Bombay High Court Seeks Response on Human Trials for Cancer Vaccine

The Bombay High Court has issued notice to the Central Drugs Standard Control Organisation (CDSCO) in a petition filed by Datar Cancer Genetics Pvt. Ltd., seeking permission to conduct phase 1 human trials of its cancer immunotherapy drug, Per-C-Vax.

The Nashik-based cancer research company applied in 2023 under the New Drugs and Clinical Trials (NDCT) Rules, 2019, which require CDSCO to respond within 30 days, or the application is deemed approved.

CDSCO rejected the application in April 2025, insisting on animal trials. The company argued that such trials are scientifically impossible and sought the court's direction to allow clinical trials.

The hearing is scheduled for June 13.