Background
1. The ex-parte Applicant (Galaxy Pharmaceuticals Limited) is a Kenyan company and describes itself as the lawful proprietor and Marketing Authorization Holder (MAH) for some forty (40) pharmaceutical products. That Prism Life Sciences Limited, the Interested party herein is a foreign manufacturer who previously produced these products under a private contractual arrangement. The exparte Applicant asserts that in 2016, it successfully varied the Marketing Authorization Holder (MAH) to reflect itself as the MAH, a change approved by the Respondent Pharmacy and Poisons Board, for eight years.
2. It is the applicant’s case that in August 2024, following a commercial dispute, the Interested Party lodged complaints of counterfeit and substandard products against the applicant. That following this complaint, the Respondent is said to have quarantined the ex-parte Applicant's products. However, according to the applicant, the laboratory tests conducted in March 2025 confirmed the said quarantined products to be compliant. That despite these findings made by the Respondent, the Respondent is said to have refused to lift restrictions on the said products and that instead, it issued a Notice of Intention to Cancel the registration on 26 th March 2025 citing alleged irregularities in the 2016 MAH variation and that in doing so, the Respondent did not provide any specific particulars, reasons nor accord the exparte applicants a fair hearing.
3. The Notice to cancel triggered the filing of Judicial Review Application No. E113 of 2025 by the ex-parte Applicant. Notwithstanding the existence of the said Judicial Review Proceedings, where there was no stay order issued, the Respondent proceeded to cancel the registrations on 22 nd May 2025.
4. It is alleged that subsequently, the Respondent cleared the quarantined products for sale, irregularly updated its database and permitted third parties, including the Interested Party herein to import and deal in the Applicant's trademarked products, while criminalizing the Applicant's own importation. Further, that that the Respondent later introduced new, contradictory reasons for the cancellation in October 2025.
5. The Interested Party’s case is that this Court lacks jurisdiction as the matter is a commercial dispute and lies within the Commercial Courts. That the suit is also time-barred, involves sub judice issues already before other courts and amounts to forum shopping. It is also their position that the matter is res judicata as the issue has previously been judicially reviewed and denied by this Court in Judicial Review Division in JR No. E113 of 2025 Galaxy Pharmaceuticals Limited versus Pharmacy and Poisons Board & Prism Life Sciences Ltd on 15 th August 2025; that the current suit repeats the same claims, constituting abuse of court process and that the applicant failed to exhaust internal dispute resolution alternatives as required by law.
6. The above is the snapshot of this case.
The Application
7. Vide its Notice of Motion dated 10 th November 2025 and filed pursuant to leave granted by this Court in HCJR E328 of 2025 on 21 st October 2025, premised on Articles 23, 40, 47, 50 and 165 of the Constitution of Kenya, Sections 7, 8, 9, and 11 of the Fair Administrative Action Act, 2015, Fair Administrative Action Rules 2024; Order 53 Rules (1), (2), (3) and (4) of the Civil Procedure Rules 2010 , the inherent power and jurisdiction of the honourable Court and all other enabling provisions of the law; the applicant seeks the following orders:
(1) Spent
(2) spent
(3) THAT An Order of Certiorari do issue to bring into this Honourable Court and quash the Notice of Intention to Cancel dated 26 th March 2025 and the subsequent decision of 22 nd May 2025 cancelling the Applicant's registration certificates for Forty (40) pharmaceutical products.
(4) THAT An Order of Mandamus compelling the Respondent to Reinstate the Applicant's drug registration certificates for the affected Forty (40) pharmaceutical products, reissue the retention certificates for the pharmaceutical products and restore the said products onto the Respondent's official register/database of approved medical products;
(5) THAT An Order of Prohibition restraining the Respondent from assigning, authorising. licensing, or otherwise permitting the Interested Party or any third party to import, distribute, market, or deal in any of the pharmaceutical products registered under the Applicant's trademarks, or in any other way interfering with the Applicant's exclusive proprietary rights over the said products.
(6) THAT a declaration be issued that the Respondent's conduct in cancelling the Applicant's registrations was unconstitutional, illegal, irrational, and procedurally unfair, in violation of Articles 40, 47, and 50 of the Constitution. [certiorari was sufficient]
(7) spent.
(8) THAT the costs of this Application be provided for.
8. The Application is premised on the grounds on the face of it, supported by the Statutory Statement dated 16 th October 2025 and the verifying affidavit of Jay Mitendra Hirani, the ex-parte Applicant’s Director sworn on 7 th November 2025.
9. The ex-parte Applicant avers that on 26 th March, 2025, the Respondent issued a Notice of Intention to cancel the Applicant’s drug registration certificates, citing vague and unsubstantiated allegations of substandard or counterfeit products, an ownership dispute and irregular misrepresentation in variation of the Marketing Authorization Holder (MAH). The reason for the cancellation in the Form 5 was stated as “For Misrepresentation of information during application for registration.”
10. It is averred that the Notice was issued in total disregard of the law and it illegally, unlawfully and unreasonably purported to cancel the drug registration certificates of over forty (40) pharmaceutical products owned by the ex-parte Applicant.
11. The ex-parte Applicant contends that the said “Notice of Intention to Cancel Registration of Health Products” was illegally, un-procedurally and irregularly issued because the Respondent failed to comply with the mandatory provisions of Rule 11(3) of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, Guideline 3.1.3 of the Pharmacy and Poisons Board Guidelines for Suspension, Withdrawal, Withholding and Cancellation/Revocation of Marketing Authorization of Health Products and Health Technologies In Kenya (herein after referred to as the Guidelines) and Section 4(3) of the Fair Administrative Action Act. That despite having investigated the ex-parte Applicant’s Pharmaceutical products and cleared the same for having met the threshold, the Respondent still proceeded to issue a notice of cancellation and cancelled the same.
12. It is the applicant’s further case that the Respondent failed to issue a well-reasoned response to the ex-parte Applicant thereby denying it an opportunity to present its case before the Respondent and that the Respondent instead gave a response through their advocates on record during the pendency of the Judicial Review No.113 of 2025 stating that the courts would be the appropriate forum to fully examine and resolve the issues raised.
