Galaxy Pharmaceuticals Ltd v Pharmacy and Poisons Board (Judicial Review Application E328 of 2025) [2025] KEHC 14690 (KLR) (Judicial Review) (21 October 2025) (Ruling)

Kenya Law

Automated Summary

Key Facts

Galaxy Pharmaceuticals Ltd sought judicial review against the Pharmacy and Poisons Board's decisions to cancel their drug registration certificates for 40 products (announced 26 March 2025, effective 22 May 2025) and requested reinstatement of certificates and prohibition against third-party use. The court granted leave to apply for certiorari, mandamus, and prohibition but denied a stay due to the cancellations occurring 5 months prior. The case was closed after the ruling.

Issues

  • Whether the court can grant a stay of the cancellation decision pending the substantive judicial review hearing, considering the 5-month delay since the deregistration in May 2025 and the absence of inter-partes hearing.
  • Whether the Pharmacy and Poisons Board complied with the Pharmacy and Poisons Act, Rules and Guidelines for suspension/withdrawal of health product registrations, and the Fair Administrative Action Act when cancelling Galaxy Pharmaceuticals Ltd's drug registration certificates and deregistering 40 pharmaceutical products.

Holdings

  • The court grants leave for the judicial review application, allowing the applicant to challenge the administrative decisions of the Pharmacy and Poisons Board regarding the cancellation of drug registration certificates.
  • The court declines to order a stay of the Board's decision to cancel the registration certificates, citing that the deregistration has already occurred and a stay would require inter partes consideration.

Remedies

  • Leave granted to apply for prohibition to restrain the Pharmacy and Poisons Board from licensing third parties for the disputed products.
  • Leave granted to apply for certiorari to quash the administrative decisions of the Pharmacy and Poisons Board.
  • Leave granted to apply for mandamus to compel reinstatement of drug registration certificates and restoration of products to the official register.

Legal Principles

The court considered the validity of administrative decisions by the Pharmacy and Poisons Board under judicial review principles, including whether the cancellation of drug registration certificates was ultra vires (beyond legal authority) or procedurally irregular. The ruling emphasized that certiorari can be granted against administrative decisions if an arguable case is made, distinguishing them from judicial orders prohibited under Order 53 Rule 2.

Cited Statute

  • Pharmacy and Poisons Act
  • Fair Administrative Action Act

Judge Name

R. E. Aburili

Passage Text

  • 1. The Chamber Summons dated 16th October 2025 seeks leave of court to apply for Judicial Review orders of certiorari, mandamus and prohibition against the Respondent Pharmacy and Poisons Board, challenging the decision of the Board made vide Notice of Intention to cancel dated 26th March 2025 and the decision of 22nd May 2025 cancelling the exparte applicant's drug Registration certificates in respect of 40 Pharmaceutical Products and removing the said products from the Respondent's official Register and database of approved medical products; by way of certiorari and mandamus to compel the Respondents to reinstate the cancelled certificates of Registration and to restore the (40) products in the official register/data base and to prohibit or restrain the Respondent from assigning or authorising or licensing the interested party or any other third party to import, distribute, market or deal in the said products which are said to be trade-marked by the exparte applicant.
  • 6. Additionally, I have considered the complaint by the applicant and in my view, without delving into the substance of the matter, the application is not frivolous. This is not to say that it is merited in the end but that there are issues for determination including whether the Respondent complied with the law – Pharmacy and Poisons Act and Rules and Guidelines for suspension, withdrawal, withholding and Cancellation/Revocation of Marketing authorization of Health products and Health Technologies and the Fair Administrative Action Act, among other alleged procedural irregularities.
  • 5. The decisions being challenged herein do not fall under the categories of matters stated in order 53 Rule 2 as they are administrative decisions, not judgments, orders, decrees, conviction or proceedings. Accordingly, I am satisfied that leave to apply for certiorari can be considered and granted where the court is satisfied that an arguable case has been made to grant such leave.