In March 2013, US Food and Drug Administration investigator Peter Baker made a startling discovery in a large Indian pharmaceutical company’s manufacturing plant. Following an intense, movie-like chase of a spooked employee carrying a suspicious garbage bag, Baker realised what the company had been trying to hide: roughly 75 manufacturing records for the company’s insulin products, hastily torn in half.
“They revealed that many of the vials contained black particles, potentially deadly contaminants, and had failed visual inspection,” writes investigative journalist Katherine Eban about the incident in her latest book, Bottle of Lies.
The company had tried to willingly hide this information to avoid a costly internal investigation, according to her. Alarmingly, the drugs flagged in the records had been released to patients in India and the Middle East, she writes.
Bottle of Lies has now been made available in India this week, but it already caused a stir in India’s pharmaceuticals industry since its US launch in May. The book encompasses Eban’s decade-long deep dive into the dubious data practices of certain Indian drug makers exporting medicines to the US and goes behind the scenes of some of the major scandals unearthed in the generic drugs industry here.
Eban carves out the culture of fraud and obscurity governing these companies, caught either forging and fudging data, or even haphazardly disposing evidence that would stop them from marketing their products in the US. Her anecdotes also don’t scrimp on the dirty details of how some of these companies, including India’s once largest drug maker Ranbaxy (years before it was sold to Sun Pharmaceuticals), viewed patients.
A sizeable portion of Eban’s book focuses on Ranbaxy, which “took its greatest liberties in markets where regulation was weakest and the risk of discovery was the lowest.”
This attitude is reflected in another incident — when issues of quality of an AIDS medicine supplied to Africa were raised in a conference call, Eban writes that one of Ranbaxy’s top medical executives responded with, “Who cares? It’s just blacks dying.” Through such anecdotes, Eban raises several questions about the quality of medicines that are made for patients in developing markets.
“If they were playing hard and fast with the world’s so-called best regulatory system, where they have got a lot of market, then what does it say about how companies have been operating for the Indian market?” asks S Srinivasan of patient activist group All India Drug Action Network (AIDAN).
Eban says she has focussed on manufacturing plants exploiting a “lax regulatory environment in order to skirt regulations and requirements entirely.”
In Ranbaxy’s case, regional representatives just “invented” the data they submitted to India’s Drug Controller General of India (DCGI), she tells The Indian Express.
“Most people assume that a pill is a pill, made identically for every market and region in the world. But my reporting has exposed that generic drug companies routinely make drugs of differing quality, depending on the vigilance of regulators in the markets to which they’re exporting,” says Eban. “They often make their worst drugs — with the lowest-quality ingredients and the most manufacturing shortcuts — for the least regulated markets, including India,” she adds. “Because we have a two-tier system of quality in our country, those manufacturing facilities that cater to what are called ‘export’ markets have seen all the investment and improvements because foreign regulators have demanded these. Sadly, our own drug supply in India has gotten worse,” claims Ranbaxy whistleblower Dinesh Thakur, whose struggles have also been highlighted in Eban’s latest work.
Since the US launch of the book, Indian pharma lobby groups and export associations have either called Eban’s exposé “fictitious” or have claimed the situation described in her book is far in the past.
Sudarshan Jain of the Indian Pharmaceutical Alliance (IPA), which represents several large Indian pharma companies, says IPA members are committed to “global standards of quality” and that the information in this book is “dated”. Ranjt Barshikar, a quality expert consultant to the United Nations, says data integrity and documentation was a larger issue a decade ago.
“Since then, the US FDA has changed their way of audition, including surprise inspections, which has made a big difference. Quality is getting due importance,” he says.
However, Eban argues that these practices are prevalent even today. Since 2016, the US FDA has flagged data integrity violations in at least 170 Indian drug plants, according to inspection data she has reviewed. “Between that and ongoing tips, I have received from whistleblowers at Indian companies, that tells me the practices continue today,” she says. Investigators are still turning up examples of “willful data manipulation”, Eban adds.
What does this mean for patients relying on affordable generics here?
Eban suggests, “Between preannounced or inadequate inspections and ongoing data-integrity violations, patients need to remain vigilant. They must ask themselves, is their medicine working? And if not, why not?”