FDA Concerned With Ranbaxy Manufacturing Practices
The FDA recently issued statements with regards to their concerns about the drug manufacturing practices at the Toansa pharmaceutical ingredients factory located in Punjab. The plant is owned by Ranbaxy Laboratories LTD. Currently all of Ranbaxy’s India-based factories are banned by the FDA and the company is not permitted to export any of their medications into the U.S.
Currently, Ranbaxy Laboratories is India’s largest drug manufacturer. According to the FDA statement, if the company does not address the FDA’s concerns about the Toansa plant’s manufacturing practices, it too will be banned from exporting any medicines into the U.S.
Ranbaxy issued the following statement in regards to the FDA observation, "The company is assessing the observations, and will respond to the FDA in accordance with the agency's procedure to resolve the concerns at the earliest.”
India-based drug manufacturers are among the largest generic drug makers in the world. As developed countries like the U.S. and England strive to keep afloat with the ever rising cost of healthcare and drugs, the sale of generic drugs have skyrocketed causing the FDA to closely monitor generic makers such as Ranbaxy and Wockhardt.
The hawk-eye observations of regulatory administrations have lead to a series of sanctions and regulatory scrutiny for both companies and those like them. Just last week the Department of Pharmaceuticals rejected Wockhardt’s application for pricing review on some of their products. In September 2013, the FDA issued an import ban on a Mohali plant owned by Ranbaxy; reportedly because the factory did not meet “good enough practices”.
The import ban on the company’s Mohali plant is just one of a string of regulatory issues the company has faced in the past year. In May, the company plead guilty to U.S. felony charges related to drug safety. Ranbaxy reportedly paid $500 million in fines in association to this event.
Sources:
http://in.reuters.com/article/2014/01/13/ranbaxy-india-fda-idINDEEA0C07C20140113
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm368445.htm