European regulators give clean chit to Ranbaxy plant.
By Deepak Chitnis
WASHINGTON, DC: European regulatory officials are disagreeing with the US Food and Drug Administration (FDA), and have said that after conducting their own inspection of a Ranbaxy Laboratories plant in India, they have found nothing that poses a significant risk to public health.
The European Medicines Agency (EMA) inspected the Ranbaxy plant located in the northern town of Toansa, which ran afoul of the FDA earlier this year, causing the US watchdog agency to bar sales of all products coming out of that facility in the US. Now that the EMA has inspected the very same plant, they announced that they found certain protocol deficiencies, but ultimately nothing that poses a risk to public health.
“Although the assessment showed that there were a number of GMP [Good Manufacturing Practice] deficiencies at the concerned site, assessment of all available information has reassured European regulators that there has been no risk to public health from these deficiencies,†EMA said in a statement, released on Friday.
EMA also said, quite plainly, that “Patients should continue to take their medicines as prescribed by their healthcare professional,†re-assuring people around the world that if they are taking medications which originated from Ranbaxy’s Toansa plant, they are safe from harm.
The plant had its GMP certificate from the European Union suspended back in January, but that certification will now be re-instated. Inspectors from the UK, Ireland, Germany, Austria, and Switzerland made an unannounced visit to the Toansa facility, in order to inspect it and make sure it had come back up to standard – apparently, it has.
EMA said that its inspection of the plant was in direct response to the FDA ban imposed earlier this year. However, EMA stated that it’s important to keep a close eye on the Toansa plant, to make sure that whatever GMP deficiencies it currently exhibits are rectified soon.
“European regulatory authorities have identified the need to keep the Toansa site under close supervision and this will be done in collaboration with India and other regulatory authorities around the globe,†said EMA.
The FDA, meanwhile, is still hewing to its ban of Ranbaxy Toansa’s products being sold in the US. Ranbaxy is currently in the process of being acquired by Sun Pharmaceutical, but that company has also run into recent troubles with the FDA. In March, the FDA imposed regulations on Sun’s plant in Karkhadi, yet another in a long list of recent woes the Indian pharmaceutical industry has faced from the US.