THE HIGHLIGHTS OF DRUG REGULATION IN KENYA

1. THE HIGHLIGHTS OF DRUG REGULATION IN KENYA

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

3. 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.

4. The areas not regulated for want of legislation • Herbal Medicine • Food Supplements & Addictives • Counterfeits

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

6. 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.

7. Regulatory activities

8. 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.

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

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

11. 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.

12. 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.

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

14. 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.

15. 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 it’s a requirement that the same be registered with the regulatory body.

16. 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.