India's Ipca slammed by FDA for litany of severe data violations
- The FDA on Tuesday released a warning letter sent to India's Ipca Labs in late January outlining serious data integrity problems.
- The agency slammed Ipca for failing to correct major quality control issues at three production plants which help produce drugs for global pharma giants such as Pfizer, Merck, and AstraZeneca. These very plants had already been banned from exporting drugs to the U.S. over quality concerns.
- Among the problems cited by the FDA: "Systemic data manipulation" including file deletions or alterations (some of which was confirmed by an Ipca analyst as seemingly standard practice).
"Our investigators observed systemic data manipulation and other CGMP violations and deviations at three separate sites," wrote the FDA in its warning letter. "Your quality system does not adequately ensure the accuracy and integrity of the data generated and available at your facilities to support the safety, effectiveness, and quality of your drugs."
The agency continued to demand that Ipca provide the FDA with a comprehensive internal investigations into the matter; a risk assessment; and a management strategy for corrective action.
"If, as a result of receiving this warning letter or for other reasons, you are considering a decision that could reduce the number of finished drug products or active pharmaceutical ingredients produced by your manufacturing facility, FDA requests that you contact CDER's Drug Shortages Staff immediately at [email protected] so that we can work with you on the most effective way to bring your operations into compliance with the law," the agency added.
Last month, the FDA lobbed similar data allegations against several Wockhardt facilities.
For their part, Indian manufacturers have argued that the FDA and European regulatory agencies have not been giving companies enough time to make the major changes that are required of them before engaging in further inspections.
Major India-based companies such as Sun Pharma, Cipla, and Wockhardt have come under intense international scrutiny over their manufacturing services, especially considering the proportion of generic drugs that come out of India.