FDA warns online shops that put prescription drugs on sale

Maris Federez   •   December 12, 2019   •   285

MANILA, Philippines — The Food and Drugs Administration (FDA) has warned online shops that sell medicines and put prescription drugs on sale, especially this holiday season.

DOH spokesperson and FDA officer-in-charge Usec. Eric Domingo said that the agency has already penalized three online selling platforms for such infraction.

“It’s very rampant. At itong ibang na fine natin nakita na natin yan. Winarningan na natin. Tapos mawawala ng dalawa, tatlong araw iyong mga produkto tapos after a while babalik na naman. And then we have to remind them again na bawal. And we urge them na that they have to police their own ranks,” Domingo said.

The official also advised pharmacies to apply for separate license to operate and certificate of product registration from the FDA should they decide to also venture into online selling.

“Unang – una ang ating mga drug stores allowed lang kayo to sell the products within the premises of the store.  Kung gusto niyong tumanggap ng online orders you can apply for it as an extra activity with the FDA. But even then, may limitations iyon,” he added.

Domingo said the limitation is basically applicable to prescription medicines.

“Maaring mag- online, mag-order online ng isang kliyente nila pero kapag kukunin na iyong gamot kailangan pa rin niyang kunin sa pharmacy kung saan naka- store nang tama at ma- check ang reseta bago ibigay sa kaniya,” the official explained.

The FDA is still verifying several reports against online shops that openly sell medicines at a much cheaper price.

They shall be meted out with fines and corresponding charges. — (from the report of Aiko Miguel) /mbmf

IATF approves Phl participation in COVID-19 vaccine clinical trials

Maris Federez   •   May 24, 2020

MANILA, Philippines — Upon the recommendation of the Department of Science and Technology (DOST), the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-MEID) has approved the proposed participation of the Philippines in clinical trials that seek to formulate a potential vaccine against coronavirus disease 2019 (COVID-19).

Based on IATF Resolution No.39 dated May 22, 2020, the task force has also ordered the creation of a sub-technical working group which will be led by the DOST.

The group will be coordinating with the four collaborating organizations composed of the Department of Health (DOH), the Food and Drug Administration (FDA), the Research Institute for Tropical Medicine (RITM), and the World Health Organization (WHO) with regard to the said clinical trials.

The IATF has also issued a directive to the FDA to facilitate the processing of necessary permits for the conduct of the clinical trials in the country.

The collaborating organizations for the clinical trials are the Adimmune Corporation, Academia Sinica, Chinese Academy of Science- Guangzhou Institute of Biomedicine and Health, the Sinopharm – Wuhan Institute of Biological Products, and the Beijing Institute.

Once the clinical trials are undertaken, these will be included in the FDA’s requirements for the registration process for the vaccine and the application for certificate of registration to make the vaccine available in the market.

The Philippines has initially participated in the WHO’s clinical trials, which include the testing of off-label drugs that show potential of being effective against COVID-19.

Meanwhile, the IATF has also approved the plans of the DOST to construct research centers for the local vaccine research development.

These include the Virology S&T Institute at the New Clark City in Tarlac and the reactivation of the Pharmaceutical Development Unit of the DOST-Industrial Technology Development Institute. —(from the report of Rosalie Coz) /mbmf

DTI, may paalala sa online sellers at shoppers sa gitna ng community quarantine

Robie de Guzman   •   May 22, 2020

MANILA, Philippines – Marami ang nahihikayat ngayong mag-online selling at shopping dahil hindi lahat ng tao ay maaaring lumabas ng bahay at suspindido pa rin ang pampublikong transportasyon sa gitna ng community quarantine.

Ayon sa ilang online shopper, mas maalwan mamili sa online sites dahil wala silang ibang gagawin kundi mag-browse sa internet, i-click ang nagustuhang produkto, makipag-usap sa seller at maghintay kung kailan idi-deliver ang biniling produkto.

Anila, sa panahon ng COVID-19 crisis, mas ligtas mamili online dahil hindi nila kailangang humarap o makihalubilo ng personal sa ibang tao.

