The Pharmacy and Poisons Board (PPB) is embroiled in a controversy involving an Indian pharmaceutical manufacturer, Prism Life Sciences Limited, and its appointed Kenyan distributor, Galaxy Pharmaceuticals Limited, over the ownership of 45 medical products.
Documents obtained by Kenya Insights suggest a potential breach of intellectual property rights, placing the national drug regulator under scrutiny for allegedly facilitating the theft of products manufactured and registered by Prism Life Sciences in the PPB’s electronic system.
In 2003, Prism Life Sciences entered into a trade memorandum of understanding (MOU) with Galaxy Pharmaceuticals, appointing it as its Local Technical Representative (LTR) in Kenya.
However, the relationship soured when Prism Life Sciences discovered irregularities in Galaxy’s conduct.
The Agreement
The initial five-year agreement outlined clear responsibilities. Prism Life Sciences, as the contractor, was tasked with manufacturing, packaging, and bottling pharmaceutical products according to agreed specifications. The contract stipulated that Prism would deliver these products to Galaxy, the principal, at its designated location.
Despite these clear terms, Prism Life Sciences grew suspicious of Galaxy’s actions and sought clarification from the PPB to establish ownership of the 45 disputed products.
Galaxy’s Move
In a letter dated April 26, 2016, Galaxy Pharmaceuticals requested the PPB to amend registration certificates for 44 products, claiming they were registered under Prism Life Sciences by mistake. Galaxy asserted that it had appointed Prism solely for contract manufacturing, implying it held ownership rights.
Prism’s Response
On December 20, 2024, Prism Life Sciences, through its legal representatives, Mutuma Gichuru & Associates, wrote to the PPB regarding the dispute.
The firm described Prism as a reputable Indian pharmaceutical company that had appointed Galaxy as its LTR in compliance with the Pharmacy and Poisons Act.
Prism expressed dismay that between 2012 and 2019, Galaxy, acting as its LTR, applied for and obtained registration certificates for over 45 products manufactured and owned by Prism.
These certificates were uploaded to the PPB’s e-portal, clearly indicating Prism as the manufacturer and owner.
However, a dispute arose when Galaxy claimed ownership of these products.
Prism alleged that Galaxy produced forged registration certificates, distinct from those in the PPB’s system, to support its claim.
Suspecting a broader conspiracy, Prism raised concerns about potential manipulation of the PPB’s e-portal to replace original certificates with fraudulent ones.
Demands for Transparency
Prism’s lawyers requested detailed information from the PPB, including:
– Names, practice numbers, and identification details of individuals and pharmacies accessing Galaxy’s account on the PPB server since 2016.
– Activities conducted through the PPB’s product registration portal (products.pharmacyboardkenya.org).
– Confirmation of the e-portal’s integrity to rule out tampering.
Prism also referenced an October 24, 2024, notification to the PPB about potential forgery, noting Galaxy’s submission of altered certificates and a “private” agreement falsely claiming market authorization.
Citing Article 35 of the Constitution of Kenya (2010), which guarantees access to information, Prism demanded a response within 10 days.
The PPB’s failure to reply prompted Prism to escalate the matter to the Commission on Administrative Justice (CAJ), also known as the Office of the Ombudsman.
Ombudsman’s Intervention
On January 27, 2025, the CAJ directed the PPB to provide Prism with the requested information.
The Ombudsman, which oversees the Access to Information Act (2016), emphasized the PPB’s obligation to address Prism’s concerns.
Allegations of Complicity
Documents suggest that Galaxy, with alleged assistance from the PPB, used forged letters to secure registration certificates for Prism’s products.
Prism accuses Galaxy of exploiting its LTR role to claim ownership unlawfully.
The PPB’s silence, despite repeated appeals from Prism—most recently on December 20, 2024—has intensified scrutiny.
The CAJ’s intervention underscores the gravity of the allegations and the need for accountability.
A Betrayal of Trust
What began as a partnership to distribute Prism Life Sciences’ products in Kenya has spiraled into a contentious battle over intellectual property.
Prism’s appointment of Galaxy as its LTR was meant to ensure compliance with Kenyan regulations, but Galaxy’s alleged actions have turned collaboration into conflict.
As the dispute unfolds, questions linger about the PPB’s role and the integrity of its regulatory processes. Kenya Insights will continue to monitor developments in this unfolding saga.
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