A local man has expressed his frustration after a DNA test kit ordered from Ireland was intercepted by the South African Health Products Regulatory Authority (Sahpra) at OR Tambo International Airport and is yet to be released after a month.
The man said the package consists of two swab tubes and earbuds.
He was advised on October 20 by the courier company meant to deliver the goods that the item he was importing was currently under investigation by Sahpra, after it was detained by Port Health at OR Tambo.
“I am not the first South African to request a DNA test. What is there to investigate: It’s 2X a swab tube and earbud(s),” he said.
He added that he was informed by the courier company that customs only allowed 14 days to clear goods once a shipment arrived in South Africa. If not cleared within the time frame it would have to be moved to the government state warehouse, which would impose a penalty for late clearance as well as charge per day for storage fees.
He reached out to the regulator, to no avail.
The man expressed disappointment, claiming that Sahpra had not fulfilled its duty within the promised time-frame, accusing the regulator of adopting an authoritarian approach, hindering the timely access to a product he said was low-risk.
“It has now been a month since Sahpra hijacked my shipment, in an authoritarian mode well beyond their mandate. The shipment is an ear(bud) DNA test. Any fool can see this poses no risk to the SA public. But does pose a risk that local pharmaceutical companies will not pay Sahpra huge fees to offer them market protection from competition,” he said.
Sahpra said they had received a complaint regarding the case, but its Customer Relationship Management (CRM) system was experiencing technical challenges.
According to Sahpra, its regulations dictate that medical devices, including DNA kits, may require specific licences for importation, depending on their intended use.
“(It was) detained by customs for Sahpra to ensure that they have relevant documents as a medical device for distribution or personal use or non-medical use.
“DNA Kits may be regarded as Medical Devices (IVD) and in accordance with Sec 22C of the Medicines Act, the importer may require a licence.
The determination is based on the intended use of the product, which Sahpra will require evidence from the importer to make such a determination.”
In terms of the turnaround time to investigate the matter, Sahpra added: “It depends on the complexity of the investigation as well as the speed at which relevant information/evidence and related contact people are accessed.
At most, customer complaints are dealt with within 30 working days “With this particular case, Sahpra has not received sufficient evidence from the manufacturer of the product, who has been engaged to provide this evidence in order to make a determination between medical or non-medical use.”
Cape Times