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Plan to manufacture medicines in DR Congo raises safety concerns – AFR


Joss Ilunga Dijimba, 52, sat at his desk overlooking a pharmaceutical factory on the outskirts of the Congolese capital Kinshasa and smiled brightly.

“It’s not easy to do business in Congo,” he said.

His family was forced to relocate the factory in the 1990s to survive mass looting. And today there are onerous taxes, tariffs and problems retaining talented employees.

His company, which employs around 40 people and makes generic drugs like acetaminophen, is one of the few drugmakers in the Democratic Republic of the Congo, an impoverished country about the size of western Europe.

But a government plan to require hospitals and NGOs to buy more locally produced medicines could soon give the fledgling pharmaceutical industry a boost – despite fears in some quarters that safety standards are well below international norms.

Several NGOs, some providing medical care in conflict-torn eastern DRC, have requested opt-outs.

In the small Pharmagros factory behind barbed wire walls near the Congo River, men in hairnets and white coats use laboratory equipment to formulate medicines with imported precursors in air-conditioned rooms.

“Promoting local industry is a good thing,” said Dijimba, a University of Texas graduate student, noting that several Congolese firms, including his, maintain high standards.

“It could grow the middle class.”

According to the World Bank, about 73 percent of the Democratic Republic of Congo’s 90 million people live on less than $1.9 a day. Most products in the African country are imported.

– “At your own risk” –

The Congolese government has identified 35 drug molecules, including acetaminophen, that medical facilities must purchase in locally manufactured forms.

The government wants to boost business without banning imports, said Donatien Kabamb Kabey, director of pharmaceuticals at the DRC’s health ministry.

He explained that all molecules could be replaced with imported equivalents, suggesting that ibuprofen could replace paracetamol, for example.

Although not yet implemented, the policy appears to be working.

Fifteen new drug companies will be set up in DRC ahead of the new rules, Kabey said, adding to the existing 24.

The policy was partly designed to encourage factories to return after fleeing the country in the 1990s, he added, when unpaid soldiers rioted towards the end of ex-dictator Mobutu Sese Seko’s reign.

However, experts warn that Congolese-made medicines face a major challenge: reassuring doctors and patients that they meet regulatory standards.

“If you go into the private sector in Congo, do so at your own risk,” said Ed Vreeke, who heads Belgium-based independent pharmaceutical accounting firm Quamed.

“They know damn well that the quality they produce is not good.”

Vreeke said Congolese regulators have improved, but the country lacks the vast resources needed to properly conduct audits, check labels and check the chemical makeup of medicines for safety.

Kabey, whose department at the Ministry of Health oversees inspections, said standards had “improved tremendously” in recent years but gave no further details.

He said the government is establishing a national quality control laboratory.

– ‘Big Thing’ –

According to the World Health Organization, substandard or counterfeit medicines kill hundreds of thousands of people every year, mostly in poor countries.

The DRC’s hot and humid climate also poses storage problems.

For example, a 2021 study of imported and locally made eyedrops sold in Kinshasa showed that three of the seven products tested were substandard. The one sample made in the Democratic Republic of the Congo was contaminated.

Outside a pharmacy in Kinshasa’s upscale Gombe district, 29-year-old corporate lawyer Joelle Mamputu, holding a bag of medicines, said she doesn’t pay attention to where medicines are made but said she had “no bias”.

However, a 52-year-old official named Olivier said there was “quite a difference” between Congolese and foreign drugs.

He added that he would buy Congolese drugs if the quality was the same.

Despite official assurances, major international NGOs such as Doctors Without Borders (MSF) and Medecins du Monde (MDM) have applied to opt out of purchase requirements, several humanitarian workers said.

MDM confirmed it had requested an exemption due to quality and capacity concerns to meet demand.

“This is a huge thing,” said a humanitarian, who asked not to be identified and explained that the new rules would affect all NGOs, hospitals and pharmacies.

Many aid workers understand the need to encourage entrepreneurship, he said, but there are internal disagreements about whether to compromise on quality.

“We need high quality standards for everyone, but the reality of the country is that sometimes it’s impossible.”

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