The past few years have been rough of Indian pharma companies, what with the US FDA raking them over the coals over alleged manufacturing lapses and discrepancies.
The one person who can be credited with for being the first to bring into focus poor manufacturing practices is Dinesh Thakur, a former Ranbaxy executive who turned whistleblower against his employer and led to the company's imports being barred by the US FDA.
In an interview with CNBC-TV18, Thakur sat down to discuss the current state of the Indian pharma industry and explained why companies still had a long way to go before their manufacturing standards in India could be considered satisfactory.
Below is the transcript of Dinesh Thakur’s interview with Shereen Bhan on CNBC-TV18.
Q: I am going to play devil’s advocate here, so let me start by asking you the question that was posed to you by Justice Thakur and the Supreme Court when you filed that petition. They asked you, “An overseas citizen has come all the way to challenge your rule, what is your locus?” Why are you bothered? Why do you care? The criticism is that perhaps, you are trying to paint an alarmist situation.
A: I think that we as a country, we have been complacent for way too long. If you want to call me an alarmist, I will wear that as a badge of honour. For the last 50 odd years, we have accepted the fact that this is how the way things are. And especially in the last two and a half years since the Ranbaxy case broke, there have been a significant number of improvements in the way our medicines are manufactured. But unfortunately, those improvements are targeted primarily to the export market.
Q: So, you are saying that the domestic market is not reaping the benefits of the stringent regulations that perhaps, the Indian manufacturers are now following as far as exporting drugs are concerned?
A: The question actually is in making two implicit assumptions. You said stringent regulation and the benefits of what has actually happened for the export quality medicines. This is precisely the reason why we went to the Supreme Court, because if you look at our regulators, if you look at they have been able to do, other than making statements around, we will prosecute people who are doing this, there have been 44 manufacturing facilities in Indian that have been joined from exporting to the United States. How many of those actually are prohibited from making product for the Indian market, and why is that?
And so, what had happened was, after the Ranbaxy case broke and this became a topic in public conversation, there are a lot of different points of view that came out. The industry obviously had its point. If you think this was a one-off case, there were well meaning, well intentioned public health activists that said the western pharmaceutical companies are out to make Indian generic Indian industry look bad. And the conversations in public view saying that we have this regulation in place where people are sent to jail for making sub-standard drugs on television programmes like with your channel and other channels as well.
And the point was at that point I started asking myself, is that really true because I worked in the industry for 18 months or so in Ranbaxy and my recollection, my experience was that was far from the truth. But the point is that at that point, if I said something, it was my opinion against the opinion of somebody else in the industry unless I had data to substantiate.
Q: So, let us talk about the data. I do not have access to the kind of data that you have, because you have been working on this, as you said for the past two years or so. But if I were to look at what is publically available and this is the Central Drugs Standard Control Organization (CDSCO) survey of 2009. The percentage of spurious drugs in the Indian market is wayward between 0.3 percent into 2003-2004 to 0.17 percent in 2007-2008. The percentage of sub-standard drugs or what is called Not of Standard Quality (NSQ) has been on the higher side – as high as 7.5 percent in 2004-+2005 before falling to about 6.3 percent in 2007-2008. What are the numbers that you have? Does this give us a sense really of the problem or is the problem far worse?
A: Again, the issue here is that you have to trust some numbers. I know that there have been studies for example, conducted by foreign officers that have found higher percentage of NSQ drugs. But the point here is that the conversation gets hijacked if you start quoting those numbers. I am going to go by what CDSCO’s numbers are. The report that was submitted to the Lok Sabha in 2009-2010 or 2010-2011 talks about 7 percent or 6.5 percent of NSQ drugs. That is the reality of what CDSCO wants to project.
Q: So, you are saying that is not the reality?
A: No, because here is the issue. Through the Right to Information (RTI) process we have asked what basis, what is the statistical model on which you have sampled these drugs? In order to get an accurate representation of the reality of the quality of drugs in this country, we have to know, are we only sampling a certain kind of drugs, do we get a representative sample, are we sampling only from cities and not the towns and rural villages that we are doing?
It is specifically to address this issue, we asked CDSCO and 36 state regulators, we have asked them can you please tell us how is it that you establish quality? One of the questions that come up quite often is that why is it foreign regulators find problems with our manufacturing facilities and our regulators do not. And the issue here is not that we do not know how to look for it, our law does not actually look at it that way. We look at quality in the final product. If you look at the drugs and cosmetics act... (Interrupted)
Q: Not in the manufacturing process itself?
A: Exactly. So, our people are not trained to look at that so we do not look at it.
Q: Which is different from what the FDA, etc. do.
