Swiss pharmaceutical firm Roche has sounded alarm against clinical trials conducted by Zydus Lifesciences on its biologic drug Perjeta, a widely-used breast cancer treatment. The Swiss company has filed a complaint against the Indian drug maker over alleged critical gaps in the clinical trial of a drug originally developed by Roche.
Roche, a global biotech giant, claims that the drug used by Zydus in the starting phase of clinical trials has not been procured from them and, hence, might be of “questionable quality”, “compromised” or “spurious”.
However, Ahmedabad-based Zydus perceives this as an attempt to “malign” its reputation and “discredit” its achievements in making expensive drugs accessible at affordable prices in the Indian market.
On November 24, Roche wrote a letter to the Drug Controller General of India (DCGI), urging the regulator to intervene and probe the issue. On February 7, it reiterated the request. News18 has seen the letter titled ‘Import of Innovator’s reference biological drug Perjeta for clinical trials in India’.
Calling it a matter related to “patient safety”, Roche has requested DCGI, the country’s apex health regulatory agency, to “inquire whether Zydus had sourced the entire volume of Perjeta (Pertuzumab) used for conducting its clinical trials from authorised sources”.
A top government official privy to the development confirmed the receipt of the complaint and told News18 that the matter is already under investigation and internal meetings are underway.
Zydus spokesperson, in an email to News18, denied the allegations, calling them “baseless and unfounded”. The Ahmedabad-based company said that it “remains committed to sharing with the regulators, relevant information as and when required”.
“Zydus has been successfully conducting trials and introducing critical NCEs, Novel Biologics and Biosimilars, many of which are first in India and first in the world products. In conducting clinical trials, all the necessary regulations and processes have been followed with regards to ethics and safety.”
“We remain committed to sharing with the regulators, relevant information as and when required. These allegations are baseless and unfounded. Despite the efforts made to malign and discredit us, we remain committed to enabling access to Biosimilars of expensive medicines that cancer patients in India can ill-afford.”
Multi-Centre Trial on 268 Patients
According to the clinical trial protocol, available on the Clinical Trial Registry, India (CTRI), the trial received regulatory clearance from DCGI on December 31, 2021 for patients suffering from “malignant neoplasm of breast of unspecified site”. It refers to a type of cancerous growth in the breast where the specific location within the breast is not specified.
While the comparator agent or drug to be used in comparison in the clinical trial is Roche’s brand Perjeta, the intervention drug being tested is Zydus’s drug labelled as ZRC-3277.
The CTRI shows that Zydus managed to achieve the final enrolment of 268 patients, with the trial starting in September 2022. The multicentre trial, as per CTRI, took place at more than 40 locations across India including All India Institute of Medical Sciences (AIIMS), New Delhi, Rajiv Gandhi Cancer Institute and Research Centre, Mumbai-based Tata Memorial Hospital and KR Hospital in Mysore Medical College & Research Institute.
Allegations and Solutions
Roche, in an e-mail to News18, has highlighted the mismatch of timelines in the procurement of their drug Perjeta for conducting clinical trials. The company’s procurement data shows that Zydus may not have procured the drug from the originator company during the starting phase of the trial.
“Zydus had procured 480 vials of the original innovator reference product (Perjeta) from Roche Pharma India in January 2023,” the company spokesperson said, adding that Zydus did not buy the trial vials in 2022 from Roche.
The clinical trial, as per CTRI, started in September 2022.
“It therefore raises important questions – whether the reference products imported in 2022 were of questionable quality (possibly compromised / spurious), what supply chain norms (safety, cold chain etc.) were followed, and the credibility of the source from where the earlier imports were made in 2022,” the spokesperson said.
According to Dr Amitav Banerjee, professor, community medicine at Dr DY Patil Medical College, Pune, “The matter is an open and shut case.”
“The regulator must ask Zydus to clarify the batch numbers and from where they picked up the product and imported it. Roche, in turn, should verify these details from their authorised dealers’ records. Everything will be clear in a matter of a day and it won’t require a long investigation.”
Banerjee formerly headed the ethical committees of clinical trials at Pune-based National Institute of Virology. Presently, he is the chairperson of the ethical committee at Armed Forces Medical College, Pune.
“The DCGI should refer this matter to the ethical committees to review the trial. Once they ask the company, they are bound to declare the source of the comparator drug.”
According to Dr Anant Bhan, Researcher, Bioethics and Health Policy: “The controversy around the clinical trial involves multiple facets, including issues around MNC-domestic pharma competition, regulatory and ethics oversight, good clinical practices.”
Bhan added that for the sake of science and credibility, the regulator should examine the issues raised, and respond formally and on priority with transparency.
News18 sought an official comment from DCGI, but hasn’t received a response so far. The report will be updated if and when the DCGI responds.
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