The Bombay High Court has issued notices to the Central Drugs Standard Control Organisation (CDSCO) and the Union government following a petition by Datar Cancer Genetics challenging the rejection of its application to conduct Phase I human trials for an indigenous cancer immunotherapy.
The bench, comprising Chief Justice Alok Aradhe and Justice MS Karnik, is reviewing the Nashik-based company's plea against CDSCO's April 22 decision to reject trials for Per-C-Vax, a therapy developed for patients recently diagnosed with solid organ cancers.
Regulatory Dispute Centers on Testing Requirements
Datar Cancer Genetics has characterized CDSCO's rejection as "arbitrary," "unscientific," and a "fraud on the statute." The core dispute revolves around the regulator's insistence on pre-clinical animal data, which the company argues is scientifically impossible given the nature of the immunotherapy.
Per-C-Vax is developed from patient-derived tumor cells or cell lines, making traditional animal testing models inappropriate, according to the company. Senior counsel Rafiq Dada, representing Datar, informed the court that the vaccine would initially be administered to critical patients during the trial phase.
"It is being used in the USA and Germany. We want to produce it in India and sell it for less than Rs 1000," Dada stated, adding that the company has invested Rs 2,000 on the vaccine's development.
Procedural Timeline and Regulatory Requirements
The company submitted its trial application on August 2, 2023, under the New Drugs and Clinical Trials (NDCT) Rules, 2019. According to Rule 23, CDSCO must respond within 30 working days, after which applications are "deemed approved." Datar claims this deadline passed on September 15, 2023, without any deficiency letter being issued.
However, 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 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 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 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 CDSCO's failure to adhere to the 30-day timeframe stipulated in the regulations. 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.
The case highlights the tension between regulatory requirements and scientific innovation in the development of novel cancer therapies, particularly those based on personalized medicine approaches that may not fit traditional testing paradigms.
