Central Drugs Standard Control Organisation (CDSCO) while awaiting to make sure that all CROs get registered from June this year has already launched audits of ongoing clinical trials by the expert teams comprised of drug inspector, pharmacologist and clinical trials experts.
This kind of audit held for the first time by CDSCO has identified glaring deficiencies with several sponsors, CROs and Monitors.
With more strict regulations being implemented along with such onsite audits, regulatory bodies can now ensure that the safety and rights of the trial subjects are well protected.
Hope the subjects volunteer to participate in trials and are not subjected to clinical trials.
