The Bombay High Court has asked an expert committee to examine a plea by Nashik-based Datar Cancer Genetics Pvt Ltd seeking approval for Phase-I human trials of its cancer immunotherapy drug, Per-C-Vax. The court directed the committee to submit its report expeditiously, preferably within three months from December 1, with further hearings scheduled for March 2, 2026.
The company approached the court, aggrieved by the April 22 decision of the Central Drugs Standard Control Organisation (CDSCO), which rejected its application to conduct the trials. Senior advocate Rafique Dada, representing the petitioner, argued that the rejection was arbitrary and that CDSCO’s insistence on pre-clinical animal study data was scientifically unfeasible due to the nature of the vaccine. The application, originally filed in August 2023 under the New Drugs and Clinical Trials Rules, 2019, required a response within 30 days, which the petitioner claimed was not adhered to.
Dada highlighted that the firm has a team of highly qualified medical professionals and scientists and several patients in multiple countries, including 10 stage-4 cancer patients, ready for the trial. He urged the panel to evaluate the submissions independently, without being influenced by previous expert opinions or CDSCO decisions. He also requested consideration of US FDA feedback from September 9, 2025, on a similar drug.
Advocate Rui Rodrigues, representing the authorities, submitted a list of nine experts for the panel, which the court allowed to be expanded by two additional names suggested by the petitioner. The court left it to the committee to decide on the methodology, including the possibility of designing experiments, animal models, and identifying Indian institutions capable of conducting such studies, if required.
The petitioner requested that if the panel agrees with its propositions, CDSCO should withdraw its rejection and permit the Phase-I trials. While Rodrigues argued that such a decision might be beyond the committee’s scope, the court clarified that the panel could examine submissions if they fell within its ambit.
The case underscores ongoing tensions between regulatory authorities and innovators seeking expedited approval for novel cancer therapies in India.