13. It is averred that the Respondent actualised its threat to cancel the ex-parte Applicant’s drug registration certificates through its letter dated 22 nd May 2025 while the Judicial Review proceedings were ongoing which letter cancelling the registration was also un-procedural and irregular for failing to comply with Rule 12 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules; Clause 3.1.4 of the Guidelines; Article 47(1) of the Constitution of Kenya; Section 4(1) of the Fair Administrative Action Act; Failure to comply with section 4(3)(b) of the Fair Administrative Action Act; Section 4 (3) (g) of the Fair Administrative Action Act’ and Rule 12 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules .
14. It is further averred that the letter was issued in outright bad faith by usurping the High Court's jurisdiction over an ongoing commercial dispute, despite there being no injunction prohibiting the Applicant's operations and failing to give a reasoned determination or disclosing any supporting documentation for the decision.
15. It is asserted that the Respondent’s decision to cancel registration of the products was arbitrary and in disregard of the laboratory findings as the Respondent had quarantined the Applicant’s products since 27 th August 2024, which, vide a letter dated 13 th March 2025 were later confirmed through laboratory analysis to have fully complied with applicable standards and the same were cleared for release and sale in the Kenyan market during the pendency of the Judicial Review proceedings. That this made the Respondent’s impugned decision unreasonable and irrational and meant that they unlawfully assumed jurisdiction over a commercial dispute Milimani Commercial Case No. E065 of 2025 and Milimani Commercial Case No 718 of 2025 , which falls within the exclusive domain of the High Court. That in doing so, the Respondent acted beyond its statutory mandate and contrary to due process.
16. It is further averred that the Respondent acted ultra vires by determining a trademark dispute based on their letter dated the 14 th October 2024 where the Respondent wrote a letter to the Applicant clearly overstepping their jurisdiction. That the letter dated 14 th October 2025 issued to the ex-parte Applicant is similarly un-procedural, illegal, irregular and irrational for several reasons inter alia , that it does not comply with the mandatory provisions of Rule 11(3) & 12 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules ; secondly, that it gives contradictory reasons for cancellation based on the contradicting allegations provided in the Notice dated 26 th March 2025 and the complaint letter by the Interested Party; it failed to comply with Guideline 3.1.5; 3.1.6; 3.17; and 3.1.10 of the Pharmacy and Poisons Board Guidelines for Suspension, Withdrawal, Withholding and Cancellation/Revocation Of Marketing Authorization of Health Products and Health Technologies in Kenya ; it failed to take into consideration the pending commercial dispute between the parties which issues of a Private agreement, meetings held and the fact that the Interested Party was only contracted to manufacture the pharmaceutical product on behalf of the Applicants; and that there is a misrepresentation of the fact that the ex-parte Applicant failed to respond within 14 days yet the ex-parte Applicant responded to the Notice of Cancellation in a letter dated the 3 rd of April, 2025 which was done eight days prior to the impugned cancellation.
17. The ex-parte Applicant further avers that the Respondent relied on complaint lodged by the complainant/interested party herein without subjecting it to the mandatory legal threshold for proving ownership of a trademark, a purview that is a preserve of the High Court and that it similarly failed to specifically disclose the nature of misrepresentation or to comply with Section 4(3) of the Fair Administrative Action Act.
18. Th exparte applicant contends that despite the Respondent’s knowledge that the ex-parte Applicant is the registered proprietor of Forty (40) pharmaceutical products with a valid trademark which was lawfully acquired through registration with the Kenya Industrial Property Institute (KIPI), which trademark the exparte applicant has been in continuous commercial use in Kenya since 2003, the Respondent cancelled the ex-parte Applicant’s drug registration certificates thereby undermining the exparte applicant’s rights under Article 40 of the Constitution and the exclusive rights guaranteed under Sections 7 and 46 of the Trademarks Act .
19. It is the exparte applicant’s further case that the Respondent reverted the drug registration certificates to the Interested Party despite a Report prepared by the Respondents on the 9 th January, 2023 in which they wrote a letter on Non-Compliance with Good Manufacturing Practices by the Interested Party, stating that the Board would not approve drugs manufactured at the Interested Party’s site for registration and sale in Kenya. That in view of this, the Interested party was required to apply for reinspection of the facility once corrective actions in the report were addressed.
20. The ex-parte Applicant avers that on 9 th May, 2023 the Respondent issued to the Interested Party through the ex-parte Applicant, a suspension of the GMP Certification of the manufacturing facility, setting out alleged serious breaches of key GMP principles and that the Interested Party was found to be operating in non-compliance with the laid down GMP requirements. That such suspension remained in force until such time when all Corrective Action and Preventive Actions would be adequately addressed.
21. Consequently, the exparte applicant asserts that the Respondent’s actions are unreasonable and disproportionate as they have created a regulatory stalemate to the effect that any importation by the Applicant is now criminalized under the guise of cancellation, while importation by third parties using the Applicant’s trademarks and which constitutes counterfeiting with a public health risk due to potential shortages of life-saving medical products are allowed.
22. The exparte applicant maintains that the Respondent has acted in a procedurally unfair, irrational, illegal and oppressive manner, in violation of the Applicant’s rights under Articles 40, 47 and 50 of the Constitution, which called for the Court’s urgent intervention, to avert irreparable, commercial and constitutional harm on the Applicant. Further, that the Applicant had a legitimate expectation arising from the Respondent’s conduct and representations, that its duly registered drug registration certificate and drug retention certificates would remain valid and enforceable unless lawfully cancelled after a fair administrative process. The abrupt cancellation is said to have violated that legitimate expectation.
23. Further deposition on behalf of the exparte applicant is that where a public body acts without affording the affected party an opportunity to be heard, or fails to follow a fair process, any subsequent action taken on the basis of such a decision risk causing irreversible harm and it is void ab initio . That unless restrained, the Respondent will continue relying on the unlawful cancellation to facilitate the infringement of the Applicant’s trademarks, displace it from the pharmaceutical market and cause grave and irreparable harm that cannot be remedied by damages.
