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
Fermer ce répertoire5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document5.1 France
Afficher le document5.2 India
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
 

5.2 India

There are currently 200 large (including multinationals) and 8000 small (including contract manufacturers) manufacturers, of which 152 have a GMP Certificate.

The Drug and Cosmetics Act of 1940, the Drug and Cosmetics Rules of 1945 and the subsequent amendments are used for the control of import, manufacturing and export of pharmaceutical products.

Drug control is exercised at central and state level. The state regulatory authorities are responsible for regulation of manufacture, sale and distribution of drugs including the issuance of product certificates and GMP certificates. The central authorities are responsible for developing standards, control of the quality of imported drugs, coordinating state activities and concurrent control of the manufacture of vaccines and sera, I.V. fluids and blood products. Joint inspections are carried out by the central and state authorities for the licensing of new manufacturing premises and for the issuance of a Certificate of a Pharmaceutical Product.

In addition to various types of national certificates, the 1975 format of the WHO-type Certificate of a Pharmaceutical Product is issued when requested by importing countries.

Moreover, pharmaceuticals manufactured by contract manufacturers and not supported by a Certificate of a Pharmaceutical Product are exported to trading centres in Europe and Asia.

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