–‘Food & Drug’ warns importers

THE Government Analyst – Food and Drug Department (GA-FDD) will not approve the importation and use of Rapid Diagnostic Tests (RDTs) that have not received clearance from the World Health Organisation (WHO), its Director, Dr. Marlan Cole announced on Wednesday.

To date, the WHO has only approved the use of the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) method of testing for the identification and laboratory confirmation of COVID-19.

“The Department will facilitate the importation of test kits that utilise the RT-PCR method from the eight countries which have been listed by the WHO to produce IVD (In Vitro Diagnostic) test kits and laboratory reagents for the COVID-19 diagnosis. Those countries are Australia, Brazil, Canada, the People’s Republic of China, the Russian Federation, Singapore, the Republic of Korea, and the United States of America,” Dr. Cole said in a statement.

“With regards to Rapid Diagnostic Tests (RDTs) that are either serological (blood –antibodies) or antigen-based (viral proteins), none has been approved or validated by the WHO, as a result of several challenges associated with sensitivity and specificity,” he went on to explain.

He iterated that the Food and Drug Department will only approve the importation and use of RDTs for COVID-19 diagnosis, which have been approved and validated by the WHO or a serious Reference Authority.

The GA-FDD Director issued the warning in response to the increasing number of requests for the importation of medical devices, such as IVDs test kits and laboratory reagents, to facilitate testing for the Coronavirus (COVID-19). The surge in applications for the importation of the items at reference comes close to two weeks after the Government of Guyana authorised private health institutions to test for COVID-19.

INCREASED TESTING
While increased testing is critical in the fight to contain COVID-19, the Food and Drug Department said that importers and distributors must be reminded that the established requirements for the import of medical devices, particularly IVD test kits and laboratory reagents, must be met.

These requirements, Dr. Cole said, are in accordance with the laws of the Guyana Food and Drug Act, Chapter 34:03, Part VI, Section 32(2); the Food and Drug Regulations, Part VII, Section 115(c), and those articulated in the GA-FDD Application Form for a Permit to Import Medical Devices. He said that in order to acquire approval, importers and or distributors must be registered with the GA-FDD as an Importer, and obtain a Permit to Import medical devices (IVD Kits and laboratory reagents). Further to that, an import licence and Customs Entry must be submitted to the Department for approval and release.
“Importers and or Distributors must demonstrate that Medical Devices are manufactured according to the International Standard Organization (ISO) 13485:2016 Standard.

Importers and or distributors must demonstrate to the department by way of a Free Sale Certificate (FSC) that the medical device (in vitro diagnostic test kits and laboratory reagent) is freely sold and used in the country of origin. The importer and or distributor must demonstrate to the GA-FDD that the company or individual is in possession of a Manufacturer’s or Distributor’s authorization from the manufacturer or a distributor,” Dr. Cole detailed.

The GA-FDD Director said consumers, healthcare professionals, s well as public and private healthcare providers must be cognizant of the growing number of falsified medical products that claim to prevent, detect, treat or cure COVID-19. On March 31, 2020, the WHO issued a Medical Product Alert on falsified medical products.

The WHO said ill-intended persons have been capitalizing on the increased demand for medicines, vaccines, diagnostics and reagents, to creates and distribute falsified medical products in wake of the COVID-19 pandemic.

“Due diligence is required from all actors in the procurement, use and administration of medical products, in particular those affected by the current crisis of, or related to, COVID-19. At this stage, WHO does not recommend any medicines to treat or cure COVID-19,” the international health organisation said.

On the local arena, the Food and Drug Department is reiterating the need for importers and distributors to follow the respective guidelines, and exercise caution to avoid undue issues or delays, and to aid in the fight against the dreaded disease.