thai fda changes rules to make antigen test kits more available and cheaper - Thai FDA changes rules to make antigen test kits more available and cheaper

Antigen rapid test kits (ATKs) for home use will become more easily available in stores and at more affordable prices after an announcement in the Royal Gazette, expected next week, of a new regulation from the Thai Food and Drug Administration (TFDA).

Public Health Minister Anutin Charnvirakul said today (Friday) that the TFDA had given approval for all stores and online outlets, not just pharmacies staffed by a pharmacist, to sell ATKs to the public.

Dr. Thongchai Keeratihattayakorn, assistant permanent secretary of public health said that store owners and other retailers will be able to sell the ATKs, which were imported by companies approved by the TFDA, as he recommended only buying products which are properly registered with the TFDA. Currently, 51 brands of ATKs have been approved for sale in Thailand.

Dr. Thongchai also said that the Government Pharmaceutical Organization (GPO) will be asked to procure ATKs, produced by a German company with a production base in China, which cost an estimated 40 baht per kit.

As for the online sale of the ATKs, he warned that, although people can post the products for online sale, but they have to get permission first from the TFDA, otherwise they may face legal action for advertising the products, which are regarded as a medical device, without a permit.

Meanwhile, Mr. Atthaporn Limpanyalert, deputy secretary-general of the National Health Security Office (NHSO), said that 244,825 Lepu ATKs, procured from China, have been distributed to 122,412 people since September 15th and, among the results of 46% of those kits distributed, 379 tested positive.

He said, however, that the NHSO has received complaints that several recipients had not used the ATKs they received, but sold them to others which, he warned, is against the law.

The ATKs bought by the NHSO are limited and intended for those who need them the most, adding that the kits have to be kept at a proper temperature and have a short shelf life.

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