Two local pharmaceutical firms — Lloyd Laboratories and Pascual Laboratories — are willing to mass produce human Ivermectin, the so-called “wonder drug” that was originally formulated as anti-parasite drug for animals, as the world races to stop the resurging infections and deaths from COVID-19.
Anti Red Tape Authority (ARTA) Director General Jeremiah Belgica revealed this after holding a meeting yesterday with the Food and Drug Administration (FDA) and the pharmaceuticals industry. ARTA will hold another meeting tomorrow, March 31, with the Department of Health.
“Lloyd Laboratories and Pascual Laboratories are taking the challenge to apply for Ivermectin,” said Belgica, who stepped in, motu propio, to facilitate the process of the application with the FDA.
ARTA is urging FDA to expedite its processing of applications after the agency announced that doctors and hospitals may now apply for a Compassionate Special Permit (CSP). The CSP allows for the registration of food and drugs for applicants that will be able to provide a License to Operate, a Certificate of Product Registration, a Letter of Intent with undertaking to take full responsibility, and other requirements.
“With this directive, FDA needs to be clear with their timelines and come up with a fixed list of requirements in accordance with their submitted Citizen’s Charter,” ARTA Director General Jeremiah Belgica said, noting that the regulatory body for food and drugs shall only take three working days to act on requests for CSPs based on its updated Citizen’s Charter.
Based on their meeting, Belgica said that according to FDA Chief Eric Domingo that there has been no application ever since for Ivermectin for humans and that the drug, which is originally intended as veterinary medicine to cure parasites in animals, is not included in the COVID-19 treatment plan approved by DOH.
The Ivermectin, however, has been used in other countries and are said to be effective in curing COVID-19 patients.
Amid the critical medical situation in Metro Manila due to the resurgent of COVID-19 infection, some drug firms in the country, local doctors, and even Congress and the private sector have urged government to look into the Ivermectin.
Once the DOH includes the Ivermectin drug as part of the COVID-19 treatment plan, the two drug companies will have to start the application processes with the FDA.
ARTA, the anti red tape watchdog, is seeing to it that there is no room for red tape in the processing of the application by the two firms. Under the ARTA Law, Belgica said this application can be acted in 7 days but not more than 20 days.
While there had been no application for human Ivermectin at the FDA, Belgica said that there was a donation to the country before and was also used as treatment. With this precedence, Belgica said there could be basis for DOH’s inclusion of the drug in its list of COVID-19 treatment plan.
The use of the said drug has been a cause for debate with the House of Representatives set to hold a hearing on this tomorrow. Ivermectin is usually prescribed by veterinarians for the prevention and treatment of parasitic infection in select animals. However, some physicians have claimed it as a potential cure to COVID-19 patients based on the promising results they saw in their trials. They also noted its cheaper price compared to existing anti-COVID-19 medicines.
The price mentioned was P35 to P45 per capsule.
But, he likewise stressed that even if there is no application yet, the FDA could call these pharmaceutical firms to facilitate the process because this is an emergency situation. Belgica further said that FDA has vowed of their cooperation.
He also asked the FDA to talk to one pharmaceutical firm that tried to produce Ivermectin before for the specific use of the patients of certain doctors.
If their work is not illegal, Belgica said they should be allowed to continue with their work.
Belgica, however, said that it would be unfair to say that there is red tape for the Ivermectin because there is no application yet.
In this pandemic, Belgica stressed that “ARTA will watch all COVID-related procurement, donations and other platforms.” ARTA will also ensure faster processes of documents and logistics and even the creation of special task force adding that at this time of pandemic, red tape can also kill.
“Let’s not allow bureaucracy get in the way of people getting better services. Mag-apply ho kayo and ARTA will hold your hand. We’ll make sure na walang panggigipit na magaganap,” Belgica added.