Two years ago the FDA turned to Sun Pharma to help it overcome a cancer drug shortage after a Ben Venue plant closed for manufacturing problems. Now it is Sun whose manufacturing has been called into question. The FDA has issued a ban against one of its plants in India continuing a crackdown there that has also blocked facilities by Ranbaxy Laboratories and Workhardt from the U.S. market.
The exact reasons for the import alert have not yet been disclosed, but a Sun Pharma plant in Karkhadi in Gujarat, India, was included on the FDA's import alert list Tuesday. A spokeswoman told Reuters that the plant accounts for less than 1% of the company's sales, so the ban would have little effect on its revenues. It is one of 25 Sun manufacturing facilities around the world, of which 11 are in India and three are in Gujarat. She said the company was working on the issues raised by FDA inspectors. The plant manufacturers antibiotic cephalosporin.
The ban comes only weeks after FDA Commissioner Margaret Hamburg returned from a trip to India where she discussed quality issues with government and industry officials. The country provides about 40% of the generic and over-the-counter drugs U.S. consumers take, and so the FDA has been placing more personnel and more emphasis on Indian drug plants. She noted during her trip that many of India's drugmakers have modern facilities with top-notch operations.
Still, the failures have been significant. Ranbaxy Laboratories, India's biggest generic drugmaker and one that has been first to market with many generic drugs, has been under tight FDA oversight for years for faking drug data at some plants. The agency has banned all four of its FDA-approved plants in India, including two in the last 6 months. It also has banned two Indian plants owned by India's Wockhardt for faking data, as well as sanitation issues. Just this week, the FDA issued a warning letter against an Indian API maker that it says never tested many of its products, then made up test results to include in required documents. Some government officials in India have complained that the FDA is singling out the country, but the FDA has taken tough actions against U.S., European and Canadian manufacturers as well.
This is is not Sun's first time to run into questions about its plant standards. In fact, in 2009, U.S. Marshals seized about $20 million worth of products from two of its Caraco subsidiary plants in Michigan and issued a consent decree on the facilities. They were tied to a string of issues that led to the recall of metformin pills for diabetes that fell on both sides of the size specification and were contaminated with metal scrapings, a 2008 warning letter said. The FDA said Caraco had poor control of its raw materials and a possible formulation error. The FDA issued a close-out letter in 2012 for the facilities, but they continued to operate under the oversight of an outside auditor.
But also that year, the agency turned to Sun Pharma for help when a shortage of Johnson & Johnson's ($JNJ) ovarian cancer drug Doxil materialized when the Boehringer Ingelheim plant that was the exclusive producer ran into FDA issues of its own. Sun was allowed to import Lipodox, a Doxil substitute the FDA had not yet approved. The company manufactured the injection at an FDA-approved facility in India. Then last year, the FDA approved a generic version of Sun's drug for the U.S. market to help ease the shortage.
- read the Reuters story
- here's the import alert