South African Health Products Regulatory Authority (SAHPRA) Bans Ivermectin with Criminal Liability

South African Health Products Regulatory Authority (SAHPRA) Bans Ivermectin with Criminal Liability

The South African Health Products Regulatory Authority (SAHPRA) has banned the importation of Ivermectin into the country. Used to treat people and animals against parasites for decades now, the drug has been hailed as a revolutionary regimen since the 1980s: since then, billions of people primarily in the tropics have been treated, and consequently, a well-known safety profile emerged. However, with growing chatter about the benefits of the drug in relation to COVID-19 (based on dozens of case series, observational and randomized controlled studies), Dr. Boitumelo Semete-Makokotela, SAHPRA’s chief executive, recently declared, “Our stance is unambiguous. This drug is not approved by SAPHRA, and any attempt to import it into the country will be dealt with by SAHPRA’s regulatory compliance unit in conjunction with law enforcement agencies such as SAPS and the SIU.” Moreover, the regulatory head pointed at a whistleblower contact to the public should anybody be aware of such activity. Given the drug’s pervasive use throughout the African continent to fight parasitic infection, the move comes at an interesting time, where mounting data points to the possible benefits of the drug. Why wouldn’t the regulatory head want to at least investigate the findings? Why an outright ban with criminal liability? What’s he afraid of?

While the World Health Organization (WHO) did add Ivermectin to its “Prequalification Unit” for the first time, it’s not clear what is behind this move. Also, as Ivermectin is used throughout equatorial Africa for fighting parasites, it’s not clear why the South African authorities are taking such a draconian stand against this well-known, FDA-approved drug. 

A recent piece in South Africa’s Independent Online showcased the ban, which appears to coincide with growing evidence that the drug may actually have some impact against the novel coronavirus. In fact, the local press there referred to Dr. Pierre Kory and the Frontline COVID-19 Critical Care Alliance’s presentation to a US senate homeland security and governmental affairs committee recently. Called a “wonder drug,” Ivermectin has been shown in a number of studies, from case series to observational and randomized controlled trials, that the drug possesses powerful antiviral and anti-inflammatory agents.

Conflicting Interpretation

Despite a growing chorus of voices from prominent doctors and researchers from America to Bangladesh, others in power don’t want to hear anything about it. For example, Mr. Semete-Makokotlela declared recently, “At present, there is no confirmatory clinical evidence available for the use of Ivermectin in the management of COVID-19 infections.

What are they Afraid of?

TrialSite points out that even the U.S. National Institutes of Health (NIH), not a big advocate of generic repurposed drug exploration targeting COVID-19, suggests Ivermectin not be used unless it’s studied in clinical trials. Even doctors promoting the magical qualities of Ivermectin are on the record that more research is needed. Why the wrathful response from South Africa’s regulatory head? Why the anger and enmity? Shouldn’t there be curiosity amongst scientists and regulators to conduct research and test for themselves? Why the extraordinary move to just band the drug, with criminal penalties for anyone that disobeys such an edict? What are they afraid of?