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Generic drug maker seeks WHO and FDA approval

    JOHANNESBURG

    An Indian generic drug manufacturer has applied to have its anti-AIDS drugs approved by the World Health Organisation (WHO) after they were removed from the WHO list of approved HIV medicines last year.

    Ranbaxy Laboratories announced last week that the company would be submitting its complete range of antiretrovirals (ARV) to the WHO for pre-qualification, and would also be seeking clearance for the drugs from the US Food and Drug Administration (FDA).

    Late last year seven ARV drugs made by Ranbaxy were removed after the company "found discrepancies" in documents proving their biological equivalence to the patented versions. In August 2004, WHO withdrew three other drugs made by the company for the same reason.

    CEO Dr Brian Tempest said in a statement: "Ranbaxy fully supports WHO's prequalification project and we are working speedily to provide adequate fresh data to the WHO on our generic ARVs...this will pave the way for the early availability of these quality medicines, in areas where they are most urgently needed."

    This article was produced by IRIN News while it was part of the United Nations Office for the Coordination of Humanitarian Affairs. Please send queries on copyright or liability to the UN. For more information: https://shop.un.org/rights-permissions

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