In her affidavit on behalf of the group, Dr Naseeba Kathrada said they believed that the drug had previously been registered for human use (for the treatment of scabies and lice), but the registration had expired and because the patent had expired, there was very little profit motive in having it registered again.
Kathrada said Sahpra’s stated intention, in allowing for compassionate use through its section 21 process, had failed because many people were still sourcing black-market product, possibly of dubious quality, and self-medicating.
She and other doctors shared their experiences of using the section 21 process, saying it took up to 45 minutes to complete the form. In spite of submitting these, along with payment, they were not aware of a single one which had been approved.
She said the problem appeared to be the sourcing of the drug.
At the time of drafting her affidavit, Sahpra had now approved four suppliers. “However, these are importers and I am not sure at this stage how this will enable ivermectin to be readily available in South Africa for prescribing purposes,” she said.
“There is little worse for an attending doctor than to watch a patient unresponsive to every available treatment, knowing that ivermectin, used by hundreds of millions of people, is showing promise in certain circumstances but it is not available.”
Kathrada said the doctors all agreed that it must be a schedule 3 drug - only available on prescription and under medical supervision.
TimesLIVE
Doctors launch interdict to access ivermectin for themselves and patients
Image: Supplied
A group of South African doctors and medical practitioners has launched an urgent court application seeking wide-ranging orders to enable them to personally use, and prescribe to their patients, ivermectin.
The group of 55 “front-line workers” initially attempted to join other applications seeking similar relief but say those did not address the dire situation faced by doctors and their patients who want effective access to the drug.
They claim that their applications to the South African Health Products Regulatory Authority (Sahpra), under its “compassionate use programme”, have not been approved and, to their knowledge, none have been so far.
“We are not asking for it [ivermectin] to be included in Covid-19 treatment protocols. We are not asking that it be made freely available without prescription or medical supervision. We are not asking that it replace vaccines,” the said.
“Some countries have already included it in their protocols, including Peru and India. However, we are of the view that the results of various clinical trials will inform that decision.”
Calling themselves the “I can make a difference doctors and medical practitioners group”, they say they are divided on whether it is a miracle drug.
“We have varying levels of optimism on its efficacy. But we are all of the firm conviction that it should be a tool in our arsenal to fight Covid-19 in a shockingly empty tool box.”
Sahpra has filed a notice of intention to oppose the application, set down for February 22 in the Pretoria high court, but is yet to file any papers.
The doctors are asking the court to issue several declaratory orders:
They want the court to direct the respondents to do all necessary to permit pharmacists to compound the drug, to provide specifications for this, and to permit importers, suppliers and retailers to sell it.
In her affidavit on behalf of the group, Dr Naseeba Kathrada said they believed that the drug had previously been registered for human use (for the treatment of scabies and lice), but the registration had expired and because the patent had expired, there was very little profit motive in having it registered again.
Kathrada said Sahpra’s stated intention, in allowing for compassionate use through its section 21 process, had failed because many people were still sourcing black-market product, possibly of dubious quality, and self-medicating.
She and other doctors shared their experiences of using the section 21 process, saying it took up to 45 minutes to complete the form. In spite of submitting these, along with payment, they were not aware of a single one which had been approved.
She said the problem appeared to be the sourcing of the drug.
At the time of drafting her affidavit, Sahpra had now approved four suppliers. “However, these are importers and I am not sure at this stage how this will enable ivermectin to be readily available in South Africa for prescribing purposes,” she said.
“There is little worse for an attending doctor than to watch a patient unresponsive to every available treatment, knowing that ivermectin, used by hundreds of millions of people, is showing promise in certain circumstances but it is not available.”
Kathrada said the doctors all agreed that it must be a schedule 3 drug - only available on prescription and under medical supervision.
TimesLIVE
Drug maker Merck warns against the use of ivermectin to treat Covid-19
Ivermectin still illegal for dispensing by unregistered professionals, warns health authority
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