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DR Congo drug manufacturing plan raises security concerns

Sitting at his desk overlooking the floor of a pharmaceutical factory on the outskirts of the Congolese capital Kinshasa, Joss Ilunga Dijimba, 52, smiled cheerfully.

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

His family was forced to move the factory in the 1990s to survive bouts of mass looting. And these days, there are onerous taxes, duties and problems retaining talented staff.

His company, which employs about 40 people and produces generics such as paracetamol, is one of the few drugmakers in the Democratic Republic of Congo, an impoverished country the size of Western Europe.

But a government plan to force hospitals and NGOs to buy more locally produced drugs could soon boost the fledgling pharmaceutical industry, despite fears by some that safety standards are far below international standards.

Several NGOs, some of which provide medical care in the conflict-torn eastern DRC, have asked for waivers.

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

“Promoting local industry is a good thing,” said Dijimba, a graduate of the University of Texas, insisting that several Congolese companies, including his own, maintained high standards.

“It could grow the middle class.”

According to the World Bank, around 73% of the DRC’s 90 million people live on less than $1.9 a day. Most of the products of the African country are imported.

– “At your peril” –

The Congolese government has designated 35 drug molecules, including paracetamol, that medical institutions will be required to purchase in a locally manufactured form.

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

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

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

Fifteen new pharmaceutical companies are setting up in the DRC ahead of the new rules, Kabey said, which will be added 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 ran amok towards the end of ex-dictator Mobutu’s rule. Sese Seko.

But experts warn that drugs made in Congo face a major challenge: reassuring doctors and patients that they meet regulatory standards.

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

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

Vreeke said Congolese regulators have improved, but the country lacks the massive resources needed to properly audit, check labels and inspect the chemical composition of drugs for safety.

Kabey, whose department at the Health Ministry oversees inspections, said standards had improved “tremendously” in recent years, but did not provide further details.

He said the government was in the process of setting up a national quality control laboratory.

– “A huge thing” –

According to the World Health Organization, poor quality or falsified medicines kill hundreds of thousands of people every year, mainly in poor countries.

The hot and humid climate of the DRC also poses storage problems.

A 2021 study of imported and locally produced eye drops sold in Kinshasa, for example, showed that three out of seven products tested were substandard. The only sample made in the DRC was contaminated.

Outside a pharmacy in Kinshasa’s upscale Gombe district, holding a bag of drugs in her hand, Joelle Mamputu, a 29-year-old corporate lawyer, said she hadn’t paid attention to where the drugs were. fabricated but said she had “no prejudice”.

However, a 52-year-old civil servant 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 Doctors of the World (MDM) have requested waivers from procurement requirements, several aid workers said.

MSF declined to comment.

MDM confirmed that it requested an exemption due to concerns about quality and the ability to meet demand.

“It’s a huge thing,” said a humanitarian who requested anonymity, explaining that the new rules will affect all non-governmental organisations, hospitals and pharmacies.

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

“We need to have high quality standards for everyone, but the reality of the country is that sometimes that’s not possible.”

eml/ri