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SA to make ARVs soon

Johannesburg - Antiretrovirals (ARVs) could cost South Africans as little as about R100 a month and local manufacturing of generics could start as early as next month, it was announced on Tuesday.

This follows the Aspen Pharmacare group in South Africa becoming the first drug manufacturer in the world to receive approval from the United States Food and Drug Administration (USFDA) to produce generic ARVs.

The USFDA gave notice to Aspen on Tuesday morning, the company announced at a press conference in Johannesburg.

Now, the company is waiting for the government to announce the result of its first ARV tender.

"Aspen is well positioned to be a major player in the supply of cost-effective generic ARVs, both in South Africa and in export markets," said Stephen Saad, Aspen's chief executive.

Aspen will be allowed to make the most widely used triple cocktail generic ARVs. This is a combination of Lamivudine, Zidovudine and Nevirapine tablets in conventional adult dosages.

Saad said that depending on which cocktail combination was required, treatment could cost South Africans as little as R100 a month.

"Manufacturing could start as early as February with maybe a four to eight week delivery time, depending on the size of the order," he said.

Where generic medicines were involved in the package, there would be significant discounts, he said.

Tuesday's approval has further made Aspen the first accredited generic supplier to have access to the United States President's Emergency Plan for Aids Relief (Pepfar) fund, which offers US15bn to Aids work in developing countries.

It came to the South African company in the face of competition from Asian manufacturers, said Saad.

United States embassy health attache Gray Handley told the press conference that while the drugs in question were not intended for use in the US, the FDA was willing to review them.

This would ensure that they met the same standards of safety and effectiveness as drugs used by US citizens.

He said the success of the ARV project depended on health care workers who would support those who come for treatment.

Elaborating of the Pepfar fund, Handley said $9bn went to 15 "focus countries" which bore the brunt of the global Aids burden.

Allocation included treatment, the training of physicians and nurses, support for voluntary counselling and testing, prevention activities and care for orphans and vulnerable children.

"Of course I think what Aspen is hoping for is that the South African government tender will shine favourably on Aspen as this will benchmark prices others will be able to look at and base their decision on," said Handley.

"Drugs are a challenge. They have side-effects and require a lifetime commitment. However, there is no reason that Africans should not have full access to antiretrovirals and a full life.

"It will not lead to a solution to the problem but those involved in the problem are now optimistic."

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