USFDA Accuses Indian CRO Semler of Data Manipulation
Manipulation of data found in studies filed by drug makers for regulatory approval
New Delhi: The US Food and Drug Administration (USFDA) has pulled up an Indian company providing clinical research services to drug developers, accusing it of data manipulation. The regulator told the companies that have filed for drug approval based on data supplied by Semler Research to repeat the studies elsewhere.
This is another regulatory blow to the Indian drug industry, with several top pharmaceutical companies already under the watch of USFDA for violation of its manufacturing standards. The US is the biggest foreign market for India’s pharmaceutical industry.
The latest development has a resemblance to the actions of the European Medicines Agency against Hyderabad-based GVK Biosciences, which was accused of manipulation of data for scores of generic drugs. That issue had snowballed into a government-level controversy and derailed discussions related to EU-India FTA.
Bengaluru-based clinical research organisation (CRO) Semler is named for manipulation of data in bioequivalence and bioavailability studies that were filed by drug makers for regulatory clearances. In broad terms, CROs work on projects from pharmaceutical companies and the data they provide are used in product filings.
Inspections at Semler between September 29 and October 9, 2015, found significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples, the US regulator said.
Aspokesperson for Semler said the company is in the process of reviewing the concerns raised. “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,” the spokesperson told ET.
FDA’s April 20 note informed sponsors — the companies for which Semler conducted the studies — that the Indian firm’s studies were not acceptable due to “data integrity concerns” and, hence, needed to be repeated. These companies had filed applications for the approval of new drugs and generic versions. The sponsors have to respond within 30 days with an amendment to their application, according to a letter by the regulator.
The regulator has also sent Semler an “Untitled Letter” detailing its findings related to the facility, according to the notification. The letter lists discrepancies in the company’s studies, including alleged replacement of plasma samples of certain subjects with those of others that were already analysed.
“This substitution of samples undermines the reliability and validity of the analytical methods used at your firm and the study data produced by your firm,” stated the letter. The company spokesperson said the regulator notified that it had not identified any serious safety concerns with the products for which it conducted the studies. Semler has conducted more than 750 drug studies ranging in size from 40 to 400 volunteers in various therapeutic areas for regulatory submissions, according to its website.