Rapid antigen/antibody test kits can only be imported into this country after an application, supporting documents and a sample of the product are submitted to the Chemistry, Food and Drugs Division (CFDD) for an assessment and issuance of a “No Objection” letter.
These requirements were highlighted by the Ministry of Health in a statement released yesterday.
According to the ministry, under the Food and Drugs Act, Chapter 30:01, the term “device” refers to any instrument, apparatus or contrivance, including components, parts and accessories thereof, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in man or animal.
It noted that rapid antigen/antibody test kits fall within this definition.
It pointed to the process for the application for issuance of a “No Objection” for the importation of Devices as:
1. Submit an application for a “No Objection” letter requesting permission to import Devices with relevant supporting documents to CFDD.
2. Application will be processed by CFDD to determine compliance with the Food and Drugs Act.
3. The applicant will be notified as to whether the application has been accepted (“No Objection” letter is issued) or rejected.
Further information on the application process may be obtained from the Chemistry Food and Drugs Division at cfdd.health.gov.tt or 868-623-5242.
Guardian Media on Wednesday highlighted that people were able to purchase these test kits at some pharmacies for approximately $200.
According to the ministry’s release, “No Objection” status can be amended based on new data and information arising with respect to the safety or quality of the test kit and anyone found importing without the relevant approvals can be fined or face jail time under the Food and Drugs Act.
However, the release did not clarify if pharmacies are able to sell these drugs to members of the public, especially since above the list of 25 COVID-19 rapid test kits approved by the Chemistry Food and Drugs Division for importation, it said ‘For Professional and Laboratory Use Only’.
On Tuesday, a Guardian Media worker (not a professional) was able to purchase a test and use it.
“All the instructions on it…you swabbing the same way like in the hospital,” the worker who sold the test advised.
Senior pharmacist with more than 50 years’ experience Jameel Rahaman said this purchase tells the population that the Food and Drugs Division has not been checking up on where these tests are being sold.
“Once that notice came out, they had a right to go down to that pharmacy and ask them where they get it from…they should be checking and I’m sure other pharmacies are selling it because it’s wasting people’s money,” he explained.
Rahaman said there is no guarantee to show if these tests are valid or regulate the results.
Even more worrying Rahaman said, was the fact that the Hightop test purchased at a pharmacy is not on the approval list.
“That is a big, big one, that means it came in illegally for sure,” he said.
The pharmacist also questioned how 25 kits were approved in less than a week when the process takes months.
“How long did the committee meet for to okay these products?” he asked.
He also asked why the names of the local distributors were not revealed.
“It could be three people bringing in all the kits because if you noticed the ones from Germany there are about eight different types,” he said.
Guardian Media is still waiting on answers to the questions sent on Tuesday from the Ministry of Health.