East Africa: Kenya Government Grapples With Counterfeit ARVs- October 20, 2011

Nairobi — Kenya’s government is scrambling to remove thousands of batches of counterfeit antiretrovirals (ARVs) from circulation after patients and health workers reported irregularities in the appearance and texture of a widely used drug.

In September, nurses working with the medical NGO, Médecins Sans Frontières – which runs HIV and tuberculosis clinics in the capital, Nairobi, and western Kenya – reported irregularities in the appearance of the antiretroviral Zidolam-N, a combination treatment containing the ARVs zidovudine, lamivudine and nevirapine.

The ARVs were found to be falsified versions of a World Health Organization (WHO)-certified generic drug purchased through a distributor endorsed by the Kenya Pharmacy and Poisons Board (KPPB), the country’s drug regulatory authority.

According to the KPPB, one batch of the fake Zidolam-N, with the number E100766, is marked as manufactured in 2009 and set to expire in May 2013, while a second carries the batch number A9366 with manufacture and expiry dates of June 2009 and May 2012 respectively. The main irregularities included discolouration, mould and crumbliness; the packaging is also of varying quality and the text differs in font and colour from the genuine drug.

Certified, generic versions of Zidolam-N distributed in Kenya are manufactured by Hetero Drugs Limited, based in India. WHO’s investigations found that Hetero’s batch number E100766 had been manufactured and controlled according to WHO-recommended specifications and was of acceptable quality and had not been supplied to Kenya.

The KPPB estimates that 16,340 batches of the counterfeit drug have been released, 15,000 of which have now been returned.
Senior officials say the government is investigating how the drugs found their way into the country, and is looking into strengthening surveillance systems.