Bombay HC Notice to CDSCO on Denial of Phase I Trial for Indigenous Cancer Drug

A division bench comprising Chief Justice Alok Aradhe and Justice M.S. Karnik is reviewing the case, where Datar alleges that the CDSCO's April 22, 2025, rejection was "arbitrary," "unscientific," and a "fraud on the statute."

Regulatory Dispute Over Testing Requirements

Datar Cancer Genetics contends that the CDSCO's insistence on pre-clinical animal testing data is scientifically unfeasible for Per-C-Vax, which is developed from patient-derived tumor cells or cell lines. The company argues that traditional animal models are inappropriate for evaluating such therapies. Senior counsel Rafiq Dada, representing Datar, informed the court that the vaccine would initially be administered to critical patients during the trial phase.

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Timeline and Procedural Concerns

Datar submitted its trial application on August 2, 2023, under the New Drugs and Clinical Trials (NDCT) Rules, 2019. According to Rule 23, the CDSCO must respond within 30 working days, after which applications are "deemed approved." As per a recent media report in Bar and Bench, Datar claims this deadline passed on September 15, 2023, without any deficiency letter being issued. However, the CDSCO raised additional queries on September 21 and ultimately rejected the application seven months later, despite Datar's detailed response submitted on November 28. The Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi, termed the application "incomplete" in the April 22 order and stated that Form CT-4A, used to invoke deemed approval, was not applicable.

Scientific Basis and International Precedents

In its defense, Datar has cited the US FDA's 2011 guidance that allows exemption from animal studies for therapeutic cancer vaccines of a previously tested class. The company also submitted in vitro data and referenced earlier human trials of similar therapies. Additionally, Datar conducted a toxicity study at IISER Pune, which the CDSCO dismissed due to the institute's lack of Good Laboratory Practice (GLP) accreditation.

Company Profile and Trial Plans

Datar Cancer Genetics boasts a team of highly qualified professionals, including seven MDs, 13 PhDs, and 78 scientists with master's degrees in pharmaceutics or biotechnology. The company currently serves patients across multiple countries, including the US, UK, Europe, Canada, and India, with a growing presence in South America and Africa. The Free Press Journal reports that the company's counsel emphasized that the vaccine "would put India on the world map" in cancer treatment innovation. The initial trial would involve ten stage 4 cancer patients receiving the therapeutic treatment.

Court Proceedings

After hearing the initial arguments, the High Court has granted the CDSCO four weeks to file its reply to the petition. The matter is scheduled for further hearing on June 13. Datar has requested the court to declare that its application should be considered "deemed approved" due to the CDSCO's failure to adhere to the 30-day timeframe stipulated in the regulations. HT reports that the company has also asked the court to direct the regulator to facilitate all administrative steps necessary for conducting the clinical trial under the NDCT Rules, 2019.