More and more of the prescription drugs sold in the United States are now manufactured in India and China. Many of those drugs are generics sold directly to the public though pharmacies and hospitals. Others are manufactured overseas by big pharmaceutical companies hoping to save a few pennies by outsourcing. The problem with many offshore drug manufacturing facilities is quality. These problems are particularly troubling in India where some estimate that more than half the drugs made and sold in India are adulterated or misbranded.

India’s leading pharmaceutical research company is GVK Biosciences.  According to the Deccan Chronicle, an English language newspaper published in Hyderabad, India, GVK Bio has been accused by European regulators of manipulating the results of clinical trials of generic drugs. Germany reportedly is considering banning the use of more than 100 drugs because of suspicion that GVK Bio may have faked clinical trials.

Press reports claim that the fake testing spanned 5 years and may have involved 10 different people forging study results.

There must be extensive testing before a generic manufacturer can sell drugs in the United States or Europe. Clinic testing and trials insure that the generics have the same health benefits of the original drug.

What does GVK Bioscience’s European woes have to do with the United States? Plenty. GVK tested drugs are also available here. Although Germany, France and European regulators are investigating the company, GVK Bio issued a press release claiming they passed an FDA audit. 

Before blaming the FDA for shoddy inspections, US regulators can’t do unannounced, surprise inspections in India. They must give notice. To us, that is like a police officer scheduling a search warrant or a raid with a criminal. 

Indian pharmaceutical manufacturers may cry foul at our use of an analogy with criminals. Certainly not all contract research and testing companies are criminal but there are many bad apples in the industry.

A press release from GVK Bio’s chief executive officer claimed that the recent FDA inspection “is a clear testimony of the high standards of quality and processes followed at GVK BIO.” Maybe, but what does he have to say about the press reports regarding faked clinical trial results?

Our take is that almost any laboratory or manufacturing facility can clean up their act for one day. The same is true when it comes to forged clinical trial results. What happens when the inspectors are not around? Unfortunately, only a few people know those answers.

Indian quality assurance engineers, lab technicians and managers are all eligible to participate in cash awards from the U.S. False Claims Act. That law empowers whistleblowers – people with inside information about fraud – to collect awards for their information. Last year $438 million (US Dollars) in award money was paid out.

Because generics and branded pharmaceuticals are often sold to Medicare and Medicaid patients or sold to VA hospitals, the False Claims Act can pay awards for adulterated drugs. One manager in an Indian manufacturing facility received $48 million (USD).

The lack of an FDA Inspectional Observation (Form 483) is not an indication of cGMP (current good manufacturing practices) nor is it an endorsement of a particular facility or drug. It simply means there were no violations observed on the day of inspection, a pre-announced inspection.

Patients and the American public increasingly rely on foreign made pharmaceuticals. Safety can only be assured if workers speak up and step up when they see violations, particularly violations involving adulterated, contaminated or misbranded products.

Luckily, Indians by virtue of their rich heritage are rooted in a culture that values integrity. The False Claims Act can help by providing large cash awards. Whistleblowers who are located in the United States or work for a company here are also entitled to strong anti-retaliation protections.