First the kidneys fail. Then the central nervous system. Then breathing becomes more difficult. The body slowly stops working until it stops working.
In the West African country of The Gambia, 69 children died of acute kidney failure from late July to last Saturday. The suspected cause: a seemingly harmless cough syrup, about which the World Health Organization published a shocking report last week. Instead of the common and safe glycerin, the toxic diethylene glycol in the cough syrup could have been processed. Ugly substance is a kind of antifreeze. Drinking it can be fatal, especially to children.
When the number of Gambian children with acute kidney failure rose remarkably fast in late July, the government quickly banned the sale of cough syrup. “Until recently, the substance was sold in private clinics and hospitals,” Gambian health scientist Mustafa Betay told Reuters news agency.
While the crow flies, Gambian authorities visit pharmacies and markets, in association with the Red Cross. They also visit people’s homes to track down and destroy deadly cough droplets as quickly as possible. The Director-General of the World Health Organization said last week that it was impossible to rule out the possibility of the toxic cough medicine spreading to countries outside the Gambia via the black market.
This is not the first time that diethylene glycol has led to kidney failure and the death of dozens of children. In 1996, 85 children in Haiti died from ingestion of a poisonous drink due to fever, sore throat, and headache. Person in charge: The Dutch company Vos, from Alphen aan den Rijn, broker of medicinal raw materials for “Medicine”.
Through a test by an outside lab called V, Voss discovered that the glycerol in the drink wasn’t pure enough, even before the substance reached the Haitian coast. “But by that time the raw materials were already on their way, via the German parent company Helm, which eventually transported the goods to Haiti,” says Wilbert Bannenberg, health consultant and president of Pharma Ter Vere Antofording. “Voss and Helm did not remember the raw material, which led to the deaths of dozens of children.”
There are more examples. In 2006, 115 people died in Panama as a result of this substance, when diethylene glycol ended up being used in 260,000 bottles of medicine. Things also went wrong in Bangladesh, Nigeria and India, killing dozens.
In short, diethylene glycol is a silent killer, The potentially catastrophic consequences that have been known for years. So why did the poisonous cough syrup seep through all the controls and could it travel undisturbed from Haryana, India, into the Gambian interior?
What is diethylene glycol?
To dissolve drugs in liquid drinks, drug manufacturers often use glycerol, also called glycerol. It is a colorless liquid that can be dissolved in water. Pure glycerol is commonly used in medicines – not unimportant – it is extremely safe.
The impure version, diethylene glycol or DEG, is very similar to glycerol in molecular formula. However, the health differences are significant: diethylene glycol is highly toxic and not medically usable. DEG solutions are used as antifreeze. Anyone who takes this substance can develop problems with the central nervous system, liver, and kidneys. This can have serious consequences, especially for children.
other raw materials
What’s clear: Somewhere in the long link from the Indian manufacturer to the Gambian pharmacy, something went wrong with the cough medicine getting under control. “It starts with the company that supplies the raw materials,” Bannenberg says. According to the manufacturer Maiden Pharmaceuticals, the raw materials are supplied by “reliable and certified” companies. “However, the trusted manufacturer still verifies in the lab that the liquid is supplied: safe glycerol, or toxic diethylene glycol.”
According to Bannenberg, Maiden Pharmaceuticals, which processes raw materials into a cough medicine, may not have performed this additional laboratory examination. “This is dangerous, because the materials are visually indistinguishable from each other.”
Maiden Pharmaceuticals has a bad reputation anyway. In 2014, the company was blacklisted by 39 pharmaceutical companies in Vietnam due to seriously poor production. Vietnam followed the Indian state of Bihar, which had already decided to do so in 2011. And in 2018, an Indian drug inspector sued the company for failing to meet quality standards. However, the company has been certified Good Manufacturing Practice by the Haryana Regional Pharmaceutical Authority.
world pharmaceutical factory
India is the largest producer of generic drugs in the world. Generic medicines are not patented, which means that they are cheaper than brand-name medicines, while containing the same substances. These lower prices are significant for India, where there is no health insurance for a large part of the population.
