New Delhi : Chennai-based Quest Life Sciences said it is considering making an appeal against the UK drugs regulator MHRA’s decision to suspend marketing of drugs which were approved based on the clinical studies done by it.
Medicines and Healthcare products Regulatory Agency (MHRA) had issued a notice to Quest Life Sciences in June suspending of marketing authorisations of drugs that had won approval based on studies conducted by the contract research firm citing data integrity issues.
“The company is also considering making an appeal in consultation with the affected sponsors,” Quest Life Sciences President Yati Chug said in a emailed response to PTI.
Five products and three companies are impacted by the MHRA action. All the studies were conducted in the year 2013-14 and one study conducted even earlier, he added.
The company, however, said its “sponsors have shown confidence in Quest and are planning to conduct the study for MHRA very soon, to enable trigger a fresh audit by MHRA” without disclosing the name of the sponsors.
Quest has received a successful closure of the inspection conducted by MHRA, recently, Chug added.
The company has already implemented the corrective actions and even demonstrated to MHRA, he added.
“However, MHRA were concerned with the conduct of the study in 2013-14 and chose to ignore the current GCP (Good clinical practice) standards, that had been implemented in Quest Life Sciences”, Chug said.
In the GCP inspection statement issued to the company by MHRA, said, “there was one critical finding identified during this inspection relating to ‘Data Integrity'” and another “one major finding identified during this inspection relating to Archiving”.
The health regulator said though it acknowledged that preventative measures have been taken in an attempt to mitigate many of the issues identified during this inspection,”the responses often indicated that corrective actions could not be implemented as the systems and data reviewed during the inspection were historical”.