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
Fermer ce répertoire4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Afficher le document4.1 Pharmaceutical Import and Consumption
Afficher le document4.2 National Drug Policy and Essential Drugs List
Afficher le document4.3 Infrastructure
Afficher le document4.4 Functioning of Bodies Responsible for Regulation, Procurement and Quality Assurance
Afficher le document4.5 Operation of the WHO Certification Scheme
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
Ouvrir ce répertoire et afficher son contenuANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Afficher le documentBACK COVER
 

4.4 Functioning of Bodies Responsible for Regulation, Procurement and Quality Assurance

4.4.1. Registration

Registration of drugs is practised by ten countries, Benin, Cameroon, Ecuador, Jamaica, Kenya, Malaysia, Myanmar, Sri Lanka, Tunisia and Yemen that have infrastructure for registration. Drugs imported by both private and public sector are registered in Ecuador, Jamaica, Malaysia, Sri Lanka, Tunisia and Yemen. In Benin, Cameroon and Kenya only drugs imported by the private sector are registered, while in Myanmar registration has not been extended to the private sector. Drugs are not subject to registration in Central African Republic, Fiji, Malawi, Papua New Guinea and Tanzania (Table 4).

Table 4. Practice of drug registration and types of certificates requested

Country

Registration unit exists

Certificates requested

% of drugs on the market registered

Benin

YES

Free Sale

100

Cameroon

YES

Not indicated

90

Central African Republic

NO

NO

0

Ecuador

YES

Free Sale

98

Fiji

NO

NO

0

Jamaica

YES

Free Sale*

98

Kenya

YES

Free Sale

50

Malawi

NO**

NO**

0**

Malaysia

YES

Product Certificate or GMP and Free Sale

100

Myanmar

YES

Product Certificate

100/50***

Papua New Guinea

NO

NO

0

Sri Lanka

YES

GMP and Free Sale

100

Tanzania

NO

NO

NO

Tunisia

YES

Batch and Free Sale

100****

Yemen

YES

GMP and Free Sale

70

* Certificate of Pharmaceutical Product is now routinely requested.

** Registration has been introduced since the assessment but information on the type of certificate requested and the number of drugs registered is not available.

*** In Myanmar all drugs imported by the CMS are registered while the majority of those imported by the Medicines and Medical Equipment Enterprise are partially registered. 50% of the drugs imported by the private sector are registered.

**** In Tunisia importation of drugs is a state monopoly. The Pharmacie Centrale de Tunis is responsible for the importation of drugs for both the public and private sectors.

The percentage of drugs on the market which are registered with 10 countries are: 100% in the private sector in Benin; 100% in Malaysia, Tunisia and Sri Lanka in both private and public sector; 98% in Ecuador and Jamaica in both private and public sector; 90% in the private sector in Cameroon; 75% in the public sector in Myanmar; 70% in both sectors in Yemen and 50% in the private sector in Kenya. Donated drugs and drugs imported by nongovernmental organizations are not registered in all countries.

There is an appreciable illicit market of pharmaceuticals in Benin, Cameroon, Kenya, and Yemen.

4.4.2 Public and private sector procurement

In many developing countries the supply of drugs for the public sector is centralized through a government drug procurement agency. Even in countries where the private drug supply covers a considerable portion of the drug market, for example, Malaysia and Myanmar, drug procurement for the public sector is carried out through formal procurement procedures. All 15 countries visited have an infrastructure for the procurement of drugs for the public sector. A majority of the countries procure drugs for the public sector by means of open and restricted tender and through direct purchase from manufacturers/agents. The rest use negotiated procurement and direct purchase methods to buy drugs from wholesalers abroad and in the countries. They also receive drugs in kind from donors.

In 1992, 13 countries procured drugs from manufacturers/agents for the public sector and the number of products purchased ranged from ten for Central African Republic to 2000 for Sri Lanka. In addition, eight countries bought drugs from wholesalers abroad and the quantity varied from five to 347. The suppliers were manufacturers located in Australia, Austria, Belgium, Canada, China, Cyprus, Czechoslovakia, Denmark, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Kenya, Malaysia, the Netherlands, Puerto Rico, Panama, Republic of South Africa, Thailand, UK, USA, as well as international suppliers of low cost essential drugs, IDA and UNICEF.

In the private sector, with the exception of Tunisia where importation of pharmaceuticals is a state monopoly, the remaining countries have private importers actively engaged in the importation and distribution of drugs. In 1992, ten countries procured drugs directly from manufacturers and wholesalers abroad and the number of products ranged from 450 to 3000. Three countries used negotiated procurement. The suppliers were the same manufacturers and international supply agencies mentioned above.

4.4.3 Quality control of imported drugs

To a varying extent, drugs procured in the public sector by the countries are subject to analytical control (Table 5). For example, in Malaysia, Sri Lanka and Tunisia, where there is an established analytical programme for the quality control of pharmaceutical products, an appreciable number of samples of products were tested. In the remaining countries only a few samples were sent for testing. Quality testing was not done at all in Malawi and Central African Republic. Jamaica, Malaysia and Tunisia were found to have clearly set criteria for the selection of samples for regular quality control. In most cases, samples were collected and sent for analysis after receipt and payment and following complaint. Few countries collected and sent samples at the time of bidding. The quality control testing was done locally by 11 countries. One country, Benin, sent samples abroad for testing.

The quality of drugs imported by the private sector is tested by drug regulatory authorities in Ecuador, Jamaica, Kenya, Malaysia, Tanzania, Tunisia, and Yemen. In Sri Lanka, products are tested by importers. The rest of the countries do not carry out quality control tests on drugs imported by the private sector. A system for health personnel to report complaints regarding drug quality exists in only Malaysia, Sri Lanka and Tunisia.

Table 5. Quality control of drugs procured in public sector in 1992

Country

No. of products procured from manufacturers in 1992

No. of products procured from wholesalers

No. of samples sent for testing

% Passed test

Benin

26

NA

5

100

Cameroon

NA

NA

32

91

Central African Republic

10

NA

0

0

Ecuador

110

NA

36

75

Fiji

400

NA

5

NA

Jamaica

250

NA

51

80

Kenya

58

NA

24

71

Malawi

80

115

NO

NO

Malaysia

NA

347

924

86

Myanmar

62

164

Few

NA

Papua New Guinea

342

14

3

NA

Sri Lanka

2000

NA

600

90

Tanzania

104

8

175

70

Tunisia

450

NA

741

78

Yemen

201

5

297

96

Data extracted from country reports submitted by the missions.
NA = Data not available.

vers la section précédente
vers la section suivante
 
 
Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 1 décembre 2019