Archive · 1 Dec 2025
HC Seeks Panel Report on Cancer Vaccine Trials
A company called Datar Cancer Genetics Pvt Ltd wants to test a new cancer vaccine on humans.
They asked the government's drug control organization, CDSCO, for permission, but their request was rejected.
The company thinks the rejection was unfair and took the case to the Bombay High Court.
The court has now asked a group of experts to look into the matter and give their opinion within three months.
The company says that testing the vaccine on animals is not possible because it's made for humans.
They also want the experts to consider feedback from the US Food and Drug Administration.
The court will hear the case again after the experts give their report.
Datar Cancer Genetics Pvt Ltd seeks approval for phase 1 human trials of its cancer immunotherapy drug, Per-C-Vax.
The Bombay High Court has appointed an Expert Committee to examine the company's grievances over CDSCO's rejection of the trial application.
The court directed the committee to submit a report within three months, with a further hearing scheduled for March 2, 2026.
The company argues that pre-clinical animal studies are scientifically impossible for their vaccine due to its human-specific nature.
The Expert Committee will consider the company's submissions and may decide on the feasibility of animal studies or proceed with human trials.
- Who
- Datar Cancer Genetics Pvt Ltd, Central Drugs Standard Control Organisation (CDSCO), Bombay High Court
- What
- A plea for approval of phase 1 human trials for a cancer immunotherapy drug, Per-C-Vax
- When
- Plea filed in August 2023, court hearing on November 21, 2023, report deadline March 2, 2026
- Where
- Bombay High Court, India
- Why
- To seek approval for human trials of a cancer vaccine and address grievances over the rejection of the plea by CDSCO
- Company
- Datar Cancer Genetics Pvt Ltd
- Drug Name
- Per-C-Vax
- Regulatory Body
- Central Drugs Standard Control Organisation (CDSCO)
- Court
- Bombay High Court
- Expert Committee Formation
- November 2023
- Report Deadline
- March 2, 2026
- Vaccine Type
- Cancer immunotherapy
- Trial Phase
- Phase 1 human trials