India’s biggest drug maker, Ranbaxy is facing a situation of changes in its plants both in US and India as permanent injunction filed in a federal court in Maryland by the US Justice Department.
As per Department, Ranbaxy plants are not accordance with standards as per the rules and there has problems with data integrity, so department filed settlement against the Ranbaxy in the court.
Ranbaxy also had received complaint from the US Food and Drug Administration (FDA) regarding its standard in December and Company promised to made changes at its manufacturing plants in the US and India.
But having no effective action by Ranbaxy, now Justice Department is deciding to act legally against Company by filling injunction. The Assistant Attorney General for the Justice Department’s Civil Division, Tony West said, “This action against Ranbaxy is groundbreaking in its international reach – it requires the company to make fundamental changes to its plants in both the United States and India.”
As per the report, consent decree filed at the request of FDA and if the court has approved the consent decree then Ranbaxy must do as per court’s order whether to comply or face contempt.
However Ranbaxy’s manufacturing drugs plant’s activities will be prevented until they do accordance with US standards. If Company wants to continuing sale of its drugs in the US market then Ranbaxy should take correct actions to resolve its violations and ensure that US people are safe by using Drugs that manufactured across the country and are as per standards.
At least 30 different drugs have supplied by Ranbaxy in the US country and cholesterol pill Lipitor is one of them that approved in November and its sale in the US market do not affect by legal proceedings.