S’pore makers of Covid-19 ART kits having difficulty applying for approval for retail use
SINGAPORE – Local company Camtech Diagnostics has been making and selling antigen rapid test (ART) kits for Covid-19 since late last year – but not in Singapore.
While Camtech Diagnostics and another local manufacturer SG Diagnostics produce such kits here, they have not been able to get approval from the Health Sciences Authority (HSA) for the kits to be sold on the retail market.
Both have test kits approved for professional use here, but this approval will be terminated by the end of the year.
The companies’ attempts to get their kits approved for use in the retail market here under the Pandemic Special Access Route have been stymied by requirements such as an invitation from the Ministry of Health (MOH), without which their application will not be accepted by the HSA.
An MOH spokesman told The Straits Times: “There is no free-for-all system for application and use of self-test kits. The types of kits used are instead limited.”
The spokesman did not say why such an invitation is required or how it may be obtained, just that it is in line with international practice – although it is not something the regulators here had previously required.
Apart from the ministry’s invitation, companies wanting to sell the kits here also need to have “stringent quality standards and clear analytical and clinical validations carried out by a credible independent organisation such as the World Health Organisation or in the form of a published peer-review journal article”.
Dr Kuok Meng Han, chief executive of Camtech Diagnostics, said he had approached several hospitals here to carry out clinical trials of his kits, but all said they were too busy to help.
So he has turned to the Emory University School of Medicine in the United States instead for the trials, and has applied to the Food and Drug Administration for approval of the kits.
The trials should be completed by early next year.
Professor John Lim, executive director of the Centre of Regulatory Excellence at Duke-NUS Medical School, said: “From an overall health security perspective, it’s obviously good to have Singapore-based companies producing accurate, reliable and cost-effective diagnostic kits. These should not just be to meet our local needs but also those of other countries in the region and internationally.”
Prof Lim, who was previously chief executive of the HSA, said he was not familiar with the requirements for the current pandemic, but that under the normal process, “HSA does have processes for early engagement with any company or developer so that they understand the regulatory requirements before product development or product submission”.
He added: “This is similar to other major regulatory agencies and helps to ensure that the kind of data eventually submitted for assessment is not off the mark.”
Mr Roy Quek, a former deputy secretary at MOH, said Singapore should look to make its own ART kits, the way it now produces ventilators, masks and swab sticks.
He noted how equipment needed for the pandemic was in short supply last year.
He said: “We saw this first-hand at the start of the pandemic when global supplies of medical-grade surgical masks dried up. Along the way, supply disruptions to swabs and vaccines affected the roll-out of our national testing and vaccination programmes.”
There was a rush then to bump up capability here to provide the much-needed equipment, and today, Singapore produces ventilators, masks and swab sticks.
Looking ahead, Mr Quek, a former CEO of Thomson Medical Group, said ART kits will likely be needed globally for a long time to come, but none is produced here for local use.
He said: “This must surely be an area where local production capability and capacity are supported and facilitated. The level of technology and scale of production are clearly within our capability and of strategic value to the country.
“Local production will reduce our reliance on imports, and, more critically, provide sustainable quality and price assurance.”
Camtech Diagnostics says it can produce 2.8 million test kits a month, while SG Diagnostics says its maximum capacity is 100,000 a day now, but the number can be easily scaled up.
Dr Kate Qi, chief executive of SG Diagnostics, said her company applied to the HSA in August for its kits to be sold on the retail market under the normal route instead, which usually takes 10 months.
There are currently 11 ART kits from American, South Korean and Chinese companies approved for retail sale here.
One of the suppliers, South Korea’s SD Biosensor, announced in October two contracts for ART kits with Singapore worth 68 billion won (S$79 million) and 67 billion won.
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