Manufacturing Anti-retro viral and anti-malarial drugs in Uganda

The Quality Chemical Industries home in Luzira is a glassy modern piece of architecture with an exterior that would pass for a grand hotel instead of a pharmaceutical plant.

But behind this façade is the adherence to a high degree of quality control that is extremely important in the pharmaceutical manufacturing industry.

This strict compliance to a set of good management practices in pharmaceutical manufacturing has won the plant approval and certification from World Health Organisation (WHO).

The journey of Quality Chemicals began in Katwe, a slummy Kampala suburb. In 1995, the World Trade Organisation’s (WTO) Trade-Related Intellectual Property Rights (TRIPS) were introduced, exempting low income countries from using patented pharmaceuticals in favour of affordable generic drugs.

This restricted India and China from manufacturing generic drugs in respect of patents. As a result, the Asian pharmaceuticals had to transfer technology to low income countries, leading to a partnership between Quality Chemical and Indian pharmaceutical giant Cipla – the world’s largest manufacturer of antiretroviral drugs.

This brought about the reduction of prices for first line antiretroviral drugs sold in low income countries today, including Uganda.

Today, the Luzira-based pharmaceutical manufacturer stands on 12 acres, with a built-up area of seven acres.

It starts with mundane things such as the green well-kept lawn with flowers at the factory’s premises.

This is not a matter of aesthetics because the greenery helps in absorbing the carbon dioxide emitted from the factory.

Equipment at the plant is sterilised before beginning the production process to ensure the drugs are not contaminated.

There are strict rules that are adhered to, even in cleaning the floor. The air in the building is ultra-filtered and the water undergoes a rigorous filtration and purification process.

The equipment is also calibrated in order to get the right measurements of the chemical raw materials because this determines the final outcome of the actual dosage in the tablets.

Even the walls and floors have no corners which might attract dust and mites. The walls are painted white, and the amount of lighting in the building is measured to ensure proper visibility.

An insect killer is on standby to trap any bugs coming into the factory.

The plant employs 300 people, of whom about 250 are pharmacists. After recruitment, the employees are trained in the production processes to ensure the maintenance of accurate dosages of active pharmaceutical ingredients.

They are taught how to document the various tasks and keep records for future reference, showing the tasks accomplished, by whom, when and at what time.

It is this army of employees that is charged with weighing and mixing the ingredients, which are then taken into a compressor and turned into granules.

The process of tablet manufacturing involves filtering to remove air and lumps, which are further compressed into tablets or capsule form.

Other production processes include coating, filling and packaging. The processes are computerised in order to monitor the set standards of quality, which makes the drugs safe and effective for the patients.

In another room, the tablets are subjected to quality tests to establish their hardness. This is intended to ensure the tablets will not chip or break during packaging and transportation.

The tablets are also tested for their ability to dissolve.

Experts warn that breaking a tablet into half, as is commonly practiced by patients, reduces the medicine’s effectiveness because a tablet may be designed to dissolve slowly in the body.

If a drug passes all the specification tests, but fails one, it is deemed to have failed all the tests because each step is a mandatory aspect in the pharmaceutical manufacturing process.

According to Samuel Opio Acuti, the company pharmacist, the quality control measures have kept out the possibility of local suppliers benefiting through the supply of pharmaceutical-grade packaging materials such as paper boxes and HDPE containers.

However, Quality Chemicals is providing technical assistance to the local packaging manufacturers and a pilot project is being run with the Namanve-based Riley Packaging.

Upon entry of the factory, one must wear a white gown, a head cap, cover the shoes and disinfect hands.

The WHO approval has opened the regional market for the company’s products and soon, the first consignment of drugs worth $13m will be exported to Kenya.

In order to meet this anticipated regional demand, the plant is set to expand its operations by setting up a second plant with a bigger capacity.

The $50m new plant will manufacture 18 million tablets of antimalarial and antiretroviral drugs per day at full capacity. Currently, the plant manufactures six million tablets per day.

This will include the antiretroviral one-pill-a-day, which is a single dose combination therapy for the treatment of HIV/AIDS, according to Frederick Kitaka, the company chief financial officer.

Kitaka explains that whereas 60% of raw materials needed for pharmaceuticals are available in Africa – including Artemisia, which is grown in Uganda, the industry is unable to purify the ingredients.

So, Afro Alpine Pharma exports Uganda’s Artemisia to India for purification before it is brought back into the country.

Kitaka says under the third phase, the company will set up an active pharmaceutical ingredients plant, which will extract and purify ingredients from locally sourced raw materials.

However, the plant management expressed concern that the market is flooded with cheap drugs imported from India and China, which is threatening the indigenous pharmaceutical companies.

By Raymond Baguma
The New Vision Newspaper
18-May-2012