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.
www.aegis.org