The Bombay High Court has directed an expert committee to review a plea by Datar Cancer Genetics for approving phase 1 human trials of its cancer immunotherapy drug, Per-C-Vax. The court aims for a report within three months amid disputes over regulatory requirements. The hearing was postponed to March 2, 2026.
On November 21, a bench comprising Justices Revati Mohite Dere and Sandesh D Patil at the Bombay High Court addressed a petition from Nashik-based Datar Cancer Genetics Pvt Ltd. The company challenged the Central Drugs Standard Control Organisation's (CDSCO) rejection of its application to conduct phase 1 human trials for Per-C-Vax, an indigenous vaccine targeting solid organ cancers.
The application, submitted in August 2023 under the New Drugs and Clinical Trials Rules, 2019, faced delays as CDSCO failed to respond within the mandated 30 days. The regulator's April 22 decision demanded pre-clinical animal study data, which the petitioner argued was scientifically unfeasible due to the vaccine's nature involving human antigens and complex Damage Associated Molecular Patterns (DAMPs).
Senior advocate Rafique Dada, representing the firm, highlighted the involvement of qualified professionals and patients from multiple countries, including 10 with stage 4 cancer. He emphasized that approving the trials could elevate India's global standing in cancer research. Advocate Rui Rodrigues, for the authorities, confirmed the formation of a nine-member expert committee, with two additional members suggested by the petitioner.
The court instructed the panel to independently assess the submissions, free from prior CDSCO views, and consider US FDA feedback from September 9, 2025, on a similar drug. If the propositions hold—such as the absence of suitable animal models—the committee may recommend withdrawing the rejection and allowing trials. The bench urged an expeditious report, ideally within three months from December 1, and scheduled the next hearing for March 2, 2026.
This case underscores tensions between innovative drug development and stringent regulatory safeguards in India.