24. The exparte applicant contends that the products in question treat serious medical conditions and that therefore, the regulatory stalemate created by the Respondent where both the Applicant and third parties cannot lawfully trade endangers public access to essential medicines which contravened the right to access to essential medication under Article 43 (1) (a) of the Constitution of Kenya, constituting a misuse of power and a threat to public health.
25. The fear by the exparte applicant, following the cancellation and the effects thereof is that it risks imminent closure of its operations if the current regulatory stalemate persists, as it had taken substantial loan facilities to support its operations in regard to importation and manufacturing of their Pharmaceutical Products. Further, that the continued disruption of its operations has rendered it unable to meet its financial obligations, exposing it to default and possible insolvency, yet it has employed over thirty (30) staff members whose families depend on the company for their livelihood such that the closure of their operations would result in loss of employment, economic hardship and social instability.
26. The exparte applicants urge this Court to find that the Respondent’s actions are disproportionate, unreasonable, and ultra vires its statutory mandate, warranting intervention by the Court through the prerogative orders sought.
The Respondent’s Replying Affidavit
27. Opposing the Application, the Respondent filed a Replying Affidavit sworn by Dr. Ahmed I. Mohammed, the Respondent’s Acting Chief Executive Officer/Registrar, sworn on 8 th January 2026. The Respondent contends that the ex-parte Applicant was afforded an opportunity to be heard prior to the decision to cancel its drug registration certificates being made and that the process of suspension, withdrawal, withholding and revocation of Marketing Authorization Holder is anchored in the law and that there was compliance with the law in the issuance of the letter dated 26 th March 2025.
28. The deponent avers that the jurisdiction of this Court has been wrongly invoked and that the suit is an abuse of the court process to the extent that the dispute herein is commercial in nature, whose proceedings are ongoing before the Commercial Division of the High Court, thereby invoking the jurisdiction of two courts at the same time. That their decision contained in its letter of 26 th March 2025 is justified as the drug registration certificates held by the ex-parte Applicant were issued out of misrepresentation.
29. It is deposed in contention that the ex-parte Applicant has not satisfied the conditions for the grant of orders of Certiorari & Prohibition sought herein and that the proceedings fatally defective, having been instituted to challenge a decision after the lapse of six (6) months, in contravention of Section 9 (3) of the Law Reform Act .
Interested Party’s Replying Affidavit
30. The Interested Party filed a Replying Affidavit dated 25 th November 2025 sworn by Ajay Joshi, its director, who deposes that the Application, the Verifying Affidavit and Statutory Statement by the ex--parte Applicant, reveal that the main issue in the suit, the ownership of the 45 pharmaceutical products, is pending before the Commercial Courts vide Milimani Commercial Case No. E605 of 2025 and Milimani Commercial Case No. E718 of 2025 . That this is well acknowledged by the ex-parte Applicant thereby rendering these proceedings duplicative and an abuse of process.
31. The Interested Party contends that the ex-parte Applicant’s application is forum shopping, duplicative, and an abuse of judicial process, adding that the ex-parte Applicant fraudulently attempted to usurp ownership of the interested party’s products through forged documents, counterfeit drugs and misrepresentation, which was confirmed by the Regulatory and investigative bodies. This then, according to the Interested Party, justified the cancellation of certificates.
32. It is deposed that the Interested Party is a global pharmaceutical manufacturer, incorporated in India, with a reputation for high-quality medicines and that it appointed the ex-parte Applicant in 2003 as its Local Technical Representative (LTR) and distributor in Kenya. It is deposed that the said appointment did not confer ownership or intellectual property rights, specifically trademarks, as these remained with the Interested Party.
33. The Interested Party avers that the ex-parte Applicant forged and fabricated a private agreement dated 20 th August 2003 and meeting minutes purportedly held in September 2004, which were proven false by two forensic reports from the Directorate of Criminal Investigations (DCI).
34. On Trademark Misappropriation, the Interested Party contends that the ex-parte Applicant relying on the aforementioned forgery and spurious private agreement, illegally and in a conniving manner registered the trademarks in its own name, despite acting only as the interested party’s Local Technical Representative. That further, the ex-parte Applicant acquired a company name: Prism Medico & Pharmacy Ltd to mimic the Interested Party’s “PRISM” brand, then imported counterfeit drugs.
35. It is further deposed that the ex-parte Applicant distributed substandard drugs e.g., LIPILOC, TELMI, MEXIC that failed quality tests, posing risks to public health and that as a result of the fraud, forgery and distribution of substandard drugs, the Interested Party terminated their appointment of the exparte applicant as LTR and appointed a new representative. That it also lodged a formal complaint with the Pharmacy and Poisons Board (PPB) in August 2024.
36. It is deposed that the Pharmacy and Poisons Board (Respondent) found that the ex-parte Applicant had irregularly varied the Market Authorization Holder (MAH) through misrepresentation and cancelled the exparte applicant’s certificates after the DCI confirmed the key documents relied on by the ex-parte Applicant were forgeries. The Interested Party also asserts that the ex-parte Applicant’s case is built on fraud and misrepresentation, and therefore it is before this Court with “unclean hands.”
37. Further, that the matter is res judicata and sub judice , making the current suit an abuse of process since prior attempts by the ex-parte Applicant to secure reliefs in other courts were denied. The Interested Party urges dismissal of the ex-parte Applicant’s case, arguing that the Respondent acted lawfully under Rule 11(b) and (c) of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules .
The Applicant’s rejoinder
38. In a rejoinder, the ex-parte Applicant filed a Supplementary Affidavit sworn Jay Hitendra Hirani on 22 nd January 2026 reiterating the contents of the Notice of Motion dated the 10 th November 2023, the Chamber Summons and accompanying affidavit dated 16 th October, 2025. In summary, the ex-parte Applicant maintains its assertions that the Respondent exceeded its statutory authority by intervening in a commercial trademark dispute, selectively investigating only one party, ignoring evidence of compliance and unlawfully cancelling the exparte applicant’s registration certificates. That the effect of the Respondent’s actions is severe commercial and social harm, which warranted the judicial review reliefs sought by the ex-parte Applicant.
