THE HIGHLIGHTS OF DRUG REGULATION IN KENYA

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THE HIGHLIGHTS OF DRUG REGULATION IN KENYA
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Presentation by

• Dr. Joseph K. Yano
• B.Pharm (Nbi)
• L.L.B (Moi)
• Legal Officer
• Pharmacy and Poisons Board
• Ministry of Health

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SITUATION ANALYSIS

• The medicines regulatory Authority in Kenya has
  had its legislation Cap 244 since 1957 hence
  colonial. Other conflicting Acts exist e.g.
• Cap 254 The Food Drug Chemical Substances Act.
• Cap 253 - The Medical Practitioners Dentists
  Act.
• Cap 260 Clinical Officers Act
• Cap 346 The Pest Control Act.
• The Narcotic Drugs Psychotropic substances Act
  1994.
• The Medical Laboratory Act 1999.
• Cap 242 The Public Health Act.
• The Veterinary Surgeons Act Cap 366.

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The areas not regulated for want of legislation

• Herbal Medicine
• Food Supplements Addictives
• Counterfeits

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Vision

• To ensure availability of safe, efficacious and
  quality drugs for the people and animals in Kenya.

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Mission

• 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.

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Regulatory activities
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Registration

• 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.

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Drug Information

• Centre for drug information for public and board
  use.
• Regulating aspects of advertisement on
  Pharmaceuticals.

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Pharmacovigilance

• Surveillance of drugs in the distribution
  channels to monitor drug failures in treatment.
• Toxicity aspects reports on new molecules.
• Counterfeits in the market.

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Inspectorate

• 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.

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Trade in Pharmaceuticals (IDFs)

• 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.

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Special permits

• Special permits are given for Narcotics and
  Psychotropic substances for their control.

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International treaties

• 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.

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Herbal/food supplements

• 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 its a
  requirement that the same be registered with the
  regulatory body.

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Limitation

• 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.