At least a dozen drugmakers with operations in India were accused by the FDA last year of routinely throwing out negative test results of bad batches of pharmaceuticals, some of which eventually made it to U.S. consumers.
Bloomberg scoured FDA records, some obtained under the Freedom of Information Act, and found that failed batch tests designed to check for impurities were often deleted by a technician and then retested and labeled as safe.
According to a November 2013 FDA document, agency computer forensics experts found 5,301 failed chromatography test results that had been deleted at one Sun Pharmaceutical Industries facility alone, Bloomberg said.
Based on FDA inspection documents and warning letters, at least 12 drug companies with facilities in India were accused by the agency of failing to report data from tests designed to determine if a drug was safe and would work as designed.
Lax production standards and other issues such as improper sterilization of equipment have become headline news for Indian drugmakers. Ranbaxy, which is in the process of being acquired by Sun Pharmaceutical, was recently banned from exporting antibiotics by Germany, and the FDA rescinded previous approval to make generics of AstraZeneca's ($AZN) blockbuster Nexium and Roche's ($RHHBY) antiviral Valcyte because of manufacturing shortcomings.
The FDA recently slapped Dr. Reddy's Laboratories with a Form 483 letter, citing problems with the drugmaker's manufacturing plant in southern India.
India is second only to the U.S. in producing generic drugs and active ingredients for medicine, and according to Bloomberg data the top 10 pharma companies based there generate about $15 billion in annual sales.
The FDA, however, only has about 12 staffers in India responsible for covering roughly 600 U.S. registered factories. Tara Goodin of the FDA told Bloomberg that by the end of October they had conducted 97 inspections in the country.
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