The Kenya Drugs Authority Bill, 2022
Status Timeline
Proposed
Active now
Public Review
Pending
Debate
Pending
Executive
Pending
Final
Pending
Centralized Health Regulator Established
Establishes the Kenya Health Products and Technologies Regulatory Authority (formerly the Kenya Drugs Authority) to regulate medicines, medical devices, dietary supplements, and therapeutic cosmetics. This consolidated body replaces legacy oversight structures of the Pharmacy and Poisons Board (PPB).
Strict Manufacturing and Import Licenses
Under proposed new clauses (such as Clause 27A), anyone intending to import, manufacture, or sell a health product must register and secure a license from the Authority. Parallel importation (Clause 29B) is strictly restricted to registered limited liability companies and requires specific clearance certificates.
Fines Up to KSh 10 Million for Manufacturing Violations
Under Clause 47, manufacturing health products without a valid license attracts a fine not exceeding KSh 10 million, imprisonment for a term not exceeding 10 years, or both. Possession of scheduled substances without a license (Clause 38) carries a fine of up to KSh 2 million (increased from KSh 100,000).
Regulation of Online Pharmacies and Telemedicine
Under Clause 46, the Authority is tasked with issuing guidelines for electronic supply, online dispensing, and telemedicine platforms handling scheduled substances. Operating an unauthorized online pharmacy carries a fine of up to KSh 1 million, imprisonment of up to 1 year, or both.
National Pharmacovigilance System Created
Introduces Clause 59B, establishing a National Pharmacovigilance System to coordinate post-market surveillance and collect data on adverse drug events, while integrating the National Quality Control Laboratory (under Clause 60) to conduct laboratory analyses on domestic and imported products.
Bill No.
No. 54 of 2022
Gazette No.
—
Sponsor
Hon. Dr. Robert Pukose, MP
Background
The Kenya Drugs Authority Bill (National Assembly Bill No. 54 of 2022) was sponsored by Hon. Dr. Robert Pukose, MP, and published on 6th October 2022. Following its first reading on 3rd May 2023, the Departmental Committee on Health carried out extensive public participation and tabled its report in November 2023 to harmonize the regulatory framework of health products and technologies (HPTs) in Kenya in line with World Health Organization (WHO) standards.
Key Amendments
- Title & Nomenclature: The name of the proposed Act and Authority is amended to "Kenya Health Products and Technologies Regulatory Authority Act" to reflect a broader scope covering medical devices, diagnostics, and dietary supplements.
- Regulatory Scope: Formally includes dietary supplements and therapeutic cosmetics under the regulatory control of the Authority, while excluding veterinary medicines and agricultural accessories from the scope of the Act.
- Board Composition: Amends the structure of the Kenya Health Products Board to include representatives from the Ministry of Health, Ministry of Finance, the Kenya Medical Association, the Pharmaceutical Society of Kenya, and the Consumer Federation of Kenya, adhering to the Mwongozo Code of Governance.
New Obligations
- Licensing Requirements: Under Clause 27A, any person intending to import, manufacture, or sell health products must apply in writing and provide product labels, certificates of analysis, and proof of a valid practicing license.
- Import Inspections: Importers must notify inspectors at ports of entry for pre-clearance and verification (Clause 29A). Product batches or lots cannot be released to the market without authorized test compliance.
- Clinical Trials: Under Clause 36A, clinical trials on any health product or technology are prohibited without formal approval from the Authority and a recognized ethics body. Detailed protocols and post-trial access programs must be submitted.
Penalties
The Bill substantially raises fines to deter substandard, falsified, or unregistered health products:
- Unlicensed Manufacturing (Clause 47): Fines of up to KSh 10 million or imprisonment of up to 10 years, or both.
- Unauthorized Possession of Scheduled Substances (Clause 38): Fines up to KSh 2 million or imprisonment of up to 3 years.
- Illegal Parallel Importation (Clause 29B): Fines up to KSh 1 million or imprisonment up to 2 years.
- Illegal Electronic Supply & Telemedicine (Clause 46): Fines up to KSh 1 million or imprisonment up to 1 year.
Transitional Provisions
- Pharmacy and Poisons Board Transition: Existing assets, liabilities, and staff of the Pharmacy and Poisons Board and the National Quality Control Laboratory will transition to the new Authority.
- Profession Regulation: To prevent a regulatory gap, the Pharmacy and Poisons Board will continue to exist solely to regulate the pharmacy profession for a transition period of up to two years, until Parliament enacts a dedicated pharmacy practice law.
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Updates will be visible here once they are approved and applied to this bill.