The Pharmacy and Poisons Board of Kenya on Saturday, January 18 issued new orders on pharmaceutical products entering the Kenyan market that reference the Indian pharmacopoeia (IP).
Through a statement, the Board raised alarm on an influx of unregistered pharmaceutical products into Kenya. According to the Board, most of these drugs are referencing Indian pharmacopeia, which is an Indian method of drug standardization.
The Indian Pharmacopoeia is a set of standards for all drugs that are sold, manufactured, and consumed in India.
The Board, whose mandate is to protect the health of the public through regulation, noted that IP standardisation does not fall in line with Kenya’s range of pharmaceutical registration requirements.
Medicine lined up on the shelves a stocked pharmacy
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“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 averred.
To this effect, the Board issued three orders to stakeholders in the pharmaceutical industry with the overall aim of prohibiting the sale, distribution, importation, or handling of unregistered products.
“Ensure that all pharmaceutical products in your possession are duly registered and approved by the Pharmacy and Poisons Board,” reads part of the statement.
The Pharmacy Board also directed that all medical practitioners adhere to the requirements outlined in the Pharmacy and Poisons Act and any other relevant regulations.
“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,” the Board added.
According to the Board, failure to adhere to the set regulations would attract stiff penalties in the area of regulation, licensing, and litigation.
“Failure to comply with this directive will attract severe regulatory actions, including but not limited to seizure of products, revocation of licenses, and prosecution as stipulated under the law,” the Board stated.
The Board went on to reiterate their commitment to uphold their mandate and ensure compliance with 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 stated.
The Board also called upon Kenyans to play their part and report any cases of ill-compliance through their channels.
A photo of drugs on a shelf.
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