Bombay High Court Issues Notice to CDSCO Over Rejection of Phase I Trial for Indigenous Cancer Drug

Mumbai, May 14, 2025 – The Bombay High Court has issued a notice to the Central Drugs Standard Control Organisation (CDSCO) and the Union government after Nashik-based Datar Cancer Genetics challenged the CDSCO’s decision to deny approval for Phase I human trials of its innovative cancer immunotherapy drug, Per-C-Vax.

Background of the Case

Datar Cancer Genetics, a leading Indian biotech firm, developed Per-C-Vax as an immunotherapy for patients recently diagnosed with solid organ cancers. The company filed its application to conduct Phase I trials on August 2, 2023, under the New Drugs and Clinical Trials (NDCT) Rules, 2019. According to Rule 23 of the NDCT Rules, the CDSCO is required to respond within 30 working days, after which the application is considered “deemed approved” if no deficiency is communicated.

However, Datar alleges that the CDSCO failed to adhere to this deadline. The regulator raised additional queries on September 21, 2023-six days after the supposed cut-off-and ultimately rejected the application on April 22, 2025, citing incomplete documentation and the inapplicability of the deemed approval provision.

Scientific and Regulatory Dispute

At the heart of the dispute is the CDSCO’s insistence on pre-clinical animal testing data, which Datar claims is scientifically unfeasible for Per-C-Vax. The therapy, derived from patient tumor cells or cell lines, reportedly cannot be adequately assessed using traditional animal models. Datar’s legal counsel, senior advocate Rafiq Dada, argued before the court that the vaccine would initially be administered to critical, stage 4 cancer patients as part of the trial.

Datar also referenced the US FDA’s 2011 guidance, which allows for exemptions from animal studies for certain therapeutic cancer vaccines, and submitted in vitro data and toxicity studies conducted at IISER Pune. However, the CDSCO dismissed these studies, citing the institute’s lack of Good Laboratory Practice (GLP) accreditation.

Company Credentials and International Context

Datar Cancer Genetics is staffed by a team of highly qualified professionals, including seven MDs, 13 PhDs, and 78 scientists with advanced degrees in pharmaceutics and biotechnology. The company serves patients in the US, UK, Europe, Canada, India, and is expanding into South America and Africa. According to the company, approval of Per-C-Vax would position India as a leader in cancer treatment innovation.

Court Proceedings and Next Steps

A division bench led by Chief Justice Alok Aradhe and Justice M.S. Karnik is reviewing the matter. The court has granted the CDSCO four weeks to file its response. The next hearing is scheduled for June 13, 2025. Datar is seeking a declaration that its application should be considered “deemed approved” due to the CDSCO’s delay, and is requesting the court to direct the regulator to facilitate the trial under the NDCT Rules.

What’s at Stake

The outcome of this case could have significant implications for the approval process of novel therapies in India, especially those based on emerging scientific approaches that may not fit traditional regulatory frameworks.

Disclaimer:
This article is based on publicly available information as reported by Medical Dialogues and other cited sources. It is intended for informational purposes only and should not be construed as medical or legal advice. For specific details or updates regarding the case or the drug approval process, readers are advised to consult official court documents or regulatory authorities.