Health regulator warns Kenyans over falsified P2 pills

The Pharmacy and Poisons Board in Kenya has issued a warning to the public about a falsified batch of Postinor-2 emergency contraceptive tablets circulating in the local market. The affected product, batch number T34197R, claims to be manufactured by Gedeon Richter Plc, but the Board asserts that it was not produced or released by the legitimate manufacturer.

This alert follows routine post-marketing surveillance, a responsibility of the Board tasked with regulating medicines and health products in Kenya. The investigation revealed significant differences between the suspected falsified product and genuine Postinor-2. These discrepancies include variations in the batch number printing, numerous printing and typographical errors in the Patient Information Leaflet, and distinct packaging characteristics.

Genuine Gedeon Richter products are sealed using a hot-melt closure, whereas the falsified packs employ a different method. Additionally, the colour intensity on the brand name and other packaging elements is notably more vibrant, and the font of the logo differs markedly when the authentication panel is scratched.

The Board emphasized that the falsified tablets might contain incorrect dosages of the active ingredient, no active ingredient, harmful contaminants, or undeclared substances, potentially rendering the product ineffective or even harmful to users. Healthcare professionals have been instructed to verify the authenticity of Postinor-2 stocks before dispensing them and to isolate any suspected falsified products.

Hospitals, procurement agencies, distributors, pharmacists, pharmaceutical technologists, and the public have been urged to report any encounters with batch T34197R. Furthermore, the Board reminded all stakeholders in the pharmaceutical supply chain to procure health products exclusively from manufacturers, importers, distributors, and retailers authorized by the PPB.

Unauthorized purchases from unlicensed sources are deemed a violation of the Pharmacy and Poisons Act, Cap 244, and detrimental to patient safety.

The Board is collaborating with government investigative and enforcement agencies to trace the origin of the falsified Postinor-2 into Kenya and determine its extent of distribution. Two individuals have already been apprehended for possession of the counterfeit tablets. Ongoing investigations aim to identify the source, entry point, and distribution channels of these illicit products.

The Board has warned of potential legal and regulatory actions against those involved in the manufacture, importation, distribution, or supply of falsified health products. The public is encouraged to report suspected falsified or substandard medicines via the PPB's online portal, USSD code *271#, the mPvERS mobile application, or by emailing [email protected] and [email protected], and by calling 0795743049.