[Music] Assuming that being alive is a good thing, we are all lucky to have been born in these times. As recently as 200 years ago, I'd have expected to be dead before 40. Leave alone reach the striped old age of 47. If I got a common cold or an allergy, I could just die of that. Forget about diseases like cancer because most people didn't live long enough to get it. In the 19th century, alternate medicine, which I'd call "crackery" thrived because mainstream medicine was a mess. The germ theory wasn't yet accepted by the profession and just going to a hospital could kill you even if disease didn't. Even basic hygiene was absent. One of my heroes, Mary Wallstroncraft, died after giving birth to her daughter, who we now remember as Mary Shelley, because her doctor hadn't washed his hands. She got a fatal infection. Well, times have changed. The medicine of today would seem like unbelievable magic to the primitives of just a hundred years ago. But it's not magic. It's science. Now here's the thing. We should still not be complacent. Our scientists might have understood our bodies and created magnificent medicines, but those medicines still have to reach us. Someone has to make them. You can create the finest of medicines in your labs, but how are they actually being manufactured in our factories? Is their jugar involved? Are people dying as a result? The answer, especially if you are in India, is yes. Welcome to the scene and the unseen. Our weekly podcast on economics, politics and behavioral science. Please welcome your host, Amit Varma. My guest today is Dinesh Thakur. Once a respected scientist in the healthcare industry and now a crusader on behalf of all of us, I first read about Dinesh in a brilliant book by Katharine Abaan called "Bottle of Lies", "Ranbhaxi and the Dark Side of Indian Pharma". Dinesh is one of the heroes of the book, which is about a great fraud committed by the company, Ranbhaxi, which no doubt took countless lives across the world. Now, some quick context. In the Pharma world, big companies spend huge amounts of money creating new drugs. When a new drug created by a company gets approved by regulators, they have the exclusive right to make it and sell it for a number of years. This allows them to recoup the expenses of research and development. Now, after this period expires, other companies can also make these medicines and these are now called generics. These generics are sold at a much lower cost than the original drug. And if you want to make something for a low cost, well India is a good place to start. The Indian Pharma industry's reputation got a big boost about a couple of decades ago when Sipla, driven by the visionary use of her meat, made cocktails of aides medicine for a dollar a day, which was a fraction of what it had cost until then. This was a big deal for the developing world, especially Africa, and probably save millions of lives. The remarkable thing about this was that the reduction in cost did not mean reduction in quality. Sipla's processes were outstanding and they helped get India the reputation of being the pharmacy of the world. Now, Indian companies rushed into make generics and one of the early giants was Ranbacksey. This is a part of the story where Dinesh comes in. He left a plus job in the USA to come work at Ranbacksey, excited by this new age of Indian Pharma. But he soon realized that Ranbacksey was a company driven by Jogar. While on the job, he found out that they routinely forged data to give to regulators. Most of their so-called medicines were never even tested. The nation's team found that over 50% of the data given by Ranbacksey to the FDA, the main regulator in the USA, was fake. 100% of the data for India was fake, all of it, and did to for the developing world. In fact, in an internal meeting, the subject came up that the medicine Ranbacksey sensed to Africa probably did not work. One Ranbacksey executive replied, "Who cares? It's just blackstiding. Stop, goad." When Dinesh realized what was happening, he resigned. And then he realized that he could not stay silent while millions of people were putting their faith in medicines that could kill them. So he complained to the FDA who began and enquiry into Ranbacksey. They filed a suit against Ranbacksey and Ranbacksey lost. They paid out a huge sum as a settlement and admitted that they were guilty of all that they had been accused. But this did not solve anything in India. The culture of Jagar continues in the Indian Pharma industry to this day. In his conversation with me, Dinesh describes in chilling detail not only his own experience at Ranbacksey, but also the state of Indian Pharma since. And why he continues to wage a crusade to reform the system. Now, I know I've spent a lot of time on this introduction giving this context, but I did it because this issue, more than any other issue I have discussed in the last five years, affects people's lives directly. It's not hyperbole to say that this is actually a matter of life and death. So please listen. But first, let's take a quick commercial break. Do you want to read more? I've put in a lot of work in recent years in building a reading habit. This means that I read more books, but I also read more long-form articles and I says, there's a world of knowledge available through the internet, but the problem we all face is, how do we navigate this knowledge? How do we know what to read? How do we put the right incentives in place? Well, I discovered one way. A couple of friends of mine run this awesome company called CTQ Compounds at CTQCompounds.com, which aims to help people uplevel themselves by reading more. A few months ago, I signed up for one of their programs called The Daily Reader. Every day for six months, they sent me a long-form article to read. The subjects covered when from machine learning to mythology to mental models and mommol it. This helped me build a habit of reading. At the end of every day, I understood the world a little better than I did before. So if you want to build your reading habit, head on over to CTQCompounds and check out their Daily Reader. New batches start every month. They also have a great program called Future Stack, which helps you stay up to date with ideas, skills, and mental models that will help you stay relevant in the future. Future Stack batches start every Saturday. Also, check out their social capital compound, which helps you master social media. What's more, you get a discount of a whopping 2500 rupees, 2500 if you use the discount code Unseen. So head on over to
[email protected] and use the code Unseen. Uplevel yourself. The next welcome to the scene in the Unseen. Thank you Ahmed. This has been a long-term coming. We've been corresponding almost for a little over a year now, almost a year and a half. And I'm finally glad to be in the same place as you to record this and talk about it. I was very fascinated by the book The Bottle of Life by Kathrinibar in which you play kind of leading role and also by the larger questions that it raises. Because one of the interesting things about our existence is that there are so many things we normalize. We take it for granted. We don't think about it. So we assume, for example, that there is a rule of law or we assume that the medicine that we take works or that the rupee that I want today will have the same value tomorrow and so on and so forth. We kind of survive on these foundations of trust, which at some points you can discover are a little shakier than one thought. But before we kind of get to the subject at hand, I want to speak a little bit about you. So tell me about your early life because someone who just heard of you in a cursory way may think of you as a crusader for a particular kind of cause or a civil activist of sorts. I mean, it's not just in healthcare, but civil rights also that you've been active. But you're also someone who is deeply into music, you're a Hindu sony classical musician who's been part of bands. So give me a sense of the young, Danish, how could you grow up, you go to school. So my family originally is from UP from Zafranagar, western UP. You know, the plays that's in the news for all the wrong reasons, but you know, that's where we are from. But with the last regeneration, we've been, you know, sort of living in, you know, the rest while on the foundation now telling, my great grandfather was a army man, you know, and then old Nizam's army. That's how we migrated there. And then ever since we've been living, you know, in that area, I grew up in a little town called Nizamabad, which is about I think about 170 kilometers north of Hyderabad. Because my grandparents had a place there, my dad essentially grew up there. He got a degree in law from the Nizam's college in Hyderabad, and he started practicing law. So that's where, you know, I grew up as a wooden Hyderabad. And then in the typical middle class family, you know, I started actually, my education started with a Hindi medium school because that was the closest school that was to be where we were left. It was a Marwadi school. I remember my grandfather sort of walking me to school and bring me back. But soon enough, you know, there was a convent school that was a little further down, you know, the road. And I think I was in second or third grade that, you know, I got into the Catholic school and that's where I graduated from. And then, you know, 11th and 12th was a local government college, just a God for second college. But anyway, went through that. But in those days, there's a state of Hyderabad used to administer what was called the common entrance examination. I think it was called EMCT or something like that, engineering and medical, you know, common entrance examination. So, you know, went through that. I think I was ranked like 3000 some odd. And, you know, by the time my turn came around, the only thing that was available at that time was chemical engineering. So, I talked to my dad and basically said, look, you know, why can't I do law because he was a lawyer. And he said, no, no, you're good math. You should actually become an engineer.
