There have been promising developments to run clinical trials in India. To speed up the time to obtain permission to run a clinical trial in India, new trial applications are divided into categories:

• Category A: There is already an approved protocol in one out of several countries on an approved list. The goal is to approve category A trials in between 2 and 4 weeks.
• Category B: All other trials are placed in this category (approval time 6 - 8 weeks).

The quality of the trials performed in India shall be improved by inspections of the clinical sites, CROs and the pharmaceutical companies involved.

As a result of theses developments, more and more phase 2 and 3 studies are conducted in India and the respective local CROs expand their activities and offer services like management of the trial and the data.

Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)