In the wake of Ranbaxy facing flak from abroad,the drug controller has made it mandatory for pharma firms to inform the regulator about any action they might have faced abroad.
Ranbaxy was fined both by the United States Food and Drug Administration and by the European Union in recently. The Indian drug regulator has maintained that there is nothing wrong with the companys drugs and the violation only relates to good manufacturing practices.
Subsequently the WHO too endorsed Ranbaxy drugs. But now,the Indian regulator has instructed its state counterparts to direct manufacturers that such action should be reported as soon as possible.
India exports drugs to 200 countries and there have been actions similar to that against Ranbaxy and even import alerts against Indian medicines in some of these countries at different times.
The mandatory disclosure would help the regulator assess whether the regulatory action abroad needs to replicated here in the interest of Indian patients.