Médecins Sans Frontières (MSF) has decided to hold on the supply of two Cipla antiretroviral drugs, lamivudine 150 mg tab and lamivudine-zidovudine combination tab, after WHO announced withdrawal of its pre-qualification given to these drugs.
The MSF informed that it would not supply these drugs until the results of new bioequivalence studies are available and are reviewed by the WHO Pre-qualification Project.
The WHO has withdrawn its pre-qualification granted to the products, lamivudine (3TC) 150 mg tablet (LAMIVIR), and the fixed dose combination lamivudine (3TC) 150mg/zidovudine (AZT) 300mg tablet (DUOVIR) of Cipla.
After suspending supply of these drugs, the MSF has stated that the first priority of MSF is to ensure that no patients in its programmes face treatment interruption. The agency would now seek to substitute other pre-qualified drugs for the suspended Cipla drugs.
It informed that the use of these two products would be decided on a case-by-case basis taking into consideration the decisions of National Drug Regulatory Authorities and availability of alternatives.
The NGO also pointed out that since the vast majority of its patients are on triple fixed-dose combinations, they would not be affected.
The WHO had on May 27, 2004 said that the two products were removed from the list as a result of the outcome of an inspection performed by the World Health Organization (WHO) in which compliance with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) was assessed, as well as data verification of the bioequivalence study at the Contract Research Organization (CRO) used by the sponsor.
Meanwhile, Cipla is known to have informed MSF that if countries or organizations prefer to return these two products rather than continue using them, the company would offer full refunds. Cipla also confirmed it has already began new bioequivalence studies on the two products and that these studies will be completed by the end of July.