The United States Food and Drug Administration (U.S. FDA) has recently issued the Import Alert 66-40- Detention Without Physical Examination Of Drugs From Firms Which Have Not Met Drug GMPs (PDF). Many Indian pharmaceutical companies have been listed on this negative list and their pharmaceutical products would not be allowed to be imported in U.S. till they are in compliance with the requirements prescribed by U.S. FDA.
For instance, the FDA sent a warning letter to Canton Laboratories in Gujarat, India, in February for a list of serious infractions, including falsifying data. The agency has taken the next step, issuing an import alert that bans products from the facility. The alert, posted last week on the FDA website, bans all of the Indian company’s drugs and drug products, from antimicrobials to root canal cleansers, as well as some food and animal products. It all came down to not meeting good manufacturing practices.
The warning letter noted that employees were not getting equipment clean enough between batches to prevent cross contamination. The company’s certificates of analysis had been showing that its APIs were within limits for microbial and metal content, but there was a problem with those tests. The FDA said: “Multiple personnel confirmed that your firm did not perform the microbial tests reported on the CoAs”.
The FDA has seen repeated instances of Indian drugmakers falsifying analytics. The agency leveled similar complaints against drugmaker USV in Mumbai recently, and the same kinds of problems factored into the long-running problems at India’s Ranbaxy Laboratories and at Wockhardt, two Indian companies that have had plants banned from shipping to the U.S. in the last year. It was also noted in a warning letter issued last year to an Indian facility owned by Germany’s Fresenius Kabi.
The nonstop problems at Ranbaxy led to a deal announced last week in which Sun Pharmaceutical will trade $3.2 billion in stock to take over India’s largest generic drugmaker. Sun Pharma, which had one of its own Indian plants banned by the FDA in March, says it will make a priority of getting Ranbaxy’s processes upgraded and its compliance problems resolved.
India’s issues with manufacturing have become a flashpoint for the two countries. FDA Commissioner Margaret Hamburg made her first trip to India in February, where she stressed quality and urged industry and government leaders to step up efforts.