Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Fermer ce répertoireANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Fermer ce répertoireA. IMPORTING COUNTRIES
Afficher le documentBenin
Afficher le documentCameroon
Afficher le documentCentral African Republic
Afficher le documentEcuador
Afficher le documentFiji
Afficher le documentJamaica
Afficher le documentKenya
Afficher le documentMalawi
Afficher le documentMalaysia
Afficher le documentMyanmar
Afficher le documentPapua New Guinea
Afficher le documentSri Lanka
Afficher le documentTanzania
Afficher le documentTunisia
Afficher le documentYemen
Ouvrir ce répertoire et afficher son contenuB. EXPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenuC. INTERNATIONAL SUPPLY AGENCIES
Afficher le documentBACK COVER
 

Kenya

1. Population

24 million in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were valued at US$ 122.5 million and the major countries/areas of origin were: Europe (excluding UK) 20%, India 40%, Pakistan 7%, UK 20%, USA 7% and Zimbabwe 6%.

Drug consumption in the public and private sector during the year amounted to US$ 103.3 and US$ 52.7 million respectively. The value of drug consumption of the NGOs in 1992 was US$ 10.8 million. The total public sector drug budget in 1992 was US$ 39.8 million and the contributions from national and external sources were 67.70% and 32.30% respectively.

3. Drug policy and essential drug lists

The Kenya National Drug Policy was drafted in October 1993.* It has all the elements relating to regulatory control, drug registration, drug procurement and quality assurance.

* The National Drug Policy was adopted in July 1994.

There is an official essential drugs list developed in 1993. The list has 195 products and is being used for procurement of drugs in the public sector.

4. Infrastructure and functioning

4.1 Regulation and registration

The Pharmacy and Poisons Act of 1957 and the revisions made in 1972 and 1989 are the legal instruments used in the control of drugs in Kenya. The Pharmacy and Poisons Rules (Registration of Drugs), 1981 (revised 1983) applies to the registration of drugs in Kenya.

The Pharmacy and Poisons Board established under the Pharmacy and Medicines Act Chapter 244 is responsible for the registration of pharmacy professionals, drug registration, issuance of licenses for manufacturers, wholesalers, and retail pharmacies. The Board is assisted by the Division of Pharmaceutical Services under the Ministry of Health.

There is a unit within the Pharmacy Division of the MOH responsible for registration of drugs. The Technical Evaluation Committee, which is part of the Board, assists in the evaluation and registration of drugs. The Board is responsible for the approval of registration of drugs.

Drug registration started in 1982 but the precise number of products on the market is not known. The percentage of pharmaceutical products registered at the time of the mission was 50%. There is also an illicit market.

4.2 Public and private procurement

The Medical Supplies Coordinating Unit of the Ministry of Health procures drugs for the public sector. Procurement is done by means of open and restricted tender. Sometimes, donors also supply in kind. A total of 58 products was procured in 1992 and the countries of manufacture were Canada, China, Denmark, France, Germany, Sweden and USA. Also, 85 products were bought from IDA.

There are 135 licensed private importers importing and distributing drugs to the private sector. Drug importation in the private sector is done by 135 licensed private importers who purchase directly from manufacturers and wholesalers abroad. In 1992, 2000 products were purchased by the private sector from Austria, China, Denmark, Germany, India, the Netherlands and UK.

4.3 Quality control of drugs

The Drug Analysis Research Unit (DARU) under the University of Nairobi, the Kenya Medical Research Institute (KEMRI) and the Government Chemist are engaged in the testing of drugs. The MOH is also in the process of establishing its own laboratory. In 1992, 24 samples were sent for testing and 70.8% passed the test. Drugs are sent for testing at the time of tender evaluation and sometimes at the time of receiving consignments and following complaints. There are no established criteria for sample selection.

Drugs imported by private sector are tested for quality by the regulatory authority. But it is not done often. There is no system for health personnel to report complaints regarding drug quality.

4.4 Inspection

The Inspection Department of the Pharmacy Division inspects premises.

 


5. Operation of the WHO Certification Scheme

Kenya accepted the Scheme on 1 January 1985 and the responsible authority is the Director of Medical Services of the MOH. The name and address of the competent authority is included in the WHO Secretariat list.

Only drugs imported by the private sector are subject to registration. The receipt of a Certificate of a Pharmaceutical Product is not indicated as a prerequisite for drug registration. However, the application for the registration of drugs requires the presentation of a legal certificate of Free Sale from authorities in the exporting country indicating that the product is authorized to be placed on the market in the country of origin. Free Sale certificates are sometimes rejected if the photocopies, stamps and signatures are not clear. Information on registered drugs is communicated through government gazette and contact with competent authorities is made directly. Sometimes, dubious certificates are submitted together with bids which the Central Medical Stores cannot verify due to lack of the WHO list of competent authorities.

Certificate of a Pharmaceutical Product is not indicated as a requirement in procurement guidelines. But, the tender guidelines for 1992/1993 specify that drugs not registered in Kenya should be accompanied by evidence of registration from the country of origin. The document is requested from manufacturers or their agents at the time of calling for tenders. Guidelines on how to obtain the document are not given to importers.

The Scheme is not used as recommended by WHO. A Free Sale certificate is required in the private sector.

Observations:

• The Scheme is not used as recommended by WHO.

• Registration does not cover the public sector.

• There is an illicit market.

• Laboratory testing of drugs is not done regularly to ensure the quality of drugs received.

• Consignments are not always accompanied by batch certificates.

• Personnel working in registration and procurement systems knew little about the Scheme.

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