PETALING JAYA: The government has told private doctors to seek the advice of Clinical Research Malaysia (CRM) if they are interested in conducting clinical trials on Ivermectin, a controversial drug touted as a cure for Covid-19.
CRM, which is a one-stop centre to facilitate such research, is a company established by the health ministry.
National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said CRM would help general practitioners (GPs) determine the feasibility of clinical trials.
For regulatory requirements, they must refer to the Malaysian Guidelines for the Application of Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption (CTX), she said.
The guidelines can be downloaded from the NPRA website.
A CTIL allows applicants to import unregistered products for the use of clinical trials and a CTX is required if an applicant wants to produce a new drug for clinical trials.
Roshayati said CRM could give its assessment of the feasibility of clinical trials on Ivermectin within 14 working days.
Last month, two professional health groups said they were concerned over the widespread sale of Ivermectin throughout the country.
The Malaysian Pharmacists Society and the Malaysian Medical Association (MMA) said studies had shown that the certainty on the effectiveness of the drug on Covid-19 was low.
Dr Koh Kar Chai, the incoming MMA president, said there was a need to create greater awareness among GPs that Ivermectin had not been consistently proven to manage Covid-19.
“A concerted effort should be made to impress on the doctors that Ivermectin is not indicated for the management of Covid-19 and they should not prescribe it knowing full well that it is not in accordance with the guidelines and also legislation,” he told FMT.
Doctors do have the option for off-label use of the drug if they want to do so for clinical trials. But Koh said they would have to bear the consequences of any adverse effect on their patients.
Dr Roslina Abdul Manap, a senior consultant respiratory physician with Universiti Kebangsaan Malaysia (UKM) agreed with Koh that doctors should apply for off-label use of the drug.
The responsibility for any adverse effect would then primarily lie with the prescribing doctor and the consenting patient, she said.
“Physicians have used the off-label option frequently in other clinical situations, but I believe that all medical practitioners are bound to follow the law of the land,” she added.
Ivermectin has attracted international attention following several case studies and clinical trials that showed promising results in treating Covid-19, but the World Health Organization has not recommended it for use outside of such trials.
In June, the health ministry said hospitals were allowed to apply to the Drug Control Authority to use Ivermectin for off-label use, including for the treatment of Covid-19 patients.
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