And that was only engineering available at that point in time given where I was. So I ended up sort of enrolling into an engineering college at Dosmani University. It's a really old university in Hyderabad, you know, irreparable. I mean, now I think it's very different, but in those days it was still stood for something, trained really good people. So those were four interesting years, you know, in, in, in Dosmani, then, you know, graduated and then, you know, it was interesting in those days. And one of the things that we all used to do was everybody graduated sort of, you know, applied to go to the United States. That was kind of a given at the point in time. So, you know, I ended up sort of applying to a bunch of schools. They had got accepted to the University in New Hampshire. They gave me a scholarship and ended up going to do it with that point in time. There's no way that I would have been able to fold it on my own without a scholarship. But that was just luck just worked out that way. And wound up in, in, in New Hampshire and then got my master's degree there and then that's how my, in a career essentially began. So I'll stay a little bit with the earlier years before you kind of end up there because what sort of interest me is, like one, you're just three or four years older than me. So we are almost the same sort of generation in a sense. I'm curious about growing up at that time, like you mentioned that chemical engineering was like the one thing left. So that's where you opt for that. So number one, what was your conception of yourself like? Like did you think in terms of I want to do this? I want to do that. What were your models? What were your heroes? Because I know so many of the influences back in those days used to come from like cinema, for example, Bollywood and our case and you know, maybe Telugu cinema in your case. I don't know. But so many of them came from cinema and also about the values that one takes like you have spoken elsewhere about how your grandmother reading the Ramayana and Ahmabharata to you had a deep influence. And I'm very interested in that because it seems that in that kind of environment where you're growing up in those 70s and 80s, there can be two kinds of influences on you when it comes to values. And one is what you see happening around you. And the other is from these kind of things that percolate down whether it's your grandmother teaching your Ahmabharata or the Amachitra Katha and so on. So tell me a little bit about that because these seem very contrary to me. One of the themes of your experiences in later times also is this sort of culture of you know, just doing whatever it takes to make money, just doing whatever it takes to get ahead and not having a sort of a deeper core there. So how did these two sort of play out when you were a kid? So you know, I think I mean look, I think that my childhood was no different than for example, I'm sure all of our childhood, right? You know, we all grew up with a larger family, a joint family where you live with your parents and grandparents. And in my case, both my grandparents had a disproportionate, a large impact on me. I think my grandfather passed away in 1970s. I was very, very young at that time. I mean, I have very few memories. But my grandma was still around. She passed away in the early 90s, but I have very fond memories of, but and think about like, you know, in the large Indian family is the matriarch, right? Grandma essentially is the one who essentially runs the house. I mean, she was a little petite lady, you know, she was like five odd, five feet odd, but you know, the will of an iron sort of strength and she was the one who essentially ran the house. This is a part of the story. I mean, that I don't think I've ever told anyone, even before. So I'm going to have to try and take you back, you know, couple of hundred years before, because life kind of, you know, in tangles, you in very different ways, right? If you know about the history of the Singh Brothers, right? The family that essentially they come from. Their maternal side of their family is very illustrious. You know, the Baba Charancing, who was the head of the Rajaswami Satsang in, you know, in base in Punjab, he essentially comes from a lineage of, you know, I mean, today's, when you think about gurus, right? You think about the, you know, the Jageebas, the Ashram, to me, those are not the kind of people that there are. I mean, there are people who essentially were mystics. And this gentleman, Charancing was one of those people who essentially came from that line. Now, for whatever reason, I think that that art that that skill is disappearing, we don't think about those things anymore. But there was a time when those people were alive, you know, they used to essentially practice Adana and they knew what they were doing, right? So if you trace the lineage of that Sufi tradition, all the way to Kusru and to Nizamuddin O'Leah and, you know, the way that that, that you world at that point in time, they were two branches of that. One was the, the Bia side, which is the Charancing side of it. The other branch was Agra side, which is where, you know, sort of the other branch of the teaching of Swamijim Haraj essentially came from that. The reason I'm saying this is because that lineage percolated down into my family. And, you know, I can't tell you whether it's an entity or what, that I had to get entangled with the people who essentially came down from the Charancing side. Because, you know, I've, as a child, I've seen, you know, what mystics can do. They were, I mean, my grandma was one of those. So it's, it's the tradition of, you know, hearing Rama and read to you. The tradition of hearing Mahabharata read to you. We had copies of Kabir Bijak, like four or five of them in the house, you know, that we ended up reading. That's why, you know, the episode that you did of Gita Press with the Akshya Mokulah Soda is an eating, you know, in the way that, you know, that entire sort of tradition about the printed word you all over the period of time. You know, so that was the environment I grew up in, where, you know, we had this notion of, you know, where you had a gathering, you know, certain date or time of the year or whatever to the year where you sat and listened essentially to Kabir Bijak being rendered back to you or Tulsi Ranshan to Manas being rendered back to you. And realize that these are written in, in Doha's, right? You don't know what that means as a child of five, six, seven years of age. But then your grandma is explaining to you what that really means, right? Providing you the context of, you know, what is specific though actually really means if you read Tulsi Ranshan to Manas, you know, it, you know, it is such a beautiful poetry. But then, you know, as a child, you don't know how to comprehend that. You listen to Kabir, you know, writing about, I mean, he says this is Nirguni, right? I mean, completely different kind of thinking in terms of how Kabir imagines the, the Almighty to be, right? And the way he describes the world around him, it's very hard for a person to reconcile those two things, right? When, when in one poem, you're trying to, to imagine God in the form of a person incarnate. In the other side, you're essentially saying this in Nirguni, there's no good, right? Kabir talked completely about a Nirguni Bhagavan, right? I mean, he says, okay, this is where you need to go. This is where you came from this way. So those are the kind of early influences trying to reconcile those dichotomies in life and figuring out those have stayed with me for a long period of time. I don't know if that's good or bad, but you know, it is what this is. Yeah. And in general, when you sort of look at current times and from what you're saying and then strikes me that we can, that there's a different kind of corruption at play here, a different kind of evolution where you have these religious and spiritual traditions, which come down over a period of time, which have popular resonance, as in Kabir Zohas and all of that. And yet over the last few decades, perhaps this political impetus to take it in a particular direction, almost as if eeping the West in terms of there, the religions are religions of the book. There is that one book. So a similar thing where you try to homogenize and understanding about Hinduism is and what religion is. And just as I keep saying, we contain multitudes, I mean, the religion contains more multitudes than anything else, not even a religion away of being as it were. And that's also gotten corrupted. And it's very interesting that, you know, you will speak of that particular tradition, the Swami Satsanghavas, which is again, you know, another strand of that is there in the Ranbhaksi folks, Malwinder and Shivindhar and the kind of nonsense that is happening there where it's essentially comes down to being a modern day, cult and nothing else. Everything else is lost. So just looking around at India, is that something that you feel that has also happened that in some ways we've let this great religion down by going on and on about how great it is? You know, that's a very deep question you're asking. And I don't know if I'm qualified enough to answer that. But, you know, as somebody who I don't practice religion, that I don't go to temples anymore because to me, you know, the experience doesn't mean anything. I mean, you see pictures of people going to a temple to be shouled around because, you know, you want to spend a few minutes in front of the D.T. I can do that at home. I don't have to go to a temple to do that. But I think that, you know, I certainly have an opinion about the politicization of religion, which I think is just terrible. I think that, you know, whether it's the new age, you know, aspect of how religion is perceived or the old age, which is the fundamentalist aspect of how the religion is practiced, it just turns me away, personally. I don't know whether, you know, that's something that I can authoritatively speak about it. But purely from a personal point of view, I think that, you know, the entire purpose of, you know, religion and tradition was to develop a sense of understanding of your place in the universe, right?
That seems to have completely gotten lost. We don't talk about, you know, why we are, you know, in where we are. We just focus on what is it that we want to do to try and advance a cause. I don't know what that causes. Some people, for that's, for some people that causes to build a temple. Some people in the causes essentially to build clean rivers. Or I'm not saying that one is better than the other. But, you know, this existential question of why we are where we are. I don't know whether we actually even ask that question anymore. Right? So I don't know what to say to the question that you're asking. Yeah. I mean, I mean, none of us, I mean, I don't know who's qualified to even speak about it these days. You know, so it's like I think everyone's sort of feeling of it is as valid as anything else. I just remembered that growing up, I would never be at odds with, say, being born a Hindu in this particular place, but not actually being a practicing Hindu. You know, being an atheist to school, having the kind of beliefs I do, which some would say enlightenment values, but having all of that was fine. I still fit in here. This was still my home. I was still part of the civilization and I could be whatever else. And today, one just feels that the space for that in one sense is not diminishing. Perhaps that's a big statement, but that there are people who would like it to diminish, who would like it to define the civilization in a particular way and just make everything so combative instead of just letting us quietly contain multitudes. Tell me more about then, you know, what going to New Hampshire was like. Like was a sort of a culture shock. What was a study like? Did you enjoy chemical engineering? You was. I, you know, it was certainly a completely new experience for me. I mean, I'd never been actually that was my, I think the first flight that I ever actually took from Bombay. Panam used to operate in those days, hadn't gone bankrupt in those days. But, you know, the way that I learned was very different. I'll just tell you an interesting anecdote. So I was thinking about this, I don't mind right coming here. One of the, the, the, the co-re�s that I took in college while I was enrolled in a small year, was mandatory course for chemical engineers was called the material energy balance, which is teaches you the fact, you know, how energy gets converted from mass, master energy. So in that course, in, I don't know if you ever happen to you, but in those days, I'm talking about the 80s and 90s, right? There were no computers. And so the question papers used to be cyclostyls. So the, the professor used to actually write the question on a piece of paper. And then they used to get cyclostyl because the rocks was really expensive, right? And you used to, we and everybody got a piece of the cyclostyl paper. And then the question had to write down the answer to your solutions that question. Unfortunately, the one that I got was kind of blurry. It wasn't like visible because you know, you really have to push down very hard to make that mark on the cyclostyl paper, right? Because then it goes to the machine and then you run around and the wax generation. So when I did my math in that, in, in that equation, I was off by two digits, because the decimal wasn't visible to me, right? So when my paper was evaluated because my answer didn't actually match what the professor was expecting, I got a zero on it. The only reason was because I couldn't read the decimal point in the question that was defined. The reason I say this to you was because when a juxtapose was this, this, this experience to the way, you know, I was taught, you know, when I went to your age. So one of the, the, the cultures that I had to take, there was fluid mechanics, right? So professor, Kar was my teacher there. And you