Ranbaxy has strengthened its manufacturing and monitoring systems to address issues raised by the US Food & Drug Administration last year with regard to its plant at Mohali.
In an e-mail sent to Business Line , Arun Sawhney, CEO and Managing Director, Ranbaxy stated, “At this point, I would like to assure you that the issues that were raised by the US FDA in 2012 have been addressed. We have taken stringent steps to ensure that we meet all US FDA concerns. It is important to take cognisance of the fact that since the last inspection by the US FDA at Mohali in 2012, Ranbaxy has strengthened its management, manufacturing and monitoring systems and processes to ensure quality and compliance in all areas.”
“We are focusing on resuming submissions and supplies to the US from our Mohali plant once we satisfy the US FDA stipulations,” he added.
Inspection report
A report prepared by inspectors of the US regulator has cited as many as 11 discrepancies in the processes followed by Ranbaxy at its Mohali plant leading to the drug import ban.
This includes presence of a black fibre in a tablet suspected to be hair from an employee’s arm and lack of written procedures for production and process controls designed to assure quality.
Lack of running water for washing hands and toilet flushing has also been reported by the USFDA inspectors.
The inspection by the FDA, done last September, also found black spots in tablets during tablet compression (a process that compresses powder into tablets of uniform size and weight.).
The report said that Ranbaxy did not do chemical analysis of the tablet to rule out contamination, which may have originated from oil in the compression machine.
The US regulator has also advised that the Mohali plant will be subject to certain terms of the Consent Decree (CD), filed in late January 2012 for Ranbaxy’s Paonta Sahib and Dewas plants. “We are assessing the terms and practical applications of this CD,” Sawhney said.
“We will continue to work closely with the USFDA on remediating the issues at our Mohali facility and will take all necessary measures to keep our facilities in full compliance to all global regulations,” he said.
Sawhney said that Ranbaxy will continue to invest in R&D to enrich its global product pipeline.
“Ranbaxy remains strongly committed to providing high quality, affordable drugs to patients in India and other parts of the world. We are guided by our philosophy of 'Quality and Patients First', and will uphold the highest quality standards that patients, prescribers, government and all other stakeholders expect from Ranbaxy,” he said.