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ARVs production starts Monday
Publish Date: Oct 06, 2007
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By charles wendo

A YEAR ago it was a potato garden. Now the 15-acre plot is hosting a hi-tech pharmaceutical factory, the first of its kind in Africa.

The factory, to be commissioned by President Yoweri Museveni on Monday, will produce the full triple therapy combination of antiretroviral (ARV) drugs, something that has not been done in Africa before.

“South Africa has a plant for producing ARVs but they do not do triple therapy combinations,” said Emmanuel Katongole, Managing Director Quality Chemical Industries (QCI).

Likewise, a few African countries like Egypt and Nigeria have ARV factories, but none of them produces the full range of three drugs required for treatment of HIV/AIDS.

The new factory, located adjacent to Luzira Women’s Prison, is a joint venture between QCI and the Indian pharmaceutical Cipla. It will produce Triomune, a combination that contains lamivudine, stavudine and nevirapine. Out of 80,000 people on ARVs in Uganda, three quarters are taking Triomune.

The factory will also produce the first-line anti-malarial combination Lumartem, containing artemisinin and lumefantrin. This is equivalent to Coartem, which the Government now uses as the first-line anti-malarial drug.

Katongole said they would begin trial runs on Monday soon after the President commissions the plant. The trial runs, technically referred to as validation, are likely to go on till November or December. The validation will help to ensure that the machines measure the ingredients accurately, mix in the right proportions and produce pills that are perfectly uniform in size and concentration. “By January, we should be in position to manufacture for the market,” said Katongole.

This will come just in time to save Uganda from a new law which will stop India from exporting cheaper versions of antiretroviral drugs, commonly known as generics. India has been Uganda’s main source of generic ARVs, which are far cheaper than those manufactured by the companies that invented these drugs in Europe and USA.

Since the late 1990s Indian companies have been able to produce and sell generic drugs without the consent of the patent holders in Europe and USA. However, having ratified the TRIPS agreement of the World Trade Organisation, India will ban the exportation of generic drugs by the end of this year.

According to Katongole, the factory will initially produce two million pills a day, but this will eventually increase to six million. This means in future it can produce 1.8billion pills a year. This number includes ARVs and anti-malaria pills. “Our first client is going to be the Government, which is committed to providing free ARVs for all those who need it,” said Katongole. “There are between 150,000 and 300,000 Ugandans who need ARV treatment now. At the moment 80,000 of these are taking ARVs, and this factory should enable Government to double that number,” he added.

The surplus will be exported to neighbouring countries. These countries are likely to turn to Uganda because effective January 2008, they will not be able to import from India, which has been the biggest supplier of generic ARVs to Africa. “For us TRIPS is a window of opportunity,” said Katongole. “India has ratified the TRIPS agreement so it ceases to be a source of generic drugs for Africa.”

The Government donated 15 acres of land on which the factory has been constructed, and President Museveni has been closely monitoring the progress. “The Government has been very supportive, especially the President. Every month he has been calling to check on the progress. He has also called us several times to State House for meetings,” said Katongole.

The Senior Presidential Advisor on HIV/AIDS, Dr. Jesse Kajimba, said local production of ARVs would lead to more independence in terms of guaranteeing supply and quality control. “We have been having ARVs anyway, but having the capacity to produce it locally is a starting point for other things. The President is thinking beyond simply making ARVs available,” Kajimba said.

Dr. Peter Mugyenyi, Director of the Joint Clinical Research Centre, said local production was the best way to guarantee availability of ARVs in Africa. “We are very excited to have a factory that produces ARVs in our country,” said Mugyenyi, one of the pioneers in prescribing ARVs in Uganda. “Our people were dying because we had to go and beg others.”

Mugyenyi, however, cautioned that the pharmaceutical should not rely too much on Triomune. He said the factory should move quickly to start producing newer combinations such as Atripla, which contains Tenofovir, Efavirenz and FTC.

The new factory will manufacture the anti-malarial drug Lumartem, Lumartem, containing artemisinin and lumefantrin, at a cost of $2.4 per dose. The equivalent, Cortem, is produced at a cost of $12 per dose.

The factory will buy the plant artemisia from farmers in Kabale for making the antimalarial drug. “Uganda, especially Kabale, has been found to have one of the best soils for to grow Artemisia. Now there is a company that has started large-scale growing of Artemisia in Kabale.

There are over 10,000 hectares of Artemisia,” said Emmanuel Katongole, Managing Director, Quality Chemical Industries. He added, “We are going to buy artemnisia from them and take it to India for extraction of the active artemisinin.

In the long run we are going to negotiate with government to support us so that in the long run we can do the extraction here instead of taking it to India.”

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