know, my turn paper was, and in those days, like this is 1991, right? Stents essentially, you know, the stuff that we put in our trees, they were not like, you know, on, in work, they were just being developed. So one of the things that you get taught as a chemical engineer is how do fluids flow? Because you know, you have to mix things. You have to make sure that, you know, you blend the flouries and stuff like that. And people who, of your listeners who have done any kind of chemical engineering will know that, you get taught about venturi flow, laminar flow, turbulent flow, eddies and things of that nature. On one hand, the experience of getting taught in India was that, you know, you used to mug these things, God then wanted to turn on a piece of paper and God forbid if you didn't read the cyclist's title paper correctly, you got a zero on it. Other side of that was, uh, professor's car's, uh, his term paper was, he wanted to, to us to sit down and think about what angle of a stent would be appropriate? Because again, you know, there is fluid, there is essentially plasma running through your arteries and veins, right? So if you have to put a stent in, you can design a stent to be a Y, right? So, you know, you can, you can have a stent go in and with bifurcating, you can design a stent to be a T, right? And even if it's a Y, you can have an acute angle, you can have a puss angle in there, right? The question he asked was, what angle is most appropriate, you know, in order for the stent, not to have accumulation of plaque? Remember, our blood actually has platelets in it, right? Red blood system, white blood cells. So it's not pure liquid. It's a sludge, right? So the question here is that if you're putting in a stent, you want to design the stent with a certain angle so that you don't cause plaque formation at the junction. So the question was, go think about designing what would the angle be? Now, the asking the question that way, I did not know how to answer because I never, I was never taught to think in those terms. Right? Here, I had to read the mechaipsmith book, figure out what the equations were, go out to the term and essentially sort of, you know, solve problems. The reason I say this is because I think one of the things education does and I'm hoping that it's happening here more now. Education is not about regurgitating stuff, right? It's making you think about what is it that you want to do differently. That question, although I got an A minus on it, I didn't, I don't think I did a great job. I think that I did the best I possibly could. But that makes you think, right? There is no one solution for it. You can design a T-Stand, you can design a vice-ten, you can design, I mean, they were drug-eduting stance, meaning you code them a drug and over a period of time they put drug in the bloodstream. Open ended questions are really important because I don't think there's a solution to every problem. If you go in and thinking that I'm going to solve this problem and find a solution today, you'll be disappointed. I think that a lot of problems that we find in life, I don't have the problems that I deal with, don't even have a definition of a problem. Forget about a solution, right? So open ended solutions, open ended problems are really important. I just hope that our education system is beginning to teach some of these things. How do you deal with an uncertain world? The data isn't available where it's not properly defined. How do you think about that when you try and solve things of this nature? Education is really important, so that's a seminal experience that I think about in terms of when I went to your nation and got my masters there. That's the kind of experience that I had, which I still remember getting a zero and that's so disappointed. I thought I did it right and then I found out that my decimal was off by 2.5 digits. Yeah, no, I did an episode with Anirban Mahapatra who pointed to an identical experience as something seminal for him as well, where he mugs up everything here and then when he goes out there, he just runs really badly in the first exam because he's not used to thinking like that. And I have the title of your master's thesis in front of me, "Celubal and immobilized catalaws." I hope I'm pronouncing that right. Effect of pressure and inhibition on kinetics and deactivation. Was it fun? Was it enjoyable? It was really fun. So this is the thing that we were looking at at that time. Again, my advisor, he was from India, he was from Chennai. He just retired as the senior provost, excellent. I mean, Vasu was Dr. Vasu was very, very good. The only thing that I didn't like about him was that he used to hold his classes at 13 in the morning. I mean, you have to, if you know anything about the geography, it's mostly like crazy in winter. And so, he insisted on all the students being in the class. We had to get up like, you know, at the 7 o'clock, go to the dorm, eat your breakfast and then get to class at 8.30. It was like minus 40 degrees outside. But yeah, no, so what I was doing there, and that was kind of interesting. And this is again, science evolves. In those days, we were doing something completely different in sense that at that time, you know, we were thinking about how do you sort of use enzymes as active catalyst to try and increase the reaction. And one of the things that we are taught in chemical engineering is that one of the factors that gives you higher rates of catalysis is surface area. So the larger the surface area, the better, you know, yield that you get from the reaction. And so, what I was trying to do there was to take, you know, porous beads, like, you know, beads with small pores in it because the more porous it is, the larger surface area it is. You take an enzyme, which is a labial thing, right? In times of not sped is stable. You mobilize it on that and then use that in a reaction and see, does the reaction proceed better? You get a better yield. The issue there was not whether, you know, what we were doing would actually work. The issue was think about, you know, how do you design experiments? How do you design? So, you know, my experimental reaction chamber was a PVC plastic pipe, a twin inch by two inch long, with two plastic flanges on both sides. And I had to build this. In the lab, I had to build this out of cut PVC to take, you know, a peplexic glass on both sides, fix it, put flanges in it, essentially, to be able to have your input and output on it. And then, you know, high pressure, right? So, you had to put, you know, high pressure
in and see what really happens in that. But the notion there was that two things. One is that it taught me how to think about experimental design. How do you think about doing an experiment with the hypothesis and testing that hypothesis and experiment and figuring out whether it works or not? I mean, nine or 10 times it fails. You still have to go back and try it in a different way. So that's experimental design point of view. The second thing it taught me was importance of data. But according what you're measuring in the lab, right? Every data point. So you know, you just use a start the reaction. Take measurements at one minute, two minutes, three minutes, five minutes, 10 minutes, and then plot that and see whether the yield at the end of the reaction time would you get a better yield or not? The fidelity of doing that, basic science, right? I mean, you go to a lab, you have a lab notebook. You think about your experiment. You write down your hypothesis. Think about how you design that experiment. You say, OK, if my experiment succeeds, this is what I'm going to get. If my experiment fails, this is what is going to happen. Happens all the time, right? But the training that school gives you, any school should give you, is this. It's not whether you're producing a Nobel Prize-winning invention. It's about making you think about how do you think about doing science? Which today, I'm sorry to say that we don't think about that anymore, right? You know, we think about science again in black and white terms. Science is not black and white. Now in order to time, 10 times things fail, right? And then you find out one fine morning, you know, after a lot of, you know, sweat and blood, that, you know, something actually works. In fact, the lessons in this go beyond science in terms of the importance of process, the importance of data, the importance of intellectual honesty even in just making sure the process and the data, right? And even that importance of getting a little meta, thinking about how to think about something, rather than kind of useful skills which they don't quite teach in India. And at the same time, while you're in this very cold place, which Indian students famously sometimes have trouble with, how's the music going? Because you've been trained in Hindustani classical music. Tell me a little bit about that side. So again, a lot of this came essentially. Remember, you know, the environment at home was this, you know, traditionalistic. So if you know anything about the tradition of the mystics, there is something called Shabbat, right? So you sing. You sing, you know, you decide, you know, that the poems of the saints and basically, it's supposed to mean something to you, right? So I ended up sort of listening at home, you know, singing along with my parents and understanding, you know, what was really happening. So it's just that training essentially with a little bit of formal training in the Hindustani classical over a period of time. I'm not any, you know, so great stinger or anything like that. It's just that the environment at home was there be used to sing Shabbat. We used to sing, you know, the traditional Satsang kind of stuff that actually happens at home. That's how I picked up a lot of this stuff, right? So and then some training, a little bit. But the good thing in those days, I'll tell you what was good. Speak McKay was very active in those days. There were chapters of Speak McKay pretty much in every US universities. I saw, you know, Pandit Bhim Sen, Joshi, like this close, like I was like right here and you know, I mean, he had come to Syriqius at that point in time. I was enrolled in a computer engineering program. I mean, what personality? You mean you are in heaven, you know, when you when you hear him sing. I mean, there was just, Speak McKay was very, very active. There's chapters of Speak McKay pretty much in every university. We used to do concerts, we used to invite, you know, M in personalities from India to come in and and and and sing play was a really good time. College days. I knew you used to sing in bands also the room. A goes long time, long time ago, not not. It's been long. Yeah, at some point the farm hall of the year is going to get hold of these old recordings and circulate them. This is a person. Exactly. So after this, you joined Bristol, my script, where you rise through the ranks very fast. And also where you, you know, eventually, your last post, there, I think is a director of discovery informatics. But there what you're doing is beyond chemical engineering in the sense that this informatics are obviously as your job title goes. There's also a little bit of robotics like the way Catherine Iban describes you. She says quote, how could play a small but cutting edge role in the company's endeavors. He ran a department that built robots automated laboratory helpmates intended to make the work of drug testing more efficient and reliable. How could slab bust with innovation more than a dozen scientists reported to him. Police, motors, bells and levers were scattered about and bright-eyed college student cycle through pitching and listening to its top code. And from there, the natural segue would be that I can totally see you kind of continue down what already was a cutting edge role till today you are sort of running an AI startup or whatever and doing all of that. Tell me a little bit about your role at BMS, what you kind of learned there. And you know, what made you decide to kind of give that up and move along. Yeah. So, you know, so we might be training that I got as a past part of the master's program was two things. One is think about how to conduct experiments. The second thing that I got, so there's a subject that is taught in chemical engineering is called programmable logic controllers and processor into design. Right. So you're building, you know, I'm so I don't if you if you ever pass by one of these big distilleries or though in GC plans, right. And you can see them big plans are actually have you know, pipes going here and there and they're doing this kind of stuff. When you sort of drill it down to basics is basically programmable logic controllers. So all you're saying is there's some switches, right. So the way the way that you kind of drive something is you turn the switch on or off so that, you know, you have a positive or negative. And then you have a pulley that basically moves things around, right. So the reason this was important was for twofolds. So I'll have to take a step back and explain to you what was really happening in those days. And and and the reason this is important because when we talk about India and India being a pharmacy to the world, right. This is a phrase that is most commonly used right now or pharmacy to the developing world, right. Even as of today, as a country that you know sort of has this prowess of, of, you know, manufacturing drugs, there's been one just one or two instances the way we're actually discovered and developed a drug that has gone to the market. We've never done that. The reason is very simple. We'll get, we'll come to that later on why we haven't done that. But the way that this thing was done back then was that the process of of drug development basically is that, you know, you identify a target in the body, right. So for example, if you have a receptor of some kind or if you have a protein that you're trying to target, right. You're trying to either make it do more than what it is doing or you're