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Cancer genetics

Bombay High Court Issues Notice to CDSCO Over Cancer Immunotherapy Drug Trial Rejection

Strategic Insights

— 1 min read

The Bombay high court has issued a notice to the Central Drugs Standard Control Organisation (CDSCO) to respond to a petition filed by Datar Cancer Genetics Pvt Ltd, a Nashik-based cancer research company seeking permission to conduct phase one human trials of its cancer immunotherapy drug, Per-C-Vax. The company claims that CDSCO arbitrarily rejected its application to conduct the trials under the New Drugs and Clinical Trials (NDCT) Rules, 2019, despite complying with the regulatory requirements. The regulator's decision has been termed as "mala fide" and a "colourable exercise of power" by the company, which asserts that it is a "fraud on the statute" and against the larger public good.

Key Takeaways:

  • Datar Cancer Genetics Pvt Ltd, a Nashik-based cancer research company, has filed a petition in the Bombay high court seeking permission to conduct phase one human trials of its cancer immunotherapy drug, Per-C-Vax.
  • The company claims that CDSCO arbitrarily rejected its application to conduct the trials under the New Drugs and Clinical Trials (NDCT) Rules, 2019, on August 2, 2023, despite complying with regulatory requirements.
  • CDSCO did not respond to the application within 30 days, as mandated by the NDCT Rules, and later insisted on pre-clinical animal study data, which the company explained was scientifically impossible.
  • The Drugs Controller General of India, Dr Rajeev Singh Raghuvanshi, rejected the application on April 22, 2025, highlighting deficiencies.
  • The company has termed the rejection as "mala fide" and a "colourable exercise of power" to defeat the legislative safeguard built into the NDCT Rules to protect the applicants.
  • Datar Cancer Genetics has filed the petition in the Bombay high court while seeking permission to conduct phase one human trials of Per-C-Vax in India.

Statistics:

  • August 2, 2023: Datar Cancer Genetics Pvt Ltd submitted an application to CDSCO to conduct phase 1 human trials of its indigenous vaccine to treat solid organ cancers.
  • 30 days: Regulatory response time mandated by the New Drugs and Clinical Trials (NDCT) Rules, 2019.
  • April 22, 2025: Drugs Controller General of India, Dr Rajeev Singh Raghuvanshi, rejected Datar Cancer Genetics' application to conduct the trials.

Sources:

  • "Bombay high court issues notice to CDSCO over cancer immunotherapy drug trial rejection". Mumbai, HT, 9 May.

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