Manufacture of anti-AIDS drugs set to begin

A Zambian government initiative to begin the local manufacture of cheap generic antiretroviral (ARV) drugs has been welcomed by AIDS activists. "We have been lobbying for affordable drugs for 10 years. This is a dream come true," said coordinator of the Network of Zambian People Living with HIV/AIDS (NZP+), Clement Mfuzi. "As NZP+, our hope has not only been accessibility, but also affordable drugs. We also hope the supply will be sustainable, because once you take these drugs, it is for life." Health minister Brian Chituwo announced recently that the domestic production of ARVs, with Cuban assistance, would begin after rehabilitation of a pharmaceutical factory in the capital, Lusaka, and licensing by the Ministry of Commerce and Industry. Clinical trials of the triple-combination pill are due to start in two weeks' time, with production expected to begin by the end of the year. At a treatment cost of US $150 per year, the generic drug - a copy of Trioumune, which combines Stavudine, Lamivudine and Nevirapine - is set to be among the cheapest in the world. "We have started the manufacture of ARVs in the country. Batches of the drug have been produced, but we need a compulsory licence [following the declaration of AIDS as a national emergency] from the ministry of commerce to enable us to put the drugs on the market," Chituwo said. "We have managed to manufacture these drugs with assistance from the Cuban government, but we need to also sort various regulatory issues and, also, there is need for verification from the World Health Organisation (WHO) and also the Drugs and Poisons Board," he added. The tablets will be manufactured by Pharco, an Italian pharmaceutical company, at the state-owned Medical Stores Limited, and will not be available for export. "We are spending K2.5 billion [US $500,000] on the modernisation of the factory to meet WHO standards," said Pharco Managing Director Giovanni Leonardi. "We are waiting for the licence, which should be out in a couple of days. With the declaration of the HIV/AIDS emergency, we are getting the compulsory licence soon." The local manufacture of fixed-dose combination drugs will butress Zambia's HIV/AIDS programme, which has seen prevalence rates drop from 26 percent in the 1990s to a current 16 percent. Under Zambia's public drug treatment programme, which began last year, 6,000 out of a targeted 10,000 people living with AIDS have access to ARVs, most of them in Lusaka and the industrialised Copper Belt province. The Zambia Central Statistical Office estimates that two million Zambians are HIV positive - 70 percent of them women. The government hopes that by the end of the four-year emergency period, during which it can produce generic ARVs, there will be enough drug supplies to roll out the programme nationally, including the rural areas, which the NZP+ regards as a priority.