39. Mr. Hirani further deposed that they had been appointed both as a sole distributor in a commercial role and as a Local Representative before the Ministry of Health and the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules 2022 , in a regulatory role. That under Kenyan law, foreign applicants had to appoint a Local Representative, confirming a formal regulatory agreement distinct from the commercial arrangement.
40. It is deposed that in terms of the commercial relationship, the ex-parte Applicant and the Interested Party traded from 2003–2014 and again from 2016–2024, and that the Respondent was not privy to their commercial dealings. He deposes further that in January 2023, the inspection revealed irregularities at the Interested Party’s facility, including inadequate documentation and non-compliance with WHO-GMP standards, that the GMP certification was suspended in May 2023, that the Interested Party complained about counterfeit/substandard drugs and trademark misuse in August 2024 and in October 2024, the Respondent quarantined the Applicant’s products despite later analysis confirming compliance.
41. It is deponed further that the Respondent required the Applicant to prove trademark ownership but did not require the Interested Party to do the same, that Certificates were reverted to the Interested Party despite its non-compliance history which was ultra vires the Respondent’s mandate, since trademark disputes fall solely under the High Court or Kenya Industrial Property Institute.
42. On the issue of Cancellation of Certificates, it is deposed that the Respondent issued a Notice of Cancellation in March 2025 citing misrepresentation which was objected to by the exparte applicant through the ex-parte Applicant’s advocates, but that the Respondent falsely claimed that no objection was lodged. That consequently, the cancellation proceeded despite ongoing Judicial Review proceedings, which cancellation decision was illegal, irrational and marred with procedural impropriety.
43. The ex-parte Applicant disputes the issue of sub judice raised by Respondent, and emphasizes that administrative decisions are exempt from certain statutory limits under Kenyan law. It decried the cancellation of its registration certificate and lamented that it not only led to severe commercial setbacks but also hospitals and pharmacies cancelled their orders resultantly denying patients critical medication.
44. Lastly, it is asserted that by admission, the Interested party has not been exporting to Kenya since 2022 therefore the effect of not trading with the exparte Applicant’s trademark is now being felt by the exparte Applicant who not only introduced the product to the Kenyan market but ensured its safety, efficacy and quality as per the objectives of the Respondent, for 18 years.
45. A Further Affidavit was filed on 5 th February 2026 sworn by the same director Mr. Hirani in response to the Interested Party’s Replying Affidavit. He deposes that the Interested Party is improperly turning Judicial Review proceedings into a commercial dispute over ownership of pharmaceutical products and trademarks yet Judicial Review is limited to examining the lawfulness, rationality, and procedural propriety of administrative decisions.
46. The deponent urges that the Interested Party is misconstruing the matter as a commercial dispute over ownership of the 45 pharmaceutical products and asserts that their allegations of proprietary claims, trust arrangements, and trademark disputes are outside the scope of Judicial Review and should only be determined in a substantive civil suit, not in these proceedings.
47. It is deposed that the timing and conduct of the Interested Party was questionable because the parties had a cordial relationship for nearly 20 years and that the alleged complaint arose only after the Interested Party was found to be non-GMP compliant in 2024, suggesting malice and inconsistency.
48. Further, the ex-parte Applicant denies claims that trademarks were registered in trust and asserts that any such issues involve complex factual and legal questions unsuitable for Judicial Review. That in any event, it is the ex-parte Applicant who has already secured a High Court Order in HCOMM 718 OF 2025 restraining infringement of its trademarks.
49. It is further deposed that the variation of the ex-parte Applicant by the Interested Party as its Local Technical Representative (LTR) occurred in 2016, well before the alleged fallout in 2022 and that the Interested Party’s claim that it was uninformed is misleading, as the change did not require notification under Rule 4(4) hence it cannot be said that the variation was effected without due process.
50. The ex-parte Applicant asserts that the allegations of unsafe pharmaceutical products are unfounded since quarantine and laboratory testing confirmed compliance and the quarantined products were released for sale. That additionally, the Interested Party’s claim of an anonymous complaint is false as the records show that the complaint was lodged only after the non-GMP findings, thereby undermining the credibility of the alleged anonymous complaint.
51. That although the Interested Party accuses the exparte Applicant of forum shopping, Judicial Review is distinct from commercial suits and that the pending suits in other courts do not challenge the Respondent’s administrative process. It is urged that the interested party’s Replying Affidavit should be struck out for improperly expanding the scope of judicial review proceedings.
52. The ex-parte Applicant makes reference to the DCI reports and an ODPP letter and asserts that the forgery charges cannot be sustained and therefore the Court should disregard or strike out the Interested Party’s Replying Affidavit and focus solely on whether the Respondent acted lawfully and procedurally in cancelling the Drug Registration Certificates.
53. The parties took directions to canvass the Application by way of written submissions which are now on record.
The ex-parte Applicant’s Submissions
54. Counsel for the ex-parte Applicant submitted that the Respondent acted ultra vires, in breach of Articles 40 and 47 of the Constitution, and statutory provisions, in an irrational, unreasonable, and disproportionate manner.
55. Counsel for the applicant isolated four issues for determination being:
a. whether the Court has the requisite jurisdiction;
b. whether the Respondent acted ultra vires, unlawfully, or on the basis of an error of law;
c. whether the Respondent breached the ex-parte Applicant's constitutional and statutory right to fair administrative action; and
d. whether the Respondent’s decisions were irrational, unreasonable, and disproportionate .
56. On the first issue of the Court’s jurisdiction Counsel for the Applicant asserts that the Respondent’s actions constitute administrative decisions under Article 47 of the Constitution and the Fair Administrative Action Act 2015 , thereby falling within the Court's supervisory jurisdiction under Articles 165 (6) and (7) of the Constitution. Their argument is that the Respondent, as a statutory body, performs public functions affecting legal rights, making its decisions amenable to Judicial Review, irrespective of underlying commercial aspects. That the existence of parallel commercial suits does not oust this Court’s jurisdiction, as Judicial Review focuses on the decision-making process, not the merits of commercial disputes.
