Wyeth claims no GCP lapse as India suspends vaccine trial
This article was originally published in Scrip
Executive Summary
Wyeth says that there were no GCP (good clinical practice) lapses in its now-suspended Indian pneumococcal conjugate vaccine trial. The Drugs Controller General of India (DCGI) halted the trial following the death of an infant, alleging that the company had flouted the inclusion-exclusion criteria for the study.