FDA has learnt from the Ranbaxy Case: Dinesh S. Thakur

Chaitanya Kalbag and E. Kumar Sharma         Print Edition: June 23, 2013

On May 13, the US Department of Justice and Ranbaxy Laboratories announced that the company had pleaded guilty and agreed to pay $500 million to resolve false claims allegations, manufacturing violations and false statements to the Food and Drug Administration (FDA) in the US. The case reached this conclusion thanks to the whistleblower policy of the United States. Dinesh S. Thakur, who between 2003 and 2005 was the director and global head, research information and portfolio management at Ranbaxy, was the whistleblower. The soft spoken professional, who has held senior positions at Bristol-Myers Squibb and Infosys, took time out and spoke over the phone from the US with Chaitanya Kalbag and E. Kumar Sharma. Edited excerpts:
 
Q. Given your experience of the substandard drug from Ranbaxy that you had once used for your son, do you believe that Ranbaxy's drugs have in any way caused harm to patients?
A.
You are asking me to conclusively answer something that I don't have data for. The FDA, when they invoked the Integrity Policy in 2008, said they did not have data to say that the drugs are not safe. That in this country (the US) where there are reporting mechanisms for patients to call in and report any harm. In countries like India, South Africa and Brazil where systems are not as robust as they are in this country, it is difficult to collect all that data. So, one cannot conclusively say that there was any direct harm with the quality of medication that Ranbaxy dispensed.
 
Q. How on earth a respected regulator like the FDA seemed to have almost willingly allowed itself to be misled for years. The second part of the question is about their inspection procedures where advance notice is given. Don't you think there was something wrong in the way the regulatory regime of the world's biggest drug market functions?
A.
It is changing. If you look at the last six to eight years, the FDA has fundamentally changed in response to drug supply becoming global. Ten years ago, we still had a significant number of drugs manufactured locally. Over the last 10 years, internationally, companies have filed marketing authorisations and the FDA has responded by a new Safety Innovation Act, which was passed by Congress last year. It empowers the FDA to have additional resources to inspect foreign manufacturing facilities to bring them in line with US facilities. They have offices now in India and China. They have two in India right now -- one in Mumbai and one in Delhi. So, clearly, the FDA is responding to what has happened and has learnt from this particular case. Having said that, clearly this was a case that demonstrated that the FDA needs to pay attention to foreign manufacturers that are outside of the country and look at the quality and the procedures they follow.
 
Q. Will this entire episode damage the reputation of all Indian drug manufacturers in markets like the US? Will there be widespread suspicion on products coming out of India?
A
. I don't think so. I think this was one particular company which was bent upon wrongdoing and it was held accountable for it. I don't think there is any data to paint this with a broad brush to say that there are other companies located in India or anywhere else that are taking the same kind of shortcuts and have data integrity issues that Ranbaxy had.
 
Q. The Indian authorities are now saying that they will be checking Ranbaxy's antecedents in India. There is obviously a question mark over the efficacy of the Indian drug regulation and you must have had time to look at this in some detail. Do you think there is a very big problem in the way India regulates its own drugs?
A.
I read the same news which you did which is that the Indian drug regulator is now asking for documentation on Ranbaxy to find out whether there was wrongdoing according to Indian law. They have just began to look at it and it is really too early to comment on what they will find and will need to wait for the investigation to get complete.
 
Q. What about the concerns over the ease of availability of medicines in India? For instance, it is possible at times to get drugs even without proper prescription. The Ranbaxy case, therefore, might just be a sign of the problem that really needs fixing in India. Do you agree?
A.
I think, generally, if you are talking as a conceptual point I would agree with you. But what I have learnt in these last nine years working with the FDA, which obviously has a much stronger regulatory framework and enforcement guidelines, I think there is certainly need for discussion on this topic in India precisely for the reasons that you have pointed out.
 
Q. Back again on Ranbaxy, it sounds like the previous owners of the company have got away and none of them has been held accountable for what is happening and Daiichi was more or less sold a lemon and it is embarrassed to admit it. It seems like a conspiracy of silence because neither side wants to really own up. What is your take on that?
A
. It is difficult for me to comment on that. I left in 2005 and I have no visibility on what happened after 2005. All I can tell you is that when I got up this morning I saw a news article where Daiichi is saying that it is going to look into this matter.
 
Q. You came in from a company like Bristol-Myers Squibb. How would you compare the culture of the two companies?
A.
I think it is not just about Bristol-Myers Squibb. I went to school here in this country and my first job was in the United States. I have worked here for 10 years. The difference that I found was that the Indian organisations are lot more hierarchical and the general norm is that your manager knows what is right and you essentially follow that line of thinking. That was the biggest learning for me. To move from a US organisation to an Indian organisation because here (in the US) it is more about what you know than who you are.
 
Q. So, when you first blew the whistle at Ranbaxy what was the initial response?
A.
I was asked to investigate the discrepancy in data the company had and what it had filed with the regulator. I kept my manager Mr (Rajinder) Kumar apprised of what I was finding. He took it upon himself to go and talk to the board and tell them that if they gave him the authority he will fix it. Unfortunately, that did not happen and as an ethical person and somebody that I look up to, he left. After he left, I tried to essentially bring this investigation to a conclusion but my tenure was also made untenable by the company, so I left. It was not a pleasant experience clearly finding out that the company you work for was making medicines that could make people potentially sick.
 
Q. What was the reaction from your peers?
A
. It has been eight years now and I was not allowed to take with me my notes that I had collected in my interviews with several functional heads and as you can imagine this was nine years ago and we were trying to in a short period time -- of about six months -- trying to get to the bottom of hundreds of drugs and essentially the entire portfolio globally to try and figure out where the gaps were. So, it is hard for me to go back and recount how it actually happened. The thing I can tell you was that this was not a hidden secret.
 
Q. Do you think this is happening in other Indian drug companies too?
A
. I have no way of knowing that. I only worked for one Indian pharma company and that was enough for me.
 
Q. When the sale to Daiichi began Malvinder Singh was quoted saying that Daiichi did due diligence. But by then the FDA had already issued letters of warning to Ranbaxy. Did Daiichi contact you at all and ask you what was going on?
A
. No. Daiichi has never contacted me.
 
Q. What do you plan to do with your story? Want to write about it?
A.
I have a blog and from whatever I have learnt I hope to generate a discussion in the pharma community through the blog. I am hoping  it will be of value and I look forward to working with those from the pharma community, if there is an opportunity to help them think through these things, help understand how the process works or how the legal system works. I have an opportunity to educate and tell what really happened.
 
Q. What do you plan to do with the money (the $48.6 million that he gets as the whistleblower in this case)?
A.
Money was never a driver in this. It was always to do with the safety of the patients. I have not yet had an opportunity to think about it. I will do so in due course of time.

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