BOMRA WIN BLOCKS AG CERA PRODUCT ENTRY
Botswana Medicines Regulatory Authority (BoMRA) has won a case to seize and refuse entry of Malaysian product called AG Cera product distributed locally by AG Nutrition Botswana (Pty) Ltd.
This followed an urgent application by local distributor AG Nutrition Botswana (Pty) Ltd seeking the court to order the regulator to release a consignment of 30 sachets of 3000mg AG Cera product, which was confiscated in August, 2020 upon entry into the country.
The product had gained traction in Botswana, as it was believed to have a cure for ailments such as cancer and fibroids.
The regulator had seized the product on the basis that the distributor had to apply for registration under Complimentary Medicines.
The decision did not sit well with the AG Nutrition Botswana (Pty) Ltd, as it took the matter to court challenging the regulator’s decision to confiscate the product.
The company also wanted the court to declare that the substance is not a medicine or related substance that is regulated under the Medicines and Related Substances Act.
However, on Friday High Court Judge Abednego Tafa dismissed the application and upheld the regulator’s decision to confiscate the product pending registration of the product with the regulator. Justice Tafa ruled that the product is a medicine or related substance and such should be registered with the regulator before it could be imported into the country.
He reasoned that even if in Malaysia, (where the product originates) AG Cera is not treated as a medicine but as food, it does not mean that would be the case in Botswana as the criteria for categorising products are not universal.
Justice Tafa said he has no doubt that the product falls under medicines as also stipulated in the distributor’s flyers that the product cures amongst others fibroids and prevents cancer.
He further stated that while he recognises the financial harm that the company is likely to suffer while the registration process is ongoing; the public interest and the interests of the regulator outweigh the company’s.
“It would be improper, in my view, for the court once it has found that the product falls within the definition of medicines, to order the release and further importation sale and or distribution of the product pending its registration,” Justice Tafa said.