Mumbai-based Alkem Laboratories will respond to European drug regulator accusations that fake data was used in clinical trials of an unspecified antibiotic and brain disorder drug in a case that mirrors a scandal last year that saw more than 700 drugs barred from Europe.
"We will be submitting suitable clarifications to the EMA within the stipulated timelines to enable the Committee for Medicinal Products for Human Use take a balanced risk-benefit view with respect to these two products," Alkem said in a statement.
The U.K.'s Medicines and Healthcare Products Regulatory Agency said an inspection of the company's Taloja site found instances of false data, including duplicate results of electrocardiogram (ECG) readings in a case similar to one that tripped up work done by Hyderabad-based CRO GVK Biosciences last year.
In that case, France's Agency for Medicines and Health Products Safety declared ECG data was manipulated, which was followed up by a European Medicines Agency suspension of more than 700 drugs tested there in a case that hit many of India's leading generic drugmakers in a price tag estimated at $1 billion in sales.
For Alkem, the International Business Times (IBT) says, Germany's Federal Institute for Drugs and Medical Devices along with their Dutch counterparts, the Health Care Inspectorate, said there was "intentional misrepresentation" in the ECG data and that contractual technicians handling the data were careless and non-compliant with protocols.
The charges follow earlier notices that Alkem faked data in two different clinical trials in 2013 and 2014, leading Germany to refuse marketing applications from the company and asking that denial apply at the European Union level.
The earlier GVK suspension caused a sharp trade rift between the European Union and India that led to the suspension of unrelated free trade talks and repeated statements by Indian diplomats the ban was unfair and should be lifted.
The IBT said the EMA would review the report from the German regulator and then decide on any actions against the firm, which sells generic drugs globally, including in the United States.
- and a story from the IBT