Fake drugs for tuberculosis and malaria kill around 700,000 people each year in less-developed countries, according to a report by the International Policy Network.
In one shocking case, over the course of three months, 84 Nigerian children died from kidney failure brought on by the industrial solvent diethylene glycol in teething syrup.
To combat the dangers of such bogus or substandard drugs in Africa, Ghana will house Sub-Saharan Africa’s first-ever center against counterfeit medications.
The multi-million dollar U.S.-sponsored Center for Pharmaceutical Advancement and Training (CePAT) will be ready for action on May 13th, setting up shop in the capital, Accra.
Fake, contaminated and adulterated medications are a serious and growing problem, especially in developing countries. In fact, criminal rings have turned the business of counterfeiting into a multi-billion global enterprise.
“The threat of counterfeit and substandard medicines is a global crisis, and we have seen, firsthand, the repercussions in developing countries,” says Dr. Stephen Opuni, CEO, Food and Drug Authority, Ghana.
It’s a different world
Unlike in the U.S., where several federal agencies regulate the medicine supply chain, in developing countries the parameters tend to be haphazard and penalties are not always enforced.
It is impossible to accurately quantify the scope of the problem, but Interpol estimates about 30 percent of medicines circulating Africa are either counterfeit or of inferior quality.
“Regulatory mechanisms are weak and, as a result, poor quality drugs have made their way into the market,” says Dr. Patrick Lukulay, vice president of Global Health Impact Programs at USP. Corruption, high demand for cheap drugs and weak surveillance at border crossings exacerbate the problem, he adds.
“What’s even more disturbing is these drugs are not just in the private sector, but in the public sector and government facilities,” says Lukulay. “Patients have nowhere to run to have confidence the drugs they are obtaining are good quality.”
Most of the fake drugs are imported from Southeast Asia for the treatment of deadly diseases, such as malaria, tuberculosis and HIV.
Paving a new path
The objectives of CePAT are twofold: to provide training for regulatory officials to offer proper oversight or quality control of medicines coming into their countries and to train pharmaceutical companies on good manufacturing practices.
In the first phase of the project, the U.S. Pharmacopeial Convention pledged $1.5 million for the construction of the building. During the first 12 months following the May launch, USP will accommodate numerous pharmaceutical companies and provide funds to train 40 regulatory officials from several African nations.
Further down the line, USP hopes to replicate the Ghana facility in other parts of Africa and developing countries.
“CePAT’s comprehensive training modules will facilitate the development of local industry talent and strengthen regulatory and quality systems in sub-Saharan Africa,” says Opuni.
Lukulay says the expertise provided by the high-tech training center is vital to root out the widespread problem because fake drugs are notoriously difficult to detect.
“Generally they are the exact mimic of what the true medicines look like,” says Lukulay. He adds that often the only way to be sure is to test the drugs in a laboratory setting.
Saving the ones really hurt
Because those that suffer are the patients. These fake, expired and unregistered drugs can be contaminated, past their expiration date or contain the wrong dose of, or none at all, active ingredients. Some even contain toxic substances such as arsenic.
Fake drugs can also prolong diseases and trigger severe adverse reactions when taken with other medicines patients are taking. Worse still, these drugs can cause death.
“The center will provide local talent with better technological know-how to test these medicines before they are delivered to patients,” says Lukulay.
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