findings, the generic drugs may be bioequivalent to the patented drugs. However, WHO had to remove them as the documentation was lacking, Rago said.

Cipla’s chairman, Dr. Yusuf K. Hamied, said the problem was that the laboratory in Mumbai did not keep adequate records. He said Cipla’s lamivudine has already been tested for bioequivalency in a US laboratory and is approved by the FDA and that he will submit that data to WHO. He said the testing was done for the US drug agency as Cipla hopes to sell generic lamivudine when the US patent expires in 2006.

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WHO did not issue a news release about the problem after it was detected in May. Rago said such an announcement was unnecessary as his agency had informed other UN agencies about the problem. — (NYT)