Transcript THE HIGHLIGHTS OF DRUG REGISTRATION IN KENYA

THE HIGHLIGHTS OF DRUG
REGULATION IN KENYA
Presentation by:
Dr. Joseph K. Yano
B.Pharm (Nbi)
L.L.B (Moi)
Legal Officer
Pharmacy and Poisons Board
Ministry of Health
SITUATION ANALYSIS
The medicines regulatory Authority in Kenya has had its legislation
Cap 244 since 1957 hence colonial. Other conflicting Acts exist
e.g.
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Cap 254 – The Food Drug Chemical Substances Act.
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Cap 253 - The Medical Practitioners & Dentists Act.
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Cap 260 – Clinical Officers Act
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Cap 346 – The Pest Control Act.
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The Narcotic Drugs & Psychotropic substances Act 1994.
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The Medical Laboratory Act 1999.
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Cap 242 – The Public Health Act.
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The Veterinary Surgeons Act Cap 366.
The areas not regulated for want
of legislation
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Herbal Medicine
Food Supplements & Addictives
Counterfeits
Vision
To ensure availability of safe, efficacious and
quality drugs for the people and animals in
Kenya.
Mission
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To create an enabling environment for the
said drugs to be available and accessible to
Kenyan market.
To ensure that those who deal in drugs are
duly qualified and are trained to ensure
Kenyans are not put to risk.
Regulatory activities
Registration
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Receipt of applications.
Market Agency authorization.
Manufacturers and Manufacturing sites.
NQCL (National Quality Control Laboratory)
CDR (Committee on Drug Registration)
Recommendation.
Practice committee.
Full Board approval.
Gazettement.
Drug Information
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Centre for drug information for public and
board use.
Regulating aspects of advertisement on
Pharmaceuticals.
Pharmacovigilance
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Surveillance of drugs in the distribution
channels to monitor drug failures in
treatment.
Toxicity aspects reports on new molecules.
Counterfeits in the market.
Inspectorate
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The enforcement wing of the regulatory authority.
It inspects and enforces proper quality services
(pharmaceuticals) in the distribution channels.
GMP (Good Manufacturing Practices) inspections of
manufacturing plants to establish their compliance
with GMP as per WHO guidelines.
Enforcement through courts of law i.e. enforcement
of the Regulating Act Cap 244.
Trade in Pharmaceuticals (IDFs)
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The control of entry and exit of drugs by
import and export of drugs to ensure that
only authorized drugs enter or leave the
country.
Special permits
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Special permits are given for Narcotics and
Psychotropic substances for their control.
International treaties
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The international community has had concerns in
Narcotics/Psychotropics and Kenya is a signatory to
some of these treaties. While there is no law- but
the regulatory authority is required to report to INCB
in Vienna – on Seizures and Precursor control which
are being used to manufacture Narcotics .
It also regulates by not granting import or export
permits to suspicious applicants.
Herbal/food supplements
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The regulatory authority has been issuing
permit for export/import of this product in the
form of a No objection letter for process of
clearance at the ports of entry/exit.
However when the said herbal preparation
has a medical claim as to what it treats then
it’s a requirement that the same be registered
with the regulatory body.
Limitation
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Most herbal preparations though bearing medical claim, the
parties owning and claiming the same cannot register them
since the registration process requires active ingredients to be
declared and many scientific information including clinical trails,
pharmacological activities etc which is too sophisticated for the
herbalist.
There is a proposal that the same should be considered under
traditional knowledge for protection and registration – a tricky
area.
A proposal for partnership between scientists and herbalist is
shrouded in suspicion.