|Ipca Laboratories' facilities in Ratlam, India--Courtesy of Ipca Laboratories|
When the FDA issued a Form 483 to Ipca Laboratories late last month, the Indian API manufacturer moved quickly to start fixing the problems by voluntarily suspending shipments to the U.S. Now the release of details about the 483 has shown why Ipca acted swiftly, with the company joining the list of Indian drugmakers accused of data falsification.
CNBC-TV18 reports that the FDA found 6 serious deviations when it inspected Ipca's plant in Ratlam, in the northwest of India, last month. The inspectors detailed serious data integrity shortcomings in two observations, while also indicating the involvement of senior staff in data falsification. Indian plants run by Fresenius Kabi, Ranbaxy and Wockhardt have all been chastised by FDA for fudging figures over the past few years.
When questioned by FDA inspectors about why they backdated and falsified temperature records, Ipca employees reportedly said their direct supervisor forced them to make the changes. The FDA also observed workers tweaking integration parameters to get the result they wanted and overwriting raw data. The publication of details of the Form 483 caused Ipca's share price to drop 10%, although it recovered partly to close down almost 5%.
Ipca is aiming to fix the problems within the next four to 6 months, but the experience of Ranbaxy and other drugmakers shows it can take years to get back on track. The FDA accused Ranbaxy of falsifying data in 2009 and the company pleaded guilty in 2013, yet inspectors discovered that staff at the drugmaker's Toansa plant were overwriting results this year. When Fresenius Kabi encountered similar failings, it responded by replacing all of the workers and managers implicated with the practice.
- read the CNBC-TV18 article