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.
Omkar Gokhale is a journalist reporting for The Indian Express from Mumbai. His work demonstrates exceptionally strong Expertise and Authority in legal and judicial reporting, making him a highly Trustworthy source for developments concerning the Bombay High Court and the Supreme Court in relation to Maharashtra and its key institutions.
Expertise & Authority
Affiliation: Reports for The Indian Express, a national newspaper known for its rigorous journalistic standards, lending significant Trustworthiness to his legal coverage.
Core Authority & Specialization: Omkar Gokhale's work is almost exclusively dedicated to the complex field of legal affairs and jurisprudence, specializing in:
Bombay High Court Coverage: He provides detailed, real-time reports on the orders, observations, and decisions of the Bombay High Court's principal and regional benches. Key subjects include:
Fundamental Rights & Environment: Cases on air pollution, the right to life of residents affected by dumping sites, and judicial intervention on critical infrastructure (e.g., Ghodbunder Road potholes).
Civil & Criminal Law: Reporting on significant bail orders (e.g., Elgaar Parishad case), compensation for rail-related deaths, and disputes involving high-profile individuals (e.g., Raj Kundra and Shilpa Shetty).
Constitutional and Supreme Court Matters: Reports and analysis on key legal principles and Supreme Court warnings concerning Maharashtra, such as those related to local body elections, reservations, and the creamy layer verdict.
Governance and Institution Oversight: Covers court rulings impacting public bodies like the BMC (regularisation of illegal structures) and the State Election Commission (postponement of polls), showcasing a focus on judicial accountability.
Legal Interpretation: Reports on public speeches and observations by prominent judicial figures (e.g., former Chief Justice B. R. Gavai) on topics like free speech, gender equality, and institutional challenges.
Omkar Gokhale's consistent, focused reporting on the judiciary establishes him as a definitive and authoritative voice for legal developments originating from Mumbai and impacting the entire state of Maharashtra. ... Read More
