THE Philippine Food and Drug Administration (FDA) has issued a Certificate of Product Registration (CPR) for Ivermectin, allowing a local laboratory to manufacture and sell it for human use, though still as an anti-parasitic drug, not as prophylaxis and treatment for Covid-19.
Still, Deputy Speaker Bernadette Herrera said on Friday the FDA’s issuance of a CPR is a perfect complement to the effort to hold local clinical trials, an initiative recently greenlighted by President Duterte with a P22-million budget.
Ivermectin, an antiparasitic drug with a long-established track record of safely treating a number of tropical diseases, has been at the center of debates among policymakers, health professionals and politicians, with those championing its use to prevent and cure Covid-19 touting numerous reports from abroad.
The CPR was issued by FDA to local pharmaceutical company Lloyd Laboratories, Inc., thus enabling the company to manufacture, distribute, and sell the drug under specified conditions.
“Although not originally intended to treat Covid-19, Ivermectin has made global headlines due to a number of doctors and medical groups who have gone on record to vouch for its efficacy as both a prophylaxis and a treatment for the SARS-CoV-2 virus. This prompted a rise in demand for Ivermectin in the Philippines, although the manufacture, distribution, and use of the drug encountered legal controversy due to its lack of an FDA certification,” Rep. Herrera said in a statement on Friday.
“It is common knowledge that the unmonitored distribution and use of Ivermectin created an entire gray-market, which subsequently led to questionable and dangerous products. With a reputable company now holding an official CPR, the public is now assured of the quality and legality of their doctor-prescribed Ivermectin dosages,” she added.
“As of now, we already have a number of foreign clinical trials that can be used as a basis. Now that the FDA has allowed a local pharmaceutical company to make Ivermectin available in the market, however, the proper documentation, observation, and follow-ups can already be used for statistical inference,” she said.
Based on the CPR issued to Lloyd Laboratories, Ivermectin will be made available as a prescription-only drug in 3mg, 6mg, 9mg., 12mg and 15mg doses.
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