As the debate continues among medical practitioners and South Africans over the use of Ivermectin to treat Covid-19 patients, there are now concerns that the approval of the antiparasitic drug for human use could fuel its illegal trade.
Last week, the South African Health Products Regulations Authority (SAHPRA) announced that it would allow a controlled compassionate use of Ivermectin to treat Covid-19, following pressure from medical professionals and AfriForum for the regulatory body to authorise the medication that was previously marketed for veterinary use in the country.
Some studies have highlighted the benefits of using Ivermectin in the management of Covid-19, but there is still insufficient evidence on its efficacy.
The Department of Health and some health professionals have raised questions over the safety of Ivermectin for human use, as well as the legal consequences for doctors who choose to administer the drug.
This week, the Pretoria High Court also ruled that doctors could begin the treatment without having to wait for the outcome of a Section 21 application from SAHPRA. The case was lodged by AfriForum.
A Section 21 application has to be submitted to SAHPRA by medical practitioners who want to prescribe medicine which has not been registered for human use in South Africa, according to the Medicines and Related Substances Control Act.
Impact on veterinary sector
Dr Aslam Dasoo, a medical expert, on Wednesday said the decision by SAHPRA could have immense consequences not just on doctors who prescribed Ivermectin, but also on the contribution to the illegal trade of the drug.
“The veterinary sector has been denuded of stock and farmers, who have large amounts of stock, have been known to sell to people wanting to buy,” Dasoo told Jacaranda FM.
“It’s the rainy season right now [and] cattle farmers around the country have to deworm their cattle. They now don’t have sufficient stock to do that. So, either the cattle have to be put down or it might enter the food chain and then where are we?” he asked.
Last week, five suspects were arrested at OR Tambo International Airport in separate incidents after they were found with R6 million worth of unregistered tablets, suspected to be Ivermectin.
The suspects face charges relating to the contravention of the Medicines and Related Substances Act 101 of 1965, including being in possession of unregistered medicines without authorisation and importing medicines without a licence from SAHPRA.
They appeared before the Kempton Magistrate’s Court on Monday and their case was postponed to Wednesday and Thursday.
Dasoo said the illegal-market trade of Ivermectin was a real problem, and law enforcement would have to deal with this.
“It’s a law enforcement problem not a health science issue or a SAHPRA issue,” he said.
Health department frowns on Ivermectin
Meanwhile, the Department of Health last Friday discouraged the use of Ivermectin for the treatment of Covid-19 until the study on its efficacy and safety was concluded.
The department said that the National Essential Medicines List Committee (NEMLC) Covid-19 sub-committee had carefully considered all available evidence on the treatment or prevention of the virus with Ivermectin.
“Currently, there is insufficient evidence to recommend Ivermectin for the treatment or prevention of Covid-19. Some studies have suggested that Ivermectin may be of benefit of management of Covid-19, however, the evidence that is currently available is preliminary and of low quality,” said the department’s spokesperson Popo Maja.
Maja said several studies were underway exploring efficacy and safety of Ivermectin in the management of Covid-19.
“The outcomes of these studies will provide the department with more scientific data to make informed decisions on the usage of Ivermectin to manage the pandemic.
“As new data becomes available, the sub-committee will continuously review and amend the recommendations accordingly. In the meantime, we discourage the use of Ivermectin outside of well-conducted randomised controlled trials,” he said.