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Imports of rapid antigen tests: GS Health responds to allegations

Responding to allegations of the company’s involvement in importing rapid antigen tests, George Steuart Health today said no government fund was utilized to bring down the goods.

In an interview, its CEO Eran Ranasinghe said George Steuart Health utilized own funds to purchase the goods and pay for the import procedure.

“We received orders from private hospitals and other institutions like the Sri Lanka Red Cross Society, after the NMRA approval was received. We placed orders with our principals on 25th October.

“Since there was a national emergency, we made special arrangements with the help of Sri Lankan Airlines to import the goods urgently. The goods reached Sri Lanka on the 03rd of November. No government funds were utilized for this purpose,” he said.

The full interview is as follows:

What is the relationship between George Steuart Health and the manufacturers of these tests?

George Steuart Health ventured in to diagnostics in 2008. We partnered with standard diagnostics in 2009. In 2013, this company was bought over by Alere Medical; a conglomerate of 200+ diagnostic companies.

In 2018, Abbott Rapid Diagnostics acquired Alere Medical. Thereafter, George Steuart Health has represented Abbott Rapid Diagnostics in Sri Lanka.

How were the products registered with the National Medicines Regulatory Authority?

The application was initiated in March 2020 and provisional registration was granted on 22nd and 29th October 2020. This was after the World Health Organisation granted Emergency Use Listing for the products manufactured by Abbott Diagnostics and Standard Diagnostics.

These two products are the only products which have been evaluated as fit for use and granted approval by the WHO. The National Medicines Regulatory Authority (NMRA) has set a price of Rs. 1,146.22 per test and strongly recommended that the tests are conducted by professionals under guidelines issued by the Ministry of Health.

What about the SPC tender for the test kits?

The SPC tender closed on 2nd November. A total of 31 bidders participated in the tender. This tender is currently under evaluation and is yet to be awarded.

Why were the products imported before the tender was awarded?

We received orders from private hospitals and other institutions like the Sri Lanka Red Cross Society, after the NMRA approval was received. We placed orders with our principals on 25th October.

Since there was a national emergency, we made special arrangements with the help of Sri Lankan Airlines to import the goods urgently. The goods reached Sri Lanka on the 03rd of November.

George Steuart Health utilized our own funds to purchase the goods and pay for the import procedure. No government funds were utilized for this purpose.

Is the product validated for use?

The WHO has already evaluated the test kits for global use and granted approval for both the products; from Abbott Diagnostics and Standard Diagnostics.

We have also provided samples to the NMRA and the Ministry of Health for evaluation, along with the recommended testing protocol issued by the WHO. Several studies are now being conducted using these samples.