Down the production line of Uganda’s HIV/AIDS drug factory
Sep 14, 2009
FROM afar it appears small. As you get closer it gets bigger and more complex in appearance. It would easily be mistaken for a tycoon’s villa stashed atop a 12-acre piece of land. It is strategically located with a magnificent view of the Mutungo hill.
By Arthur Baguma
FROM afar it appears small. As you get closer it gets bigger and more complex in appearance. It would easily be mistaken for a tycoon’s villa stashed atop a 12-acre piece of land. It is strategically located with a magnificent view of the Mutungo hill.
As you walk around, the environment is serene and quiet. After a lull of waiting at the reception, a tall man calls us through. We climb the stairs to the second floor of the four-storeyed building. On the second floor of the building we are ordered to put on white gowns and wash our hands. Even our shoes are dressed up in a white protective wrapping. A not so disturbing sound of machines cuts through the air.
Men are roaming in the cool room in white gowns and head masks. They are covered behind glass walls moving and pushing up machines and pressing buttons in a systematic mode. Some are Ugandan natives and others Indians.
A slender tall man appears from one room and intercepts us. “You cannot go inside but you can watch everything from here,†he says as we stand in the corridor. A metallic machine with a circular plate in the middle keeps churning out white small droppings at sporadic speed.
The man who I later discover is an expatriate of Indian origin tells us that it is the final process in the production of the drugs. “That is called the compressing stage when the granules are compressed into tablets,†says Ramakanta Panda, the production manager. He goes inside and comes out with three tablets. I pick one to get a feel. It feels hard and white in colour.
I am holding a drug made in Uganda by Africa’s first anti-retroviral and anti-malaria manufacturing plant.
Location
The facility is located in Luzira a city suburb of Kampala. It was established in January to produce low-cost drugs to treat HIV/AIDS and malaria.
Panda says the entire production chain goes through several stages before a final product is put out on the market.
Acquisation of materials
The raw materials in powder form are imported from India and tested. For anti-malarials, it is Artemether and Lumafantrine. For ARVs it is Lamivudine USP, Zidovudine-USP and Nevirapine-USP which are imported as a raw material.
The raw materials also include inactives like micro-crystalline cerulose and starch, among others.
Authentication
Once the raw materials pass the test, they are taken to manufacturing which goes through several stages.
The ARVs are manufactured under Cipla licence, a leading Pharmaceutical company based in India and reflect Cipla stamp of world class. Cipla has wide technological expertise in pharmaceutical manufacturing.
“We have so many points of cross-checking and counter-checking to ensure that our production is up to international standards,†Panda explains. In a shift of eight hours the factory churns out two million tablets using one line of production. The factory has the capacity to produce six million tablets per day when all the lines of production are active.
Challenges of production
However, high interest rates, lack of government support in the subsidies, bureaucracy in government procurement process, cost of flight and importation of raw materials are weighing heavily on the manufacturing process.
Currently locally made ARVs cost much more compared to the imported ones. The entire project worth $32m (about sh64b) is a 50-50 partnership between privately owned local manufacturer Quality Chemicals and Indian pharmaceuticals giant Cipla CIPLnsc1.
According to management, if these challenges are addressed the locally produced drug will probably cost less than $15 (about sh30,000) a month.
Emmanuel Katongole, the chief executive officer, cites bureaucracy in the procurement process.
Government involvement
Currently the Government is the only buyer of the drugs from the factory spending about sh60b annually.
“We wish to have a contract with the Government which is less bureaucratic to make our work easier,†Katongole says. The Government pays the factory sh15b per quota to manufacture the drugs. ARV treatments per month are a strain on cash-strapped government budgets.
“The procurement process can go up to three months for each quota and this affects the entire production process of the drugs because the money does not come in time,†says Katongole.
According to market analysis, about 300,000 Ugandans need ARVs yet only half have access. However, management says there are several factors for high expenditure. For instance in India, the government offers high subsidises causing a reduction in price. Another problem is dumping by multinational companies.
The cost of doing business in Uganda is still high. The factory faces frequent power cuts. The factory imports the raw materials from India which also pushes the cost of production up.
