South Africa is now one step closer to having locally manufactured antiretroviral, malaria and tuberculosis drugs on shelves, following the launch of a completed multipurpose fluorochemical pilot plant at on Thursday.
Government is targeting the pharmaceutical industry as a growth area for high-technology economic development and employment.
Fluorochemicals, made from naturally occurring fluorospar, are used to make, among other things, the active pharmaceutical ingredients in drugs. Up to 15% of the drugs that have been commercialised in the past 50 years contain fluorochemicals.
According to the department of trade and industry, the medical goods sector – which includes pharmaceuticals, medical devices and medical diagnostics – is the fifth largest contributor to South Africa’s trade deficit, with pharmaceuticals responsible for a trade gap of R20-billion in 2011.
South Africa has the largest reserves of fluorospar in the world, but only 5% of these reserves is being beneficiated; abouth 95% of mined fluorospar is exported in its raw form.
The plant, based at the Nuclear Energy Corporation of South Africa’s (Necsa’s) campus at Pelindaba, falls under subsidiary Pelchem, which is the only fluorochemical producer in southern Africa.
"[South Africa] is one of the few countries in the world that can handle [these chemicals which are], corrosive and dangerous. We have the capacity at Necsa and in the science sector to work with these chemicals and develop new products," says Imraan Patel, a deputy director-general in the department of science and technology.
The department has invested about R135-million in fluorochemical capacity over the last eight years, says Beeuwen Gerryts, chief director at the department, adding that about R30-million has been spent on the facility itself. The department of trade and industry hasalso partnered in the initiative.
On Thursday, science and technologyminister Derek Hanekom launched phase three and four of the pilot plant (phase one and two were completed last year).
Pelchem managing director Petro Terblanche says: " Phase three and four allow us to work with more complex materials … especially the pharmaceuticals.
"The pharmaceuticals and agrochemicals industries are important for us. Those are high-value products, although they use small amounts of fluorine."
At the moment, Pelchem is looking for prospective partners to manufacture pharmaceutical ingredients locally, in a project called Ketlaphela.
The aim of Ketlaphela is to make affordable drugs and secure their supply in South Africa. The country has one of the highest HIV infection rates int eh world, with nearly 6-million people infected, according to the Joint United Nations Programme on HIV and Aids. According to the health department, there are about 1.9-million on ARVs in the public sector.
Earlier this year, international company Lonza Pharmaceuticals pulled out of the partnership with Pelchem and the Industrial Development Corporation (IDC), but department and Necsa officials at the time said that this would not affect their targets both in terms of time and money. The project is expected to cost about R1.6-billion, with R1-billion coming from the IDC, R100-million from Pelchem and the remainder from a partner.
"We are in the middle of a tender process … which closes on February 7. In March-April, we will appoint a partner," says Terblanche. "We still want to have [pharmaceuticals] in clinics by April 1 2017; it’s a tight schedule, but it’s possible."
However, Patel and Terblanche both emphasise that the development of new products, not necessarily pharmaceuticals, is a focus area for Pelchem.
"Fluorochemicals … are required in the modern economy," Patel says, citing their use in solar panels, Teflon coating and circuit boards, amongst other things.
"Government said: ‘We have this capacity, how do we enhance capabilities and look at new products?’" he says. "
The pilot plant is "a step between a fully fledged production facility and a laboratory … it helps South Africa position itself in this market. It is essential step to get buyers to say, ‘yes, we’re interested’," Patel says. "It is multipurpose because it can produce a small batch of a substance [for developing a new application] or a few kilograms to send to a buyer in Europe to test."
The facility lends itself towards collaboration with universities, says Terblanche, as tertiary institutions are not equipped to deal with the chemicals while Pelchem is.
While Pelchem is a commercial entity and operates without government grants, the department of science and technology funds research and development, she says.