The Bombay High Court on Wednesday issued a notice to the Central Drugs Standard Control Organisation (CDSCO) seeking its response to a petition filed by Nashik-based Datar Cancer Genetics Pvt Ltd, which has challenged the rejection of its application to conduct phase 1 human trials of a cancer immunotherapy drug named Per-C-Vax.
A division bench of Chief Justice Alok Aradhe and Justice M.S. Karnik sought a reply from the central drug regulator within four weeks, following which the matter will be heard on June 13.
The company has alleged that CDSCO’s rejection of its trial application was arbitrary and in violation of the New Drugs and Clinical Trials (NDCT) Rules, 2019. According to the petition, the application for clinical trials was submitted on August 2, 2023, and as per Rule 22(3) of the NDCT Rules, the regulator was bound to respond within 30 days. The company claims that no such timely response was received, and therefore, the application must be deemed approved.
The petition also challenged the April 22, 2025, rejection by Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi, terming it “mala fide” and a “fraud on the statute.” The company contended that CDSCO’s insistence on pre-clinical animal data was unscientific and not feasible given the nature of the drug, which is intended to treat solid organ cancers in humans.
Datar Cancer Genetics said its research team includes seven MDs, 13 PhDs, and 78 scientists, and it operates in regions including the US, UK, Europe, Canada, India, South America, and Africa. Its counsel argued that Per-C-Vax could be a groundbreaking therapy and would position India at the forefront of cancer research. As part of the first phase, the company plans to treat ten stage-4 cancer patients with the immunotherapy.
