Ahmedabad: Initiating a slew of measures to regulate the country’s booming clinical trials market, the office of the drug controller general of India (DCGI) is conducting audits for the first time to ensure that they meet norms, besides making registration of contract research organizations (CROs) mandatory.
“For the first time, audits of clinical trials are being conducted. During the audits, we have found glaring deficiencies as the sponsors, monitors and CROs do not adhere to protocols,” DCGI Surinder Singh said at a pharmaceuticals exhibition.
“We intend to take stringent action against these CROs, sponsors and clinical research associates (monitors) for not taking appropriate safeguards while conducting clinical trials,” he added.