trying to stop that from doing something, right. Those are the kind of things that you're trying to do to try and develop a drug. Now, the way discovery worked in those days and it's more now a little bit with with computer design, artificial intelligence is that what you used to do was you used to take scaffolds of chemical structures, right. And you throw that particular sort of target and see what sticks. Now, remember these targets are large protein molecules. These are not, so these are very large molecules. They fold, right. So this is not like a, you know, strict chemical structure. For example, a simple chemical structure you think about is benzene, right. Benzene looks like rings, you know, so hexagonal rings. That's how benzene looks like. If you've got, you know, among your audience, if people who are chemist, they'll realize that you can have structures that become really, really complex. You can have hydrogen molecule, oxygen molecules, right of branching off of that, right. So you're trying to take a chemical molecule and you're trying to throw that at this target to either block something or make it do something differently, right. And the way we used to do that was called high throughput screening, meaning that you take a thousand of these chemical structures, right. And in an experiment, you see if these chemical structures bind to the protein at all. Now, if you, out of the thousand, you may see one or two showing some activity, activity, meaning that is some, it is actually making it do what you want it to do, right. Then you take that basic structure and then you modify it, right. You add additional things around it and see if it makes a difference because remember proteins essentially are like ribbons. So you take a long ribbon, you fold it, right. And there is this one site in that ribbon that is that type of site. So you're taking a small chemical molecule and you're trying to attach to that site to make it do something, right. So you're essentially now dealing with thousands and thousands of these experiments that you're doing. And it's very hard to make, you know, people do that because remember, you know, I mean, if you ask me to do the same thing 10 times, I'll make a mistake in the ninth time because it's repetitious and it becomes really rude, right. So the way that we thought about this was, why don't we automate it? Why don't we essentially build, you know, these systems that actually do these things at night during the day, you know, and then we can keep an eye on what was really happening. So my job was essentially to build this, it was really fancy. I have a Havish Arden video, but basically, you know, it looked like, you know, if you've seen, um, four motor companies manufacturing or even Maruti's company, you have these big robots that look like robots right now that pick up a piece of the car and put it on a manufacturing, you know, the line, right. You take a door and you just stick it on. That's exactly what it looked like. We had robots, but the smaller ones, you know, so again, you know, it had please and and and and you know, motor
in them and they used to move things around from place to place. Now you see a lot more automation. I mean Amazon facility has all robots in it right now. In those days, it was an novelty. So my job as an engineer was to build those things. For two reasons. One was because we needed to run thousands of experiments. It was not like you're doing one or two chemicals, right? You do thousands and thousands of these. Number one, number two is that the way that you read out this stuff. Like how do you know that something actually attaches to protein and does something? There are one of two ways that you could do that. You could take a FFS and you know molecule that would light up, right? So if it attaches to the protein and you take the rest of it out, you'd read that because that would generate light. You know, and you'd be light will actually show up or you take a radioisotope, right? You take you know cotton 14 or one of these things and you take a radioisotope and attach it to it and you use a guy who can't do to read it. Now you don't want people to expose to radiation, right? I mean, if you were using a radioisotope in your assay, you don't want people essentially to expose themselves to unnecessary radiation, right? So that's where robots become really important. So the job that I was assigned based on my training was to build these things. This is what we used to do essentially build, you know, systems that isn't the run day and night. They would just pick up. So think about it like a manufacturing line. It would know where to get, go get the compound from. It would know how to dilute it because you're not going to do the same concentration, right? So think about if you go to pathology lab, they take your blood sample, but then they run the assay. It's not run the same concentration of that you actually think the blood, they would dilute it down, spin it, take the white blood cells out and then they would actually use that to do bionautical assets. That's what I was tasked to do. And even it up sort of building, you know, those kind of systems, you know, for the company at that time. What I also found fascinating reading about your years at BMS was that you've spoken about this orientation program they put you through and there was such a stress of this orientation program on a particular set of values and how you were supposed to kind of approach your role just in the industry. Tell me a bit about that. Yeah. So I mean, this is one of the things that these companies, I they used to do. I hope they still do it, right? So one of the things that they did was when you joined in as a fresh engineer or a fresh scientist, right, you used to get us a batikolts kind of rotation basic. You'd used to go spend a month in every apartment to try and understand what they did. So that you would at least get a sense of, look, you're not button hold into this one job that you have, but you get a bigger picture. But the biggest thing that that that was drilled into you into all the people who they hired was, why are you doing this? Right? It's not about trying to punch a machine or a tablet, give the tablet out. It's not about designing a robot. At the end of that line, there's a patient and you know, you're doing this essentially to try and make a difference in the patient's life. That was the biggest thing that I think was was was was was really important because what happens is that when you graduate from college, right, you don't have that perspective. You're going in as a computer engineer to design stuff where you're going in as a mechanical engineer to be able to design some, you know, machines and systems. You're going in as a chemical engineer to design chemical reactions and figuring out, you know, how to make, you know, what you don't see is that how all of this comes together in the end and it impacts somebody's life, right? So bringing in people to be able to sort of to correlate to that, right? Where you get to interact with a patient who says, look, I'm taking this drug. You know, I've been diagnosed with a melanoma and I'm on your drug and it making my life better. That's a really powerful, you know, message that goes to somebody to say, you're making a difference in somebody's life. I just don't know whether we do it often enough these days, right? We're so focused on the bottom line that I don't know whether we do it, you know, in a way that the try and put context into young people that yes, you're doing a job, I understand that, you know, you're only living, you know, you're really trying to make a difference, but there's a bigger picture out there. You really are trying to make a difference in somebody's life. That I think is really important and be honest did that very, very well, you know, for people like me who joined the ground level, you know, and worked our way up. So yeah, that kind of training also plays one part in explaining sort of this deeper cultural difference that seems to be there between say, US, Farma and Indian, Farma and and just as sinking of the end user, you know, applies to a lot else. Like I think like even in writing, like, you know, the very first lesson of my course essentially is that when we write too often, we think of writing as an act between Asana laptop, Maver Mary laptop that I have thoughts in my head. I put them down on paper or on the laptop and it's done and you're not thinking of the reader because your writing only becomes meaningful when it has a intended effect on the intended reader and we don't often enough think of that. And I think that this can then be extrapolated as a danger to any calling or any profession of occasion that you forget that end purpose that you kind of get lost in the mechanics or whatever it is that you're doing at any point in time and you kind of let that go. So tell me a little bit about then how, you know, you rise up rapidly as a millennium begins, you are the director of informatics at this very well-regarded company in the US and then you decide to come back. So take me, take me through that process. Basically, you know, it was against her end of it, right? So, you know, an opportunity presented itself. So, so I was a, you know, I was working in informatics and this is gentleman who was a fairly senior person. His name was Rashmi Barwa here. He was responsible for pharmaceuticals. Now, what that means is basically how do you design a drug so that your body can absorb it, right? So think about it. We talked about how, you know, to find this one drug that works against a target, right? Let's assume that you find that, right? You find something that is novel that, you know, works against a particular disease. That's not the end of this story because, you know, how do you actually get it to a patient that patient will take it, right? You have to figure out, look, if I, if I formulate that as a capsule, you know, will the patient take it? If I make it a suspension, like a liquid formulation, will the patient take it? Does it have to be injectable, meaning that, you know, it has to be available immediately? Remember, if you eat something, it takes time for the, for the chemical or the biological, to go into your stomach, get absorbed and then become bio-eulable, right? If you want something immediately, for example, if somebody's suffering, if they're stroke, you can't give them a tablet. You want to inject a clot-busting drug right away. So the clot essentially, sort of, you know, vanishes in that point in time. So these things, how do you make the drug available? Is the remit of what is called pharmaceuticals? And he was the head of that group at that point. He had accepted a role to join an Anne-Baxi as the head of their research and development. I did not know this. So one day, you know, the campus where I used to work, you know, there was time that, you know, we used to walk around in the afternoon, after lunch, just kind of clearer, had topic people, it's just a cultural thing there. So one day, he asked me whether, you know, we would do that. And while we were walking around, you know, he told me that, look, you know, I am, I'm leaving the MS and he was there for a long time, I mean, much longer than I was there. And he said, I'm going to go to India, I'm going to be heading this company and I didn't know what that company was. And he told me, look, you know, you've recently really, really fast in this, in this organization, but you're going to hit a glass ceiling here. You know, there's only so many vice presidents and directors in the company, right? It is an opportunity for you to go back and do something very different, you know, the skills you have, I really need that skills along with me and my new role there. It's a good way for you to give back to the country as well, because this is not something that the country has. I'm going to try and do something very different, you know, in this case, and the company has told me that I had a free hand in doing what I need to do and why don't you come with me, right? So that came out of the blue for me because I had no idea that I would even be considering something like that. But how did you thought about it? And, you know, I did my own research. There was one time that I'd come to visit my parents. I went and met, you know, people in New Delhi. In fact, the interesting bra who was the CEO of Ranback's here at that time had come to New York once. He was at the, the health and, you know, in the Grand Central. He does need to come meet with him. So I'd went and met with him there. So what a period of time this courtship happened and, you know, comfort developed and, you know, given the fact that this was a very unique opportunity. I decided that I would come here and helping Rushney build what he wanted to build. He really wanted to turn Ranback's here from a manufacturer of drugs to a company that actually researched and developed drugs. That was his vision in terms of what he wanted to do. That's the reason I accepted this position to come here. And, you know, he said, look, you know, I need people like you because it's going to be a, it's a big job and I need people like, so he had another gentleman, his name is Kasi Muktiya, who was also a fairly senior person. He came along with him. I came along with him. Namesh came along with him. So there's a bunch of people essentially sort of, you know, came along because we really saw an opportunity to try and make a difference and, and then rebuild this kind of the raw prowess that we saw within Indian farmer because, you know, Indian farmer was doing really, really well in those days, you know, from a price competition point of view in the US, obviously healthcare costs are really, really expensive, right? So the Indian companies were making, you know, huge sort of, you know, dent into into that market and it was a very unique opportunity to say, can you steer the ship from just making stuff to doing something innovative? Could we do all something new.
