Clinical trial registration in India: 12% of drug regulatory trials are not registered, as required by law

This study highlights that not all regulatory trials approved by CDSCO are registered with CTRI, despite legal requirements. The absence of a significant number of trials from CTRI raises concerns about transparency in the clinical trial enterprise in India. To improve trust and regulatory compliance, it is essential to establish explicit linkages between CDSCO and CTRI records to avoid the challenges of identifying matches. This study contributes to ongoing efforts to increase transparency and accountability in clinical trial registration in India.