The Bombay High Court on Wednesday issued a notice to India’s drug regulator in response to a petition filed by Datar Cancer Genetics, a Nashik-based cancer research firm, challenging the rejection of its application to conduct Phase I human trials for its indigenous cancer immunotherapy drug, Per-C-Vax.

A division bench comprising Chief Justice Alok Aradhe and Justice M.S. Karnik sought responses from the Central government and the Central Drugs Standard Control Organisation (CDSCO) after the company alleged that the April 22 order denying trial approval was “arbitrary,” “unscientific,” and amounted to a “fraud on the statute.”

Filed through S Mahomedbhai & Co Advocates & Solicitors, the petition argues that the CDSCO’s demand for pre-clinical animal testing data is scientifically unfeasible given the nature of Per-C-Vax, which is developed from patient-derived tumor cells or tumor cell lines. The company contends that animal models are neither viable nor appropriate for evaluating such therapies.

According to the petition, Datar Cancer Genetics first submitted its application under the New Drugs and Clinical Trials (NDCT) Rules, 2019, on August 2, 2023. Rule 23 of the NDCT Rules mandates the CDSCO to respond within 30 working days, after which—if no objections are raised—the application is deemed approved. Datar claims the 30-day window lapsed on September 15, 2023, without any deficiency letter being issued.

Subsequently, on September 21, the CDSCO raised additional queries, to which Datar responded in detail by November 28, 2023. However, months later, on April 22, 2025, the Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi, issued an order declaring the original application incomplete and stating that Form CT-4A, used to claim deemed approval, was not applicable in the present case.

Datar supports its case with international precedents, including a 2011 guidance issued by the U.S. FDA, which permits exemption from pre-clinical animal testing for certain therapeutic cancer vaccines. The company asserts that Per-C-Vax falls within that category and has submitted in vitro data and references to earlier human trials involving similar tumor lysate-based therapies.

To further establish safety, the company conducted an ad-hoc toxicity study at IISER Pune. However, the CDSCO reportedly rejected the data on the grounds that the laboratory lacked GLP (Good Laboratory Practices) accreditation.

Labeling the rejection as a “mala fide” and “colourable exercise of power,” the petition accuses the regulator of undermining statutory protections that ensure timely decision-making. Datar has requested the Court to quash the CDSCO’s April 22 order and direct it to allow commencement of the Phase I clinical trials.