The U.S. FDA has cited Bangalore-based CRO Semler Research for data problems in bioequivalence studies dating back to an inspection in autumn that raised "significant concerns" about the validity and reliability of two studies submitted to the regulator.
The focus of the studies was blocked out, but the FDA said in an April 19 letter to Krathish Bopanna--president and CEO of Semler--that failure to adhere to statutory requirements has undermined submissions in support of Abbreviated New Drug Applications, or New Drug Applications.
The data integrity issue for an India CRO is not the first, with accusations of false electrocardiogram data last year by Hyderabad-based CRO GVK Biosciences leading to a European Medicines Agency suspension of more than 700 drugs tested there. This case hit many of India's leading generic drugmakers in a price tag estimated at $1 billion in sales.
In the case of Semler, the FDA said the firm's responses to the inspection findings were "inadequate" and that it had 30 days to detail corrective actions--which could include repeating the studies.
A Semler official told the Economic Times that the company is reviewing the letter and will respond to the concerns.
"We have engaged high quality consulting firm to review the data and we would be providing a detailed response to these concerns with appropriate steps undertaken as advised by the agency," a company official told the newspaper.
- here's the redacted FDA link
- and a story from the Economic Times