Africa will be setting up its first agency to check the spread of spurious drugs
ON DECEMBER 10, 2018, drug regulators and health experts from 55 African Union (AU) nations came together in Rwanda’s Kigali to rein in a giant killer: fake medicines in the continent. Sub-Saharan Africa received almost half of the world’s “fake and low-quality” medicines between 2013 and 2017, says the World Health Organization’s (WHO) report titled The Global Surveillance and Monitoring System of Substandard and Falsified Medical Products. It adds that fake drugs alone kill more than 0.16 million people suffering from malaria every year in the region. This costs $38.5 million to patients and health providers for further care due to failure of treatment.
In August 2017, AU member nations had floated the idea of setting up the continent’s first-ever drug harmonisation programme, under which a medicine entering Africa will be tested using common regulatory guidelines. In May 2018, the idea was given shape when health ministers from member nations met in Geneva and adopted a treaty to set up the nodal African Medicines Agency (AMA), under AU’s New Partnership for Africa’s Development (NEPAD), by January 2019 “to harmonise medical regulations of member countries”.
The December 10 meeting, attended by 80 participants, including representatives from AU nations and experts from WHO, East African Community, an intergovernmental organisation composed of six eastern African countries, and NEPAD, was called “to discuss how AMA will operate, before the heads of states approve it”, says Diane Gashumba, health minister, Rwanda. It was decided that NEPAD’s regional economic committees will be used to “ensure the coordination and strengthening of continental initiatives”. It also identified that spurious drugs flourished in the continent due to “weak legislative framework, sluggish medicine registration processes, delayed approval decision and limited technical capacity, among others”.
Rwanda’s Food and Drugs Authority issued a warning to doctors and pharmacists on December 7, 2018, about the availability of fake medicines used to prevent post-partum haemorrhage. It said two medicines, Misoprostol (manufactured by India-based Bio-generic and Remedies Private Limited) and Oxytocin (manufactured by China-based Jiangxi Xierkangtai Pharmaceutical), imported between 2017 and mid-2018 were “fake” and should not be administered. The statement added that fake drugs had already been distributed to district government hospitals and faith-based health centres across the country. The drugs are extremely important to Rwanda as post-partum haemorrhage is one of the main causes behind the country’s high maternal mortality rate (210 per 100,000 live births in 2015). In fact, Rwanda set up the Food and Drugs Authority in July 2018 to check the growing market of spurious drugs and vaccines.
The problem is equally acute in Sierra Leonne that imports all its medicines, bulk of which come from illegal channels, says Alphan Tejam Kelle, a medical professional at the meeting in Kigali. “Our bordering countries Liberia and Guinea have different regulatory systems. So many of our people travel to these countries and try to illegally get the medicines,” he adds. In Burkina Faso, non- registered medicines are openly sold on the roads of its capital Ouaga-dougou despite the fact that the country has policies against fake medicine, says Oula Ibrahim Olivier Traore, a medical practitioner. Over nine per cent of medical products sold in the country are fake, says a 2015 study published in Plos One.
Exorbitant drug prices are one of the main reasons why fake medicines flourish in the continent. Experts believe AMA will immediately bring down drug prices as country-specific testing and registration of drugs would become redundant. “This will make high quality medicine affordable to all people,” says Christophe Bazivamo, deputy secretary general of East African Community.
Andrea Julsing Keyter, deputy director, medical devices, South Africa Health Products Regulation Authority, highlights another advantage of AMA when she says that if a country finds an issue with a medicine, it will inform other African countries, allowing for quick action. This is important as the 2017 WHO report says complex supply chains make detecting spurious drugs difficult. “A tablet taken in Germany may be made in Egypt from ingredients imported from India, Brazil and Spain, packaged in foil that came from China, inserted into a box designed for the United Kingdom of Great Britain and Northern Ireland, and shipped to Liverpool by way of Dubai,” says the report. A September 2017 study by the World Customs Organization and the International Institute for Research against Counterfeit Medicines in 16 African countries found that India and China accounted for more than 96 per cent of the spurious drug imports.
Gashumba says along with AMA, countries should start manufacturing medicines to reduce their dependency on imports, which currently stands at 70 per cent. South Africa and Morocco are the only African countries that manufacture medicines in a big way. In December 2017, Rwanda allowed Moroccan firm Cooper Pharma to start constructing the country’s first manufacturing plant. It should be operational by 2019.
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