Opposition questions the import of Antigen tests for Covid “without due process”

News date: 11 November 2020Source: https://economynext.com/opposition-questions-the-import-of-antigen-tests-for-covid-without-due-process-75779/

ECONOMYNEXT- Opposition politicians are accusing the government of permitting the import of Rapid Antigen test kits to Sri Lanka without following due processes needed to clear medical equipment.

Former Health Minister and Opposition Member of Parliament Rajitha Senaratne said the test had not been cleared by the Health Ministry’s technical evaluation committee and therefore had not received the validation of the Ministry.

Senaratne told reporters yesterday that “National Medicines Regulatory Authority (NMRA) gave the approval subjected to the validation from the Health Ministry. So before the validation and the evaluation is over the test kits had arrived,” he claimed.

Meanwhile, former MP Sunil Handunnetti speaking to media today questioned how the test kits were brought to the country before the government lays down a proper method of importing these test kits.

However, replying to the accusations the importer George Steuart Health said in a statement last week that they sought NMRA approval for product registration early in October 2020 highlighting the Emergency Use Listing granted by the World Health Organization.

It also said that the NMRA granted Provisional Registration for the test kits, under the condition that the tests be made available to healthcare institutions alone, at a regulated price of LKR1,146.22 per test. Samples of these tests have also been provided to the NMRA and the Ministry of Health for validation purposes.

“Having received the certificate of registration and import license on 22nd October, we received orders from major private hospitals and the Sri Lanka Red Cross Society. Requests were also received from WHO affiliated agencies, for supplies to the Ministry of Health,” it said.

Subsequently, orders were placed with the manufacturers on 25th October considering the national emergency, the kits were imported through a special aircraft operated by Sri Lankan Airlines on 03rd November 2020, paying the necessary airfreight and handling charges.

It added that virtual training was conducted on Microsoft teams for microbiologists, virologists, epidemiologists and officials from the Ministry of Health on 2nd November, by experts from Abbott Diagnostics. Further training has been scheduled in the forthcoming weeks.

George Steuart Health said that the goods were distributed among private hospitals and the Sri Lanka Red Cross Society on 06th November and following a similar routine, registration was also granted to the product from Standard Diagnostics shortly thereafter, to be marketed at the same price.

“A tender for the test kits was closed by the State Pharmaceuticals Corporation on 2nd November 2020. This tender is under evaluation and is yet to be awarded,” it said. (Colombo/Nov11/2020)