The Botswana Medicines Regulatory Authority (BoMRA) wishes to assure the public that all medicines circulating
in the Botswana market are continuously and closely monitored. Allegations of poor-quality or fake medical products are taken seriously and investigated thoroughly.
Since its establishment, BoMRA has consistently taken decisive action to remove unsafe or non-compliant products from the market. These actions follow established regulatory procedures guided by the World Health Organisation (WHO). The Authority maintains a robust market control programme that includes:
- Routine, risk-based and intelligence-led market surveillance
- Spot checks across pharmaceutical operations, including government facilities
- Track-and-Trace verification for selected medical products along the supply chain
- Targeted joint operations with other lawenforcement agencies
When a product is found to be non-compliant, BoMRA takes immediate steps to protect the public. These actions may include collecting and testing samples, issuing alerts to healthcare professionals and stakeholders, and recalling products depending on the level of risk. Recalls may be mandatory (initiated by BoMRA) or voluntary (initiated by the manufacturer or distributor).
Since 2019, BoMRA has recalled 37 medical products of varying quantities. These include tablets, syrups, medical gases, and cosmetics. The Authority also uses additional preventative mechanisms such as preshipment inspections conducted in countries of origin to ensure that only quality-assured products enter Botswana.
To further assure the public, BoMRA provides the following facts regarding products that have recently been the subject of public discussion:
- DOLOWISE 500
BoMRA is aware of quality complaints related to specific batches of this product. These batches were recalled and disposed of under BoMRA’s instruction.
- ELYMOL PARACETAMOL
Certain batches of Elymol were found to have quality defects during distribution. These were removed from the market and destroyed. It is important to note that Elymol is a registered product; only the affected batches were found to be defective.
- COUGH SYRUPS
Following safety concerns raised in the Gambia in 2022, BoMRA intensified monitoring of cough syrups in both formal and informal markets. None of the named harmful products were found in Botswana. Routine testing of cough syrups continues, and precautionary alerts are issued when concerns arise in other countries. To date, no cough syrups containing harmful substances have been found in the Botswana market.
- SPINAL CORD STIMULATORS
BoMRA received reports of post-surgery complaints related to spinal cord stimulators in 2022. At the time, the Authority had not yet commenced full regulation of medical devices due to capacity limitations. Registration
of medical devices has since begun, and these devices are now listed with BoMRA. No new complaints have been reported since 2022.
While it is not possible to make absolute guarantees, BoMRA has not received any reports of fatalities directly linked to any of the products mentioned above.
BoMRA strongly advises all public and private procuring entities to source medical products that have undergone full assessment and are registered for use in Botswana. The public is also urged to avoid sharing unverified or misleading information on social media or other platforms. Anyone with concerns or questions is to seek clarification directly from BoMRA.