the country's never done before, right? That was a great attraction for somebody like me to come here. So do contextualize that. I want to sort of examine a couple of parallel tracks that are sort of also developing during this time. And one of course is the whole funder of you know, innovator companies which will develop a medicine, say they'll have a patent on it that will last for I think 17 years. And during that time they charge whatever they make their money back and they make their profits. And after that you have generics coming in where pretty much anybody who demonstrates that they can make it with a different process can just get in there and that's a middle thing. And for a lot of Indian companies then they became good at sort of reverse engineering that how is this made figuring out a slight difference in the process and getting into that generics market where you're making cheap medicines and making your money that way. And part of what you guys when they're to do as you said, Rushmeen and you and all the others was take it up the value chain where you're kind of innovating and developing your own medicines. The others sort of interesting parallel track I find here is what you said for me did with Sipla when they made that when they made the AIDS cocktail for Africa at less than a dollar a day. So tell me a little bit about that and also the significant you know what was really happening in that generics market which perverted those incentives. So I think that's a story that needs to be told and told again because I don't think that we as Indians really understand what Mr. Hamid actually did. And I think that you know I mean it's it's a really powerful story to think about right because the drugs that were developed to combat the AIDS epidemic characteristically right this is what farmer does they essentially try and extract blood from a stone if they have a product even today right look at hepatitis C that the drug that is available to treat hepatitis C is that that Galea it's now you know it's a soul of thousand dollars per pill. Now the argument that they make is you know essentially it's actually a quality of life it's a value of what we are adding to you know to to to to somebody's life who's offering with a really bad infection whether it's hepatitis C or HIV but let me just diagnose a little bit here for a second right this is this is really interesting because you know given your background and your interest in economics so there are two pricing models right one pricing model that basically says what a value do I add to my consumer right I charge that based on the value that I add this is what most farmer companies do right they say that if I can keep you out of the hospital for X number of days and hospitalization costs X number of dollars per day that is the that is a value that I'm adding to you right by taking this pill you don't have to go to the hospital and that's how you extrapolate and say okay my drug has to cost 30 thousand dollars years unreal so stupid right the other way we think about when it comes to genesis this cost plus model what does it make what does it take you to make something and there's a decent margin on top of that that's a cost plus model this is really interesting you think about this right how then when Pfizer developed vaccines the MRNA vaccines right now right and Pfizer said okay you know what we are going to they were the first ones who got regulatory approval emergency approval for vaccine how do you determine the value the price of that particular vaccine the entire world is shut down this is essentially is you have a product that has the ability to return the economy back to normal now they charge the US the Center for Medical Services I think paid between 26 and 30 dollars per short for Pfizer how they arrived it I don't know but you can make take that argument to a ridiculous nature saying look because I'm going to now enable the world's economy to come back I can charge a thousand dollars per day right if you if you follow the value best model you can't do that anymore nobody will be able to afford something like that so this notion about companies charging you know a lot of money it's it's you know it's it's you know it's you will come back and revisit that a little bit but what happened with Hamid and mr. Mead and and and and Dr. Mead and and and Sipula was basically they broke that model because there were companies in the United States who were charging an anomaly like for you know this therapy for very very poor people they didn't care whether you know that this this disease was inemic in Africa they were still asking Africans to pay the same price that the United States would pay there's no way that model works right and so there were a couple of different people in the you in the US activists who worked with Dr. Mead and they basically broke that model and basically said look we are going to reverse engineer this thing we are going to essentially give you a dollar a day cocktail while they were charging 300 dollars and that essentially revolutionized people's lives you know I mean what happened in Thailand what happened here in Bombay what happened in in in Africa people all they they're life to Dr. what Dr. Mead did he basically broke that model of of you know farmer companies holding poor patients hostage for the kind of money that that they were looking for and the reason that happened was because two things right one was in the 70s our prime minister in the Iragandhi was basically provided this this pathway where she said look if you can figure out a different way of making the same product you have protection right so this is how we develop to reverse engineering skills in the country we began to sort of figure out how to make the same product but in a different way right that's for how our genetic industry evolved and so we had those skills so when you know the activists in the US we bill had they came and talked to Dr. Mead they figured out this is what they would do and and they broke that model so that was what was happening in that at that particular time that was one the second thing that was really happening at that time what this is concept called a patent cliff so as you said you know once you register a patent or appeared of time where you have exclusivity you it's essentially you know after that multiple companies come in and the price drops what was unique in that time period the late 90s and early 2000s right they were in the number of blockbuster drugs that went off patent I've never seen that many drugs actually go off patent in any time after that that was a period of 7 to 8 years where drugs like Lipitor right drugs like you know all the statin drugs which is essentially billion dollar drugs at that point in time they were all going off patent so it was a great opportunity for the Indian farm industry which had this promise to be able to think about how to remake this this particular sort of chemicals in a different way there was a one-ten-a-lifetime opportunity for them to be able to do that so those two things came you know together very you know it became sort of a you know sort of harmonization of those two things which essentially provided like a fallip to the industry to sort of you know dream big and say look you know we can manufacture in reverse engineering manufacture but even these guys realize look this is not going to last forever right once the patent cliff vanishes you're going to be back to essentially doing the same thing over again so we have to invest in doing something different we have to innovate we have to be able you know get our own products because you see if you have an innovator product you command a premium you can charge a lot more money doing that so that was the context of that point yeah and it's also fascinating to me how you know it's easy to sort of paint everyone with the same passion say oh this is a culture in India you know the kind of thing that runbuxy did but if you kind of look at use of me then sipla and the kind of values that they believed in that the importance in processes and quality and all of that it's just of the charts and at the same time you have some of the newer companies like runbuxy where everything was bottom line where you went in and there were you know you had posters in the world pushing you towards getting a higher profit percentage of you know reaching say one billion in the US when they were 100 million at the time I think or reaching a total of five billion whatever sort of one billion at the time and another sort of interesting nuance to the way that companies were allowed to make generics was that you know when you applied for the permission to make a generic medicine there was an added incentive for whoever was the first to get approved because that company would get six months of a clear run to be able to make the generic when they could make a lot of money and then after six months everybody else kind of comes in and Ibanez book describes like it's like you know wars in the streets where you have the parking lots of the FDA and people from different generic companies are camping out there and different groups because when the door opens in the morning they want to be first with their application and all of that and this also meant cutting corners because you have this era of the patent cliff you have a limited number of drugs which are going off patent and you've got to be first and whether you're ready with the signs or not yeah so this was an unfortunate outcome of this US law right the Vatch Axman Act that created this nonsense this was a compromise that was reached with the big farmer right remember initially when the generic came around big farmer basically tried to malign them and saying okay these are not good quality drugs they don't know what you're doing and obviously you know activists pushed and pushed and pushed right so the compromise was that look you know we'll you know they'll try and get another you know a little bit out of it and the six months was essentially to say we are going to license a technology to some other company that will give us six more months to try and milk the market as much as we possibly can that was the this this whole genesis of this six month exclusivity. But you know, in sent, you never
