|Cadila Pharma's Formulations manufacturing plant at Dholka, near Ahmedabad--Courtesy of Cadila Pharmaceuticals|
Yet another Indian drugmaker has run afoul of the FDA, this one for not doing enough to track down the source of impurities in some products and failing to investigate when customers complained about odors emanating from its APIs. The action comes as the FDA has stepped up oversight in a country that accounts for about 40% of U.S. generic and over-the-counter products.
The warning letter was sent Oct. 15 to Cadila Pharmaceuticals, not to be confused with Indian competitor Cadila Healthcare. It spanked the Indian drugmaker for its failures to determine the source of impurities. Instead, it said, Cadila made assumptions about what caused odors in APIs, tweaked its processes and then went about its business. Inspectors said the plant didn't bother to determine if the same problems might have affected other batches that were still in the market. Some of the issues tracked back to 2011 and 2012.
On top of that, the agency cited the company for an issue that has come up a lot during FDA inspections lately: Failing to secure testing data on computers to make sure that employees can't discard or change data when products fail testing. In fact, the FDA said some data asked for by inspectors could not be retrieved.
In a statement emailed today, the company said that it was addressing the FDA concerns to make sure it was meeting the agency's requirements. "We have always maintained the highest global level quality at all our manufacturing plants and will ensure that these best of standards are always maintained."
Since Ranbaxy Laboratories, India's largest drugmaker, was discovered faking testing data on drugs more than 5 years ago, the FDA has opened and expanded a regulatory office in India. Ranbaxy has continued to have issues with regulators and some of India's other large drugmakers like Wockhardt and Sun Pharmaceutical, also have had plants banned from shipping to the U.S. in the last year. That has has taken a bite out of their earnings and India's export numbers.
On a trip to the country early this year, FDA Commissioner Margaret Hamburg urged the country to step up its own regulatory oversight. Indian officials have indicated they are making improvements, but they also believe their industry has been singled out, sometimes unfairly. In a recent meeting, some Indian regulators argued that the FDA's attention to process is sometimes out of step with EU regulations which focus on end products meeting specifications. Some of the same products the FDA has banned are fine as far as EU regulators are concerned, they pointed out.
Worried that its reputation as the world's source of cheap but high-quality products has been undermined by FDA actions, the Indian pharma industry this year hired a Washington, DC, public relations firm. It has initiated a campaign that accuses U.S. drugmakers of "tar brushing" Indian companies for competitive reasons.
- here's the warning letter