Investigative journalist and author Katherine Eban’s book, Bottle of Lies is an alarming revelation of the dangerous, dark side of India’s pharmaceutical companies. It shines new light on the mysterious global generic drug manufacturing business.

Investigative journalist and author Katherine Eban’s book, Bottle of Lies is an alarming revelation of the dangerous, dark side of India’s pharmaceutical companies. Eban through her powerful style of writing has exposed the shocking truth of how cheap generics have become the web of deception – deception that may prove fatal to medical consumers at large.

As you delve into the book to dig down the finer details, you’ll come across a hard-hitting story that unravels the uglier side of the generic drug boom in India and China.

The gripping detective narration on pharma industry is a whistle-blower, Dinesh Thakur’s tale. The informer who worked at Ranbaxy India highlights how the demand for cheaper drugs owing to skyrocketing prices of prescribed medicines opened a dangerous chasm between what regulations were required of drug companies and how they chose to prefer profits over promises of quality. Through her viewpoint, the author forces her readers to take a step back and question long-held assumptions regarding cheaper generics.

Bottle of Lies will certainly force you to think that if substandard drugs are regularly shipped from plants in India and China to the developed countries like the US and Europe then how dangerously ineffective would be the drugs available to the developing markets and Indians back home?

Here are five key takeaways from Bottle of Lies:

Table of Contents

1. The monopoly of power:

Big pharmaceutical companies in India have their monopoly of power and greed. The book documents several instances of how big pharma companies such as Ranbaxy, Wockhardt, Mylan, the CRO Vimta Labs and GVK Biosciences—and to a smaller extent Zydus and Dr Reddy’s—used low-standard ingredients, manipulated quality control data and hid crucial details during FDA inspections.

The book starts with a bold narration of Indian generic drug company Wockhardt Limited inviting FDA officials to inspect its Aurangabad plant. The findings of FDA officials during the inspection lead them to a secret area in the plant, where medicines for the U.S. market were manufactured using defective equipment and machinery. So much so, that the drugs found in the area were found to contain visible contaminants that endangered patients and caused threat to their lives.

2. Coming of the Hatch-Waxman Act:

In response to the rising costs and influence of a few pharmaceutical giants on the US market, Congress, in 1984, unanimously passed the Hatch-Waxman Act. The act created a new regulatory track for generic drugs. As long as generic manufacturers could prove their drugs were bioequivalent to branded drugs, they could get approval. It was a boon for both generic drug makers and consumers, allowing the latter access to less expensive, but equivalent quality drugs.

3. Dishonest approach:

The FDA has stricter standards for pharmaceutical companies. If a company is exporting to any country, it needs to comply with that country’s regulatory requirements. However, going by the grim picture painted in the book, it suggests that the documentation done at manufacturing sites of some Indian pharmaceutical companies was totally cooked up. At one instance, when FDA investigators visited a Ranbaxy plant a day in advance, “In the lab, they were stunned to see a hive of activities. They found dozens of workers hunched over documents, backdating them in preparation for investigators’ anticipated arrival the following day,” writes Eban. At another account she narrates that pharma companies, instead of performing tests and chromatograms, copied them from that of the reference drug and recorded as having been done, exposing the greed that grips the players of this industry.

4. Growing scepticism towards some generics:

It was not late that people, beginning doctors, began to notice problems with generic drugs. Eban documents the growing scepticism towards some generics among doctors in the US and Africa. After numerous registered cases, where patients experienced problems as soon they swapped their branded drugs with generics, many medical professionals became apprehensive of prescribing them. In fact, by the end of the book, the author alarms her readers that generics, especially those made in India could be bad and, therefore, they must go for innovator company’s brands!

5. FDA’s struggle to address safety gaps:

Interspersed between detailed histories of the evolution of the FDA and the rise of Indian pharmaceutical companies like Ranbaxy and Cipla are the astounding scenes of factory workers fleeing from FDA inspectors with garbage bags full of manipulated documents, hurriedly cleaning workspaces and destroying contaminated drugs.

In the U.S., FDA inspectors can show up to a plant without any prior notice, but the globalisation of the pharmaceutical industry has complicated this practice. To minimise diplomatic tensions, the FDA notifies plants in advance of their visits, which give overseas companies ample time to prepare for inspections.

According to the book, Ranbaxy’s shady practices began in the early 2000s, but it took long for the FDA to learn about it and longer to take stern action. Eban mentions in her book that in response to Ranbaxy’s fraudulent practices, Dinesh Thakur resigned and, in 2005, contacted the FDA. However, it was not before 2013 when Ranbaxy’s U.S. subsidiary was finally pled guilty and fined on various accounts of falsifying data, selling adulterated drugs and lying to the FDA. This shows how ill-equipped the FDA was to regulate its overseas manufacturers.

Through her book, Katherine Eban has emphasised that the purpose of introducing generic drugs was to serve a vital role in public health, but it’s appalling to see how sub-standardised drugs are considered fit for export instead of being destroyed.

Written with fierce passion and substantiated with in-depth research, Bottle of Lies is a searing indictment of an industry that has spun out of control.