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
 

Sri Lanka

1. Population

18 million in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were estimated to be US$ 30 million. Main exporting countries were: China 5%, Germany 4%, India 25%, Malaysia 4%, Singapore 5%, South Korea 5%, Switzerland 4%, and UK 5%.

Drug consumption in 1992 in the public and private sector amounted to US$ 20 and US$ 70 million respectively. The estimated public sector drug budget for 1992 was US$ 13 million and the national contribution was 100%.

3. Drug policy and essential drugs list

There is no written and approved national drug policy as such but elements relating to drug regulatory control, registration and procurement are being practised.

There is an essential drugs list, first published in 1985 and revised in 1988. The list comprises 350 products and is used for the procurement of drugs for the public sector.

4. Infrastructure and functioning

4.1 Regulation and registration

The Cosmetic, Devices and Drugs Act No 27 of 1980 and Drug Regulations No. 38 of 1984 empower the Drug Regulatory Authority to issue product licenses and carry out other regulatory activities. Drug registration started in 1986 and the Drug Regulations No. 38 of 1984 relate to drug registration.

Evaluation of products is handled by the Drug Evaluation Committee, which is a sub committee of the Technical Advisory Committee headed by the Director of Medical Services. No product can be made available in the country without first being approved by the Drug Evaluation Committee. The percentage of pharmaceutical products on the market which are currently registered is 100%. Customs officers have been informed not to release cargo without a valid import license and original registration certificates. Private sector importers have to refer to the gazette.

4.2 Public and private procurement

In the public sector the State Pharmaceutical Corporation (SPC) is the leading importer and distributor of pharmaceuticals. There are 22 SPC regional distributors and ten retail outlets throughout the country. The Corporation procures by means of open and restricted tender, as well as through direct purchase from wholesalers abroad and in the country. There is also donors' supply in kind. In 1992, the organization purchased 2000 products from manufacturers in China, Germany, India, South Korea, and UK. Vaccines were also purchased from UNICEF.

In the private sector, drugs are procured directly from manufacturers/agents. In 1992, 1900 products were purchased from China, Germany, India, Korea, Malaysia, Singapore, Switzerland and UK.

4.3 Quality control of drugs

The National Drug Quality Assurance Laboratories are responsible for testing the quality of locally manufactured and imported drugs. Laboratory testing is not a requirement at the time of registration. However, testing is done when there are doubts as to the quality of drugs. In 1992, in the public sector, about 600 samples of products were sent for testing to the National Drug Quality Assurance Laboratories and 90% passed the tests. In general, tender items, products manufactured locally and products about which complaints have been made, are sent for testing. Selection of samples is made at the time of bidding, after receipt and after payment, and following complaints. Sometimes samples are sent to the Bureau of Pharmaceutical Laboratories, Kuala Lumpur, Malaysia and to the Medical Department in Norway for testing.

In the private sector, drugs are tested by the drug regulatory authorities in connection with registration. Complaints regarding the quality of drugs imported by SPC are sent to the Technical Unit of the State Pharmaceutical Corporation. In 1992, a total of 25 complaints were received .

4.4 Inspection

The Food and Drug inspectors supervise local manufacturers for GMP certification. But, there is a dire lack of enforcement in the whole set-up.

 


5. Operation of the WHO Certification Scheme

Sri Lanka accepted the Scheme in 1980 and the Director of National Drug Quality Assurance Laboratories is the competent authority designated by the Government.

Sri Lanka has not incorporated the WHO Certification Scheme into its drug control and supply systems. Since 1986, all manufacturers are required to meet GMP status before their products can be considered for registration. Besides, it is mandatory that Certificates of Free Sale from the country of origin accompany each application.

In 1992, GMP and Free Sale certificates were received for all product license applications submitted. Certificates are sometimes rejected on the grounds that signatures are not legible and that manufacturing licenses are submitted instead of Free Sale certificates. Contact with competent authorities is through intermediaries.

In the public sector, GMP and Free Sale certificates are requested at the time of supplier appraisal. Free Sale and Batch Certificates are requested at the time of calling for tenders. Free Sale certificate is also requested at the time of placing orders. Documents are requested from manufacturers or their agents and are filed by the procurement authority, by product and by manufacturer. When generic products are indicated in a tender document, special facilities such as "fast-track" registration are used.

Moreover, the Tender Committees give preference to Free Sale and GMP certificates when selecting bids. The percentage of products purchased in 1992 for which Free Sale and GMP certificates were received was 95%. The percentage of approved manufacturers that submitted such certificates was 100% and those that submitted batch certificates was also 100%. The percentage of products which failed quality control in 1992 for which Free Sale and GMP certificates were received was 5-10%.

Observations:

• All the drugs imported by the private and public sector are registered.

• A Certificate of a Pharmaceutical Product is not requested as recommended by WHO.

• Free Sale and GMP certificates are requested for drug registration. A batch certificate is required to accompany each batch of an imported drug.

• Sometimes manufacturing licenses are submitted in place of Free Sale certificates and also signatures are not legible.

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