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"
Cipla Chair Dr. Yusuf Hamied said that the removal of the drugs stemmed from "inadequate record keeping in the testing laboratory," according to the Times. He added that the company's generic version of lamivudine had undergone bioequivalency tests in a U.S. laboratory in anticipation of applying to FDA to sell the drug when the U.S. patent expires in 2006, according to the Times. Cipla said that the situation is "on the mend" and that it expects to have the medicines relisted with WHO within a few weeks, the Times reports. Rago said that delisting the two medicines would not affect WHO's 3 by 5 Initiative to treat three million people with antiretroviral drugs by 2005, the Times reports (New York Times, 6/16). Hudson Institute Senior Fellow Carol Adelman and adjunct fellow Jeremiah Norris said in a statement that WHO should "be applauded for taking these responsible steps on behalf of AIDS patients" because "[d]eficient products can catalyze a serious public health concern specifically by promoting HIV resistance." They added that WHO should "use this delisting experience to develop recall procedures for the products it had prequalified whenever that becomes necessary," saying that the agency could "reevaluate its entire prequalification program" (Hudson Institute release, 6/15).
Join kaisernetwork.org on Wednesday for a session of "Ask the Experts" featuring a panel discussion of low-cost antiretroviral drugs, including generic drugs. Call toll-free at 1-888-KAISER8 (524-7378) during the scheduled showtime or submit your questions to firstname.lastname@example.org before and during the discussion. The panel will include Jennifer Kates, director of HIV Policy at the Kaiser Family Foundation; Dr. David Hoos, assistant professor at Columbia University Mailman School of Public Health; and Dr. Mark Dybul, deputy chief medical officer in the Office of the U.S. Global AIDS Coordinator.