The FDA issued an import ban for certain pharmaceuticals manufactured by Emcure Pharmaceuticals Ltd. One of India’s largest drug manufacturers, the ban applies to products from the company’s Hinjawadi, India facility. Drugs made in Emcure’s U.S. facilities are not affected.

The FDA has released little information on the ban. We do know, however, that the ban is connected to a recent inspection of the plant and centers on violations of current Good Manufacturing Practices (“cGMP”) regulations. These rules establish minimum inspection, testing, cleanliness, sterility and manufacturing standards.

A cGMP violation does not mean that adulterated or misbranded drugs have made there way into the marketplace. Without adequate inspection or sanitary standards, however, there is always a real danger that some contaminated or under / over strength drugs slipped through and are now in our medicine cabinets.

India has faced a rash of cGMP problems in recent years. As more drug companies now contract to have their drugs made in developing countries, safety and quality problems abound. Two years ago Ranbaxy, a large Indian generic manufacturer, was fined $500 million for similar violations. In that case, a large quantity of a defective generic version of Lipitor made it into the U.S. commerce stream.

The FDA has a number of sanctions it can impose for quality control violations in the manufacturing process. Banning products is one of the most extreme.

Emcure Pharmaceuticals not only produces it’s own products but also manufacturers for Sanofi, Novartis, Roche and Pfizer.  The industry publication FiercePharma Manufacturing claims that a recent drug recall from pharma giant Teva is also connected to problems at the Hinjawadi site.

By themselves, cGMP violations alone are not per se violations of the federal False Claims Act. If an adulterated, contaminated or misbranded drug makes it into the commerce stream, however, the violation does become actionable under the False Claims Act. (Medicare, Medicaid or Tricare must also approve the product but virtually all drugs are on the approved list.)

The False Claims Act pays whistleblowers a percentage of whatever the government recovers from the wrongdoer. With triple damages and fines of $5000 to $11,000 per each false claim submitted to Medicare, the damages can add up quickly. (The whistleblower in the Ranbaxy case cited above received $48 million for his information.)

As one of the nation’s leading whistleblower firms, we are interested in learning of any contaminated or mislabeled drugs being distributed in the United States. “Dirty pharma” is a growing problem in the United States as more and more manufacturing is sent overseas. Many physicians and pharmacists are becoming increasingly concerned about the quality of drugs that wind up on hospital shelves and in our medicine cabinets. A recent batch of heparin was linked to multiple deaths in dialysis centers located across the U.S.