Accrued benefits
There are several benefits the plant has realised. It is creating self-sufficiency within the country to ensure availability and accessibility of the drugs. It has created jobs for Ugandans and will soon bring in foreign exchange.
Locally the factory has also created market for Ugandan farmers in Kabale who grow atemether.
However, the atemether is still exported to India to be formed into Active Pharmaceutical Ingredients (API), Geofrey Nalima, the marketing manager of the plant, says.
Nalima says there are secondary plans to start processing the raw materials in Uganda. He adds that the primary plants from which most of the raw materials are got are not in Uganda.
The human resource manager, Harrison Kiggundu, says the factory which currently employees 200 people, has a capacity to employ more than 500 people. Out of 200 employees, only 10 are expatriates, the rest are Ugandans while ninety percent of the employees are Ugandans. Ugandans working at the plant are being trained on the job by the Indian expatriates to take over the entire production process.
WHO pre-qualification
The thrust of the factory’s break-even is hinged on the pre-qualification by World Health Organisation (WHO).
Once the factory gets the pre-qualification nod, it is expected to increase its production capacity and to widen its market. The factory is yet to be pre-qualified by WHO. It has been prequalified and given both manufacturing and marketing authorisation by Uganda National Drug Authority, the International Committee of the Red Cross in conjunction with The United Nations Children’s Fund and Doctors without Frontiers. The plant has also been pre-qualified by Drugs for Neglected Diseases Initiative.
“We expect WHO to pre-qualify us before the year ends. We have manufactured a number of batches for their analysis,†says Katongole.
Global Fund Support
Most international funding including the Global Fund Initiative insists on WHO endorsement. Uganda won international praise for her efforts on HIV/AIDS prevention having cut the prevalence from 30% to around 7%.
The World Health Organisation says only 40% of the 300,000 Ugandans are getting ARV treatment.
Malaria remains Uganda’s biggest killer, with 80,000 Ugandans, mostly children, dying last year.
Other African countries such as South Africa and Kenya started producing their own antiretrovirals in the last four years after resolving patent disputes with big Western pharmaceutical companies.
The Quality Chemicals factory is a blessing to Uganda’s fight against HIV/AIDS and malaria.
FROM afar it appears small. As you get closer it gets bigger and more complex in appearance. It would easily be mistaken for a tycoon’s villa stashed atop a 12-acre piece of land. It is strategically located with a magnificent view of the Mutungo hill.
As you walk around, the environment is serene and quiet. After a lull of waiting at the reception, a tall man calls us through. We climb the stairs to the second floor of the four-storeyed building. On the second floor of the building we are ordered to put on white gowns and wash our hands. Even our shoes are dressed up in a white protective wrapping. A not so disturbing sound of machines cuts through the air.
Men are roaming in the cool room in white gowns and head masks. They are covered behind glass walls moving and pushing up machines and pressing buttons in a systematic mode. Some are Ugandan natives and others Indians.
A slender tall man appears from one room and intercepts us. “You cannot go inside but you can watch everything from here,†he says as we stand in the corridor. A metallic machine with a circular plate in the middle keeps churning out white small droppings at sporadic speed.
The man who I later discover is an expatriate of Indian origin tells us that it is the final process in the production of the drugs. “That is called the compressing stage when the granules are compressed into tablets,†says Ramakanta Panda, the production manager. He goes inside and comes out with three tablets. I pick one to get a feel. It feels hard and white in colour.
I am holding a drug made in Uganda by Africa’s first anti-retroviral and anti-malaria manufacturing plant.
Location
The facility is located in Luzira a city suburb of Kampala. It was established in January to produce low-cost drugs to treat HIV/AIDS and malaria.
Panda says the entire production chain goes through several stages before a final product is put out on the market.
Acquisation of materials
The raw materials in powder form are imported from India and tested. For anti-malarials, it is Artemether and Lumafantrine. For ARVs it is Lamivudine USP, Zidovudine-USP and Nevirapine-USP which are imported as a raw material.
The raw materials also include inactives like micro-crystalline cerulose and starch, among others.
