Hospitals can apply for Ivermectin permit
In a radio interview, FDA Director General Eric Domingo said that as of Friday afternoon only one hospital has secured a CSP from the agency.
“All of the hospitals can apply for compassionate special permit for Ivermectin. As you know, many of the drugs being used against Covid-19 are not yet registered as these products are still under investigation,” Domingo said.
Earlier, Domingo disclosed that the FDA approved the CSP application of a hospital for the use of Ivermectin as cure for the virus but failed to disclose the name of the health facility.
“So, Ivermectin is one of the drugs under investigation for Covid-19, although there is not enough evidence to register it as Covid-19 drug but it is eligible as compassionate special permit from the FDA. All hospitals can avail of the CSP,” Domingo added.
Domingo noted that it will only take 24 to 48 hours for the processing of CSP for Ivermectin.
“As long as the requirements are complete, we will process the compassionate special permit within 24 hours to 48 hours. The requirements include, first the doctor should show proofs that the drug is registered in the country of origin, he will take full responsibility for the use of the drug and he should show evidence that there is indeed ongoing clinical trial,” he explained.
Domingo added that the hospital should also present evidence that it has license to import the drug to process the compassionate special permit for Ivermectin.
Domingo noted that it will only take 24 to 48 hours for the processing of compassionate special permit for Ivermectin.
At the same time, Domingo said the FDA is still awaiting the submission of necessary documents after two companies expressed their intention to register Ivermectin.
“The two companies asked the FDA on the list of requirements to register Ivermectin and they have yet to submit the necessary documents to us,” he said.
Domingo said that the FDA can process the product registration within few weeks once the documents are completed.
“Of course, we need to make sure the quality and safety of the product before approving its registration,” Domingo said.
CIDG crackdown
Meanwhile, the Philippine National Police Criminal Investigation and Detection Group (CIDG) said it will arrest illegal sellers of Ivermectin as part of the FDA crackdown on unregistered sellers of the anti-parasitic drug.
The hospital should also present evidence that it has license to import the drug to process the compassionate special permit for Ivermectin.
CIDG chief Maj. Gen. Albert Ignatius Ferro said the FDA requested the local government units and law enforcement agencies to ensure that said product will not be sold or used illegally in their respective areas of responsibilities.
In response to the directive of President Rodrigo Duterte’s last March 24 and in coordination with the FDA, the CIDG has directed its operating and field units to implement measures to monitor the dispense and use of Ivermectin across the country and to conduct an investigation and intensified police operations against any violations of Republic Act 9711 and of the FDA’s CSP.
Ferro also said that they will go after those who will violate the said provisions specifically on fake, unregistered/ unlicensed, and no permit on the sales and distribution of the said drugs.