The Pharmacy and Poisons Board is at the centre of a dispute involving an Indian pharmaceutical manufacturer and a company it appointed to do its local distribution over product ownership.

Documents in the possession of the People Daily stop short of highlighting it as a case of breach of patent rights, and has put the national drugs regulator on the spot allegedly for aiding theft of some 45 medical products manufactured and registered in the PPB electronic by Prism Life Sciences Limited.

The company completed an agreement with Galaxy Pharmaceuticals Limited and appointed it as its Local Technical Representative (LTR) in Kenya, a trade MOU signed in 2003. However, along the line, Prism Life Sciences realised that its LTR had become fishy.

Key contractor

In the agreement, which initially was to run for five years, one of the key requirements for the contractor in this case Prism Life Sciences Limited was to; “Manufacture the pharmaceutical products as well as packing and/or bottling in accordance with the requirements, features, qualities, volumes and previously agreed terms.”

“The Contractor is bound to: deliver the pharmaceutical products and packing and/or bottling at the domicile/residence of the Principal,” part of the agreement reads, where in this case the Principal is Prism Life Sciences Limited’s LTR, Galaxy Pharmaceuticals Limited.

However, despite the agreement showing the clear contract demarcations on what each partner is entitled to, along the line Prism Life realised some fishy outcomes of the contract, and decided to write to the regulator, PPB to request for important information to facilitate determination of ownership of the 45 products that are in question.

Galaxy Pharmaceutical Limited in a letter to the PPB dated April 26, 2016, requested the Board to correct registration certificates for 44 products as registered under Prism Life Sciences Limited instead of Galaxy Pharmaceutical Limited.

“We have appointed Prism Life Sciences for contract manufacturing as per the certificates,” Galaxy wrote to the PPB.

Various registrations

Through its advocates, Mutuma Gichuru & Associates, on December 20, 2024 wrote to the PPB in reference to the dispute with Galaxy Pharmaceuticals Limited over various registrations of drug certificates.

“We refer to a matter whose specific details are well within your knowledge..

The lawyers described Prism Life Sciences Limited, their client as a reputable pharmaceutical company based in India and that it had appointed Galaxy Pharmaceutical Ltd as its Local Technical Representative (LTR) in line with the provisions of the Pharmacy & Poisons Act and its enabling regulations.

However, Prism Life Sciences Limited expressed regret that despite this contractual terms, its LTR misbehaved along the line as shown in the letter to the Chief Executive Officer, PPB, a copy of which was also shared later with the Commission on Administrative Justice (CAJ), known as the Office of the Ombudsman.

“That between the years 2012 and 2019, acting as our client’s LTR, Galaxy Pharmaceutical Limited, applied and obtained various registration of drug certificates for over 45 products manufactured and owned by our client Prism Life Sciences Limited,” the company wrote.

It also emerges that the said certificates were subsequently uploaded in the PPB e-portal with a clear indication that each of those products was manufactured and owned by Prism Life Sciences.

“Subsequently, there arose a dispute between our client and the said LTR whereby the latter is now claiming ownership of the said pharmaceutical products,” said Prism, even indicating that attempts have been made to produce forged ‘clearly altered’ drug registration certificates separate from what was uploaded in the PPB system as drug registration certificates separate from what was uploaded in the portal as at the date of issuance or registration.

In this letter, Prism Life Sciences Limited is even suspecting that there might be a bigger conspiracy by Galaxy Pharmaceuticals Limited, which may include but not limited to attempts to manipulate the e-portal so as to illegally replace the original registration certificates with the forged ones.

“Whereas the integrity of your e-portal system is not being doubted, out of abundance of caution, we have been instructed to make a number of requests,” Mutuma Gichuru & Associates Advocates wrote.

Prism Life Sciences Limited wanted the PPB to provide a number of items, most of them on the integrity of its e-system including companies and individuals who have access to the PPB server (s) and databases therein.

“Provide details of names, practice numbers and identification numbers of the superintending officers, and pharmacies that have had access on behalf of Galaxy Pharmaceuticals Limited and the activities thereof, since the year 2016 to-date for the said account through the url: products.pharmacyboardkenya.org,” Prism further requested the PPB.

Prism Life Sciences Limited also reminded the PPB that on October 24, 2024, it notified the Board of a potential crime of forgery with respect to claims that Galaxy had allegedly written to provide attachments of Registration of Drugs Certificates and “private” agreement purporting they are the Market Authorisation Holder.

“Note that the request for this information is made pursuant to the provisions of vArticle 35 of the Constitution of Kenya 2010,”  wrote the company’s lawyers requesting the PPB to respond within 10 days, but the PPB didn’t respond.

The silence from the Board prompted Prism Life Sciences Limited to seek solace in the Office of the Ombudsman in order to compel PPB to respond.

On January 27, the Office of the Ombudsman wrote to the Board prevailing upon it to provide the pharmaceutical manufacturer with the information it was looking for. Prism Life Sciences Limited is accusing Galaxy of forging various registration certificates of its drugs with intent to own them.

What’s intriguing in this matter is that Prism Life Sciences Limited appointed Galaxy Pharmaceutical Limited as the Local Technical Representative (LTR) of its pharmaceutical products in an agreement, but the latter turned against the manufacturer.

Documents obtained by People Daily  show that with the aid of the PPB, Galaxy Pharmaceutical Limited used forged letters to obtain various registration certificates for Prism Life Sciences Limited’s manufactured products.

The Board has been silent about this matter, even after Prism Life Sciences Limited raised it severally, the latest being December 20, 2024, prompting the CAJ to intervene. The Office of the Ombudsman is the Oversight and Enforcement Agency of the Access to Information Act 2016.

“The Commission is in receipt of the letter dated 20th December 2024 from the applicant, Mutuma Gichuru & Associates Advocates on behalf of Prism Life Sciences. The request relates to the dispute between Prism Life Sciences and Galaxy Pharmaceuticals Limited regarding the various registrations of drug certificates,” says the letter sent to the Board CEO, Dr. Fred Siyoi.

The Office of the Ombudsman further indicated that Prism had raised several other concerns relating to the conduct of the PPB CEO’s office in dealing with the dispute as the Regulator and sought the said information to enable them defend the matter in court.

“The Commission notes that the timeline for responding to the request has lapsed without a response to the requestor. As such , this is to request for your institutional report pursuant to Section 22(3)(a) of the Access to Information  Act, 2016 within Seven (7) days to enable the Commission make a decision  on the application,” reads the letter authored by Dorothy Jemator, Access to Information Commissioner.

A google drive link containing details of the products as captured in the server for old registrations and retentions. However, Prism Life Sciences Limited allege that there’s a new server hosting the url: prims.phrmacyboardkenya.org that contains the changed status of the products which it doesn’t have access to.

On May 9, 2023, the PPB suspended issuance of Good Manufacturing Practice (GMP) certification to Prism Life Sciences Limited claiming that its manufacturing facility based in India did not meet the GMP.

“In the course of conducting GMP inspection of your facility located at Prism Lifesciences Limited, located at 122/1 RAVI Industrial Estate, Bileshwarpura Chhatral, Gandhinagar, India on 4th to 5th January 2023, serious breach of key GMP principles was observed,” PPB said in a letter signed by Dr. Siyoi, noting that the company was found to be operating in non=compliance to the laid down GMP requirements.