After taking down Ranbaxy, whistleblower Dinesh Thakur could have retired to live a quiet life, secure in the knowledge that he’d protected likely millions of people around the world from the subpar prescription medicines the company was making with either manipulated data or in some world markets, none at all.
Surely, any number of Indian pharma CEOs have wished for Thakur’s retirement.
But instead, he has used the considerable proceeds he earned under the American justice system as a whistleblower in the Ranbaxy settlement – roughly $48 million – to take up an even more impossible battle than tackling corruption in one generic pharma company. He is fighting to better regulate and safeguard the medicines consumed by everyday Indians.
Though it has often been a lonely fight, Thakur is not motivated by the odds of success. Instead, he is motivated by the rightness of his cause.
A national failure
In October, he published The Truth Pill: the Myth of Drug Regulation in India with his co-author, attorney Prashant Reddy. The need for the book, which chronicles the porous regulations and laws in India that allow low quality drugs onto the market, became evident immediately.
That same month, it emerged that a New Delhi-based pharmaceutical company, Maiden Pharmaceuticals, sold a children’s cough syrup in the Gambia that was laced with diethylene glycol, a toxic industrial solvent. The formulation is believed to be responsible for the deaths of 70 Gambian children, who succumbed to acute kidney injury, according to the Gambia Ministry of Health. (In an official statement, Maiden’s director said the company had been “diligently following” the protocols of Indian health authorities and only procured raw materials from certified and reputable companies.)
How could this have happened? In fact, similar incidents have occurred at least five times before, with different Indian pharma companies, as The Truth Pill chronicles.
The book’s prologue opens with a similar incident in the winter of 2019. More than 20 children in Jammu suffered from kidney failure, and over ten of them died. The cause was ultimately traced to a cough syrup manufactured by an Indian company in Himachal Pradesh, which contained lethal amounts of diethylene glycol.
The book recounts the profound injustice of these deaths. The children “were born to parents who were daily wage labourers, a truck driver, a school teacher, and a soldier in the Indian Army.” It goes on to note, “Though these children were all equal citizens of a democratic India, the news of their deaths struggled to get the attention of the Delhi-centric-English-language media which often sets the national agenda.”
Such gruesome incidents occur because “Indian pharmaceutical companies quite often fail to test either the raw materials or the final formulation before shipping it to the market,” despite laws requiring them to do so, the book states.
The cycle of injustice
But that perilous failing is just one small part of a larger set of injustices that The Truth Pill documents. While low wage families suffer the consequences, culpable pharmaceutical executives skate free, in a legal and bureaucratic system prone to corruption and freighted with inequity. At times, the judicial laxity the book documents is so stunning, the results seem worthy of a legal proceeding as chronicled by the English novelist Charles Dickens.
In one instance, the book relates how a pharmaceutical company in Tamil Nadu substituted a cheaper, more dangerous active ingredient in place of a safer, more costly one in a diabetes drug. Given the egregious nature of the offense, inspectors from the Tamil Nadu Drug Control Administration actually descended on the errant manufacturing facility, rather than simply requesting records. A criminal complaint was filed against the company in December 2014. But stunningly, by March 2022, the case had yet to go to trial.
Judging by the letter of the law, manufacturing drugs that are “not of standard quality” or NSQ, is a grave offense, punishable by imprisonment and hefty fines. But in case after case, as the book documents, judges impose the remarkable sentence of “simple imprisonment till the rising of the court.”
What is that, you might ask? As the book explains, “It basically allows the convicted persons to go free once the judge ‘rises’ from the court for the day. Technically, if the judge rises 15 minutes after passing the sentence, the guilty can leave court in 15 minutes. This is the most lenient form of sentencing.”
Thakur and Reddy are not alone in their efforts to clean up this quagmire of failed regulation and enforcement. The book chronicles the efforts of a number of stalwart public servants who did their best to prompt reforms. Among them was Justice Lentin on the Bombay High Court, who was appointed to head an inquiry into the diethylene glycol poisoning deaths of 14 people at a Mumbai hospital in 1986.
In a foreword to the scathing 300-page report that he issued two years later, Lentin laid out among his findings “errors of judgment, misuse of ministerial power and authority, apathy towards human life, corruption, nexus and quid-pro-quo between unscrupulous license holders, analytical laboratories, elements in the Industries department controlling the awarding of rate contracts, manufacturers, traders, merchants, suppliers, the FDA and persons holding ministerial rank. None of this will be palatable in the affected quarters. But that cannot be helped.”
Sadly, the corruption Lentin documented remained largely unchanged, as Thakur would discover. In 2003, he arrived at Ranbaxy headquarters in Gurgaon, to take up his post as global head of research information and portfolio management. In that new role, he was also supervised by a newcomer, Dr Rajinder Kumar, the company’s head of research and development.
Kumar, a deeply ethical physician, grew concerned about the accuracy of the company’s data. At his behest, Thakur investigated and step by methodical step, uncovered the company’s secret: that it manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data that would bolster its bottom line. (Thakur dedicated The Truth Pill to Kumar.)
I first detailed the story of what Thakur uncovered in May 2013, just two days after Ranbaxy pleaded guilty in a US courtroom to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government. That legal reckoning was entirely due to Thakur’s perseverance in bringing Ranbaxy’s crimes to the attention of US regulators.
I stayed on the story and went on to write the book Bottle of Lies, which chronicled not only Thakur’s journey as a whistleblower but the data fraud so prevalent in the Indian pharma industry. Among the surprises during my reporting was Thakur’s pivot, not just to being a corporate whistleblower, but to becoming a champion for the regulatory overhaul of India’s pharmaceutical sector.
In a world with little accountability or transparency, Thakur’s crusade has not been an easy one. And most people, less troubled by dysfunction and corruption, might certainly have given up long ago, in the face of such seemingly intractable problems. But Thakur has no intention of giving up. “This is only the beginning to start a conversation to demand better,” he recently told me. “The end goal is to get the Indian regulator on par with the US regulator. That’s the kind of competence we ought to have.”
Katherine Eban is an investigative journalist, a contributing editor at Vanity Fair, and the author of the Bottle of Lies.
The Truth Pill: the Myth of Drug Regulation in India, Dinesh S Thakur, Prashant Reddy T, Simon & Schuster.