Probe Against Ranbaxy

Ranbaxy, finally wins, and gets the justice. Again it was proved that truth always wins. Ranbaxy was fighting the laws because there was no fraud it had committed with the quality of the drug. The spokesperson from Ranbaxy commented that how can we put the lives of our customers in danger by manufacturing inferior quality of the drugs. Ranbaxy submitted all the papers that were asked by the US Department of Justice. The officials from the Food and Drug administration from the United States checked all the documents thoroughly and found these documents absolutely correct as per the standards.

Department of Justice in United States today withdrew a motion against Ranbaxy Laboratories after India’s biggest drug maker submitted a comprehensive set of audit documents to the authorities. The officials from the Food and Drug Administration along with some member of panels of Department of Justice visited the manufacturing units in India at Panota Sahib and Dewas. The officials noted that Ranbaxy has made changes in their manufacturing unit as the norms and conditions recommended by Food and Drug Administration. Drugs from these manufacturing units were checked and were found to harmless. The safety standards were also maintained high as per the standards mentioned by the Food and Drug Administration in US.

The formulations followed for the manufacturing of generic drugs by Ranbaxy were same as followed by the original drug manufacturers. About 30 drugs that were banned by the FDA were checked. The officials from the FDA noted that no alterations are made by the Ranbaxy while manufacturing the drugs. Ranbaxy also showed all the audit papers that were maintained by the Ranbaxy from the date when these manufacturing units started. Thus, Ranbaxy received a positive signal from the officials and these officials declared drugs manufactured by Ranbaxy as the very good and quality drugs.

Previously, FDA barred the supply of 30 drugs manufactured by Ranbaxy in its Indian manufacturing units located at Dewas and Paonta Sahib. The probe of FDA was based on the fact that Ranbaxy has altered with the formulation of the generic drugs and is not following the quality standards. FDA demanded for the documents on two specific draft standard operating procedures (SoPs), details on Toansa plant and active pharmaceutical ingredient (API) facilities of Panota Sahib, validation protocols and reports for two products and certain quality control procedures detailed by the consultant. Ranbaxy was not able to produce those documents in time and thus the FDA filed a suit against Ranbaxy. But now Ranbaxy has provided a comprehensive set of audit documents to the US Department of Justice. They checked those documents and thus have taken back the case against Ranbaxy.

Experts claimed that US Department of Justice’s action was on the expected lines, since the company had earlier announced to cooperate with the investigations. Following the motion, a US Congressional Committee had also announced an inquiry into Ranbaxy’s drug approvals in the US and potential violations of manufacturing regulations and FDA’s role in approving products of the Indian drug major. But, at last Ranbaxy won and will soon be able to sell its drugs in United States that were banned by FDA.