have a full appreciation of the incentives at the time that you give incentives, right? How they play out in the market is something that you get a sense of it later on. And this was an incentive that was well intention. Unfortunately, it was completely taken upside down and it became a reason for companies to put corners and then try and figure out what they need to do. So let's talk about your time at Renberg Cino. So you kind of get out there and Rashmi doesn't last very long. No, so he doesn't. I think what happened was that he had developed a difference of opinion with the family. And so there are two, there's a power struggle happening in those days because you know, he, Diaz Braw, who was the chairperson and the CEO of the company, right? So they were the family waiting in the wings, right? Well, when they're and it was as if he was warming the chair for the, you know, see on the family to take over and obviously there's power politics going on in there. And then between all of that, you know, Rashmi's equation with the company kind of deteriorated to the wet and he decided to leave and start his own. So I think after me, with any year of me joining a little over year of me joining, he decided to leave. At one point, you know, he apparently said to you, you'll never believe the kind of shenanigans that are going on, but he didn't elaborate. And at that point, did you have a sense that something is dodgy here, something is not right? Yeah, so I never thought that there was an issue with the quality of stuff that was going on. I mean, you know, Scott, but was that Rashmi wasn't getting along, wasn't getting along with the family with Malvin there and in the meetings we could see right body language, you could see in a meeting sitting across the table because Malvin there was at that point in time head of India business. So he was running the India business at that point in time. So I would see him in meetings and you could see the body language. They're not like, you know, not like colleagues and colloquial kind of stuff. So my suspicion was that there's something going on personally between them, not so much in terms of the product that they were making. Another interesting side note that I kind of realized from Iban's book was that when Rashmi left, he actually got a big settlement when he left, which can also be interpreted. And I think Iban implies that it was sort of just a silent about whatever you might have seen. I unfortunately, I've never got this straight answer what that was for. All I know is that, you know, yes, there was a big settlement. You can read it to say, well, you know, just go away and keep your mark shut. Or, you know, this was something that was negotiated right. I just don't know. I mean, I didn't get anything, you know, I just walked away with whatever was due to me that was it. So. Yeah, Indito, Rajendra Kumar, your next course. Yes. When you talk about, you know, unsung heroes, right? The doctor, Hamid. Dr. Kumar is another one of those. I mean, it's very few people that you're running to who really have the courage of their conviction to say, look, I am who I am. I'm not going to be a part of the shenanigan. And the guy was ahead of, you know, the CNS clinical research at GSK. Like, I mean, he was among the four top four or five people in Glacosmith, Clim Arandi. Gives up that position. Comes to India. On principle, he says, I'm a medical doctor. I know what is happening here. I'm not going to be a part of it. You want me to fix it. I know how to fix it. Give me the resources to try and put this thing right. And if you don't, I'm going to walk away from it. Walk away. Let's zoom into the story and stretch it out a bit. He's your new boss. You instantly take a liking to him and, you know, medical doctor, great values, obviously incredibly competent at his work. He goes to South Africa and he comes back and he's shaken. You know, take the story forward from there. See, this is what happened, right? So there was a French inspector named Olivier LeBlais. He's still there. He's still working for the French regulatory agency. It's a friend of mine. Good friend. He was a part of a WHO group. Now I'll explain a little bit about how it works. So what happens is the WHO is a world health body, right? Not every country has their own regulatory structure, right? They evaluate the quality of medicines, right? There's a lot of countries in Africa that they don't have that capability. Nigeria does today, right? They have done a really good job. Tanzania does. Congo does. But not there are several different countries that don't have the capability, right? What they do is they rely on the world health body to say, do you think that we can buy these medicines, right? So the way the WHO thinks about this is they develop, you know, a framework to say, these are pre-qualified manufacturers. So we have done our due to religions on them. We believe that they know what they're doing. We can vouch for the quality of what they're producing, right? And they put that list out. And these countries that don't have the regulatory capacity, then look at that list and say, okay, we know what WHO has said this. We can trust the assessment. So we'll go ahead and buy it from this particular manufacturer. That is how the process is supposed to work. Now as a part of that assessment, the WHO relies on doing inspections, right? They go out there and obviously check before they can prove some manufacturer out there. WHO doesn't have regulatory capacity, right? So it pulls in from countries regulatory capacities, wherever countries have good regulatory capacity, they'll say, can you lend us your inspectors? Right? We'll come and do this. So the gentleman who was leading that effort at the world health organization was the gentleman named Andre Wanziel, who was a medical doctor. And he pulled in regulators from different countries. And this was the German French regulator. Olivier, he came in to basically inspect run-back C-sport for you. Because remember that time what was happening was, Bush was elected. AIDS was rampaging through the world at that time. In public pressure, they established the president's emergency relief for Africa and Southeast Asia. Part of that thing was that the Clinton Foundation, they basically said, look, we are going to work with these companies in India who certainly know how to make these drugs. We will negotiate a really good price for you because we'll combine all the volumes from across the African countries. We will combine the volumes. We will negotiate a really good deal. And we will help you get you really good quality AIDS drugs that are manufactured in India. As a part of that process, the WHO was evaluating the run-back C-sport for you of Lemibu D in Stavidin, Zidu-Vidin. These are the antifroilant drugs that are essentially used to treat HIV. So they stop replication of the virus. The way things work is that farmer companies, what they do is that they usually work with outside contracting companies who run clinical units. So the antibax they had it's own in a clinical unit as well. In Delhi, there's a hospital called the Magidia Hospital. This is where the antibax they didn't internal work. But usually, the number of molecules you're developing is much larger than the capacity of your internal unit actually can do. So you're outsourcing. So they're giving it to this company called Wimptal Aboratris in Hyderabad. So Olivia goes there, he does the inspection and he finds out that these guys are fudging data. So they're saying essentially that we've enrolled 20 patients, he can only find one ECG. And he says this is nonsense. So he goes back, makes a report. And that report goes to the South African regulator. Because remember, South Africa is going to buy, they're going to look at this report. How are they going to buy? Because the WHO puts out this report, the buying agency is going to look at that report and say they call up and back and say, "Oh, thank is happening here." You guys are outsourcing your work to the third party company and they're fudging data. So Brian, who was CEO at that point in time, Raj was like, maybe not even a month, maybe three weeks into his job. He calls Raj and says, "Look, I need you to go to South Africa. I need you to go to Johannesburg and sit down and tell them that we'll fix it." Whatever the problem is, we make sure that all of these things will be straightened out. And the reason they did that because he was counting on Raj is essentially standing as a doctor, right? Brian would never be able to make that kind of a case. You're getting a qualified medical doctor with that kind of standing to vouch for the company. So Raj goes there to Johannesburg, along with another gentleman who is responsible for outsourcing. So this guy's job was to get the work done from all of these other contract companies. He has his meeting, he tells them, "Look, don't worry about it. You know me, I can fix these things. Don't worry about it." On the way back, he's told on the flight that, you know, you're new here. You don't know the whole story, but this is not a unique situation that you're dealing with. You'll have to deal with this, you know, other instances coming. He's like, "What the heck are you talking about?" I thought this was like one of the things that, you know, something happened with the bad contractor. We're trying to fix this thing. Now, you're telling me that there's more to it? He says, "What? Tell me more." And he said, "I don't know. You'll have to figure it out." He wasn't kind of in a non-comital at that point. I wouldn't give him the real story. So when he got back, he called, and my job was portfolio management at that point in time. So he called me back and basically said, "Look, I really need to know to get to the bottom of this because I'm being told, when Brian told me, you're still one of the things, I said, just go and talk to them and make sure the things were sorted out. Now I'm being told that this is not unique to just South Africa. This is a bigger issue here. I really need to know what that is. How the entire thing will start? Take me through the next step because at this stage, the assumption is that something went wrong with the contractor and whatever. And they might be.
