The Bombay High Court has intervened in a significant case concerning the development of an indigenous cancer vaccine, directing the national drug regulator to expedite a fresh expert review. The court has asked a newly formed committee to examine a plea by a Nashik-based biotechnology firm and submit its findings within a strict three-month deadline.
Court Orders Fresh Expert Scrutiny
On November 21, a division bench comprising Justices Revati Mohite Dere and Sandesh D Patil heard a petition filed by Datar Cancer Genetics Pvt Ltd. The company challenged what it called the "arbitrary" rejection of its application by the Central Drugs Standard Control Organisation (CDSCO). The firm sought approval to begin Phase I human clinical trials for its cancer immunotherapy drug named Per-C-Vax, designed to treat solid organ cancers.
The CDSCO informed the court that it had already appointed a nine-member expert committee to examine the grievances raised in the plea. The court deemed it appropriate to request the authorities to include two additional expert names suggested by the petitioner company to ensure a balanced review.
The Core of the Scientific Dispute
The legal battle hinges on a fundamental scientific disagreement. The petitioner company applied under the New Drugs and Clinical Trials (NDCT) Rules, 2019, in August 2023. It alleged that the CDSCO failed to respond within the mandated 30-day period and later, in its rejection order dated April 22, 2025, insisted on pre-clinical animal study data.
Represented by senior advocate Rafique Dada, the firm argued that providing such animal data was "scientifically impossible" for their vaccine. Their propositions, which they requested the new panel to consider impartially, stated that no animal species can express the full set of human antigens required for the drug's pharmacological activity. They also contended there is no validated method to extrapolate a human-relevant dose for this Investigational New Drug (IND).
The company urged the panel to consider US FDA feedback from September 9, 2025, on a similar drug. Furthermore, they requested that if the committee disagreed with their scientific stance, it should provide a detailed experimental design, specify the animal model, and name a competent institution in India capable of conducting such studies.
Path Forward and Next Hearing
Advocate Rui Rodrigues, representing the regulatory authorities, assured the court that the petitioner would get an adequate opportunity to make presentations before the expert committee. The court clarified that the panel should examine all submissions within its ambit and left the final decision to its expert judgment.
The bench directed the committee to submit its report expeditiously, preferably within three months from December 1, 2025. It scheduled the next hearing in the matter for March 2, 2026. The outcome could set a precedent for how India's regulatory framework evaluates complex, next-generation biological therapies where traditional animal testing models may be inadequate.
