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India To Begin Surprise Audits Of CROs In December

This article was originally published in PharmAsia News

Executive Summary

India's Drug Controller General says it will begin random audits of the programs of clinical research organizations beginning in December. The DCGI said any CRO found in violation of government guidelines would have its trials suspended. The plan is to provide only short notice before the audits, and include not only internal processes of the firm, but also the data of the trials themselves. The U.S. FDA is training 24 officials from India's health ministry to conduct the audits, according to a DCGI official. After they are trained, the plan is then to have them train state drug inspectors around the country. The intent is to restore India's tarnished CRO industry, the official said. (Click here for more

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