The Pharmacy and Poisons Board of Kenya has raised alarm over an influx of unregistered pharmaceutical products gaining entry into the country.
In the statement issued on Saturday, January 18, 2025, the board issued a warning over the products saying the majority of the aforementioned products are referencing the Indian standardization.
The board, while highlighting that their mandate is to protect the health of the public through regulations, reiterated that pharmaceutical products not duly registered by them were strictly prohibited for importation, distribution, sale and handling.
“The Indian Pharmacopoeia is not within the purview of drug registration requirements in the country, and as such, products citing this standard are not compliant with Kenyan regulations,” the board’s statement reads in part.
PUBLIC NOTICE: PROHIBITION OF TRADING, IMPORTING, AND HANDLING UNREGISTERED HEALTH PRODUCTS AND TECHNOLOGIES IN KENYA pic.twitter.com/oJDcjyBnIi
— Pharmacy and Poisons (@ppbkenya) January 18, 2025
Consequently, the board has issued three directives to stakeholders in the pharmaceutical industry to enhance further regulations.
In the directives, the stakeholders have been asked to cease trading, importing, or handling any unregistered products, including those with references to the Indian Pharmacopoeia.
“Ensure that all pharmaceutical products in your possession are duly registered and approved by the Pharmacy and Poisons Board. Adhere to the requirements outlined in the Pharmacy and Poisons Act and any other relevant regulations,” the statement added.
The board warned that failure to comply with the directives will attract severe penalties as stipulated under the law.
“The Pharmacy and Poisons Board will continue to monitor the market and take necessary enforcement actions to ensure compliance with the applicable regulatory framework,” the board added.