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Fake HIV medications uncovered in Kenya

Falsified Zidolam-NFake versions of the anti-HIV medicine Zidolam-N - a triple therapy combining lamivudine, zidovudine and nevirapine manufacted by Indian drugmaker Hetero Drugs Ltd - have been discovered in Kenya.

The counterfeits were first discovered in September and have been under investigation by the World Health Organization's Prequalification of Medicines Programme.

The WHO has confirmed that tablets bearing the batch E110766 have been confirmed as fake, while others carrying the numbers E110467, A9351, A9357 and A9366 are under suspicion. Some of the batches were never supplied to the Kenyan market, or have been discovered in quantities exceeding Hetero's shipments to the country.

The falsified products (packaging pictured) are of poor quality, and contain tablets in varying degrees of deterioration, i.e. moulding, discolouration and friability, according to the WHO. Kenya's Pharmacy and Poisons Board has confiscated all falsified Zidolam-N products identified to date.

WHO said that Zidolam-N was included in the list of WHO prequalified products in 2006 after a prequalification process which included both assessment of the product dossier and inspection of the manufacturing site. Since prequalification, the manufacturing site has undergone and passed two further inspections by WHO in 2007 and 2009.

The agency has warned medicine procurers in Kenya and neighbouring countries to be wary of Zidolam-N shipments bearing the suspect batch numbers and indeed any shipment which seems to deviate from the usual quality of the genuine product.

"Please bear in mind that the genuine Hetero products, circulating with the same batch number, were found to be of acceptable quality and that treatment regimens dependent on this product should not be interrupted indiscriminately," it said in a statement.
 




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