India plans periodic inspections of all clinical-trial sites

05/5/2013 | Business Standard (India)

India's Drug Controller General office announced plans to inspect all of the nation's clinical-trial sites at least annually to verify regulatory compliance. The inspections will cover Schedule Y drugs, good clinical practice, and other regulatory requirements. The move follows criticism of the agency's failure to monitor human clinical trials more closely and accompanies several other recent measures, including establishing an ethics committee and setting guidelines for compensation to those injured in clinical trials.

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Business Standard (India)

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