New York: Sun Pharmaceutical Industries Ltd said it is has improved the integrity of drug-testing information at a plant in India after a US Food and Drug Administration (FDA) inspection concluded that workers were deleting data on batches of drugs to be exported.
“The US FDA observations were taken very seriously and necessary changes to the relevant systems and equipments have been made which will prevent data issues,” the company said in an e-mailed statement. “We are continuing to work hard on remediating balance issues at Karkhadi to ensure that the unit returns to compliance. In fact some of these changes are also being rolled out to other factories within the group as part of our commitment to compliance.”
A report this week by Bloomberg News, based on a review of FDA documents, found a pattern of data integrity breaches at Sun and dozens of other companies’ plants across India that make drug ingredients and pills for export to the US Doctors said the breaches make them fear prescribing generic drugs that may not do what they’re supposed to.
The Bloomberg story cited a May FDA warning letter to Sun that discussed the deleted data, along with a November 2013 FDA inspection document that provided additional details.
“The issue about data integrity was already mentioned in the US FDA warning letter of May 2014,” Sun said. “Since then till now there is no additional data or new observations on Karkhadi; hence we are not sure why is this issue being raised at this point in time.”
The company said it has assembled a team to work with external experts to address the FDA’s observations.
“We stay fully committed to comply with all regulatory requirements,” Sun said. “Despite our acceptance of there being some compliance gaps, as well as our sincere intent and significant efforts currently under way to remediate our units, it is unfortunate that past events are being revived and misrepresented.”
Sun shares fell less than 1% on Thursday in Mumbai. Bloomberg
