The Central Drugs Standard Control Organisation (CDSCO) informed the Bombay High Court earlier this month that it has appointed an Expert Committee to examine grievances raised in a plea by Nashik-based Datar Cancer Genetics Pvt Ltd.
The company sought approval for phase 1 human trials of its cancer immunotherapy drug, Per-C-Vax. The court directed the committee to examine the submissions and submit a report within three months
A bench of Justices Revati Mohite Dere and Sandesh D Patil on November 21 heard a plea by Nashik-based Datar Cancer Genetics Pvt Ltd aggrieved by the “arbitrary” rejection of its plea by the Central Drugs Standard Control Organization (CDSCO) to conduct phase I human trials for its indigenous vaccine to treat solid organ cancers.
The petitioner claimed that the application was made in August 2023 under the New Drugs and Clinical Trials (NDCT) Rules, 2019 and CDSCO’s did not comply with the rule mandating its response within 30 days. On the other hand, it insisted upon pre-clinical animal study data despite the petitioner having stated that the same was scientifically impossible considering the nature of the vaccine.
Aggrieved by the April 22 decision of the Drugs Controller General of India, the petitioners approached HC alleging the ‘mala fide’ action by the authority defeated the legislative safeguard built through the new rules.
Senior advocate Rafique Dada for the firm argued it had a pool of highly qualified medical professionals and scientists and several patients in multiple countries including 10 patients on stage 4 cancer for the trial, and the vaccine would put India on the world map.
Advocate Rui Rodrigues for the respondent authorities submitted a list of nine experts who will form part of the expert committee to look into the petitioner’s grievances. The court said it was appropriate to request the authorities to add two more names suggested by the petitioner.
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The petitioner also sought that the panel be directed to consider its submissions without being influenced by the earlier views of CDSCO or any other previous expert panels.
The propositions made by the petitioner include that there was no animal species to express full set of human antigens required for pharmacological activity, and there was no known scientific method capable of resolving constituents of an Investigational New Drug (IND) that could theoretically generate or engage with 38 trillion potential Damage Associated Molecular Patterns (DAMPs), the active ingredient of the IND. The firm also said there was no validated method or recognised animal species to permit extrapolation of a human-relevant dose for this IND.
Dada also sought that the panel should consider the US FDA feedback of September 9, 2025 on a similar drug. The authority said the petitioner shall get adequate opportunity to make presentations.
The firm also said that if the panel disagrees with its propositions, they should provide a design of experiment, animal model to be used and the Institution in India which can conduct these experiments along with the competent principle investigator to do so. The court left it to the expert panel to take a decision on the same.
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Moreover, if the committee finds the firm’s propositions to be correct, the firm sought that the authority shall withdraw the impugned decision and permit the petitioners to proceed with the Phase-I trial. However, Rodrigues claimed the same may be beyond the committee’s scope, to which the court said the panel can examine submissions if they are within its ambit. Seeking its report in an expeditious manner and preferably within three months from December 1, the bench posted further hearing to March 2, 2026.
