India’s Drugs Controller General has moved to tighten up monitoring of clinical trials across the country as concerns continue to well up about the safety and integrity of trials as well as the impact of associated negative publicity on inward investment.
With health activists pushing for tough restrictions in the Supreme Court, amid allegations that industry has exploited impoverished patients in clinical trials without proper consent or oversight, Drugs Controller General Dr G N Singh has written to all zonal offices of the Central Drugs Standard Control Organisation asking them to set up Expert Committees to conduct inspections of clinical-trial sites.
The Expert Committees should visit clinical-trial sites at least once a year along with drug inspectors to verify the sites’ compliance with India’s Schedule Y regulations on clinical trials, Good Clinical Practice Guidelines and “other applicable regulatory requirements”.
The zonal offices should also keep records detailing the names, qualifications, etc of study investigators and clinical-trial sites falling under their jurisdiction, the Drugs Controller General says.
According to a report in India’s Business Standard citing a senior official in the Controller General’s office, if any discrepancies are found during the Expert Committee inspections, the regulator will take strict action against the company involved and may suspend the clinical trial.