57. On limitation of time, counsel for the applicant submits that the Court is properly seized of jurisdiction and that S
[...truncated]
1. The ex-parte Applicant (Galaxy Pharmaceuticals Limited) is a Kenyan company and describes itself as the lawful proprietor and Marketing Authorization Holder (MAH) for some forty (40) pharmaceutical products. That Prism Life Sciences Limited, the Interested party herein is a foreign manufacturer who previously produced these products under a private contractual arrangement. The exparte Applicant asserts that in 2016, it successfully varied the Marketing Authorization Holder (MAH) to reflect itself as the MAH, a change approved by the Respondent Pharmacy and Poisons Board, for eight years.
2. It is the applicant’s case that in August 2024, following a commercial dispute, the Interested Party lodged complaints of counterfeit and substandard products against the applicant. That following this complaint, the Respondent is said to have quarantined the ex-parte Applicant's products. However, according to the applicant, the laboratory tests conducted in March 2025 confirmed the said quarantined products to be compliant. That despite these findings made by the Respondent, the Respondent is said to have refused to lift restrictions on the said products and that instead, it issued a Notice of Intention to Cancel the registration on 26 th March 2025 citing alleged irregularities in the 2016 MAH variation and that in doing so, the Respondent did not provide any specific particulars, reasons nor accord the exparte applicants a fair hearing.
3. The Notice to cancel triggered the filing of Judicial Review Application No. E113 of 2025 by the ex-parte Applicant. Notwithstanding the existence of the said Judicial Review Proceedings, where there was no stay order issued, the Respondent proceeded to cancel the registrations on 22 nd May 2025.
4. It is alleged that subsequently, the Respondent cleared the quarantined products for sale, irregularly updated its database and permitted third parties, including the Interested Party herein to import and deal in the Applicant's trademarked products, while criminalizing the Applicant's own importation. Further, that that the Respondent later introduced new, contradictory reasons for the cancellation in October 2025.
5. The Interested Party’s case is that this Court lacks jurisdiction as the matter is a commercial dispute and lies within the Commercial Courts. That the suit is also time-barred, involves sub judice issues already before other courts and amounts to forum shopping. It is also their position that the matter is res judicata as the issue has previously been judicially reviewed and denied by this Court in Judicial Review Division in JR No. E113 of 2025 Galaxy Pharmaceuticals Limited versus Pharmacy and Poisons Board & Prism Life Sciences Ltd on 15 th August 2025; that the current suit repeats the same claims, constituting abuse of court process and that the applicant failed to exhaust internal dispute resolution alternatives as required by law.
6. The above is the snapshot of this case.
The Application
7. Vide its Notice of Motion dated 10 th November 2025 and filed pursuant to leave granted by this Court in HCJR E328 of 2025 on 21 st October 2025, premised on Articles 23, 40, 47, 50 and 165 of the Constitution of Kenya, Sections 7, 8, 9, and 11 of the Fair Administrative Action Act, 2015, Fair Administrative Action Rules 2024; Order 53 Rules (1), (2), (3) and (4) of the Civil Procedure Rules 2010 , the inherent power and jurisdiction of the honourable Court and all other enabling provisions of the law; the applicant seeks the following orders:
(1) Spent
(2) spent
(3) THAT An Order of Certiorari do issue to bring into this Honourable Court and quash the Notice of Intention to Cancel dated 26 th March 2025 and the subsequent decision of 22 nd May 2025 cancelling the Applicant's registration certificates for Forty (40) pharmaceutical products.
(4) THAT An Order of Mandamus compelling the Respondent to Reinstate the Applicant's drug registration certificates for the affected Forty (40) pharmaceutical products, reissue the retention certificates for the pharmaceutical products and restore the said products onto the Respondent's official register/database of approved medical products;
(5) THAT An Order of Prohibition restraining the Respondent from assigning, authorising. licensing, or otherwise permitting the Interested Party or any third party to import, distribute, market, or deal in any of the pharmaceutical products registered under the Applicant's trademarks, or in any other way interfering with the Applicant's exclusive proprietary rights over the said products.
(6) THAT a declaration be issued that the Respondent's conduct in cancelling the Applicant's registrations was unconstitutional, illegal, irrational, and procedurally unfair, in violation of Articles 40, 47, and 50 of the Constitution. [certiorari was sufficient]
(7) spent.
(8) THAT the costs of this Application be provided for.
8. The Application is premised on the grounds on the face of it, supported by the Statutory Statement dated 16 th October 2025 and the verifying affidavit of Jay Mitendra Hirani, the ex-parte Applicant’s Director sworn on 7 th November 2025.
9. The ex-parte Applicant avers that on 26 th March, 2025, the Respondent issued a Notice of Intention to cancel the Applicant’s drug registration certificates, citing vague and unsubstantiated allegations of substandard or counterfeit products, an ownership dispute and irregular misrepresentation in variation of the Marketing Authorization Holder (MAH). The reason for the cancellation in the Form 5 was stated as “For Misrepresentation of information during application for registration.”
10. It is averred that the Notice was issued in total disregard of the law and it illegally, unlawfully and unreasonably purported to cancel the drug registration certificates of over forty (40) pharmaceutical products owned by the ex-parte Applicant.
11. The ex-parte Applicant contends that the said “Notice of Intention to Cancel Registration of Health Products” was illegally, un-procedurally and irregularly issued because the Respondent failed to comply with the mandatory provisions of Rule 11(3) of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, Guideline 3.1.3 of the Pharmacy and Poisons Board Guidelines for Suspension, Withdrawal, Withholding and Cancellation/Revocation of Marketing Authorization of Health Products and Health Technologies In Kenya (herein after referred to as the Guidelines) and Section 4(3) of the Fair Administrative Action Act. That despite having investigated the ex-parte Applicant’s Pharmaceutical products and cleared the same for having met the threshold, the Respondent still proceeded to issue a notice of cancellation and cancelled the same.
12. It is the applicant’s further case that the Respondent failed to issue a well-reasoned response to the ex-parte Applicant thereby denying it an opportunity to present its case before the Respondent and that the Respondent instead gave a response through their advocates on record during the pendency of the Judicial Review No.113 of 2025 stating that the courts would be the appropriate forum to fully examine and resolve the issues raised.
