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Semler appoints US consultant to make detailed response to US FDA's charges of data integrity

Nandita Vijay, Bengaluru
Friday, April 29, 2016, 08:00 Hrs  [IST]

Semler Research Centre chief Dr. Krathish Bopanna exudes confidence that all investigations by the global drug regulators namely US FDA and WHO will conclude towards a favourable outcome. The company has appointed a US-based consulting firm to review and respond to the charges.

The US FDA ‘Untitled’ in its notification to Semler Research Centre (SRC) and to pharmaceutical companies dated April 20, 2016 regarding the company’s clinical & bio-analytical studies, the regulator alleged certain violations applicable to its bio-analytical facility in Bengaluru. “Prior to this we have been successfully audited numerous times by FDA and other global regulatory agencies as well as global pharma companies,” stated Dr. Bopanna in an email to Pharmabiz queries.

“We understand the seriousness of the US FDA notification. We have engaged a high quality consulting firm in the United States to assist us to review the matter and prepare a more comprehensive response to the FDA within the 30 days’ time that has been given by FDA,” he said.

“Based on the US FDA findings of data integrity concerns, there was a knee jerk reaction by WHO which went on to issue the Notice of Concern (NOC),” said Dr. Bopanna.

“Now that these issues are related only to the company’s bio-analytical facility and other business like the clinical unit and formulation development are not tainted we would be able to defend our stand before the regulators,” stated the SRC chief.

 “The US FDA has also notified that they have not identified any serious safety concerns with the products for the studies conducted at SRC. In the meantime, WHO has extrapolated on FDA findings and issued NOC. There are no specific points by WHO specifically. Further, WHO has sent out individual letters to applicants/sponsors to perform risk assessment and submit the application with Corrective and Preventive Actions for all the studies at the earliest and within 30 days for products that are already prequalified,” stated Dr. Bopanna.

“To this end, we will continue to work diligently to rectify this situation and cooperate with FDA. We are confident that our response to this investigation will conclude towards a favourable outcome to the company and its customers. The company stands committed to uphold the GCP (good clinical practices) standards of studies conducted at its facilities”, averred Dr. Bopanna.

When asked if the Semler would make efforts to request the Union government to form an expert committee to look into the issue and be able to come out clean like GVK Biosciences, Dr. Bopanna said, “We are working with high quality consulting firm at US to assist us to frame a comprehensive response to USFDA. At the moment, we have still not thought about the option of requesting Union government to come to our rescue.”

On how Selmer’s employees responded to this issue, Dr. Bopanna stated, “This came as shocker to staff. It is very unfortunate to have this notification when the company was in a right spirit of growing as reputed service centre.”

Semler Research Centre, which is a holding company of Semler Group, US was set up in Bengaluru in late 2009.


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