The Medicines Control Council (MCC) has declared a generic version of antiretroviral (ARV) Duovir undesirable and ordered a recall, the manufacturer confirmed on Thursday.
A Government Gazette of August 6 also advised that patients using the drug consult their doctors for equivalent or alternative treatment.
We have suspended sales and quarantined the product and have sent our letter of withdrawal to the MCC, Cipla-Medpro medical director Nic de Jongh told SAPA. 'We have suspended sales and quarantined the product' Duovir is the name of a product that combines the ARV medicines zidovudine
(AZT) and lamivudine in a single tablet.
The MCC was not immediately available to comment, but the Treatment Action Campaign
(TAC) and NGO Medecines Sans Frontieres (MSF) said the drug was ordered withdrawn by the MCC after the World Health Organisation (WHO) removed it from a list of prequalifying medicines for the treatment of HIV and Aids.
The Government Gazette said: The council is of the opinion that it is not in the public interest that Duovir tablets are made available to the public, in terms of Section 23 of the Medicines and Related Substances Act.
De Jongh confirmed the UN health body found that a laboratory in India contracted to conduct trials on the bioequivalency of the generic did not comply with certain requirements of good laboratory practice and good clinical practice.
A bioequivalency test is conducted to determine that a generic is as effective as the original patented and registered drug, in this case Combivir, manufactured by GlaxoSmithKline. The results of these laboratory tests form part of the information the MCC uses when it decides to register a drug.
De Jongh said the MCC had given Cipla-Medpro 30 days to rectify the matter and the drug was already being retested at another laboratory, with results expected soon. It had already conducted successful surrogacy tests at a WHO-accredited testing facility in Potchefstroom and forwarded these results to the MCC.
The TAC and MSF called on the drug company to speedily and publiclyaddress the concerns of the MCC and lauded the MCC's decision to deregister it until the matter was resolved.
They added that another WHO inspection found that the tests for Cipla's Triomune, which combines lamivudine, stavudine and nevirapine in a single tablet, were carried out in compliance with required standards.
The TAC and MSF also called on the companies providing the alternatives to resist increasing their prices.
The minister of health and HIV and AIDS specialists were already meeting on Thursday to discuss the MCC's concern that the ARV nevirapine was showing increased resistance as a monotherapy to prevent the transmission of HIV and AIDS from mother to child. (Source: SAPA 12 August 2004)