The Pharmacy and Poisons Board of Kenya, on Saturday, January 18, issued directives concerning pharmaceutical products referencing the Indian Pharmacopoeia (IP) entering the Kenyan market.
In a statement, the Board raised concerns about an influx of unregistered pharmaceutical products in the country, many of which reference the IP—a drug standardization method primarily used in India.
The Indian Pharmacopoeia outlines standards for drugs sold, manufactured, and consumed in India. However, the Board noted that this standard does not align with Kenya’s pharmaceutical registration requirements.
“The Indian Pharmacopoeia is not within the purview of drug registration requirements in the country. As such, products citing this standard are non-compliant with Kenyan regulations,” the Board clarified.
To address this issue, the Pharmacy and Poisons Board issued three key directives to stakeholders in the pharmaceutical sector, aimed at preventing the sale, distribution, or importation of unregistered products:
- Ensure that all pharmaceutical products in possession are registered and approved by the Board.
- Adhere strictly to the provisions of the Pharmacy and Poisons Act and other relevant regulations.
- Avoid handling any pharmaceutical product not duly registered by the Board.
The Board warned that failure to comply with these directives would result in strict regulatory action, including product seizures, license revocations, and legal prosecutions as provided under the law.
“The Pharmacy and Poisons Board will take severe regulatory actions, including but not limited to product seizure and prosecution, against those who fail to comply,” the statement read.
Reaffirming its commitment to public health, the Board promised continued market surveillance to enforce compliance with Kenya’s regulatory framework.
Additionally, the Board urged Kenyans to report any cases of non-compliance through its official communication channels.
By tightening these measures, the Board seeks to safeguard public health and maintain high standards in Kenya’s pharmaceutical industry.