As a home manufacturer of generic medicines, India plays an important role on the world stage. Half of India’s pharmaceutical industry, which was worth $42 billion in 2021, is going abroad. More than 50 percent of generic medicines in Africa come from India.
out of sight
Bad medicines are more likely to seep into Indian control, says Lina Minghani of Doctors Without Borders in India. In 2015, researchers at the University of Maryland found that Indian companies sometimes produce lower-quality, cheaper drugs for markets with poorly controlled systems, particularly in Africa and Southeast Asia.
“India’s 28 regional drug watchdogs operate largely out of the sight of the most professional national authority,” Megani said. As a result, low-quality and sometimes even toxic drugs can enter the market. The chance that these drugs will end up substandard in Europe or the United States is slim, because the US and European authorities, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), conduct very strict safety checks.
“In reality, a large proportion of Indian medicines are of good quality,” said Nicole Spiker, CEO of Pharmaccess, a nonprofit organization dedicated to healthcare in Africa. Since India has managed to keep prices low, the country plays an important role in the supply of medicines. But a lot of money is also being made in India from producing bad drugs, even fake ones.”
It wasn’t just the Indian side of the story that mistook the deadly cough medicine. After all, the toxin also passed through the gambiense control. “While Dutch authorities usually structurally check imported drug samples for quality, this is often not possible in The Gambia,” says Spiker. “Sometimes there are only three or four inspectors working at the port, who together have to check all the incoming medicines.” That is why this examination is usually done on a random basis. Is one sample good? Then the rest can go on.
Speicher says corruption also weakens the regulatory system. “It regularly happens that the inspectors are bribed at the port, and the drugs enter the country invisibly.”
Inside, the drugs end up in an inconspicuous transfer process. “Often in Africa, medicines have to reach remote, inhospitable places in the interior,” Spiker says. This is the reason why the package moves from one medium to another. What these middlemen do with drugs along the way is not transparent. It may be that a medicine in good condition has arrived at the port, but the dealers are replacing the medicines with fake medicines or even dangerous substances.”
Because of substandard controls and the maze of dealers, substandard drugs often reach patients’ kitchen cupboards. It recently reported that 10 per cent of medicines in poor countries do not meet the requirements of the World Health Organization.
That must change, say pharmaceuticals in various African countries. This is why trials continue to be conducted on a small scale using digital technologies that provide insight into the journey of medicine, Spiker explains. “In Nigeria, producers put QR codes on medicine packages. For example, small hospital pharmacists can better verify middlemen that such a drug has gone through, even if the package is in a convenience store in a supermarket. stuck he is.”
Countries like Nigeria and Ghana have already taken legal action to ban the sale of medicines from some substandard Indian suppliers. And Spieker in Ghana works with Pharmaccess on Med4all, “a kind of bol.com for small hospitals, where pharmacists and hospitals buy drugs without middlemen.”
But the best long-term solution, according to Spiker: The African continent should also build its own pharmaceutical factories. The pandemic has shown how quickly medicines run out on the continent when the need is greatest, think of Corona vaccines. If there is a pharmaceutical factory located in your country, you also complain loudly when something goes wrong.”
The search for killer cough medicines is now in full swing. A Red Cross official recently told the BBC that more than 16,000 products have now been located and destroyed. Maiden Pharmaceuticals has since stopped production after the Indian Medicines Authority concluded the company had breached numerous regulations “in both manufacturing and testing”. Both the Indian government and the Gambian government are investigating the matter further.
“It is time for the Indian government to improve the fight against drugs,” said Lina Minghani of Doctors Without Borders. “Exporting cheap medicines comes with great responsibility.”
Parents of deceased children are considering a lawsuit against the Gambian state. “This should not happen again,” Maryam Sisaw, who lost her five-month-old daughter Aisha, told the BBC. “Before medicines enter the country, it is necessary to check whether they are fit for human consumption or not. This is a lesson for parents, but above all a great responsibility of the neglected government.”
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