Spurious Drugs Flooding Indian Market, Consumers Suffering Due To Data Fraud: Katherine Eban

Journalist Katherine Eban’s Bottle of Lies: The Inside Story of the Generic Drug Boom is seen as a damning indictment of the Indian pharma industry and the Indian regulators. It is the reason that many in the pharma industry in India try to dismiss the book as a crime thriller and sensationalist, an attempt to undermine the Indian Pharma industry.

In conversation with Outlook's Naseer Ganai, journalist and author Katherine Eban says her book exposes how spurious drugs are flooding the Indian market and how consumers are suffering because of the data fraud.

Excerpts:

Why did you decide to write a book on Indian pharma industry in the first place?

 Well, the book is really about the generic drug industry. It is not that I specifically went out to report on Indian companies. But I had got a tip in 2008 that patients in the US were complaining about their generic drugs. Once I started following that tip-off, I began to investigate what some of the issues were and I learned about Ranbaxy. And I learned about what was an ongoing investigation about Ranbaxy in the US. So I had a big article that came about Ranbaxy in 2013 in Fortune Magazine.

But after that came out, I still had a question about whether the practices at Ranbaxy were just isolated to that company or were these issues in other companies. So I really was at that point looking at the whole industry and that is what led me to look at some of these Indian companies more closely. Simply, because they are so dominant in this space.

And that is not to say that those are the only companies that commit fraud. The problem isn’t isolated to India. But my reporting exposed that the FDA had caught a number of big Indian companies committing data fraud. That is really the journey I wound up looking at Indian companies.

You got a tip-off in 2008 and wrote about in 2013. Your critics from pharma industry allege you are resurrecting an old issue in 2019, that according to them, has been resolved long ago and the company (Ranbaxy) no longer exists. How do you respond to that?

 Well, this is absolutely untrue. Because, for example, the FDA’s own investigators have found evidence of fraud at numerous different Indian companies. Very recently a company was hiding data in a scrapyard. It is not an old issue. It is an ongoing issue. It is a current issue. The FDA continues to find data fraud inside Indian companies. And while Ranbaxy is the dominant narrative thread in the book, it does go up until 2018. It examines the conduct of companies and the discoveries FDA has made until recently.

The book is also highly critical of global regulators. These companies are regulated largely on an honour system. So, by and large, the FDA is conducting pre-announced inspections. They are giving these plants time to clean up before the investigators arrive. And we know when they did an experiment to do an unannounced inspection: that was about a year and a half ago, in India, the rate of serious findings increased by almost 60 per cent. The book is not just criticising the companies, it is looking at the regulators as well.

Your critics accuse of projecting the US pharma industries as all good, spotless white; and targeting Indian companies, even though “they help the developed world” to have drugs at the cheap rates. What is your take on this?

First of all, the book never says the western companies are all good and Indian companies and Indian drugs are all bad. At no place in the book do I mention that. So, for example, the book talks about data fraud at a company that was purchased by a German company. It talks about data fraud at a company in China that tied up with Pfizer. So the book doesn’t make those claims. My critics happen to make those claims but they happen not to be true.

How do you respond to critics who say your book is more of a biographical sketch of Danish Thakur, the whistleblower in Ranbaxy case, rather than inside story of Indian pharma industry?

Danish Thakur is the central character in the book. But the book also tells the evolution of the generic drug industry in India. I have several chapters on Yousuf Hamid and Cipla’s role in the growth of the generic drug industry in the West. And a groundbreaking collaboration in using US taxpayer dollars to pay Indian companies to make drugs for Africa. It tells that whole story. It tells the story of the FDA investigator Peter Baker, who went into all these plants. Not just Ranbaxy. And over the course of four years of investigation, he in India and China inspected 86 plants. He found fraud in four-fifth of them. And it describes his journey. I suspect most of overt criticism is coming from people who haven’t read the book. I think Managing Director of one of the companies in an interview had said, “I haven’t read the book but I know enough about it to say it is biased and one-sided." If you are accusing someone of bias or one-sided, it is usually good to have read what you are criticising.

I think part of the problem is that the Indian drug industry has grown up in an environment where there are not vigilant Indian regulators on the ground. I am yet to meet someone, who says that the Indian regulatory system is working well. No one really says that. So the problem is these companies are not being challenged by their own regulator. They are being protected by their regulators. So that leaves them to deal with the US regulators and the European regulators. And the mindset is “let us figure out how to trick them” as opposed to “let us figure out how to comply with these regulations.” I think that is part of the problem.

Your critics say the allegations of data fraud might be true about smaller companies. What do you think?

The FDA has found data fraud in big companies, Dr Reddy’s, Aurobindo Pharma, Wockhardt, Ranbaxy. I can name more and more. There are findings at the big companies. They have found real integrity issues. They can make that claim if they want. But I have read thousands of pages of the FDA inspection reports and their findings relate to the big companies as well as small ones.

During your own investigation while writing the book, what was the most shocking thing that you came across?

The level of fraud! There were many companies that were even faking microbial testing data. The microbial testing is that you are testing air, water, the surfaces for contamination. And that is telling you whether you are running a sterile plant or not and some of these plants are running sterile injectable drugs. It is a very serious situation if you are faking data. One lawyer for a generic drug company told me, 'If you are at a point where you are faking hundreds and thousands of data points, you could fake anything.'

Did you observe any difference in attitude among the regulators in India since your book has come out?

One thing I have been told by people who have dealt with the Indian government and the Chinese government is: there is a lot of data fraud in China. But one thing I have been told is that there is more interest among Chinese regulators to root out corruption, change or fix the system. For example, the FDA conducts a workshop in India to talk about best practices in data. It is hard to get the Indian regulator to show up in those workshops. While as in China, all regulators turn up. My sources tell me that they see a little interest in changing or fixing the system among Indian regulators.

Many in the Indian pharma industry accuse you of writing a crime thriller, that too a sensational one?

(Laughs). The book is all true. Everything in the book is corroborated, down to the smallest details. There is nothing these critics can point out that the book is false. The book has 40 pages of endnotes to show wherefrom much of my information came from. So, if the book seems sensational, it is because the facts in it are sensational. If everyone was following rules, I would have a very boring book to write, I suppose. In all of the criticism, no one points what wrong I did and where. Because there is nothing factually inaccurate in the book. They don’t like reflection it creates.