Ranbaxy products sold in India safe, says drug controller
Analysts point out that the US FDA gave Ranbaxy adequate time, almost a year, to rectify these lapses. It would however be important to now understand, what went wrong with Ranbaxy‘s remediation plans and processes so as to attract the strict action of an import ban from the US FDA, a year after the issues were first reported.
September 20, 2013 / 16:54 IST
Ranbaxy stock saw an upward trend in second half of the day’s trade. After slipping in early trade, the stock gained momentum after reports of Indian drug controller statement that Ranbaxy’s drugs sold in India are safe. It closed 3.55 percent up at Rs 346.10. (Read More)
Though the US supplies are still a concern. Ranbaxy stock has been underperforming since Monday when the US FDA issued an import ban for the drug major’s plant in Mohali. Now the US FDA has made public its inspectional observations issued in September and December for this plant, which highlights some significant lapses, reports CNBC TV18’s Archana Shukla. For the US drug regulator the biggest concern has been Ranbaxy’s inability to identify and establish the root cause of the lapses. USFDA found black fibers, suspected as an employee’s hair, in a tablet. Traces of machine oil were also found in tablets. The USFDA noted use of dirty glassware in tablet manufacturing and inadequate exhaust systems to avoid contamination. The observations also list Ranbaxy’s failure to maintain lab records and follow documented procedures to avoid reoccurrence of these deviations.Analysts point out that the US FDA gave Ranbaxy adequate time, almost a year, to rectify these lapses. It would however be important to now understand, what went wrong with Ranbaxy’s remediation plans and processes so as to attract the strict action of an import ban from the US FDA, a year after the issues were first reported. Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