Authentication
Once the raw materials pass the test, they are taken to manufacturing which goes through several stages.
The ARVs are manufactured under Cipla licence, a leading Pharmaceutical company based in India and reflect Cipla stamp of world class. Cipla has wide technological expertise in pharmaceutical manufacturing.
“We have so many points of cross-checking and counter-checking to ensure that our production is up to international standards,†Panda explains. In a shift of eight hours the factory churns out two million tablets using one line of production. The factory has the capacity to produce six million tablets per day when all the lines of production are active.
Challenges of production
However, high interest rates, lack of government support in the subsidies, bureaucracy in government procurement process, cost of flight and importation of raw materials are weighing heavily on the manufacturing process.
Currently locally made ARVs cost much more compared to the imported ones. The entire project worth $32m (about sh64b) is a 50-50 partnership between privately owned local manufacturer Quality Chemicals and Indian pharmaceuticals giant Cipla CIPLnsc1.
According to management, if these challenges are addressed the locally produced drug will probably cost less than $15 (about sh30,000) a month.
Emmanuel Katongole, the chief executive officer, cites bureaucracy in the procurement process.
Government involvement
Currently the Government is the only buyer of the drugs from the factory spending about sh60b annually.
“We wish to have a contract with the Government which is less bureaucratic to make our work easier,†Katongole says. The Government pays the factory sh15b per quota to manufacture the drugs. ARV treatments per month are a strain on cash-strapped government budgets.
“The procurement process can go up to three months for each quota and this affects the entire production process of the drugs because the money does not come in time,†says Katongole.
According to market analysis, about 300,000 Ugandans need ARVs yet only half have access. However, management says there are several factors for high expenditure. For instance in India, the government offers high subsidises causing a reduction in price. Another problem is dumping by multinational companies.
The cost of doing business in Uganda is still high. The factory faces frequent power cuts. The factory imports the raw materials from India which also pushes the cost of production up.
Accrued benefits
There are several benefits the plant has realised. It is creating self-sufficiency within the country to ensure availability and accessibility of the drugs. It has created jobs for Ugandans and will soon bring in foreign exchange.
Locally the factory has also created market for Ugandan farmers in Kabale who grow atemether.
However, the atemether is still exported to India to be formed into Active Pharmaceutical Ingredients (API), Geofrey Nalima, the marketing manager of the plant, says.
Nalima says there are secondary plans to start processing the raw materials in Uganda. He adds that the primary plants from which most of the raw materials are got are not in Uganda.
The human resource manager, Harrison Kiggundu, says the factory which currently employees 200 people, has a capacity to employ more than 500 people. Out of 200 employees, only 10 are expatriates, the rest are Ugandans while ninety percent of the employees are Ugandans. Ugandans working at the plant are being trained on the job by the Indian expatriates to take over the entire production process.
WHO pre-qualification
The thrust of the factory’s break-even is hinged on the pre-qualification by World Health Organisation (WHO).
Once the factory gets the pre-qualification nod, it is expected to increase its production capacity and to widen its market. The factory is yet to be pre-qualified by WHO. It has been prequalified and given both manufacturing and marketing authorisation by Uganda National Drug Authority, the International Committee of the Red Cross in conjunction with The United Nations Children’s Fund and Doctors without Frontiers. The plant has also been pre-qualified by Drugs for Neglected Diseases Initiative.
“We expect WHO to pre-qualify us before the year ends. We have manufactured a number of batches for their analysis,†says Katongole.
Global Fund Support
Most international funding including the Global Fund Initiative insists on WHO endorsement. Uganda won international praise for her efforts on HIV/AIDS prevention having cut the prevalence from 30% to around 7%.
The World Health Organisation says only 40% of the 300,000 Ugandans are getting ARV treatment.
Malaria remains Uganda’s biggest killer, with 80,000 Ugandans, mostly children, dying last year.
Other African countries such as South Africa and Kenya started producing their own antiretrovirals in the last four years after resolving patent disputes with big Western pharmaceutical companies.
The Quality Chemicals factory is a blessing to Uganda’s fight against HIV/AIDS and malaria.