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
Ouvrir ce répertoire et afficher son contenuA. IMPORTING COUNTRIES
Fermer ce répertoireB. EXPORTING COUNTRIES
Afficher le documentFrance
Afficher le documentIndia
Ouvrir ce répertoire et afficher son contenuC. INTERNATIONAL SUPPLY AGENCIES
Afficher le documentBACK COVER
 

India

1. Drug legislation

The Drug and Cosmetics Act of 1940, the Drug and Cosmetics Rules of 1945, and the subsequent amendments are used for the control of pharmaceuticals. Under these regulations, the regulation of manufacture, sale and distribution of drugs is primarily the concern of the State authorities.

2. Drug control administration

2.1 Central level

The central authorities are responsible for developing standards for drugs; quality control of imported drugs; coordination of state activities; giving expert advice for uniformity in enforcement; concurrent control over the manufacture of vaccines/sera, I/V fluids and blood products.

2.2 Zones

The country is divided into four zones. They are:

WEST ZONE: States of Maharashtra, Guarat, Madhya Pradesh, Goa and the Union Territory of Daman and Diu;

SOUTH ZONE: States of Tamil Nadu, Andhra Pradesh, Kerala, Karnataka and the Union Territory of Pondicherry;

NORTH ZONE: States of Uttar Pradesh, Rajasthan, Himachal Pradesh, Delhi, Punjab, Haryana and Jammu and Kashmir;

EAST ZONE: States of West Bengal, Orissa, Arunachal Pradesh, Bihar, Assam, Mizoram, Nagaland, Sikkim, Meghalaya, Tripura, Lakshadweep and Andaman and Nicobar Islands.

Besides, one sub-zonal office under each of the above zones has been created, namely at Ahmedabad in West Zone, at Hyderabad in South Zone, at Lucknow in North Zone and at Patna in East Zone. The sub-zonal offices at Ahmedabad, Hyderabad, Lucknow and Patna look after matters pertaining to the States of Gujarat, Andhra Pradesh, Uttar Pradesh and Bihar respectively.

Central government offices are situated in four main ports, namely Cochin, Bombay, Calcutta and Madras, in these four zones. The liaison officer in each zonal office is Deputy Drug Controller.

2.3 State authorities

Responsibilities for drug control are vested with the Food and Drug Administration Commissioner or Drugs Control Department. They are responsible for the regulation of the manufacture, sale and distribution of drugs.

2.4 Inspection

Joint inspections are carried out in the licensing of new manufacturing premises, and the issuance of a Certificate of a Pharmaceutical Product. Licences and certificates are issued by the State authorities.

2.5 Testing laboratories

The Central Drug Control Laboratory in Calcutta is responsible for the control of the quality of imported drugs and supply of reference standards to government testing laboratories. The Central Indian Pharmacopoeia Laboratories in Ghaziabad in Uttar Pradesh validate pharmacopoeial monographs; act as government analyst; and test condoms.

The Central Research Institutes in Jasauli and Himachal Pradesh are responsible for testing of saline preparations and vaccines.

The State testing laboratories are accredited by the state drug control department.

2.6 Board/Committee

• Drugs Technical Advisory Board: The Board is appointed by the Central Government to advise the Central and State Governments on technical matters arising out of the administration of the drug legislation.

• Drug Consultative Committee: The Drug Consultative Committee constituted by the Central Government advises the Central and State Governments, and the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout India in administration of drug legislation.

3. Pharmaceutical manufacturing

There are 200 large (including multinationals) and 8000 small (including contract manufacturers) manufacturers.

All manufacturing premises must comply with the GMP requirements specified under scheduled medicines. Of the above-mentioned manufacturers, only 152 have GMP certificates.

4. Findings

4.1 Use of the WHO Certification Scheme

The old format of the WHO Certification Scheme is still being used. Certificates are issued to those who export their products, on request. Certificates are issued after satisfactory joint inspection of Central and State inspectors with a standard checklist. Amendments to existing legislation are being considered, e.g. issue of a certificate for each individual product.

All manufacturers have been issued with GMP certificates. However, variations in standards were observed. Increased requests for the issue of a Certificate of a Pharmaceutical Product by importing countries have led to the upgrading of existing facilities of manufacturers dealing substantially in export trade.

4.2 Exports not certified under the WHO Certification Scheme

Pharmaceutical products not certified under the WHO Certification Scheme are being exported to centres in Belgium, Germany and Hong Kong. In case of contract manufacturing, the details of the contractor appear on the labels of products manufactured by a contracted manufacturer.

 

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