Bombay High Court seeks Centre's response to plea to allow human trials for Indian cancer vaccine

The Bombay High Court on Wednesday issued notice to India’s drug regulator in a plea filed by a cancer research company seeking permission to begin Phase I human trials of its indigenous cancer immunotherapy drug Per-C-Vax, for patients recently diagnosed with solid organ cancers..The company has challenged the Central Drugs Standard Control Organisation (CDSCO) order dated April 22 rejecting its trial application, calling it “arbitrary,” “unscientific,” and a “fraud on the statute.”A Bench of Chief Justice Alok Aradhe and Justice MS Karnik issued notice to the Central government and CDSCO on a plea by Datar Cancer Genetics, a Nashik-based cancer genetics company involved in cancer research..In its petition filed through S Mahomedbhai & Co Advocates & Solicitors, Datar Genetics claims that its application to begin trials for patients recently diagnosed with solid organ cancers was unfairly blocked by demands to submit pre-clinical animal testing data - something the company says is scientifically impossible given the nature of its therapy.The company argues in its petition that since Per-C-Vax is developed using patient-derived tumor cells or tumor cell line, "hence testing it on animal models is not optimum and is unviable". .Datar Genetics first submitted its application on August 2, 2023, under the New Drugs and Clinical Trials (NDCT) Rules, 2019. As per Rule 23 of the NDCT Rules, the CDSCO is mandated to respond within 30 working days, failing which the application is considered “deemed approved.” Datar claims this statutory deadline expired by September 15, 2023, with no deficiency letter received.On September 21, the CDSCO raised further queries. Datar submitted a detailed reply on November 28, 2023. Months later, on April 22, 2025, Drugs Controller General of India Dr. Rajeev Singh Raghuvanshi issued an order stating that the original application was “incomplete” and that Form CT-4A, used to claim deemed approval, was “not applicable.”.In support of its case, the company has cited international guidelines, including a 2011 US FDA guidance which allows exemption from pre-clinical animal studies for therapeutic cancer vaccines of a previously tested class. Datar says Per-C-Vax falls under that category and provided in vitro data, along with references to prior human trials of similar tumor lysate-based therapies. The company also initiated an ad-hoc toxicity study at IISER Pune to demonstrate safety, but says CDSCO dismissed it as inadequate because the lab lacked GLP accreditation..The petition calls the rejection “mala fide” and a “colourable exercise of power” aimed at bypassing the legal safeguards intended to ensure time-bound decision-making. It has asked the Court to set aside the April 22 order and direct the CDSCO to permit the trial.