Roche Seeks DCGI Inquiry into Perjeta Clinical Trial by Zydus

Naming the matter “issue of medical safety,” Roche has requested DCGI, the Indian regulatory body, to investigate the alleged critical gaps in the clinical trial conducted by Zydus using the drug developed by Roche previously.

The last couple of months had some reports in media where Big Swiss pharma Roche raised questions; this is about approximately Ahmedabad-based Zydus daring to violate the rules during its biosimilar pertuzumab drug clinical trials. 

The reports made it explicit that the reference drug during the beginning of Zydus’ clinical trial was bought from unrecognized sources (it could be procured from the parallel trade in which Roche India or another Roche Affiliate appointed distributor is not involved), so the quality of this drug might be “questionable,” “compromised,” or “spurious.”

A world-famous biotech company, Roche publicly announced that Zydus brought in nearly 400 vials of Perjeta via direct courier service from one of their production plants in Germany in both the month of August and September 2022, with Roche being the actual official supplier.

The company denies these claims by saying they are senseless and baseless claims against it. The author has made it understood that Zydus is going by the regulations and applying all efforts to ensure safety and effectiveness as part of their research process.

Not long ago, more sources of information appeared. It has been established that Zydus may have tried to exploit the existing systems to rush the process, hoping to get their biosimilars out to tap the lucrative breast cancer market without the necessary permissions.