Another Indian drugmaker faces FDA import ban
The FDA has banned imports from a factory run by Indian drugmaker Aurobindo following an inspection there in December. The ban on products from the company’s Cephalosporin facility near Hyderabad echoes an import ban on Claris Lifesciences in November after fungal contamination of IV medications made in India went unaddressed. Products from several Ranbaxy factories in India are also still under import bans after widespread manufacturing violations three years ago.
In January, Aurobindo sold its active pharmaceutical ingredients (API) division to a Chinese manufacturer, Sinopharm. China’s drug industry has been in the news in recent weeks as Congress opens an investigation into the heparin crisis that three years ago was linked to more than a hundred American deaths.
Import bans are critical to preventing drugs with suspected or known safety problems from entering the country. However, earlier action is vital as well, since such extreme and sudden blocks in the supply chain can also contribute to problematic drug shortages in hospital and other acute-care settings. To prevent such disruptions, we need to ensure that manufacturers are held accountable for Good Manufacturing Processes (GMP) through audits and sanctions. And FDA needs the authority and resources to inspect foreign plants frequently, instead of the current sometimes-to-never schedule.
For more on the safety of the drug supply, visit Community Catalyst and the Pew Prescription Project.
–Kate Petersen, PostScript blogger