Ranbaxys USFDA nod obtained by fraudulent data brought to notice
It has been noticed that the Mumbai based drug company, Ranbaxy, had taken the aid of fraudulent data to obtain permission from the USFDA to sell generic drugs. As the data presented to the health regulators is looked upon at a global level in order to give a marketing authorization, such data is very crucial.According to an official, who had been investigating on the suspected malpractices, the fraudulent files were noted during investigations. Most of the files presented did not seem to exist in reality. This clearly meant that the approvals from the USFDA to market and sell these drugs were obtained out of no data or such fake data.
In some instances, in the laboratory reports sample blood work of one case had been copied for the rest in order to meet the minimum subject criteria for that category. Since early this year, the company had been facing the heat of the USFDA. On account of good manufacturing practice (GMP) violations, one after the other the company’s manufacturing plants had been in trouble along with import ban for a few.