GVK Biosciences, a contract research organization that conducts clinical trials for many reputed generic manufacturers in India and foreign countries is facing rough weather following the harsh recommendations made by the European Medicines Agency (EMA).
The trouble started for GVK last May when ANSM, the French drug regulatory agency alleged data manipulation of “check-out ECGs” during its inspection at the Hyderabad center of GVK. It further alleged systematic falsification of the data over a period of about five years. GVK countered the allegations by submitting necessary evidence with the EMA to establish good clinical practices followed by the company. In spite of that, by December, four European countries including France, Germany, Belgium and Luxembourg had suspended marketing authorization of about 25 generic drugs that were tested in GVK. In January 2015, EMA recommended suspension of the marketing approval of about 700 generic drugs that were approved based on the clinical trials conducted at GVK. The Agency has clarified that its recommendations are only precautionary measures and that they do not suggest problems in the safety or efficacy of the drugs.
The “check out-ECGs” have no direct relevance to the quality of the tested generic drugs and sometimes may not be even mandatory. But EMA’s extrapolation of the alleged data falsification of “check out-ECGs” to that of the quality of the core clinical research process seems overreaching and farfetched.
The company had offered to repeat the clinical trials in spite of the huge losses it has suffered since the controversy broke out. It had appealed to the Indian Government to resolve this issue. Subsequently a panel of experts constituted by the Government found no evidence for data manipulation and an Indian Government delegation had visited EU authorities for diplomatic talks. Recently in an interview to the Business Line of the Hindu group, Rajeev Kher, Secretary to the Ministry of commerce suggested that the government is contemplating commercial and legal actions against EMA’s recommendations, if needed. The legal recourse could be taken through WTO. He contended that the grounds for such harsh recommendations by EMA are flimsy and the suspensions have been recommended in spite of a plethora of evidence submitted by GVK as well as by the generic drug manufacturers for which GVK conducted those trials.
As of now, the EMA had decided to conduct a re-examination of its recommendations following requests for re-examination from many marketing authorization holders. Once the grounds of request are given by the marketing authorization holders, the EMA’s committee for Medicinal Products for Human use (CHMP) will start a re-examination which will conclude within a time limit of 60 days. Whatever may be the outcome of the re-examination, there can be no denial of the fact that many reputed Indian companies have come under the scanner of regulatory authorities of different countries such as US and UK for lack of good manufacturing practices and data integrity which needs some serious introspection from these companies.