Drug maker Alkem laboratories on Saturday said it will submit 'suitable clarifications' to the European Medicines Agency (EMA) over a decision by the drug regulator to review two drugs for which clinical trial studies were conducted by the Mumbai-based firm.
“We will be submitting a suitable clarifications to the EMA within the stipulated timelines to enable the Committee for Medicinal Products for Human Use (CHMP) take a balanced risk-benefit view with respect to these two products,” Alkem laboratories said in a regulatory filing.
The review of the two drugs antibiotics cefuroxime and rulizole that are sold both by Alkem and Slovenia’s Krka, has been ordered after German drug regulator raised concerns over their trial study data. Alkem conducted trials on the drugs at its Taloja facility in Maharashtra for Krka.
“After the inspection of March 2015 by German regulator, BfArM, Alkem has responded to the regulator with a robust remedial plan and has also been implementing several measures which include changes in staffing, upgrading equipment and improving quality assurance systems to ensure proper controls during bioequivalence studies and thorough review of the acquired data,” it said.
The Federal Institute of Drug and Medical Devices (BfArM), Germany, and Health Care Inspectorate (IGZ), Ministry of Health of the Netherlands had performed a joint inspection in March 2015 at Alkem's unit at Taloja in Maharashtra.