Last Updated on January 18, 2025 by NewsTurkana
The Pharmacy and Poisons Board of Kenya announced new directives on Saturday, January 18, targeting pharmaceutical products entering the Kenyan market that reference the Indian Pharmacopoeia (IP).
In a statement, the board raised the alarm regarding the increasing influx of unregistered pharmaceutical products in the Kenyan market, particularly those referencing the IP.
The Pharmacy and Poisons Board (the Board) is statutorily mandated to protect the health of the public by regulating the profession of pharmacy and ensuring access to quality, safe efficacious and affordable health products and technologies.
The Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. The set of standards is published under the title Indian Pharmacopoeia (IP).
IP contains a collection of authoritative procedures for analyzing and specifying drugs for their identity, purity, and strength. The standards of IP are authoritative and are enforced by regulatory authorities to ensure the quality of drugs in India.
“NOTE that any pharmaceutical product that the Pharmacy and Poisons Board does not duly register is strictly prohibited for importation, distribution, sale, or handling in Kenya,” stated the Board in part.
“FURTHER NOTE THAT the Indian Pharmacopeia 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.”
As a result, the Board issued three directives to stakeholders in the pharmaceutical industry with the overall aim of prohibiting the sale, distribution, importation, or handling of unregistered products.
First, they were instructed to cease trading, importing, or handling any unregistered products, including those containing references to the Indian Pharmacopeia.
Moreover, the stakeholders were directed to ensure that all pharmaceutical products in their possession are duly registered and approved by the Pharmacy and Poisons Board;
Additionally, they were urged to adhere to the requirements outlined in the Pharmacy and Poisons Act and any other relevant regulations.
“TAKE NOTICE THAT, 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,” warned the board.
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,” added the statement.
The Board has further advised Kenyans to play their part and report any cases of ill-compliance through their channels.
-Courtesy