13. It is averred that the Respondent actualised its threat to cancel the ex-parte Applicant’s drug registration certificates through its letter dated 22 nd May 2025 while the Judicial Review proceedings were ongoing which letter cancelling the registration was also un-procedural and irregular for failing to comply with Rule 12 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules; Clause 3.1.4 of the Guidelines; Article 47(1) of the Constitution of Kenya; Section 4(1) of the Fair Administrative Action Act; Failure to comply with section 4(3)(b) of the Fair Administrative Action Act; Section 4 (3) (g) of the Fair Administrative Action Act’ and Rule 12 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules .
14. It is further averred that the letter was issued in outright bad faith by usurping the High Court's jurisdiction over an ongoing commercial dispute, despite there being no injunction prohibiting the Applicant's operations and failing to give a reasoned determination or disclosing any supporting documentation for the decision.
15. It is asserted that the Respondent’s decision to cancel registration of the products was arbitrary and in disregard of the laboratory findings as the Respondent had quarantined the Applicant’s products since 27 th August 2024, which, vide a letter dated 13 th March 2025 were later confirmed through laboratory analysis to have fully complied with applicable standards and the same were cleared for release and sale in the Kenyan market during the pendency of the Judicial Review proceedings. That this made the Respondent’s impugned decision unreasonable and irrational and meant that they unlawfully assumed jurisdiction over a commercial dispute Milimani Commercial Case No. E065 of 2025 and Milimani Commercial Case No 718 of 2025 , which falls within the exclusive domain of the High Court. That in doing so, the Respondent acted beyond its statutory mandate and contrary to due process.
16. It is further averred that the Respondent acted ultra vires by determining a trademark dispute based on their letter dated the 14 th October 2024 where the Respondent wrote a letter to the Applicant clearly overstepping their jurisdiction. That the letter dated 14 th October 2025 issued to the ex-parte Applicant is similarly un-procedural, illegal, irregular and irrational for several reasons inter alia , that it does not comply with the mandatory provisions of Rule 11(3) & 12 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules ; secondly, that it gives contradictory reasons for cancellation based on the contradicting allegations provided in the Notice dated 26 th March 2025 and the complaint letter by the Interested Party; it failed to comply with Guideline 3.1.5; 3.1.6; 3.17; and 3.1.10 of the Pharmacy and Poisons Board Guidelines for Suspension, Withdrawal, Withholding and Cancellation/Revocation Of Marketing Authorization of Health Products and Health Technologies in Kenya ; it failed to take into consideration the pending commercial dispute between the parties which issues of a Private agreement, meetings held and the fact that the Interested Party was only contracted to manufacture the pharmaceutical product on behalf of the Applicants; and that there is a misrepresentation of the fact that the ex-parte Applicant failed to respond within 14 days yet the ex-parte Applicant responded to the Notice of Cancellation in a letter dated the 3 rd of April, 2025 which was done eight days prior to the impugned cancellation.
17. The ex-parte Applicant further avers that the Respondent relied on complaint lodged by the complainant/interested party herein without subjecting it to the mandatory legal threshold for proving ownership of a trademark, a purview that is a preserve of the High Court and that it similarly failed to specifically disclose the nature of misrepresentation or to comply with Section 4(3) of the Fair Administrative Action Act.
18. Th exparte applicant contends that despite the Respondent’s knowledge that the ex-parte Applicant is the registered proprietor of Forty (40) pharmaceutical products with a valid trademark which was lawfully acquired through registration with the Kenya Industrial Property Institute (KIPI), which trademark the exparte applicant has been in continuous commercial use in Kenya since 2003, the Respondent cancelled the ex-parte Applicant’s drug registration certificates thereby undermining the exparte applicant’s rights under Article 40 of the Constitution and the exclusive rights guaranteed under Sections 7 and 46 of the Trademarks Act .
19. It is the exparte applicant’s further case that the Respondent reverted the drug registration certificates to the Interested Party despite a Report prepared by the Respondents on the 9 th January, 2023 in which they wrote a letter on Non-Compliance with Good Manufacturing Practices by the Interested Party, stating that the Board would not approve drugs manufactured at the Interested Party’s site for registration and sale in Kenya. That in view of this, the Interested party was required to apply for reinspection of the facility once corrective actions in the report were addressed.
20. The ex-parte Applicant avers that on 9 th May, 2023 the Respondent issued to the Interested Party through the ex-parte Applicant, a suspension of the GMP Certification of the manufacturing facility, setting out alleged serious breaches of key GMP principles and that the Interested Party was found to be operating in non-compliance with the laid down GMP requirements. That such suspension remained in force until such time when all Corrective Action and Preventive Actions would be adequately addressed.
21. Consequently, the exparte applicant asserts that the Respondent’s actions are unreasonable and disproportionate as they have created a regulatory stalemate to the effect that any importation by the Applicant is now criminalized under the guise of cancellation, while importation by third parties using the Applicant’s trademarks and which constitutes counterfeiting with a public health risk due to potential shortages of life-saving medical products are allowed.
22. The exparte applicant maintains that the Respondent has acted in a procedurally unfair, irrational, illegal and oppressive manner, in violation of the Applicant’s rights under Articles 40, 47 and 50 of the Constitution, which called for the Court’s urgent intervention, to avert irreparable, commercial and constitutional harm on the Applicant. Further, that the Applicant had a legitimate expectation arising from the Respondent’s conduct and representations, that its duly registered drug registration certificate and drug retention certificates would remain valid and enforceable unless lawfully cancelled after a fair administrative process. The abrupt cancellation is said to have violated that legitimate expectation.
23. Further deposition on behalf of the exparte applicant is that where a public body acts without affording the affected party an opportunity to be heard, or fails to follow a fair process, any subsequent action taken on the basis of such a decision risk causing irreversible harm and it is void ab initio . That unless restrained, the Respondent will continue relying on the unlawful cancellation to facilitate the infringement of the Applicant’s trademarks, displace it from the pharmaceutical market and cause grave and irreparable harm that cannot be remedied by damages.
