The Government Pharmaceutical Organization (GPO) on Tuesday defended selling cheap NovaGen Antigen Test Kits (ATK) that have been banned in the EU, saying that they could be used in the country because the product has been approved by the Food and Drug Administration (FDA) of Thailand.
Sirikul Methivirangsan, GPO's deputy managing director, explained the EU's Health Security Committee has recently changed some regulations for ATK registration in the region and requires additional documents before issuing a licence. NovaGen had yet to update its licence and so was removed from sale on Oct 20.
"We've contacted the company regarding the case and been told that the company has already submitted the required document for EU consideration. When approved, it will create more confidence in the product. But the product has already been certified by Thai FDA so it is effective for use," she told at a press conference on Tuesday.
Last month, the GPO sold ATKs to the public for 40 baht per set and received a lot of positive feedback for the move. The first two-million lot sold out very quickly and a fresh round of bidding was initiated for the import of more kits which Eurofins Food Testing (Thailand) won.
GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) is manufactured by HangZhou AllTest Biotech company in China.
Dr Surachok Tangwiwat, the FDA's deputy secretary-general, said the agency has a clear process to approve ATK products based on submitted documents evidence and laboratory tests that stipulate that sensitivity and specificity must be 90% and 98% respectively.
"No brand can give 100% accuracy. The product approved by the FDA has a false positive rate of around one-two percent," he added.
According to the FDA, it has already approved 193 ATK items under 100 brands for home use and 93 for professional use, with NovaGen earning approval in July.
Meanwhile, the FDA on Tuesday began work with online retail platform Lazada and HDmall.co.th to introduce safety and legitimacy standards for ATKs sold through their portals by linking with the FDA's website so people can ensure the kits are genuine.
Since the turn of the fiscal year, the FDA and police have made seven arrests in connection with the sale of illegal test kits worth 600,000 baht. It is also working with Facebook and other e-market places to eradicate illegal ATK adverts on 2,621 websites. All adverts for the product must be legally approved by the FDA. The FDA has set up the 1566 hotline for people to report any suspicions or they can be emailed using the 1556@fda.moph.go.th email address.
