Alkem changing systems after rap from regulator

European sales contribute less than one per cent of its total revenue, says drug maker

Drug maker Alkem Laboratories, which is facing charges from the German health regulator of fudging trial data, on Saturday said it had put in place a remedial plan and was also improving quality assurance systems.

The company also said that its European business contributes less than a per cent of its nine-month revenue of FY 2016. In a statement to the stock exchange, Alkem said it was submitting suitable clarifications to the European Medical Agency which has now ordered a review of medicines of drugs manufactured by the company. Alkem said the European Medical Agency's directives referred to findings of an inspection carried out in March 2015.
 

According to a Reuters report, Alkem was found to have engaged in “intentional misrepresentation” of data and duplicated results of electrocardiogram (ECG) readings of patients in trials as per the German regulator’s observations. The observations were shared with the European Medical Agency (EMA).

FACING CHARGES

• Alkem Laboratories found to have engaged in “intentional misrepresentation” of data and duplicated results of ECG readings of patients in trials
   
• Alkem’s quality management system “neither avoided nor detected” the data manipulation
   
• European Medical Agency, the medicines regulator for EU, considering if impacted drugs should be suspended or recalled

Alkem said inspection findings relate to bioequivalence studies done between March 2013 and March 2015 and in particular to bioequivalence trials of two products, of which one is commercialised and another is yet to be commercialised.

Bioequivalence refers to the condition in which the same medicine in different formulations is equally absorbed when it flows into the body.

“Our company 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. After the inspection of March 2015 by the German regulator, 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,” the company said in its statement. The drugs include antibiotics cefuroxime and rulizole — used to treat the neurological disorder, amyotrophic lateral sclerosis — sold both by Alkem and Slovenia’s Krka, the EMA said. Alkem was conducting trials on the drugs for Krka.

The German regulator said Alkem’s quality management system “neither avoided nor detected” the data manipulation. The regulator has urged the EMA, the medicines regulator for the EU, to take necessary action and consider if impacted drugs need to be suspended or recalled. The EMA’s opinion will be considered by the European Commission, which will take a final decision on the medicines, the EMA said.