MUMBAI, May 9 -- The Bombay high court on Wednesday issued a notice to the central drug regulator to respond to a petition filed by a Nashik-based cancer research company seeking permission to conduct phase one human trials of its cancer immunotherapy drug, Per-C-Vax. A bench of chief justice Alok Aradhe and justice MS Karnik sought a response from the Central Drugs Standard Control Organisation (CDSCO) after the petitioner, Datar Cancer Genetics Pvt Ltd, claimed that the regulator had arbitrarily rejected its application to conduct phase 1 human trials of its indigenous vaccine to treat solid organ cancers. In its petition, the company said that it had submitted an application to CDSCO to conduct the trials under the New Drugs and Clinical Trials (NDCT) Rules, 2019, on August 2, 2023. The rules mandate CDSCO to respond to the application in 30 days, failing which the plea is deemed to be approved, the petition said. The regulator did not respond to the application within 30 days, it added. Later, CDSCO repeatedly insisted upon pre-clinical animal study data despite Datar Cancer Genetics explaining that, given the nature of its vaccine, this was scientifically impossible, the petition said. On April 22, 2025, the Drugs Controller General of India, Dr Rajeev Singh Raghuvanshi, rejected the application after highlighting deficiencies, the petition said. The company called the rejection "mala fide" and a "colourable exercise of power" to defeat the legislative safeguard built into the NDCT Rules to protect the applicants. It also said the rejection was "a fraud on the statute" and against the larger public good. The company said it has a team of highly qualified individuals comprising seven MDs, 13 PhDs, and 78 scientists with master's degrees in pharmaceutics or biotechnology. It also claimed that it serves patients in multiple countries and regions, such as the US, UK, Europe, Canada and India, and also has a presence in South America and Africa....