WHO Removes Two Generic Antiretroviral Drugs From List of Approved HIV/AIDS Treatments
June 16, 2004
A World Health Organization official on Tuesday said that the agency has removed two generic antiretroviral drugs produced by Indian generic drug manufacturer Cipla from its list of approved HIV treatments, the New York Times reports. Dr. Lembit Rago, WHO's coordinator for quality assurance and safety of medicines, said that Cipla's versions of lamivudine and zidovudine were removed from the list because of problems detected during a routine inspection of an independent laboratory that Cipla had hired to conduct bioequivalence studies of the drugs. WHO routinely conducts inspections among makers of drugs included on its list of medicines that are "acceptable for procurement" by United Nations agencies, the Times reports (Altman/McNeil, New York Times, 6/16). The WHO inspection found that the company's records did not meet industry standards known as "Good Clinical Practices and Good Laboratory Practices." Following the inspection, the WHO Department of Essential Drugs and Medicines Policy's Prequalification Project on May 27 removed from its approval list 150 mg tablets of lamivudine produced by Cipla at a facility in Kurkumbh, India, and 150 mg lamivudine plus 300 mg zidovudine tablets produced at Cipla's Vikhroli, India, facility (Access to HIV/AIDS Drugs and Diagnostics of Acceptable Quality, 5/27). The bioequivalency tests, which were conducted among volunteers whose blood had been tested after receiving treatment with the two drugs, determine whether the blood concentration of the generic drug is similar to the patented version. Although the drugs were removed from the list of approved treatments because of Cipla's poor documentation, they still may be bioequivalent to the patented drugs, Rago said, the Times reports.
"On the Mend"
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