be other issues but they're minor issues. They are kind of fixable. There is no sense that there is a problem with the edifice itself that everything is shaken that most of the data might just not be falsified, that it's all just a pack of cards. So what he asks you and your team to do is therefore to look at every different market, what medicines are going there, what is the data and go back to the source of the data and see that it matches. So tell me about how you now approach this problem. Like you're sitting with your team, what's going on there? What are you telling them? How big is the problem for you just in terms of getting to the next stage of this investigation? So thankfully at that point in time, we had to hide only higher group of five people and they were responsible for each of the spot for you. So the company's portfolio was essentially divided into regions. They called it regions for whatever reason. So India was region one, right? Europe was region two. So all the countries in Europe are region two. Region three was Latin America. So Mexico, Argentina, Brazil and region four, region four was United States and Canada, right? So I had one person for each of those. So we've a course for region three, which was Latin America. Hakaash was looking at the your spot for you. Karnav was looking at Europe. So four people and then I had two other people was one was looking at the medicines from Malayri Ventures because you're developing in your novel molecule there. So we were doing this at that point and thankfully I had a few hands to help me, right? Now to answer the question that you're asking, how did I go about doing that? In order to answer that question, how to first explain to you how a generic drug is developed, right? So there are essentially like four pieces to this, right? So the first thing is that, you know, remember, you're not innovating anything like you know this, there is a product out there that works. What we are trying to do is to figure out how to make it in a way that still produces the same therapeutic benefit. That is the question that we are trying to solve, right? So the first thing that you need to do is to be able to figure out what is the formulation? What I mean by formulation is how do you deliver it to the patient, right? Do you make a tablet out of it? Do you make a capsule out of it? Do you make an injectable out of it? Do you make a liquid solution out of it? That's number one, right? Once you develop that in the lab, the next thing is I can make it on a lab like I can make five milligrams of it or ten milligrams of it. How do I get it to scale, right? How do I make hundred kilograms of this thing? There's some signs behind that, right? So what works in lab will not work in a much higher scale vicinity, right? So just like, you know, you can cook, you know, Rajma of two people, you can figure it out what the recipe is. You have a party of fifteen people, you better be very careful with the recipe otherwise the mags are the skin, right? So you really have to control all of those things. So scaling that process is also really, really important. Once you do that, then the third thing is you then take it to the clinic, right? You're trying to test whether your formulation, the one that you made, right? Does it mimic in the body of a patient the way that the innovators formulation does, right? So if I'm trying to make a copy of lipitor, which is autoverstatin, which is the drug that is used right now, the best-selling drug, right? Four or five attention blood pressure. So if a patient takes Pfizer's autoverstatin and this is how it behaves in the body, my drug, my formulation has to behave kind of similar way, right? Regulation, say, plus or minus twenty percent. So you have to be within that range of, there are two things that we measure in there. One is how much drug is available and how fast does it excrete? Now, remember what happens when you take medicine, right? Think about, like, for example, if you drink, I don't know whether you do or not, but if you drink, you take one, you know, one drink, you may not get a bus. You take a second drink, slowly you start getting, you know, to get a bus. Well, maybe this is a better example. Holy, right? Everybody has fun. You can get a lassi or you can get, you know, mbdhaye and there is, there is opium in it, right? You take one bite, you don't feel anything. You take a second bite, you kind of start feeling a little busy. You take that one complete ladu, then you start laughing, right? Because, you know, the concentration of that particular rupee oil within your, within your body essentially gets to a point where it's really high at that point. Now, the second thing that actually happens is that the body then excreeds that out, right? So either through urine, you get it out, you know, to sweat, you can get it out, right? So again, if you over drink, what happens? Start throwing up, right? The body says, I can't handle it and just kind of warm it's it out, right? So these are, you know, processes essentially sort of get the drug from our body. So when you are testing this drug in the clinic, right? You're essentially trying to see what is the highest concentration of that, you know, particular formulation, you get to that point, right? And how fast does the body actually get it out of your system? The reason why you need to do this is because doctors need to know, when you then write the prescription, is it one pill a day? Or do you have to take two times a day? Or do you have to take months after morning, after breakfast, after lunch, and after dinner? How do you know that? You know that because you've done these experiments to figure out, your body takes eight hours to get this drug out of your system, it takes four hours to get. That's how you figure out whether you take it once a day, twice a day, three times a day, right? So you test it in the clinic. The final part of this is you put it all together. What you do is you you put together a file and you say, this is how I made it in the lab. This is how I scaled it up. This is how I tested it in in the clinic. And then, you know, I pulled it all together and say, okay, now I'm going to send it to a regulated state. This is what I need to do. Now, in order for me to map out this entire process, I had to ask each of these guys basically say, for each of these area, look at the steps that are required, right? So when you are scaling it up, how do you go from making, you know, five grand quantities in a lab to 100 kg and point this, right? How do you scale that up? What are the processes involved in doing that? Who did that? Is there a lab notebook there? Has did somebody record that particular experiment that was done, right? So we came up with the matrix of all its activities for each drug. And these, and they were essentially to go and figure out where that data existed or not. And this took forever because, you know, they were essentially sort of, there was hurdles in every step of the way. People wouldn't let them come into the labs. People wouldn't give them information. But over a period of time, we managed to develop a reasonably good idea of where the holes were. I just want to read out this little bit from the book which summarizes what you found where Catherine Ibn Wright scored. At the behest of managers, the company's scientists substituted lower purity ingredients for higher ones to reduce costs. They altered test parameters for at formulations with higher impurities could be approved. They faked the solution studies to generate optimal results, a crushed up brand name drugs into capsules so that they could be tested in lieu of the company's own drugs. This superimposed brand name test results onto their own in applications. For some markets, the company fraudulently mixed and mashed data streams, taking its best data from manufacturing in one market and presenting it to regulators elsewhere as data unique to the drugs in their market. For other markets, the company simply invented data. Document forgery was pervasive. The company even forged its own standard operating procedures which FDA investigators rely on to assess whether a company is following its own policies. In one instance, employees backdated documents and then artificially aged them in a steamy room overnight in an attempt to fool regulators during inspections. Stop code. And you've also spoken elsewhere about how the steam rooms were a part of the system. In the sense that the FDA and other regulators have their systems in place that these are the processes by which drug should be made and these are the processes by which we evaluate them. And runbuxy has a system within a system. In the whole point of the system within a system is to subvert the other system. So you actually have a steam room where the only purpose is to forge documents and to make them look old. And there's another, I think the gentleman in regulatory affairs who told you that you told him that okay, the data doesn't match the dossiers what's going on here. How much of the data is forged? What did it tell you? Well, it varied. I mean, I think in the stringent regulatory markets like Europe and US, almost half of it was. And then I asked him, what do we do in India? And he laughed at me and basically said, who looks for data in India? The hundred percent. I just want to sit back and if you're listening to this, you should also sit back. This impacts real people. This means that if all the data that is coming to you, if you're in India or half the data in the US, if you're taking a generic made in India is forged at that point in time. The people making the medicine didn't give a shoot about whether it works or not. And life's, it's take it. I mean, this is just bizarre. You can have any kind of medical condition and the medicine, the so-called medicine can actually make it worse because it's manufactured in this crazy manner where all the data is forged. Unfortunately, that's the truth. And you know, the sad part about this, Amit, is that after this book came out, after this entire episode where the company, blood guilty paid fines, the biggest beneficiaries of this are the patients in the United States in here. Because the FDA got smart, it started enforcing the regulations much more stringently. It knows what to look.
Nothing's changed for us. Nothing. Let's get back to that story. You know, one of the things we uncovered was that data and entire markets was completely invented like Brazil, Kenya, Ethiopia, Uganda, Egypt, Myanmar, Thailand, Vietnam, Peru, Dominican Republic. And at one point, you know, this lady called Kathy Spree joined the US office of Ranbhaksi and at first she was really impressed by the results of the generic versions of Rihanna and sorted because she said, wow, Ranbhaksi's data is so good. You could actually superimpose it on the data of the originals. And the truth was that the data had been taken from there. And at one point, and this really just struck me so hard at one point where she was on a conference call with company executives from India. She spoke about, you know, that the AIDS medicine that Ranbhaksi is applying to Africa, it probably doesn't work. And one of the company's top executives said, quote, who cares? It's just blackstying, stop good. Yeah, unfortunately that's true. Just reading about this stuff just gives me goose bumps, right? And it's just completely shocking to me. You're getting this shit in real time. It is. Unfortunately, that's true. You know, I mean, sometimes what happens is there been the middle of something, right? And there's so much happening around you. You don't get a chance to sort of internalize and think about this thing in the way that you ought to, right? The benefit of handside, you know, that quote about, you know, just the blacks dying, it's so offensive. It is so offensive. And the interesting thing is that Kathy says that not one person on the call objected to it. It just blows my mind. So what's happening there? You've gathered this data. This data is incredible. It is incredible to the point of being unbelievable that here is a company with more than a billion dollars in sales, more than 100 million of that from the US. I don't know if these are 2001 figures or these were the figures at the time, but obviously with ambitions of getting much bigger, you know, Bill Clinton has come and he's partied with Malvinder and Shivendra and all of that. And you've got this data where everything is based on lies. So one, what's going through? What are you and your team thinking and two, what happens next? So we used to sort of as a team, we used to meet once a week because these guys used to travel, right? So used to travel to Devaz. There was an MP was a very big manufacturing facility. They used to go up to Pontasai, that's again a fairly, fairly large manufacturing facility. Goa, Goa was a very big manufacturing facility. So all my guys used to travel so that you could go look on the ground, what was really happening. So the process was Monday morning, they met in office and then everybody went their own way, did whatever they needed to do, come back on Monday. And I used to meet with Rajan Tuesday because I used to collect all that data, essentially compile it and then go see him every week kind of. So some weeks, you know, he was traveling, so he wasn't around. But some days, the weeks that he was there, I used to go see him and tell him, look, this is off RV. We got, we had great difficulty getting data, but at some point where the picture began to emerge and when I told him that this is what it is, he didn't believe me. He said, there must be something really wrong. I mean, how is it possible that there is so much of this kind of issues that