Drug maker Alkem Laboratories today 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.
The review is being carried out by the CHMP, responsible for all questions concerning medicines for human use, which will adopt an opinion.
The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
Alkem said the review would not have any significant impact on the company's revenues.
"Currently sales from Europe contributes less than 1 per cent to Alkem's total consolidated sales for 9MFY16," it said.
The Mumbai-based firm said it takes quality issues very seriously and is committed to comply with all the required regulatory norms to ensure that safe and effective products are supplied to the market.
EMA had earlier recommended suspension of about 700 pharmaceutical forms and strength of medicines for which authorisation in the EU was primarily based on clinical studies conducted at GVK Biosciences at Hyderabad.
After the instruction of EU for withdrawal of these 700 products, the government had at that time temporarily deferred resumption of the talks on free trade agreement with EU.
