Local pharmaceutical firm Lloyd Laboratories is now a step closer to manufacturing the Molnupiravir, a drug developed by MSD to treat novel coronavirus disease (Covid-19) patients, according to the Food and Drug Administration (FDA).
Last Monday, Food and Drug Administration (FDA) office-in-charge director general Oscar G. Gutierrez, Jr. announced they already submitted the final draft of the guidelines for Locally Manufactured Drugs for Covid-19 to the Department of Health (DOH) for clearance.
Among the salient points of the new guideline, he said, is the inclusion of good marketing practice (GMP) inspection for the concerned manufacturer.
“Although the [Molnupiravir] capsule will be made here in the Philippines, the active pharmaceutical ingredient it will contain will be imported,” Gutierrez explained.
“So it is important for us to monitor the quality of the active pharmaceutical ingredient, which will be supplied to Lloyd,” he added.
Until the new guidelines are approved by DOH, Lloyd will still not be allowed to manufacture Molnupiravir, which will make it available locally at a cheaper price.
“In the absence of the locally manufactured guidelines or EUA (Emergency Use Authorization), we will continue our pre-assessment [of Lloyd],” Gutierrez said.
More applications
In a related development, Gutierrez reported that 9 additional companies are now applying for Special Certification for their self-administered Covid-19 antigen test kits on Jan. 13 and 14, 2022.
He said this was aside from the applications from Clearbridge Medical Philippines, Inc. at MOHS Analytics, Inc. as early as Jan. 9. 2022.
All of the said applications were already forwarded to the Research Institute for Tropical Medicine (RITM) to undergo “performance validation” before they could be certified.
The certified products will finally allow the manufacturers to sell their products in the local market, according to Gutierrez.
FDA said it will continue to conduct quality tests for said products even after they secure the needed certification to ensure their consistent quality.
“We will still collect samples [of the said products], which we will send to RITM so it could be tested,” Gutierrez said.
DOH will also be issuing the necessary guidelines for the use of so-called home-based test kits.