Double blow for pharma distributor caught in counterfeits row

However, Justice Roseline Aburili struck out the judicial review case following a finding that the intended cancellation of certificates had indeed happened, and therefore the application for orders was irrelevant.

“The legal position is settled that where a decision under challenge has been overtaken by events and no steps have been taken to amend pleadings to reflect the new reality, the court cannot purport to issue orders on a spent cause of action,” said the judge.

The cancellation letter titled “Notice of Intention to Cancel Registration of Health Products” showed that the Board’s decision followed a complaint from an Indian company, Prism Life Sciences Ltd.

The Board cited various grounds, including alleged misrepresentation, counterfeit formulations, and fraud, among other intellectual property violations, following complaints by the Indian company, which was the manufacturer of the said products.

Galaxy, which was a distributor of the said products and agent of Prism Life Sciences Ltd, challenged the notice, arguing that the notice was issued unlawfully and without due process.

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It is also noted that a separate civil suit was pending before the High Court's Commercial Division, filed by the patent holders and manufacturers against the Indian company.

The PPB decided to cancel the certificates of Galaxy after receiving a complaint from Prism Sciences regarding alleged counterfeit pharmaceutical formulations and the product ownership dispute between the two companies.

“… it has been established that the procedure for variation of the Marketing Authorization Holder (MAH) on the disputed products herein from Prism Life Sciences Limited to your company, vide your request letters dated April 12 and 26, 2016, was irregular,” reads the letter.

During the pendency of the court proceedings, the PPB cleared some of the drugs to be released into the market for sale after tests on the same proved that the products were safe for administration.

The Board then proceeded to cancel the registrations and demanded surrender of the cancelled certificates about the said health products through a letter dated May 22, 2025. The letters were signed by PPB Chief Executive Officer Dr F.M. Siyoi.

“Please note that the affected products, whose list was attached to the notice of cancellation, have been removed from the Board’s database,” the letter reads.

Justice Aburili explained that the law does not allow a party to litigate one administrative decision and invite the court to issue orders on another cause of action that is neither pleaded nor supported by affidavit evidence.

In this case, Galaxy’s challenge was directed solely at a notice of intention to cancel the certificates of the 40 products.

The judge said the implementation of the contested decision rendered the original challenge to the notice moot and academic.

“The new decision, the cancellation, has created a new and distinct cause of action, requiring fresh procedural compliance and grounds for review. Judicial review, by its nature, does not allow the introduction of new causes midstream, particularly when no amendment has been made,” said Justice Aburili.

The judge also noted that the underlying proprietary dispute relating to the pharmaceutical products was also the subject of a separate civil suit in the Commercial Court Division.

“In view of the foregoing, this court finds that the judicial review application subject of these proceedings has been overtaken by events and is now moot. The challenge to the notice of intention to cancel the registration certificates no longer presents a live controversy,” said Justice Aburili.

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