Bottle of Lies , a book about the quality problems plaguing generic drugs, should make Indian readers furious. While it focuses on medicines intended for American consumers, the real and continuing victims of the failings described in the book are consumers in developing countries, including Indians.
In May 2013, soon after the erstwhile Ranbaxy Laboratories admitted in an American court to selling adulterated drugs, journalist Katherine Eban published a gripping 10,000-word account of the saga in Fortune magazine. But the story left Eban wondering if Ranbaxy was an isolated case. Could there be more rotten eggs, she asked, given the United States Food & Drugs Administration’s (FDA) lax policing of overseas manufacturers? Bottle of Lies is the result of the multi-year investigation that followed.
Web of chicanery
It begins with Dinesh Thakur, the whistle-blower who exposed Ranbaxy’s misdeeds. In 2003, Thakur left his job at Bristol Myers Squibb’s New Jersey office to join the Gurgaon office of Ranbaxy — then a rising star of the Indian generics industry. There, he encountered a shocking web of chicanery. An early warning sign came when Thakur’s boss told him that the World Health Organization (WHO) had uncovered fraud at Vimta Labs — the company that tested Ranbaxy’s AIDS drugs. Vimta, it emerged, had never carried out these tests.
The finding led to Thakur unravelling an elaborate tapestry of fraud that enveloped all of Ranbaxy. When he dug for quality data supporting the company’s drugs in other countries, he found falsification everywhere, with weakly regulated markets like India being the worst hit. In a dramatic scene in Eban’s book, Thakur asks a colleague how much of the data supporting the company’s Indian drugs was fraudulent. The executive tells him the number is 100%. Thakur eventually shared his findings with the FDA, leading to Ranbaxy’s conviction.
Indian readers will note a disturbing fact here: despite the substantial evidence against Ranbaxy, FDA’s Indian counterpart, the Central Drugs Standard Control Organisation (CDSCO), never found problems with the company’s drugs in India. The glaring discrepancy between the FDA’s and CDSCO’s responses to quality problems is a recurring theme in the book. While Eban’s investigations paint both agencies as ill-equipped and under-funded, the FDA does redeem itself at times. Ranbaxy Laboratories did end up paying a record $500 million fine, thanks in part to the FDA’s efforts. Other companies with quality issues have also been under the American agency’s scanner: three of Wockhardt’s manufacturing plants are blocked from exporting drugs to the U.S., for instance. Further, in 2018-19, over 15 Indian companies received FDA import alerts, according to the regulator’s website.
Turning a blind eye
The CDSCO, on the other hand, never acted even against the biggest offenders, such as Ranbaxy and Hyderabad’s GVK Biosciences. In the latter’s case, the European Medicines Agency (EMA) found the company to be manipulating drug-quality data in 2015. Still, former CDSCO chief G.N. Singh tried to explain away the findings by alluding to conspiracies against the Indian industry.
For those inclined towards conspiracy theories, there’s plenty of grist for the mill. Earlier this year, several U.S. states sued 20 generic drug-makers, including Indian firms, for price collusion. American trade bodies, such as the medical-device association AdvaMed, have often expressed their displeasure with India’s intellectual-property regime and price-caps. Is the American industry’s simmering unhappiness driving the FDA’s tough stance against Indian manufacturers?
It’s a valid question, but one that is easily answered. A reader merely needs to ask whether Eban presents evidence for the claimed malpractices. The answer is yes. Ranbaxy’s misdeeds are a matter of public record today. Details of other companies that subsequently came under the FDA’s or EMA’s scanner, such as Wockhardt and GVK, are also verifiable.
Eban convincingly answers the question she set out to ask: was Ranbaxy an isolated case? The answer is no. While not every company flagged by foreign regulators is indulging in systematic fraud, it is obvious that quality slip-ups happen frequently enough to endanger patient safety. The only defence that consumers have is a strong drug regulator. Eban’s powerful book may force the USFDA to pull up its socks. But who will force the CDSCO to do its job? Indian consumers must start asking tough questions.
Bottle of Lies ; Katherine Eban, Juggernaut, ₹699.