Mumbai: The Bombay High Court has issued notice to the Central Drugs Standard Control Organisation (CDSCO) and the Union government in a petition filed by Nashik-based Datar Cancer Genetics, challenging the rejection of its application to begin Phase I human trials of its cancer immunotherapy drug, Per-C-Vax, for patients recently diagnosed with solid organ cancers.
A bench of Chief Justice Alok Aradhe and Justice MS Karnik was hearing the plea filed through S. Mahomedbhai & Co, Advocates & Solicitors. Datar, which is involved in cancer research, has termed the CDSCO’s April 22 rejection of its trial application as “arbitrary,” “unscientific,” and a “fraud on the statute.”
Per-C-Vax is an indigenous immunotherapy developed from patient-derived tumour cells or cell lines. The company argues that traditional animal testing is scientifically unviable for such a therapy. However, CDSCO rejected the application for lacking pre-clinical animal data. Datar contends that this demand ignores the nature of the therapy and international regulatory practices.
Senior counsel Rafiq Dada, representing Datar, submitted that the vaccine would be given to critical patients first at the trial stage. “It is being used in the USA and Germany. We want to produce it in India and sell it for less than Rs 1000,” Dada said, adding that they have spent Rs2,000 on the vaccine.
Datar had applied for trial approval on August 2, 2023, under the New Drugs and Clinical Trials (NDCT) Rules, 2019. As per Rule 23, CDSCO is required to respond within 30 working days, after which the application is “deemed approved.” Datar claims the deadline lapsed on September 15, 2023, without any deficiency letter being issued. Yet, CDSCO raised further queries on September 21 and, despite Datar’s detailed reply submitted on November 28, rejected the application seven months later.
The Drugs Controller General of India, in its April 22 order, termed the application “incomplete” and said Form CT-4A, used to invoke deemed approval, was not applicable.
Datar has cited the US FDA’s 2011 guidance allowing exemption from animal studies for therapeutic cancer vaccines of a previously tested class. It also submitted in vitro data and referred to earlier human trials of similar therapies. A toxicity study was also conducted at IISER Pune, which the CDSCO dismissed due to lack of GLP accreditation.
Calling the rejection mala fide and a misuse of power, the company has urged the Court to set aside the order and direct CDSCO to grant trial approval.
