With Covid-19 deaths continuing to grow at an alarming rate, appeals to President Cyril Ramaphosa to review the country’s stance on Ivermectin were raised in a petition endorsed by nearly 100 medical professionals, and included a Durban doctor’s letter.
In the letter circulated this week, the president was reminded about the evidence which confirms the drug’s potency. But the standard laid down by the South African Health Products Authority (Sahpra), the medicine regulatory authority, is that Ivermectin is not for human consumption locally.
Sahpra confirmed they remained unmoved on their classification of the drug, until more conclusive evidence to sanction its use in the fight against Covid-19 was received.
While Ivermectin was cleared for use in some countries, in South Africa, Sahpra has permitted its use only in animals. Sahpra indicated in some countries Ivermectin was used off-label in the treatment of Covid-19, even though it did not receive specific approval for that purpose.
However, Dr Naseeba Kathrada, a Durban-based general practitioner raised in her letter the fact that scientific evidence had emerged daily, showing the positive effects of Ivermectin.
She implored Ramaphosa to set up an urgent special council to do a thorough overview and rapid review of the drug, which would bring “some hope back to families who have infected loved ones.”
“Front-line workers will be re-energised knowing that you trust us to uphold the oath ‘first to do no harm’ by giving us this potent anti-inflammatory drug to add to our seemingly defenceless fight against this new strain,” an extract from Kathrada’s letter read.
While Kathrada acknowledged Sahpra’s jurisdiction, she believed the call for doctors to make a Section 21 application on behalf of each patient to use Ivermectin in Covid-19 cases was “ridiculous”.
Sahpra requires Section 21 applications in instances where doctors believe, according to their clinical judgement, that administering unregistered medicine was warranted.
Kathrada said some doctors handled as many as 60 Covid-19 patients a day and the Section 21 application, which cost R300 each, was long and tedious. “We just do not have the time!” Kathrada said she didn’t consider Ivermectin to be a “miracle drug” but believed that it was “safe”, and warned that the continued blocking of the drug would allow the “blackmarket” trade to flourish.
“Give us the freedom of choice to take this drug as prophylaxis (a preventative measure) so that we have a better chance to be around when the vaccine arrives and help with the rollout,” appealed Kathrada.
Yuven Gounden, Sahpra’s spokesperson, reiterated that Ivermectin was not authorised as a prophylaxis for Covid-19 and had already turned down Section 21 applications.
“When new emerging evidence has been reviewed by Sahpra and is found to be supportive for the treatment of Covid-19 infections, then Section 21 applications will be authorised for the human use formulation of Ivermectin.”
He confirmed the interest in Ivermectin multiplied when the second wave of Covid-19 infections surfaced.
“The first wave was between June and September and that has not prompted any applicant to submit a randomised controlled clinical trial application to research the use of Ivermectin in the treatment and prevention of Covid-19.”
Gounden said Sahpra will expedite applications once received, and they were an independent health products regulator, thus they would not conduct their own clinical trials on the drug.
He said Sahpra was open to considering new and emerging clinical data to review its stance on this matter.
Gounden said Sahpra would continue to maintain a firm stance against illicit formulations or veterinary use formulations for the treatment and prevention of Covid-19 infections in humans.
Last week, a 43-year-old man was arrested for being in possession of 2464 tablets at King Shaka Airport. He appeared at the Verulam Magistrate’s Court, charged for being in possession of unregistered drugs and was granted R5 000 bail.
Last Thursday, Sahpra officials were also present when members of the Provincial Organised Crime Unit raided Durban’s Ahmed Al-kadi Hospital on suspicion the drugs might be on the premises.
Brigadier Jay Naicker, Provincial spokesperson for the Saps said: “A case of contravention of the medicines and related substances act is being investigated.
“The matter is still under investigation and once completed, it will be forwarded to the National Prosecuting Authority for a decision.”
Attorney Anand Nepaul, the hospital’s legal representative, said no such substance was found at the premises, and there were no arrests or charges against his clients who denied any wrongdoing.
“We await the outcome of the investigation,” said Nepaul.