28. November 2011 10:22
Sub-standard counterfeits the anti-HIV drug Zidolam-N have been tracked down in Kenya. The genuine product marked with the same batch numbers as the counterfeited versions, was however found to be of an acceptable grade. READ MORE.
Anti-HIV medicine Zidolam-N, manufactured by Indian drug maker Hetero Drugs Ltd., had made it to the list of WHO prequalified products in 2006 after its product dossier was assessed and its manufacturing site inspected. Additional WHO inspections too vindicated Zidolam-N’s authenticity - the manufacturing site was inspected afresh and given the thumbs up, first in 2007 and again, in 2009.
Subsequently, in September 2011, WHO’s Prequalification of Medicines (PQM) programme, discovered counterfeit Zidolam-N in Kenya. PSM reports that the tablet pakages marked “Batch E110766” were ascertained to be fake, while tablets with the batch number labels E110467, A9351, A9357 and A9366 were suspect. The counterfeited products, which were found to be sub-standard or in a deteriorated state, have been confiscated by Kenya’s Pharmacy and Poisons Board. Genuine Hetero products with the same batch numbers as the counterfeits were however found to be of an acceptable grade, WHO affirmed, adding that indiscriminate termination of treatment was hence not called for.