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Friday, April 26, 2024

Online selling of non-prescription drugs up, FDA drafting guidelines

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The Food and Drug Administration may allow online selling of nonprescription drugs by establishments without physical stores, its chief said Wednesday.

The FDA is drafting guidelines on “e-pharmacy” which will be released for public comment, said its officer-in-charge Oscar Gutierrez.

“There’s a limitation. We will only allow non-prescription drugs to be sold,” he said in a televised public briefing.

“In the future, establishments do not need to have a physical store. But they definitely will be required to have an office and an identified warehouse where the drugs will be sourced. We will release the draft guidelines for public comment,” Gutierrez added.

Meanwhile, Gutierrez said the FDA has conducted operations on 50 sari-sari (assorted goods) stores that sell counterfeit analgesic and antipyretic medicines, as he urged consumers to check the agency’s verification portal.

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The stores were located in Cavite, Laguna, Albay, Caloocan, Quezon City, and Parañaque, he said.

“We continue to gather reports from our regional field offices,” the FDA chief said.

Also, the agency has approved the emergency use of more brands of COVID-19 drug molnupiravir, including a local manufacturer, and is evaluating Pfizer’s COVID-19 treatment course Paxlovid.

Gutierrez, in a taped public briefing with President Rodrigo Duterte, said the following brands have received emergency use authorization: Molnarz (Faberco), Molnaflu (Medethix), Auxilto (German Quality Pharma), Molxvir (Sun Pharma), Molnatris (Mykan), and Molnupiravir Generic (Lloyd Laboratories/Dr. Zen’s Research).

Lloyd Laboratories can produce 1 million capsules per year that can cater to 25,000 to 50,000 COVID-19 patients, according to the FDA chief.
Generic products are usually sold for 30 percent to 50 percent less than the price of branded ones, he said. Products granted an EUA can only be bought by the national government, Gutierrez added.

“These will be delivered by the DOH to health facilities and healthcare providers, which will administer and provide these to patients,” he said in a televised public briefing Wednesday.

Molnupiravir is a prescription drug used to treat mild to moderate COVID-19 patients, Gutierrez said.

“The patient should take this under the strict supervision of a physician,” he said.

The FDA has also approved the antigen self-test kit of Getein Biotech Incorporated, Gutierrez said. It has forwarded some 54 self-test kits to the Research Institute for Tropical Medicine for performance validation, he added.

“If the applicant does not comply with RITM’s requirements for evaluation, it’s possible it would not be issued a performance validation,” he said.

Meanwhile, Pfizer has submitted its application for emergency use authorization of Paxlovid, Gutierrez said. Willie Casas

“It’s now under evaluation. I can give updates in the coming days,” he said during Duterte’s “Talk To The People” that aired Monday.

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