The Ministry of Health, through the Pharmacy and Poisons Board (PPB), has raised alarm over the influx of unregistered pharmaceutical products flooding the country.
In a statement issued on Saturday, January 18, 2025, PPB noted that the importation, distribution, sale, or handling of the unregistered pharmaceutical, particularly those citing the Indian Pharmacopoeia (IP) is strictly prohibited in Kenya.
“The Board’s attention has been drawn to an increasing influx of unregistered pharmaceutical products in the Kenyan market, particularly those referencing the Indian Pharmacopoeia. Note that any pharmaceutical product that is not duly registered by the Pharmacy and Poisons Board is strictly prohibited for importation, distribution, sale, or handling in Kenya,”
What is Indian Pharmacopeia
The Indian Pharmacopeia is a method of standardization of drugs that applies to all drugs that are manufactured and sold in India.
While IP specifies the quality, safety and efficacy requirements for drugs, it is not an acceptable standardisation in Kenya.
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.
Directives to local pharmaceutical companies
While highlighting that its mandate to protect the health of the public, PPB directed all local pharmaceutical companies to stop trading, importing or handling unregistered medicinal products within the country.
All stakeholders are hereby directed to: Cease and desist from 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.
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The Pharmacy and Poisons Board will continue to monitor the market and take necessary enforcement actions to ensure compliance with the applicable regulatory framework.