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Sellers of unregistered self-test kits may face the following penalties: DTI

The Department of Trade and Industry (DTI) cautioned on Monday that businesses providing unlicensed self-test antigen test kits for Covid-19 could be held accountable and penalized.

This, according to Ann Claire Cabochan, DTI Assistant Secretary and Head of the Consumer Protection Group, comes with the surge of online marketers of allegedly costly self-test kits.

“It should not be sold in physical stores or online stores as long as it has not been allowed to be marketed in the Philippines,” she said in a Laging Handa public briefing.

The Food and Drug Administration has not yet approved any self-administered antigen test kits (FDA).

Secretary of Health Francisco Duque III authorized the FDA last week to prepare for the approval of registered self-test antigen test kits for Covid-19.

“First and foremost, we must distinguish. “Iyong (Those) self-test kits, because they haven’t been registered, they haven’t been certified by the FDA as a product that can be marketed in our market, wala po iyang SRP (recommended retail price),” Cabochan explained.

She stated that the DTI is collaborating with the FDA to expedite applications for certificates of product registration, which are required to sell these self-test kits.

“Pinag-aaralan po iyan (It’s being looked into) and I’m aware that the FDA is expediting any applications for product registration certificates. So, at this point, wala po iyang SRP, wala po iyong mga self-test kits, kasi wala pa naman silang FDA registration. (As a result, these self-test kits do not have an SRP because they are not registered with the FDA),” she explained.

Consistent paracetamol supply

Meanwhile, Cabochan stated that paracetamol supply, which may be used to treat moderate Covid-19 symptoms, is likely to return to normal once drugstore inventories were replenished.

“Nagkaroon lang po ng (There was only an) overwhelming demand,” says the narrator. But, because we were working closely with the manufacturers of these items, as well as the drugstore, iyong (the) association of drugstores, we already had reported last week,” she said.

She stated that since January 5, when several brands of paracetamol ran out of supply in select drugstores, the country’s main drugstores have been refilling their inventory.

“We anticipate (that) over the weekend, the situation would normalize na iyong issue kasi makakarating na ng distribution channels, iyong mga major drugstores po natin,” she continued.

She stated that “there is more than adequate supply” now that the restocking has been completed, and that “manufacturers will continue to produce as they have in the past.”

She also reaffirmed her warning against the selling of counterfeit drugs, stressing that offenders may face fines, imprisonment, or both.

Persons who make, sell, or distribute fake medications will face a maximum punishment of life imprisonment and a PHP5 million fine under Republic Act (RA) No. 8203, or the Special Law on Counterfeit Drugs, if “a counterfeit drug is the proximate cause of death of a victim.”

The Food and Drug Administration Act of 2009, also known as RA 9711, makes it illegal to import, sell, or offer for sale counterfeit pharmaceuticals.

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