A: And the fact is that science has evolved to a point where it is not as simple as punching tablets with active pharmaceutical ingredient (API) to make a drug. Look at the number of fixed dose combinations we have in this country. Forget about fixed dose combination, extended release medicines, parenteral drugs, injectibles that we make right now, they require a certain amount of process and science that goes into the process. If you only look at the final product, it may actually be that that final product may comply with you standards at a point in time.
But, we know that every product that we buy has a date of stability on it. It tells you when it expires. Do we really know what that date is based on because there are many states in this country today that give out manufacturing licences without requiring you to tell the regulator how long your product is stable for. How do you believe in that?
Q: Let us get back to the data issues because there are several issues and this is a complex matter. So, let us break this down for our viewers. You are saying that we focus on the product, not necessarily the manufacturing process which is different from what the global regulators are monitoring of assessing at this point in time. But go back to the data that you have been able to get by way of the RTI process to tell us how different is the picture from the numbers that I just read out as per the CDSCO’s own finding.
A: What we have done is that we have actually looked at states because this is where the regulations are actually enforced, individual states and state drug regulators. We have looked at their own records. We have asked them how do you do sampling. How many samples do you collect? Where do you send these samples to get analysis done? What kind of results do you get? And if you get an NSQ, if the central drug lab in Kolkata or in Lucknow actually tells you that this is an NSQ, what do you do with it? How do you take that forward? How do you conduct investigations? How do you prosecute?
Q: What are the answers?
A: The answers are completely varied between one state and another. The southern states actually do a reasonably good job – Tamil Nadu and Karnataka. But the fact is that we do not have consistency, and even when inspectors want to do the right thing, the people who are actually found guilty are not prosecuted according to the fullest extent of the law. So, the numbers that the CDSCO’s reports is and has been reporting are significant under-reported based on the data that central drug labs actually provided to us.
Q: So let me then ask you is this the problem of the regulation or the problem of the regulator, we just discussed the multiplicity of regulators and clearly that seems to be an area of concern, but do you believe that the bottom line is that in law, we are not adequately protecting consumers?
A: I still think you can’t separate these two things out. The regulators and the regulatory system is a consequence of the regulation. If the regulation that was actually written and before we became independent in 1940s when states didn’t exist, provinces were there, that regulation hasn’t kept pace.
Q: You are talking about Drugs and Cosmetics Act?
A: Absolutely, so in India we say if a new chemical or a biological drug that’s not present to the market, if that ever comes in that was classified as a new drug and that status exists for four years, that has to be approved by Central Drug Regulatory (CDSCO), after four years it becomes a remit of the state regulators and there is no requirements today in our law for any state drug regulator to ask the manufacturer, can you prove to us that what you are making actually is therapeutic. We give out manufacturing licences without requiring any of these manufacturers today to prove that these drugs are bioequivalent.
Drug consultant committee has debated this point and they basically said, “look because of infrastructural issues, we don’t want to mandate our manufacturers to do that”. I don’t understand this, on one hand we say we are a clinical research country, we do some many bio-studies, when we can do bio-studies for export, why can’t we do bio-studies for our internal consumption as well. Why are the two different standards? I mean our lives any less meaningful in India compare to the west.
Q: So the issue of whether a drug is therapeutic or not is now being debated on the back of the recommendation that have come in, dealing with this whole business of fixed dose combinations and of course that continues to be controversial, but you are saying the process of approval itself is flawed?
A: Yes, because our drug regulation doesn’t require the regulators to actually ask the manufacturer who applies for licence to manufacture a drug, prove to us that the product that you are making actually is therapeutic, so unless you change the law, unless you change the regulation itself and tell that the regulators that’s a part of your approval process you need to demand.
Q: So the conversation that you and I are having on the issues that needs to be addressed, this is not a new conversation because I understand that the conversation that has been had by the standing committee which has tabled its report, the 59 Standing Committee, in fact the Katoch Committee had also suggested and recommended that there be changes as far as the regulatory mechanism and regulatory structure is concerned, so this is the matter that has been debated and discussed by Parliamentary Standing Committees. What’s been the response, you I know been trying to reach out to this government, previous government as well. Has there been any action taken?
A: As you also said, this is a complex issue. This is not an issue of call drop where you drive from Gurgaon to here you try to be on the phone call drops 5 times. As a common person I know when my phones go dead, but as a common lay person it’s very hard for me to figure out that the medicine that I take, that’s been given to me is working or not.
Specifically, if you are prescribed medicine for chronic stuff, if you have fever, fever doesn’t go down you go back to the doctor and say, “mera fever kam nahi ho raha hai”. How many times does it happened to you or the people that you know the doctor here say, “dawai aapko suit nahi karti, apki dawai badal denge”, have you ever ask the doctor, “what do you mean by dawai suit nahi karti hai”, is the same chemical right, why are they changing medicines, why are they changing manufacturers and giving you the same medicine from a different manufacturer.
