The Bombay High Court on Wednesday issued a notice to the Central Drugs Standard Control Organisation (CDSCO), asking it to respond to a petition filed by Datar Cancer Genetics Pvt Ltd, a Nashik-based research company. The firm has challenged the CDSCO’s rejection of its application to conduct Phase 1 human trials for an indigenous cancer immunotherapy drug named Per-C-Vax.
Company Alleges Arbitrary Rejection of Trial Application
A bench comprising Chief Justice Alok Aradhe and Justice MS Karnik sought the CDSCO’s response after the company claimed the regulator had arbitrarily rejected its application under the New Drugs and Clinical Trials (NDCT) Rules, 2019.
Datar Cancer Genetics submitted its application on August 2, 2023, seeking approval to begin human trials. As per the NDCT Rules, CDSCO must either approve or reject an application within 30 days. If no decision is communicated within this period, the application is deemed approved.
Regulator Failed to Respond in Time, Says Petition
As reported by Hindustan Times, the company argued that the CDSCO failed to respond within the 30-day window. Instead, the regulator allegedly insisted on pre-clinical animal study data, which the company explained was scientifically irrelevant due to the nature of its vaccine.
Despite these clarifications, the Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi, officially rejected the application on April 22, 2025. The rejection cited unspecified deficiencies.
Petitioner Calls CDSCO’s Action “Mala Fide”
Datar Cancer Genetics strongly criticized the decision, calling it a “mala fide” act and a “colourable exercise of power.” The company argued that the rejection violated the NDCT Rules, describing it as a “fraud on the statute” that undermined the regulatory safeguards intended to support drug developers.
The petitioner also emphasized the public health value of its cancer vaccine. It claimed that the trial could position India as a global leader in cancer immunotherapy.
Trial Intended for Stage 4 Cancer Patients
The company’s counsel informed the court that they would administer the vaccine to ten stage-4 cancer patients. This would form part of the Phase 1 trial, marking a critical milestone in the therapy’s development.
Petitioner Seeks Trial Approval Based on Regulatory Delay
Due to CDSCO’s failure to meet the 30-day deadline, Datar Cancer Genetics has approached the High Court. The company seeks to have its application declared as deemed approved. It also urged the court to direct the CDSCO to facilitate all necessary administrative steps required to initiate the clinical trial under the NDCT Rules.
Court Grants CDSCO Four Weeks to Respond
After hearing the initial arguments, the court granted CDSCO four weeks to file its response. The next hearing is scheduled for June 13.