At dahil mahalaga ang supply ng pagkain at mahirap magtinda sa mga pisikal na pamilihan sa panahon ng quarantine, bumaling na rin sa digital platform ang ilang nagtitinda ng gulay at iba pang food products.

Ayon kay Barbara Belangue, isang online vegetable seller, sa Facebook lang sila nagpo-post ng kanilang mga paninda at may opsyon ang customer na i-pick up o ipa-deliver ang biniling produkto.

“Y’ong pagbebenta namin ng gulay, ginagawa namin is y’ong mga customers na makakapag-order sila sa Facebook, Messenger o kaya, my second option is, dadaan sila dito pero dahil noong nag-ECQ, ang mas madalas na magpa-order is through online tapos via delivery,” ani Belangue.

Suportado naman ng Department of Trade and Industry (DTI) ang online selling o electronic commerce lalo’t nasa gitna ng krisis ang bansa.

Ngunit paalala ng DTI, dapat naka-rehistro ito maging ang gagamiting delivery service, at ang presyo ng produkto ay kailangang nakasunod sa itinakdang suggested retail price ng ahensiya.

Babala ng DTI, maaaring kasuhan ang online sellers na magpapatupad ng overpricing o kung iba ang itsura ng idi-deliver nilang produkto kumpara sa nakapaskil sa kanilang online page.

“Kung ano y’ong naka-advertise doon sa online page mo sa social media page, kailangan ‘yon mismo y’ong ide-deliver mo sa tao,” ani DTI Undersecretary Ruth Castelo.

“Hindi y’ong fine-fake mo lang y’ong advertisement mo para lang makaengganyo ka ng pagbili pero hindi naman ‘yon y’ong actual na ipapa-deliver mo doon sa tao because it is going to be a crime,” dagdag pa ni Castelo. – RRD (mula sa ulat ni Correspondent Asher Cadapan Jr.)

DOH admits COVID-19 testing capacity still below 8,000 to 10,000 daily target

Marje Pelayo   •   April 29, 2020

MANILA, Philippines — The Department of Health (DOH) on Wednesday admitted that the country’s testing capacity for coronavirus disease (COVID-19) is still below the target.

The Department had planned to expand its mass testing to 8,000 – 10,000 tests daily starting Thursday (April 30).

But, according to Health Undersecretary Maria Rosario Vergeire, they may not be able to achieve the target as scheduled.

Mukhang hindi po aabot dito sa walong libo for April 30, though sinusubukan natin dahil ngayon po dumating na ang cartridges natin for GeneXpert [I don’t think we can achieve the 8,000 target for April 30 though we are trying, especially with the arrival of the cartridges for GeneXpert,]” the official said.

The DOH was able to conduct a total of 6,320 tests on Tuesday (April 28) in 19 licensed testing laboratories across the country. 

Vergeire noted the recent scaling down of operations at the Research Institute for Tropical Medicine (RITM) as one reason for the delay in testing of samples which left the processing of results pending for about a week.

The RITM has just resumed full operations on Sunday after more than 30 of its COVID-19 positive medical staff recovered from the disease.

With the use of GeneXpert test kits, the DOH expects the results to be out within 45 minutes which will definitely improve the country’s testing capacity and hopefully achieve its daily target.

“But ngayon po itong ating goal ay pilit na maabot, aabutin [We will try hard to achieve our goal in] the coming days as all the resources had been falling in coming from private side and coming from the government,” Vergeire said.

Meanwhile, the Food and Drug Administration (FDA) has added a polymerase chain reaction (PCR) test kit from Singapore and two brands of rapid antibody test kit from Germany and China among the list of approved test kits that may be used in hospitals across the country.

To date, the country has a total of 33 FDA-approved PCR-based test kits and 24 rapid antibody test kits. 

The DOH reminds the public, however, that these test kits may only be administered by licensed doctors and experts who are also authorized to interpret test results. –MNP (with details from Aiko Miguel)

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