Q: But you can’t naturally conclude that is because it’s substandard?
A: I am not, I am not, I am not. All I am saying is that this is complex issue. In order to create awareness around this, it is going to take dialogue of this nature where we get this is public discussion, right. Call drops are much easier your phone goes dead, you understand the call is got disconnected. The medicine that you have been taken, that you have been given to control your hypertension for life, if that doesn’t work, there is nothing like a switch in our body that just flips up and says okay this medicine is not working. The long term effect for us a country are humungous, if you are not paying attention to this.
Q: I was asking about recommendations that have been made by various committees and you have also been trig to elicit answers and responses on what has finally happened on the ground. As far as those recommendations are concerned, what has changed in terms of the action taken?
A: I do not know what has changed. All I am trying to do is to educate the members of the parliamentary health committee that this is an issue. Clearly, their predecessors, the 59th parliamentary committee and standing committee on health has put out a scathing report on the way that we currently work. There was an action taken report where the Ministry of Health went back and said this is what we have done. If you look at it, how much of that actually got implemented? The point here is that it has be a political will.
And political will only comes in when there is awareness among people who vote. If people begin to start asking why am I being given medicine that does not work, the elected representatives will start thinking about this ask these questions of the ministry, of the CDSCO, of the regulators of this country. There is Comptroller and Auditor General of India (CAG) report that the armed forces procurement says that one in five medicines that we procure is sub-standard.
Now tell me this. People who fight for this country, our armed forces are being given sub-standard drugs, one in five, where is the public discussion on this? Why do we not talk about this?
Q: I am glad that you mentioned the CAG report because I have got that data as well. The average rate of rejection during the three year period between 2008-2009 to 2010-2011 was about 24 percent as per the CAG report.
A: What does it tell you?
Q: So let us now talk about the way ahead and the way forward. From a legal perspective and from the law, we have talked about some of the changes that need to be addressed. But from a regulatory mechanism perspective and complexity of dealing with multiple regulators is not some of what we are talking about getting lost in translation because of that structure?
A: It is. I am not disputing what you are saying at all. But the thing is we have to make a start some place. You have started the interview by asking me, am I being an alarmist or activist. I think the time has come for us to put aside complacency and be a little alarmist about this. Let this pendulum swing the other way a little bit. Let us have some discussion around it. It may be that there are parts of the current structure, the part of the current regulation is working properly. I have given you examples, Tamil Nadu and Kerala, I think the inspectors are doing what they ought to be doing.
But think about this. How many manufacturers and facilities are in Tamil Nadu? They are all in Uttarakhand. They are all in Himachal Pradesh.
Q: Because of the tax benefit.
A: Exactly. So, the point here is that even if an inspector in Tamil Nadu finds an NSQ drug, there is very little that inspector can actually do in Uttarakhand or in Himachal Pradesh.
Q: But what about the quality of the regulators? And how different is it from the way the regulators are staffed globally and the way regulators are staffed in India?
A: Quality of regulators falls in line with the regulation itself. I will give you a simple example. The head of public health, the person responsible for public health in this country, the drug controller of India, our regulation says that that person does not need to have a public health background. That law says that the person has to be a graduate of pharmacy or related science. Is public health not important? You are asking me are they qualified enough.
You will find qualified people if the regulation asks you for qualifications. Our regulation asks for pharmacy and so we have a pharmacist or people for sciences. Look at the regulations globally. Peggy Hamburg is a Master of Public Health (MPH) and I cannot believe that there are not people in this country who do not have public health background. I just cannot believe that.
Everything follows from the law, from the regulations. We change the regulations, change the law, these things will fall in place. We will find people who have the right background. We went and hired Raghuram Rajan from the University of Chicago. For a billion and a quarter people, you think we cannot put a qualified competent person responsible for public health in this country?
Why is there such a difference here? Because, money is obviously something that hurts. Somebody takes money away from your provident fund or your stock market, you feel it. Medicine, as an individual, as a patient today, I have very little control. The doctor prescribes it, I take it, maybe I feel better, maybe I do not. I do not find out six months down the line that my medicine is not working.
Q: A provision for recall, would that be one of the key priority?
A: They are not to be. If we had a provision for recall, why would the government banned drugs, we don’t have a provision for recall in our drug regulation, that’s the reason why we have to go and ban drugs. Look medicines when they get tested, before they come to the market, they are usually tested on a small subset of people in a clinical study. When the medicine gets to the patient population you will see things, this is normal.
There is a drug called Vioxx, this is back in 2003, it got to the market and we have to put it back because we saw things that we didn’t see in the clinical study. The regulations have to provide, the framework for this thing to happen. In India, we do not have a national regulatory system where we can actually effectively recall drugs from everywhere.
