Audit report on Wyeth’s clinical trial
New Delhi: An audit by India’s drugs quality regulator has found a clinical trial sponsored by Wyeth Pharmaceutical Ltd and monitored by GVK Biosciences Pvt Ltd has violated protocol, standard operating procedure and good clinical practices norms mandatory in the country.
The office of the drugs controller general of India, or DCGI, issued warning letters on Tuesday asking for explanations, based on the audit findings
The audit, conducted by a team of officials from the DCGI’s office and headed by a pharmacologist from the All India Institute of Medical Sciences, investigated suspended patient trials of an advanced pneumococcal vaccine at Bangalore’s St John’s Hospital’s National Academy of Health Sciences.
The report was recently submitted to drugs controller general Surinder Singh. Details of the report were shared with Mint.