The Bombay High Court has issued a notice to the Central Drugs Standard Control Organisation (CDSCO) in response to a petition filed by a Nashik-based biotechnology company seeking permission to begin human trials for its cancer immunotherapy drug.
Cancer Research Firm Challenges CDSCO Rejection
A division bench comprising Chief Justice Alok Aradhe and Justice M.S. Karnik directed the CDSCO to respond to the plea by Datar Cancer Genetics Pvt Ltd. The firm is seeking approval to conduct Phase 1 human trials of its vaccine, Per-C-Vax, developed to treat solid organ cancers. The company argued that the CDSCO had arbitrarily rejected its application, thereby obstructing a potentially life-saving treatment.
Petitioner Cites Regulatory Violations
In its petition, Datar Cancer Genetics stated that it filed an application on August 2, 2023, under the New Drugs and Clinical Trials (NDCT) Rules, 2019. According to these rules, the drug regulator must respond within 30 days. If it fails to do so, the rules deem the application approved. The company claimed that the CDSCO missed this deadline and later began raising objections.
Demand for Animal Data Called Scientifically Unviable
After the 30-day period had passed, the CDSCO reportedly began insisting on pre-clinical animal study data. However, Datar Cancer Genetics explained that such data was scientifically unfeasible for the specific nature of its vaccine. Despite repeated clarifications, the Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi, officially rejected the application on April 22, 2025, citing deficiencies.
Allegations of Abuse of Power
Datar Cancer Genetics strongly criticized the rejection, calling it a “mala fide” and “colourable exercise of power.” The company alleged that the CDSCO made the decision to circumvent the legal safeguards enshrined in the NDCT Rules, which protect applicants from arbitrary delays.
The company called the action “a fraud on the statute” and emphasized that the CDSCO’s move to block the trial of an indigenous cancer therapy violated the larger public interest. Hindustantimes.com reported that the court has now directed the CDSCO to file its response. This sets the stage for a legal examination of how India’s clinical trial regulations are being applied.
