Gauri Kamath
By now, many in the drug industry will be familiar with Katherine Eban's expose of the manner in which some generic drug companies took short cuts to speed their drugs to market and to maximise profit at the cost of drug quality and patient safety. Eban devotes much of her book ‘Bottle of Lies: The Inside Story of the Generic Drug Boom’ to painstakingly detailing how Ranbaxy Laboratories, the erstwhile flag bearer of India's generic industry, systematically faked pharmaceutical data over several years to get important drugs speedily approved by the United States Food & Drug Administration.
Ranbaxy (now no longer in existence as a company), was the largest Indian drug company selling into in the US at one time. As the book details data integrity and other non-compliance issues uncovered at other Indian, Chinese and a few American plants in the not-too-distant past, it is bound to raise questions about the generics industry as a whole.
As the story unfolds, the dubious and outright fraudulent practices at Ranbaxy and a clutch of other Indian companies that are enumerated in the book put a different complexion on India's generic drug boom and its moniker of ‘pharmacy of the world’.
Fudging or making up data, destroying unfavourable test results and backdating documents seem to have been par for the course. Far from appearing like a saviour bringing much-needed affordable medicine to those in need of it, they begin to resemble a bunch of devious opportunists out to make a quick buck by hoodwinking under-resourced regulators and promising large savings to cash-strapped healthcare budgets.
Needless to say, Eban’s book has not gone down well with the proponents of Indian industry; it has been criticised by some including India's Pharmaceuticals Export Promotion Council.
Having read the book, I can say this: it's a thoroughly researched, fast-paced, riveting read and a timely, meaningful addition to the meagre collection of works that critically examine the global rise of India's drug industry from the early 2000s. The book does not dismiss the entire Indian generic industry as fake or fraudulent, not at all. In fact, Eban states that Indian companies lack neither the know-how nor the equipment to make quality, affordable generic drugs.
Rather, like other books on corporate fraud, this is a cautionary tale about how the relentless quest for high growth and profits at any and all costs can corrupt organisations in the absence of a strong, ethical core and sustained, rigorous, regulatory oversight. As, in this case, it concerns the pharmaceutical industry, the book is not just about corporate ethics but also about human safety and well-being.
If one has to see this account as a failure of organisations then it is as much a failure of the US FDA, viewed as the world's most stringent of drug regulators, as it is of Ranbaxy. Eban makes it clear that the inability (or unwillingness) of the US FDA to audit overseas factories as often and as rigorously as it did those in the US allowed data integrity issues in those factories to persist.
It is also a comment on the US healthcare system that, thanks to the runaway prices of innovative drugs, finds itself between a rock and a hard place; too many tough inspections and warning letters to generic companies could lead to shortages of affordable generic medicine to replace pricey originator products, it points out.
This is a book which makes several points that are pertinent to several different audiences. Lawmakers should read it to comprehend that under-resourced, under-trained, and under-staffed regulators armed with outdated laws are no match for ambitious, profit-hungry corporations and cannot, realistically, be expected to perform their job effectively.
Leaders of corporations should read it to understand, once again, that actions have consequences. Ranbaxy, once at the pinnacle of the Indian drug industry, paid $500 million in civil and criminal fines to the US FDA in 2013 and was sold off by its Japanese owner Daiichi Sankyo to one-time rival Sun Pharma. Daiichi, for its part, sued the original promoters of Ranbaxy, the Singhs, for, in effect, selling it a lemon.
For doctors, the message is that along with trusting regulators and companies, they might want to rely more heavily on their own observations, and listen harder to patients when they say that certain drugs aren’t working or yielding side-effects. Anyone who has ever taken a drug should read it because an informed consumer is a more alert, demanding one.
Finally, if anyone has to be galvanised into action by this book, it is the Indian drugs regulatory regime and those in charge of its stewardship. The book is a stark reminder of how vital it is that regulators do their jobs well, and stay immune to inducements. That ultimately, it is they and only they, who stand between a faulty product and the patient.
For several years now, expert committees, observers and the media have made recommendations on the beefing up of the Indian regulatory regime including the making of an updated law, and hiring more and better-trained inspectors. It is time to put these on the fast track.
Gauri Kamath, a former business journalist, is a pharmaceutical and healthcare content writer. Twitter: @Apothecurry. Views are personal.
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