FDA orders seizure, warns public of Cosmic Carabao Gin

Robie de Guzman   •   July 9, 2019   •   2342

Cosmic Carabao | Courtesy: Juan Brew Facebook page

MANILA, Philippines – The Food and Drug Administration (FDA) on Tuesday ordered the seizure of Cosmic Carabao Gin products after its samples were found positive for methanol.

In an advisory, the FDA said the order was issued following the reported incidents involving two women who fell ill shortly after allegedly consuming the said gin. The victims were rushed to separate hospitals where one of them reportedly died.

FDA officer-in-charge Eric Domingo earlier said he received a report that one of the victims had methanol poisoning.

Methanol, according to the FDA, a widely available chemical that has many industrial applications is also found in household products and fuel for aircraft.

Non-toxic trace amounts of methanol can also be naturally found in fruit juices. It can also be a product of natural fermentation and is found in both alcoholic and non-alcoholic drinks.

The FDA said higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks.

Signs and symptoms of methanol poisoning include vomiting, abdominal pain, hyperventilation and feeling of breathlessness. Blindness can also happen in severe cases.

The FDA said the Cosmic Carabao Gin was manufactured by Juan Brewing, Inc.

In its website, Juan Brew said the clear liquid craft gin is “an out of this world citrus-forward Gin,” made with “distilled water, neutral spirit (from sugarcane), juniper berries, coriander seeds, dayap lime, angelica plant root, kaffir leaves, green, cardamom pods.”

In its Facebook post, the company said it is now verifying reports but did not address questions regarding the product’s certificate of product registration.

“We would like to emphasize that our company is dedicated to the highest standard in [the] processing of our products and puts the health of our consumers above all,” it said.

In a separate advisory, the FDA said it has ordered the “sealing of all raw materials, including in-process distillates, and seizure of all unregistered Cosmic Carabao Gin” in the facility of Juan Brewing Inc. and all those that are on sale in the market.

It also requested local government units and law enforcement agencies to ensure that this product is not sold or made available in their areas of jurisdiction.

The FDA also warns the public against the consumption of the said product as “this is currently unregistered and has been confirmed to contain a high level of methanol.”

“Consumers must also exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals,” it added.

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

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)

Duterte approves hiring of additional workers for FDA, DOST

Marje Pelayo   •   April 28, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) is busy processing applications for licenses of coronavirus disease (COVID-19) test kits and all other products necessary in the country’s fight against the global pandemic.

The Department of Science and Technology (DOST), meanwhile, is focusing on research and development of treatment or vaccine against COVID-19.

Due to the volume of work and the high demand for additional workforce, President Rodrigo Duterte has allowed the two agencies to hire more personnel to join the government’s COVID-19 response.

“I have authorized these two offices — the FDA and the DOST — to employ as much as many that would be required to expedite [the processes] and to enable the agencies to work day and night. As I have said, we are fighting a war here, a crisis,” the President said in Filipino during his live address to the nation on Monday (April 27).

Meanwhile in his Joint Congressional Oversight Committee report, the President noted that the Department of Budget and Management (DBM) already approved the hiring of additional workers for the Department of Health (DOH). 

The DOH requested for additional 15,757 healthcare professionals who will be given three-months contract of service and will be funded with P2.7-billion.

The DOH said seven hospitals have signified their request for additional medical personnel to cope with the volume of workload in relation to the COVID-19 pandemic. MNP (with reports from Rosalie Coz)

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