24. The exparte applicant contends that the products in question treat serious medical conditions and that therefore, the regulatory stalemate created by the Respondent where both the Applicant and third parties cannot lawfully trade endangers public access to essential medicines which contravened the right to access to essential medication under Article 43 (1) (a) of the Constitution of Kenya, constituting a misuse of power and a threat to public health.
25. The fear by the exparte applicant, following the cancellation and the effects thereof is that it risks imminent closure of its operations if the current regulatory stalemate persists, as it had taken substantial loan facilities to support its operations in regard to importation and manufacturing of their Pharmaceutical Products. Further, that the continued disruption of its operations has rendered it unable to meet its financial obligations, exposing it to default and possible insolvency, yet it has employed over thirty (30) staff members whose families depend on the company for their livelihood such that the closure of their operations would result in loss of employment, economic hardship and social instability.
26. The exparte applicants urge this Court to find that the Respondent’s actions are disproportionate, unreasonable, and ultra vires its statutory mandate, warranting intervention by the Court through the prerogative orders sought.
The Respondent’s Replying Affidavit
27. Opposing the Application, the Respondent filed a Replying Affidavit sworn by Dr. Ahmed I. Mohammed, the Respondent’s Acting Chief Executive Officer/Registrar, sworn on 8 th January 2026. The Respondent contends that the ex-parte Applicant was afforded an opportunity to be heard prior to the decision to cancel its drug registration certificates being made and that the process of suspension, withdrawal, withholding and revocation of Marketing Authorization Holder is anchored in the law and that there was compliance with the law in the issuance of the letter dated 26 th March 2025.
28. The deponent avers that the jurisdiction of this Court has been wrongly invoked and that the suit is an abuse of the court process to the extent that the dispute herein is commercial in nature, whose proceedings are ongoing before the Commercial Division of the High Court, thereby invoking the jurisdiction of two courts at the same time. That their decision contained in its letter of 26 th March 2025 is justified as the drug registration certificates held by the ex-parte Applicant were issued out of misrepresentation.
29. It is deposed in contention that the ex-parte Applicant has not satisfied the conditions for the grant of orders of Certiorari & Prohibition sought herein and that the proceedings fatally defective, having been instituted to challenge a decision after the lapse of six (6) months, in contravention of Section 9 (3) of the Law Reform Act .
Interested Party’s Replying Affidavit
30. The Interested Party filed a Replying Affidavit dated 25 th November 2025 sworn by Ajay Joshi, its director, who deposes that the Application, the Verifying Affidavit and Statutory Statement by the ex--parte Applicant, reveal that the main issue in the suit, the ownership of the 45 pharmaceutical products, is pending before the Commercial Courts vide Milimani Commercial Case No. E605 of 2025 and Milimani Commercial Case No. E718 of 2025 . That this is well acknowledged by the ex-parte Applicant thereby rendering these proceedings duplicative and an abuse of process.
31. The Interested Party contends that the ex-parte Applicant’s application is forum shopping, duplicative, and an abuse of judicial process, adding that the ex-parte Applicant fraudulently attempted to usurp ownership of the interested party’s products through forged documents, counterfeit drugs and misrepresentation, which was confirmed by the Regulatory and investigative bodies. This then, according to the Interested Party, justified the cancellation of certificates.
32. It is deposed that the Interested Party is a global pharmaceutical manufacturer, incorporated in India, with a reputation for high-quality medicines and that it appointed the ex-parte Applicant in 2003 as its Local Technical Representative (LTR) and distributor in Kenya. It is deposed that the said appointment did not confer ownership or intellectual property rights, specifically trademarks, as these remained with the Interested Party.
33. The Interested Party avers that the ex-parte Applicant forged and fabricated a private agreement dated 20 th August 2003 and meeting minutes purportedly held in September 2004, which were proven false by two forensic reports from the Directorate of Criminal Investigations (DCI).
34. On Trademark Misappropriation, the Interested Party contends that the ex-parte Applicant relying on the aforementioned forgery and spurious private agreement, illegally and in a conniving manner registered the trademarks in its own name, despite acting only as the interested party’s Local Technical Representative. That further, the ex-parte Applicant acquired a company name: Prism Medico & Pharmacy Ltd to mimic the Interested Party’s “PRISM” brand, then imported counterfeit drugs.
35. It is further deposed that the ex-parte Applicant distributed substandard drugs e.g., LIPILOC, TELMI, MEXIC that failed quality tests, posing risks to public health and that as a result of the fraud, forgery and distribution of substandard drugs, the Interested Party terminated their appointment of the exparte applicant as LTR and appointed a new representative. That it also lodged a formal complaint with the Pharmacy and Poisons Board (PPB) in August 2024.
36. It is deposed that the Pharmacy and Poisons Board (Respondent) found that the ex-parte Applicant had irregularly varied the Market Authorization Holder (MAH) through misrepresentation and cancelled the exparte applicant’s certificates after the DCI confirmed the key documents relied on by the ex-parte Applicant were forgeries. The Interested Party also asserts that the ex-parte Applicant’s case is built on fraud and misrepresentation, and therefore it is before this Court with “unclean hands.”
37. Further, that the matter is res judicata and sub judice , making the current suit an abuse of process since prior attempts by the ex-parte Applicant to secure reliefs in other courts were denied. The Interested Party urges dismissal of the ex-parte Applicant’s case, arguing that the Respondent acted lawfully under Rule 11(b) and (c) of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules .
The Applicant’s rejoinder
38. In a rejoinder, the ex-parte Applicant filed a Supplementary Affidavit sworn Jay Hitendra Hirani on 22 nd January 2026 reiterating the contents of the Notice of Motion dated the 10 th November 2023, the Chamber Summons and accompanying affidavit dated 16 th October, 2025. In summary, the ex-parte Applicant maintains its assertions that the Respondent exceeded its statutory authority by intervening in a commercial trademark dispute, selectively investigating only one party, ignoring evidence of compliance and unlawfully cancelling the exparte applicant’s registration certificates. That the effect of the Respondent’s actions is severe commercial and social harm, which warranted the judicial review reliefs sought by the ex-parte Applicant.
