A major organisation advocating for whistleblower rights in Washington presented its “Whistleblower of the Year” award to Dinesh Thakur, the former Ranbaxy executive who exposed wrongdoing at the company that led to its coughing up a $500-million fine in June 2013.
This week the Taxpayers Against Fraud Educational Fund (TAF), a public interest group combating fraud against the U.S. government, recognised Mr. Thakur’s work over eight years in uncovering evidence showing that “certain lots of specific drugs produced [at multiple Ranbaxy facilities in India] were defective, in that their strength differed from, or their purity or quality fell below, that which they purported to possess”.
Speaking to The Hindu TAF co-executive director Patrick Burns argued that while India had aspirations to be a “first-world power”, it had not yet put in place “first-world regulation and oversight” for the pharmaceutical industry and laws that “incentivise integrity”, in particular an equivalent of the U.S. False Claims Act that protects and rewards whistleblowers.
Mr. Thakur, who joined Ranbaxy in 2003 and was compelled to resign in 2005 when he brought to Ranbaxy’s notice certain irregular practices with regard to drug testing data, said that it was initially the “perfect data” produced by the facilities that got his attention.
This data, which investigators by the U.S. Food and Drug Administration discovered to be fraudulent, along with “false, fictitious, and fraudulent statements to the FDA” in 2006 and 2007 regarding stability tests for certain drugs, led to seven felony charges, all of which Ranbaxy pled guilty to.
Over the years of Mr. Thakur’s close cooperation with the FDA and U.S. Department of Justice, federal authorities here imposed several import alerts, warning letters and in 2012 a consent decree of permanent injunction against Ranbaxy. Further the FDA has increased the number of inspectors it has for India and China from four in 2009 to nearly 15 at present, Mr. Burns noted.
Yet, despite these measures, Mr. Thakur explained during his acceptance speech at the TAF awards ceremony, Ranbaxy’s procedures with regards to data were the “secret sauce” that made it possible for the company to win six-month exclusivity clauses for certain generic drugs that it made.
Ranbaxy in this regard exploited the U.S. Hatch-Waxman legislation to bring generics to market quickly, and in the case of anti-cholesterol drug Lipitor it raked in $600 million within those six months.
Presenting him the award his attorney in the case, Andrew Beato, praised Mr. Thakur for undertaking action that proved to be “professionally and personally perilous” especially “because back then India enjoyed no laws comparable to ours, preventing retaliation”.
Not long after Mr. Thakur arrived at Ranbaxy the first alarm bell went off. Early initial hints of drug quality issues emerged after an inspection of Ranbaxy facilities by the World Health Organisation, which discovered data on generic anti-retroviral drugs distributed in Africa that “appeared to be fabricated”.
Mr. Beato noted that Mr. Thakur then spent many months documenting the fraud and realised that it permeated “hundreds of drugs, dozens of countries… [in a systematic] pattern of missing and fabricated data, substandard ingredients and cGMP violations”.
In this regard Mr. Beato said that entire manufacturing sites in India were infected with fraudulent data and shoddy products and there was little or no commitment that the drugs made were safe, effective and free from contamination.
Reflecting on the consequences of the case against Ranbaxy Mr. Beato noted that the largest generic drugs cGMP case thus far has in addition to the seven criminal felonies imposed for importing adulterated drugs, led to two entire plants in India being “put into the mothballs” due to pervasive falsification of data and more than 30 drugs barred from being imported into the U.S.