‘Bottle of Lies’: Book on Generic Drugs ‘Exposes’ Indian Companies

The book spells new trouble for Indian companies who have for long relied on overseas market for their generic drugs

‘Bottle of Lies’ opens a can of worms for Indian drug companies. The new book by Katherine Eban, called an “invaluable exposé” by The New York Times, alleges severe cases of quality compromise by Indian big pharma exporting generic drugs to the United States (US).

Drug makers in India have relied on Americans to buy a big chunk of their produce for a long time now. Nearly 40 percent of US’ generic drugs come from India, states Evan. The book argues that these generic drugs are “poisoning” people.

She bases her book on a controversy that broke more than a decade ago, a can of worms opened by whistleblower Dinesh Thakur, who claimed that Indian drug major Ranbaxy was cutting corners and compromising on quality of drugs. That case has since been settled after Ranbaxy Laboratories Ltd pleaded guilty to felony charges related to drug safety and paid USD 500 million in civil and criminal fines in the US in 2013.

Friends, my book Bottle of Lies: The Inside Story of the Generic Drug Boom comes out today. When this journey began 10 yrs ago, I never thought it would lead me to expose egregious fraud in overseas generic drug plants we rely on. Looking back, here are a few key moments (thread)

— Katherine Eban (@KatherineEban) May 14, 2019

“But still, I wanted to know: was Ranbaxy an outlier – or tip of iceberg? A new source contacted me, just as the book project began,” writes Evan in a Twitter thread about her book that has since gone viral.

11) But still, I wanted to know: was Ranbaxy an outlier – or tip of iceberg? A new source contacted me, just as the book project began. pic.twitter.com/45b6OM8PEj

— Katherine Eban (@KatherineEban) May 14, 2019

The book implicates other companies in India manufacturing these generic drugs.

“As it turned out, Ranbaxy was tip of the iceberg. With the help of multiple corporate whistleblowers, 20,000 internal FDA documents, and reporting on four continents, I learned that a culture of fraud permeated the industry.”

Katherine Eban on Twitter

16) Companies were using hidden laboratories, secretly repeated tests and altered results, and submitting fake quality data to regulators to gain market approval. Here’s one such hidden lab in a drug plant in Mohali, the door blocked by a bulky appliance: pic.twitter.com/LduairrrZA

— Katherine Eban (@KatherineEban) May 14, 2019

19) .@US_FDA investigators have found bird/insect infestations, toilets w/ no drainage piping (urine on floor), lizards. At one FDA-regulated drug plant in India, inspectors found this fella, perched above a computer monitor. pic.twitter.com/WXtcveAAfE

— Katherine Eban (@KatherineEban) May 14, 2019

“US patients end up getting drugs made with dubious data,” claims Eban on the basis of her 10-year-long investigation.

13) Around 5 yrs before taking top @US_FDA job, @ScottGottliebMD recounted to me the struggle to secure quality of @PEPFAR drugs for Africa: pic.twitter.com/sqDVs0pPpH

— Katherine Eban (@KatherineEban) May 14, 2019

Apart from quality issues, Indian companies are facing lawsuits for high drug prices. Seven Indian companies – Sun Pharma, Dr Reddy’s Laboratories, Glenmark Pharma, Lupin, Wockhardt, Zydus Pharma and Aurobindo Pharma – have been dragged to court in over 40 American states for driving up drug prices, according to a Business Insider article.

The book could spell new trouble for Indian companies who have for long relied on overseas market for their generic drugs.