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India’s DCGI Issues Warning Letter To Wyeth, GVK Over Trial

This article was originally published in PharmAsia News

Executive Summary

The Drug Controller General of India issued warning letters to U.S.-based Wyeth Pharmaceutical and a clinical trial monitor for violating Indian trial rules. The CDGI said an audit of a suspended trial of a pneumococcal vaccine in India disclosed violations of protocol, standard operating procedure and good clinical practices. The monitor was GVK Biosciences. DCGI ordered the trial suspended last November after the death of an infant, which the agency said protocol dictated should not have been included in the trial. The incident, involving a trial that began in 2007 with 350 children, is the first recorded in India. (Click here for more
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