The inspector in Kerala fines a non-standard drug the least that they can do is report back to the CDSCO and put on their website. There is no enforcement behind law to account for all the SKUs and packs that are available in the country. We need to have that kind of system in place and look this is nothing that I am saying here has not been thought about. The expert committees have thought about all these things and made very sound recommendations.
Q: But the recommendations have not been fallen through?
A: It needs political will to implement those recommendations. Let start there.
Q: You know speaking of the experience that you had and once again questions on why do you care, I mean you are not even in India. You done the Ranbaxy case, you made USD 45 million on account of that and there are questions on why should you care about what’s happening here in India and if there was a problem surely somebody would have noticed it. I come back to that because that’s the criticism that you are up against?
A: So I think that’s a valid criticism, I am not discounting any of what is being said, but my issue is as follows, right. I think what the Ranbaxy case did, it opened up a pandora's box, but the beneficiaries are primarily patient in western and established countries. Things have gotten worse for us, for Africans, for people who live in Latin America.
Now the question which you asked is why do I care, I care because my family lives here, my dad lives here, my mum lives here, they are 70 some years old and they go to the same pharmacy and biomedicines. I have friends who live here. It’s not possible for people to continue buying medicines from abroad and bring them back in here and the problem that I have is not like that we don’t know how to do things right.
We know how to do things right, but the problem with us is the moment somebody is not looking over your shoulder, we try to take shortcuts. That is what needs to be fixed and the only way to fix that is a force of law and force of enforcement.
Q: How easy is it been for you to actually to get access to the information that you have put together as part of your public interest litigation (PIL) that you submitted before?
A: It’s been difficult, look we have been working on it for two years right now. PILs are not the easiest thing to file because we studied every PIL that was filed and looked at the kind of data that was presented to the Court. RTI process is although the law is very good, implementation is still challenging. I can tell you with all the RTIs we filed with the CDSCO Central, they all were shunted off to the zonal offices and zonal offices have sent them back to the Centre.
You really will not get answers for the first time around, that’s the reason why it took us two long years to collect and collate all this information, but what I am doing right now is putting all this information in public. If somebody wants to take it and run with it, look you can argue with me, with my opinion, but you can’t argue with the data and what I am hoping is the industry moves away from me as an individual as a messenger and focuses on the data.
Q: Have you had any conversation with industry in this two year period. They don’t like you very much, but if you had any conversation with industry on the problem, on identifying the solution which we already know?
A: Look I have tried okay. I have reached out to the CEO of a very large company because I thought he had made some comments in public saying, I want to do the right thing, right. So I wrote to him and said look, if you genuinely feel that you can do the right thing, I will help you. I reached out to Dr JN Singh. He and I was on a panel at the World Public Health Congress in Kolkata in 2015.
Unfortunately he didn’t show up so I was hoping to actually talk to him at that time. YK Gupta, the AIIMS professor was there so he and I had a conversation because he is influential in policy making as well. I am trying, look I am trying and the reason I care is because somebody has to say something about this.
Q: You giving up on the legal route now given what happened at the Supreme Court?
A: I think that the legal route will probably become a reality once there is enough public awareness. I cannot believe that the Court would react in this way, if they had a better understanding of the problem. I don’t think the level of awareness exists among us at the moment. We need to be able to educate our people and if it becomes a topic of conversation in public consciousness perhaps the Court will look at things differently.
Q: So before I end this programme and for viewers who are watching and again because it’s a complex issue, what is the key message that you want to put out there to start this public discourse?
A: I just want people to start paying attention and ask questions that’s where it starts.
Q: What would you identify as being the big problem?
A: The problem is the quality of medicines because our first line in healthcare because of the lack of primary health centres in India medicines is essentially the first line of defence for us. I just want people to ask questions, if the doctor says the next time, “ye dawai aapko suit nahi karti, ya aapki dawai badal dete hai” ask the doctor, “kyun badal rahe ho doctor sahab ye”.
I mean, the person who earns Rs 300 a day in this country goes and buys medicines for Rs 30-50, goes back to the doctor 3-5 days later and says, doctor says, “badal de rahe hai dawai aapki” what about the money that he spent. Is that a charity towards pharma companies. What are the long term implications of that on overall healthcare. I just want people to ask questions. See grassroots change happens, when people starts to ask questions. Why is that the TRAI is paying so much attention to call drops, because we are all frustrated.
We ask this question, why does my phone go dead every 5 minutes in the car. When you do that TRAI ask questions. Similarly, SEBI ask questions when there is financial irregularities. People ask questions what is happening to my provident fund, why is the insurance company is doing this that and other. If people start asking questions, governments which are representative of people respond to those questions. All I want is people to ask questions.