- India's largest pharmaceutical company should soon be able to ship products from one of its manufacturing facilities into the U.S. now that the Food and Drug Administration has decided to end a more than three year-long ban.
- The company revealed the agency lifted the ban on its Mohali, India plant on March 13 in a statement released the day after. The FDA put the facility, which Sun Pharma acquired along with three others from a 2015 acquisition of Ranbaxy for about $4 billion, under an import alert in 2013 following inspections that raised red flags about whether it complied with current Good Manufacturing Practices (cGMP).
- "This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements," the company wrote in a March 14 statement.
The news is a step in the right direction for Sun, which up until this point has suffered from continued manufacturing-related problems at formerly Ranbaxy-owned plants.
Issues at the Ranbaxy plants stretch back to at least 2005, but it wasn't until 2008 that the FDA placed two facilities located in the cities of Dewas and Paonta Sahib on import alert for CGMP and data quality violations. The Department of Justice filed a consent decree of permanent injunction — a form of settlement in which the defendant takes some kind of action without admitting wrongdoing — four years later against the company for those violations.
By May 2013, Ranbaxy had plead guilty to producing and distributing adulterated products at the two sites. The company accepted seven felony charges and agreed to pay $500 million in criminal and civil penalties — the largest drug safety settlement for a generic pharmaceutical company in U.S. history.
Unfortunately for Sun, the settlement didn't solve all its manufacturing issues. The company received two Form 483s, which signal that FDA investigations reveal a facility is not meeting standards set by the Food, Drug and Cosmetic Act (FDCA) in 2012 for the Mohali plant and another late last year for its Halol site.
Inspections of the Mohali facility in September and December 2012 found a host of cGMP issues, including products that were the wrong weight or were contaminated, capsules that had dents or didn't dissolve properly, and inadequate investigations on Ranbaxy's part to remedy quality control failings.
Ranbaxy's inability to correct its manufacturing shortfalls led to the import alerts. Additionally, the consent decree holds that any improvements or reforms required at the Dewas and Paonta Sahib can be extended to other Ranbaxy plants provided that an FDA inspection provides evidence of similar FDCA violations, as was the case with the Mohali site.
Some of those provisions remain intact despite the ban's recall, according to Sun's March 14 statement.