The Antigen Test Kits have been imported by deviating from due process, Rajitha Senaratne alleges

Colombo (News 1st): Various views are being expressed over the importation of Antigen test kits to identify individuals infected by COVID-19 in Sri Lanka. A controversy had arisen after a private company had imported 200,000 Antigen test kits while the Ministry of Health had invited bids to make the purchase. The management of the private company today responded to allegations that the test kits had been imported in violation of health laws and without following the due procedure. Chairman of the George Steuart Health (Pvt) Ltd - Dilith Jayaweera said that the kits were imported with the intervention of a private company upon the request of the private sector. He said that the Government is not associated with this and that external entities are trying to portray this as a strange transaction by incorporating the Government and the President of the country. Former Minister of Health - Rajitha Senaratne said that The World Health Organization had accepted this test on the 22nd of September and that company in question had obtained permission from the National Medicines Regulatory Authority on the 22nd of October. Former Minister added, saying that the company in question received approval to import the test kits within a week (29th Oct.) He said that the company was informed that the Ministry of Health has not issued the validation report for this test and that the process had not been completed. ********** The Antigen test kits that are to be used in the detection of COVID-19 patients fall under the category of medical devices. The approval of the National Medicines Regulatory Authority is required to import the product regardless of whether it involves the private or the Government sector. On the 22nd of October, the National Medicines Regulatory Authority had granted George Stuart Group of companies a license that is valid for a year. Based on the legal framework of the country, the National Medicines Regulatory Authority has issued clear guidelines on the importation of medical devices. According to these guidelines, it will require at least two years to obtain the license. Based on the NMRA’s guidelines to import medical devices, samples must be imported first using the license, for the registration of the product. The samples must then be subjected to an evaluation. Following the initial evaluation, the kits must be referred to an external evaluation committee whose report would be studied extensively, before being subjected to another evaluation. The final approval to import the product will be given upon successfully completing the process. However, according to the National Medicines Regulatory Authority, permission to import the antigen test kits had been granted based on the recommendations of the World Health Organization.