In vitro diagnostics Licencing in India( www.ubio.in)

Slide 1: In-vitro Diagnostics Licensing in India In-vitro Dia g nos tic s a nd Drug Lic e ns ing P roc e dure s in India © 2008 ubio. All rights reserved. 1

Slide 2: Critical Devices  Used in HIV HBsAg HCV Blood grouping reagents Malaria tests interpreted as less critical than others  All other devices are non-critical © 2008 ubio. All rights reserved. 2

Slide 3: Critical Devices Licensing © 2008 ubio. All rights reserved. 3

Slide 4: Non-Critical Devices  Test manufacturing license not needed  Test batch evaluation not needed  Inspection by central authorities not needed  Application filed to state drug offices © 2008 ubio. All rights reserved. 4

Slide 5: ubio in Licensing  Consultancy support for drug licensing Preparation of application and documents Evaluation of project plan for compliance Audit facilitation Co-ordination with regulatory agencies for required approvals Fire Safety Pollution/Environmental Control Biomedical Waste Disposal  We also provide full project life-cycle consultancy for IVD manufacturing Details at http://www.ubio.in/professional-services/ © 2008 ubio. All rights reserved. 5

Slide 6: www.ubio.in © 2008 ubio. All rights reserved. 6