MANILA – Lloyd Laboratories Inc. and Pascual Laboratories Inc. are willing to apply for registration with the Food and Drug Administration (FDA) to produce Ivermectin for human use, Anti-Red Tape Authority (ARTA) director general Jeremiah Belgica said on Tuesday.
In a virtual press briefing, Belgica said the two local pharmaceutical companies expressed their intent to register for Ivermectin production during their meeting with FDA Tuesday morning.
He added that their registration will be pursued once the Department of Health (DOH) will include Ivermectin in its Covid-19 treatment plan.
“If Ivermectin will have the accreditation to be part of the treatment plan, then their application will be under emergency use authorization (EUA). Otherwise, it will be under compassionate use or the regular certificate product registration (CPR) process. So it’s important that we get the response from DOH if they are willing to include Ivermectin in the treatment plan,” the ARTA chief said.
In recent statements, health authorities do not recommend the use of Ivermectin for viral infection treatment including Covid-19 as this product is not registered with the FDA.
The only registered Ivermectin products in the country are used for certain animal species to treat internal and external parasites as well as prevention of heartworm disease.
Belgica said once there will be mass production of Ivermectin, prices of this medicine could be lower from the current price range of PHP35 to PHP40 per capsule.
‘Too much bureaucracy’
Pharmaceutical companies and business groups have mentioned during their hearing with ARTA and FDA that no one has tried to apply for Ivermectin registration for human use due to cumbersome process of registration, Belgica said.
“Excessive government bureaucracy especially during the pandemic is deadly,” he added. “We only need the necessary processes, and the government offices should be proactive.”
But Belgica said DOH and FDA should not be blamed for “not doing their jobs” since there are no companies yet that submitted their registration for Ivermectin use for treating human.
Study Ivermectin for Covid treatment
The top anti-red tape official said his office has invited DOH officials for a meeting to explain why they have not included Ivermectin in the Covid-19 treatment plan.
“We also requested that it will also be endorsed for study immediately,” added Belgica.
Dr. Homer Lim of Concerned Doctors and Citizens of the Philippines said in his podcast Monday that there are clinical trials that can prove Ivermectin’s efficacy in treating Covid-19 symptoms.
“(The clinical trials) really show that Ivermectin has a really good track record in improving patients’ outcome with Covid-19, especially if you give them as an early treatment for Covid. That would prevent them in getting severe form of Covid, and prevent them or avoid them from going to the hospital, and therefore deaths,” Lim said.
Belgica also said Lim reported to ARTA that a pharmacy compounding Ivermectin for human use was raided for producing the said medicine.
He added that the Ivermectin that were being produced in the raided pharmacy are those with requests from doctors who are giving Ivermectin to treat their patients, and not for mass production.
In their meeting, the FDA said they will be allowing pharmacies for compounding Ivermectin but for those with doctors’ request only, Belgica said. (PNA)