Page 4 - Guidance document for import of Drugs & Pharmaceuticals from India

Functions of State Level FDAs

 Licensing of Manufacturing sites for Drugs including APIs and Finished

Formulations

 Licensing of Establishment for sale or distribution of Drugs

 Issue of CoPP (Certificate of Pharmaceutical Product)

 Approval of Drug Testing Laboratories

 Monitoring of Quality of Drugs and Cosmetics marketed in the Country

 Investigation and prosecution in respect of contravention of legal

provision

 Recall of not of standard quality drugs

Joint Responsibilities:

Central and State FDA perform the following functions jointly:

 Issue of WHO GMP Certificates

 Issue of Written Confirmations for export of APIs required by EU

International Cell of CDSCO:

In order to cope with the quality related challenges of international markets,

recently a separate cell “International Cell’ was established. When becomes

fully functional, the cell is expected to perform the following functions: