The Growing Problem of Data Falsification by Overseas Drug Manufacturers

The Indian generic drug market is becoming increasingly synonymous with sub-par quality and substandard regulation – which has resulted in possible drug resistance and the spread of disease.
Image source: Wikimedia Commons

In yesterday’s post, we reviewed a controversial phenomenon plaguing the international drug market involving the production of substandard generic medications in India. More specifically, we looked at how patients in America and worldwide could face harm by taking drugs manufactured by companies like Ranbaxy, as studies have revealed that key ingredients are either insufficient or missing altogether. In many nations, the fear of drug resistance has been aggravated by the use of these medications, particularly with regard to conditions like aggressive tuberculosis.

In today’s post, we look at how these companies are able to keep producing these medications, despite a major international outcry against the fraudulent scheme.[1. “Beware Of ‘Made In India’: Whistleblower Keeps The Pressure On The Indian Pharmaceutical Industry.” August 13, 2015. http://taf.org/blog/beware-%E2%80%98made-india%E2%80%99-whistleblower-keeps-pressure-indian-pharmaceutical-industry] We will also explore the applicability of the False Claims Act to this type of misconduct.

Ignoring the problem

According to an article recently penned by Ranbaxy whistleblower Dinesh Thakur[2. Thakur, Dinesh, “Beware of ‘Made in India’ medicine.” August 12, 2015. http://www.thehindubusinessline.com/opinion/columns/beware-of-made-in-india-medicine/article7531267.ece#comments] – who is currently the executive chairman of Medassure Global Compliance Corporation – India’s most wayward producers are able to capitalize on fraud thanks to the nation’s penchant for turning a blind eye to transparency in pharmaceutical investigations.

Despite the enactment of a Food and Cosmetics Act similar to the American version, Indian investigators and inspectors have allegedly allowed companies like Ranbaxy to either falsify data or not keep records altogether. Following the historic $500 million settlement between Ranbaxy and the U.S. Department of Justice, India’s minister of health, Ghulam Nabi Azad, made a public commitment to revamp efforts to hold Ranbaxy and other companies culpable for any deviations from public health standards – a promise which has yet to hold true (two years later).

According to the details of Thakur’s article, the United States – through the Food and Drug Administration (FDA) – has issued at least 15 warning letters to other Indian drug makers regarding their use of substandard manufacturing protocol, none of which has been investigated by Indian health inspectors.

Lobbying and politics

Lastly, Thakur highlights the dual threat of an aggressively strong Indian pharmaceutical lobby and the “impotence of drug regulators.”[3. Mathur, Aparna; Bate, Roger; and Zhe Jin, Ginger, “India Must Fix Its Drug Quality Problem.” September 17, 2014. http://www.forbes.com/sites/theapothecary/2014/09/17/india-must-fix-its-drug-quality-problem/] With this combination, companies like Ranbaxy are able to coerce Indian lawmakers to ignore problems within the industry, while allowing outside nations to be exposed to the dangers of ineffective drugs. Most alarmingly, the Indian Parliament seems to place blame on India’s Central Drug Standard Control Organisation (CDSCO) and its “skewed priorities and perceptions.”

The False Claims Act

Thakur concludes his article by reminding Indian authorities that “policymakers in the US and EU will and have enacted their own measures to ensure the safety of their citizens. These measures will undoubtedly reduce profits of the Indian industry and ….[n]o amount of sabre-rattling and trade threats from India will scare the West, the largest market for Indian pharmaceutical companies, into subjecting its citizens to questionable Indian medicine.”

What’s more, our False Claims Act has made this sort of despicable fraud punishable by civil penalties up to $11,500 per violation[4. Harris, Gardinier, “Medicines Made in India Set Off Safety Worries.” February 14, 2014. http://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html] – and the Department of Justice undoubtedly has no problem targeting any of the other Indian violators in the way it did Ranbaxy.

Contact a False Claims Act attorney today

If you are aware of healthcare fraud in any form, please do not hesitate to contact Berger Montague today.