The World Health Organization has removed two generic antiretrovirals manufactured by the Indian company Cipla from its list of prequalified antiretrovirals following the detection of irregularities in paperwork produced by one Bombay contract laboratory carrying out bioequivalence tests on the products, it emerged today.
The products were removed from the list on May 27th but the news did not become widely known until today when the New York Times reported the story.
The two products removed from the list are Lamivir (3TC) 150mg tablets and a tablet combining AZT and 3TC marketed as Duovir.
The suspension of Duovir is particularly problematic because it is widely used in developing country ARV projects as a backbone for efavirenz-containing regimens, and to a lesser extent for nevirapine-containing regimens. Some projects are known to have purchased large quantities of the product from Cipla and are waiting to find out whether it can be used.
Cipla has informed one of its customers, Medecins sans Frontieres (MSF), that if countries or organisations prefer to return these two products rather than continue using them, Cipla will offer full refunds. Cipla has also confirmed it has already begun new bioequivalence studies on the two products and that these studies will be completed by the end of July.
MSF announced today that it would put supplies of the two drugs on hold until the issue was resolved and in the meantime use other prequalified products. However the organisation noted that since most of MSF’s patients are on fixed dose triple combinations, they will not be affected by the change.
No direct evidence of poor quality drugs
WHO removed the products from its prequalification list after a recent inspection of a contract research organisation in Bombay that had carried out bioequivalence studies of the products in 2001. At the time of submission WHO accepted the documentation provided by Cipla as sound, and the products have been used subsequently in many countries without evidence of early virological failure or unforseen adverse events that might suggest they were sub-standard.
However the recent inspection showed that the contract research organisation was not adhering to Good Clinical Practices and Good Laboratory Practices guidelines laid down for the international pharmaceutical industry. This discovery forced WHO to go back and ask Cipla to carry out the studies again in a laboratory that adhered to the guidelines.
The Hudson Institute, a right wing US think thank that has been vocal in its criticism of WHO's prequalification process for generic antiretrovirals, seized the opportunity to call for WHO to review its entire prequalification process.
Gregg Gonsalves, Director of Treatment and Prevention Advocacy at Gay Men’s Health Crisis, rejected this view.
“The recall shows that the pre-qualification process is picking up irregularities in the system and addressing them,” he told aidsmap.com.
Further information on this website
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