39. Mr. Hirani further deposed that they had been appointed both as a sole distributor in a commercial role and as a Local Representative before the Ministry of Health and the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules 2022 , in a regulatory role. That under Kenyan law, foreign applicants had to appoint a Local Representative, confirming a formal regulatory agreement distinct from the commercial arrangement.
40. It is deposed that in terms of the commercial relationship, the ex-parte Applicant and the Interested Party traded from 2003–2014 and again from 2016–2024, and that the Respondent was not privy to their commercial dealings. He deposes further that in January 2023, the inspection revealed irregularities at the Interested Party’s facility, including inadequate documentation and non-compliance with WHO-GMP standards, that the GMP certification was suspended in May 2023, that the Interested Party complained about counterfeit/substandard drugs and trademark misuse in August 2024 and in October 2024, the Respondent quarantined the Applicant’s products despite later analysis confirming compliance.
41. It is deponed further that the Respondent required the Applicant to prove trademark ownership but did not require the Interested Party to do the same, that Certificates were reverted to the Interested Party despite its non-compliance history which was ultra vires the Respondent’s mandate, since trademark disputes fall solely under the High Court or Kenya Industrial Property Institute.
42. On the issue of Cancellation of Certificates, it is deposed that the Respondent issued a Notice of Cancellation in March 2025 citing misrepresentation which was objected to by the exparte applicant through the ex-parte Applicant’s advocates, but that the Respondent falsely claimed that no objection was lodged. That consequently, the cancellation proceeded despite ongoing Judicial Review proceedings, which cancellation decision was illegal, irrational and marred with procedural impropriety.
43. The ex-parte Applicant disputes the issue of sub judice raised by Respondent, and emphasizes that administrative decisions are exempt from certain statutory limits under Kenyan law. It decried the cancellation of its registration certificate and lamented that it not only led to severe commercial setbacks but also hospitals and pharmacies cancelled their orders resultantly denying patients critical medication.
44. Lastly, it is asserted that by admission, the Interested party has not been exporting to Kenya since 2022 therefore the effect of not trading with the exparte Applicant’s trademark is now being felt by the exparte Applicant who not only introduced the product to the Kenyan market but ensured its safety, efficacy and quality as per the objectives of the Respondent, for 18 years.
45. A Further Affidavit was filed on 5 th February 2026 sworn by the same director Mr. Hirani in response to the Interested Party’s Replying Affidavit. He deposes that the Interested Party is improperly turning Judicial Review proceedings into a commercial dispute over ownership of pharmaceutical products and trademarks yet Judicial Review is limited to examining the lawfulness, rationality, and procedural propriety of administrative decisions.
46. The deponent urges that the Interested Party is misconstruing the matter as a commercial dispute over ownership of the 45 pharmaceutical products and asserts that their allegations of proprietary claims, trust arrangements, and trademark disputes are outside the scope of Judicial Review and should only be determined in a substantive civil suit, not in these proceedings.
47. It is deposed that the timing and conduct of the Interested Party was questionable because the parties had a cordial relationship for nearly 20 years and that the alleged complaint arose only after the Interested Party was found to be non-GMP compliant in 2024, suggesting malice and inconsistency.
48. Further, the ex-parte Applicant denies claims that trademarks were registered in trust and asserts that any such issues involve complex factual and legal questions unsuitable for Judicial Review. That in any event, it is the ex-parte Applicant who has already secured a High Court Order in HCOMM 718 OF 2025 restraining infringement of its trademarks.
49. It is further deposed that the variation of the ex-parte Applicant by the Interested Party as its Local Technical Representative (LTR) occurred in 2016, well before the alleged fallout in 2022 and that the Interested Party’s claim that it was uninformed is misleading, as the change did not require notification under Rule 4(4) hence it cannot be said that the variation was effected without due process.
50. The ex-parte Applicant asserts that the allegations of unsafe pharmaceutical products are unfounded since quarantine and laboratory testing confirmed compliance and the quarantined products were released for sale. That additionally, the Interested Party’s claim of an anonymous complaint is false as the records show that the complaint was lodged only after the non-GMP findings, thereby undermining the credibility of the alleged anonymous complaint.
51. That although the Interested Party accuses the exparte Applicant of forum shopping, Judicial Review is distinct from commercial suits and that the pending suits in other courts do not challenge the Respondent’s administrative process. It is urged that the interested party’s Replying Affidavit should be struck out for improperly expanding the scope of judicial review proceedings.
52. The ex-parte Applicant makes reference to the DCI reports and an ODPP letter and asserts that the forgery charges cannot be sustained and therefore the Court should disregard or strike out the Interested Party’s Replying Affidavit and focus solely on whether the Respondent acted lawfully and procedurally in cancelling the Drug Registration Certificates.
53. The parties took directions to canvass the Application by way of written submissions which are now on record.
The ex-parte Applicant’s Submissions
54. Counsel for the ex-parte Applicant submitted that the Respondent acted ultra vires, in breach of Articles 40 and 47 of the Constitution, and statutory provisions, in an irrational, unreasonable, and disproportionate manner.
55. Counsel for the applicant isolated four issues for determination being:
a. whether the Court has the requisite jurisdiction;
b. whether the Respondent acted ultra vires, unlawfully, or on the basis of an error of law;
c. whether the Respondent breached the ex-parte Applicant's constitutional and statutory right to fair administrative action; and
d. whether the Respondent’s decisions were irrational, unreasonable, and disproportionate .
56. On the first issue of the Court’s jurisdiction Counsel for the Applicant asserts that the Respondent’s actions constitute administrative decisions under Article 47 of the Constitution and the Fair Administrative Action Act 2015 , thereby falling within the Court's supervisory jurisdiction under Articles 165 (6) and (7) of the Constitution. Their argument is that the Respondent, as a statutory body, performs public functions affecting legal rights, making its decisions amenable to Judicial Review, irrespective of underlying commercial aspects. That the existence of parallel commercial suits does not oust this Court’s jurisdiction, as Judicial Review focuses on the decision-making process, not the merits of commercial disputes.
57. On limitation of time, counsel for the applicant submits that the Court is properly seized of jurisdiction and that S
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