you're dealing with? How you can't have a portfolio for company where all the data is missing. Go back and redo this. So after a while, I just got like, you don't believe me. I mean, I'm telling you what I thought I would have. You don't believe me. So why don't you come next Monday morning when I meet with my group? Why don't you come and join? I'm eating. So he didn't. And he heard from people, all of them across the table. He said, down and basically people told him, look, this is what it is. After that meeting, I think the penny dropped for him to and he was really upset. And he basically said, I just, I can't believe this nonsense is going on. I need you to prepare a summary of how far you've come along here. I need you to give it to me in terms of what was really happening. So that was the first time actually put together a spreadsheet. There were multiple pieces of information, the spreadsheet that was there. That was a consolidated was that was the first time that I did. There was a business development meeting in Bangkok. And part on the sidelines of that meeting, he was supposed to be meeting with Brian and the business heads in Malvin, then everybody else. I said, give me that spreadsheet. Let me take it. I'm going to go talk to them. So that was the first time that he told, this is what was happening. So he came back, we continue doing this. And another month and a half month and a half after that, he said, give me a PowerPoint presentation. So I made a PowerPoint presentation, gave it to him. This was discussed in the scientific subcommittee of the Buddha directors. He made the presentation, not one person basically said anything. There was one scientist, Nithyanandhu basically said, we really need to do something to fix this. Everybody else just destroyed. He was very honest. He told me when he came back from the meeting, he said, I know how to fix it. The right way to do this is to withdraw the entire portfolio. Be honest with the regulators. Tell them that we have a problem. We redo the thing, bottom up, clean this thing up. Yes, there's going to be a short term loss to the company. Next couple of quarters, we're not going to make a numbers. But it will be a bit stronger if you do this thing right. Nothing. There's a lot of silence in the room. He came back that evening, he said, I'm leaving. Next day, he resigned. No, and just to be clear, what happened in that meeting, which is again, so revelatory of people's approaches, is that the shock and horror that was in that meeting was not about the fact that these things are happening, that we basically lied about everything. The shock and horror is that someone has collected this data and they could get caught. So they immediately say not only destroy all copies of this PowerPoint presentation, but destroy the laptop that it was made on. So the entire laptop was taken from Mr. Kumar and destroyed. And destroyed. And luckily, copies existed, including a copy of you, which is useful later in the story and keeps in fact, cropping up a different parts of the story, which is really interesting. So he comes back and he quits. Yeah, basically, the next day, resigned, then they actually had a sharad. They basically didn't tell the street. They said that his mom was there living back to the UK, some shenanigans. They did, they until January, they did not disclose the street that they had a foreign dehat design. That was not a big issue, losing two heads of R&D since quick succession. So they covered it up. Didn't say anything. Another sort of incident struck me and this happened, I think much earlier around the time, Rashmi Barba here was leaving, where you pointed out that you had no idea why he had left and exactly what the deal was, but your son, Ichan, who was three years old, he had a near infection and you first gave him Ranbhakshi's version of Moksi Kla, which was generic. And it didn't seem to help at all. And the moment you shifted him to the brand name version, things worked. And this is something that has happened throughout the world and is known to doctors everywhere, like Iban in her book, describes in great detail about how in America, at various points in time, doctors basically knew their allies, study fear on the brand name version of a medicine. It's fine. But the moment you shift to a generic, either you adjust a dosage and give the person much more of it to make sure that you know, you have the equivalent amount of the drug or if it doesn't work. And in some cases, it took lives. And if it doesn't work, you shift back to the brand name version. And the political incentives are of course to keep the generic version as popular as possible because the government is spending 18% of GDP on healthcare. And generics are a big part of that. And in Africa, also there are these, you know, vivid reports from Iban and others of how everyone in hospitals knew that you have a bunch of brand name medicines in a corner somewhere for an emergency. But you give generics to the other people and they probably don't work. And runbuck scene particular was one name to avoid, but not just runbuck. See, like through this book, there are mentions of work hard and doctorate days and so on. The list is kind of almost feels endless. So at this stage, when Dr. Kumaris left, right, and you are left with your team and you realize why he's left, you realize that what is happening is criminal that is costing lives for sure. And that's in fact, one of the great examples of the scene in the unseen, where what is unseen here is actually incalculable. Like the, the lives lost or impacted through this, there's just no way to calculate it because a medicine did not work or because there was an impurity and it worked in the wrong way, there's no way. So what now Dr. Kumaris left, you are left with your team. What are you thinking? So obviously, I mean, I will know target at that point in time because they knew I was the one who actually collected that data, right? So they sent the internal audit group after me. The odd guys just, you know, they essentially sort of descended on my department state. They're almost like a month and a half ducked through everything they possibly could, didn't find anything. And then finally, I think what they did was they planted some, you know, you are in the IP table to say that I was browsing porn on my computer. That was the thing that they wanted to make an issue out of that somehow I was violating company policy. I was browsing porn from there were unfortunately, I also had an IT department in mind because you know, we were doing a lot of, you know, systems installation. So Sanjay Munshi was the guy who was a network administrator. He was the one who looked it up and found it that it was being planted from the corporate office. Once I found that, then I knew exactly what the game, he goes up. So I went to Brian and basically told him, look, can't work this way, right?
I mean, how would you like to work every second minute? You have to look over your shoulder, trying to figure out who's going to come after you with the dagger. It just doesn't work like this. I can't, you know, this is not a way that I will survive here. And he was fine with it. He was like, okay, that's fine. I said, you know, he asked me, what are you going to do? So I said, I don't know. I'm going to try and figure out something else to do here. So it's like, that's fine. You know, one day, go Monday, turn into things and pick up your personal effects. And, you know, the bubble set, your last and final, whatever the thing that, you know, what was old to you at that point in MSL. Why is that settled there? That was it. That was the end of it. And when you sort of landed up to take your things, you took the pictures of your kids from the dance, but you weren't even allowed to open it. No, because the problem was that the drawers actually contained a lot of hundred notes of people who were interviewed. You know, so my guys had done a lot of interviews. I had done a lot of interviews. And we had hundred notes of who we spoke to, when we spoke to, what did we find? The drawers actually contained a lot of those hundred notes. And obviously, that was not something that I was, they were going to let me in or lay my hands on. So I got to collect the Mishant's picture. I had some personal effects, you know, on the table that I, and that was it. They physically stood there and stopped. Yeah. So there was this HR manager, Nemus, who's above Ghanju. He was the director of HR and a security person, both of them essentially should over must show. It took all of like five minutes on Monday morning. I went in there. I took the picture. I collected my pictures and had some BMS personal effects on the table. So I took that. It took all of five minutes. They walked me off of there. Yeah, it's insane. No, I, you know, one of the things that struck me from Iban's book also is that as I was reading through it, I was entering little rabbit holes on the side, googling all the names of the people and thinking to myself that surely this person's career was, was over at this point. But they all continued to flourish in the farmer business. All of these people who admitted to these wrongdoings, who forged documents, whose actions certainly led to so many deaths, they all continued to flourish in the business. Unfortunately, that's the sad truth of how this industry works. So this has happened. And meanwhile, there's a lot of other cloak and dagger stuff going on within the company, little politics, like after DS Bra goes, brand tempest takes over a CEO and later on Malvinder basically takes over himself and in 2008, you know, the company is sold to the Japanese company. The FDA investigation is completely hidden from them. What do you do? So you quit, you kind of go back home and you had, of course, shifted back and back in the backage to Gurgao. So you're in Gurga not, not something I would, you know, necessarily envy being there. And there's an early part of the book, which mentions an interesting incident, which also I found kind of revelatory. And it's credit to Iban, I think, to put that incident in, because it does reveal character. It tells you a little bit more about what's going to come where she talks about the traffic accident, which you witness. Where your driver is driving you through a particular part of the road and you see that someone after an accident is lying there, injured. And your driver's instinct, as honestly, I think most people in India's would be, it's just a drive-on. Don't get involved with this shit. But you stop, you take the person in the car and bleeding, injured, whatever you take that person to hospital. And because the doctor asks for some money off front, you pay $7,000, $8,000, whatever it is. And you go away. And the next day at Runbhag's seat, the cops visit you. And they are trying to frame you for running over that person so that they can extract something out of you. And your HR settles it. Yeah, he makes him go. I don't know what he did. But he made them go away. Yeah, so clearly. So maybe the same Mr. Ganshu, I don't know if he-- Yeah, he was a bit of a Mr. Ganshu. So Mr. Ganshu was the head of HR. There's another gentleman who worked with him very closely. His name is Mohanah Hoja. Both of them were very well connected. And they made them go away. Wow. Fascinating. So you've quit. Now, obviously, you're the exponent. What are the different things going through your head? Because you've got a young family. And your skills, in a sense, the industry is not ready for them. So you're not really going to get a job right away in India. And eventually, you do with enforcers and all of that. And you have to move back to the US. But in the interim, you're setting in your basement in Gurgao. You're processing all of this. What's your state of mind? What do you want to do at what point do you decide that I can't work away? I can't let this rest. Two things I just said, I think that I did approach other companies offered my services. But they were not ready because they didn't recognize the value of what I was doing. Why do you need somebody who can do all of this stuff? We know how to do our manager on portfolio. So that was one. The second thing-- I mean, then I started looking at IT services companies, actually, to be with data conservancy as well. Again, it's the same situation. You don't need somebody to do the skill that I bring to the table. So never worked out. And so I started thinking about, OK, what do I do now? Because going back to the US was the option, but then moving my entire family back again, trying to start again from scratch. And even there, I didn't have a job at this point. I'd be enough to find some work and start again from scratch. It's not easy to do that. And remember, this is when in 2007, this is when the entire market collapsed. People weren't hiring. Nothing was really happening in the market. People who I knew were employed were essentially being laid off at that point. Why would you want to hire somebody who left you for two years to go more than to go to India? So what does he have to offer to you at that point in time? And there's so much other mayhem happening in the economy at that point in time. So it took a while to think through all of these things. That the trouble is when you're not focused on doing something productive, right? And your mind reflects back on the things that you've experienced. And I had nothing better to do at that point in time. The two other guys who came with me, the Nishikashtura and Venkat, they also in a very difficult position. So all three of us were in a really bad shape. But unfortunately, the thing is, one was the fact that I didn't have anything to do. Number one, number two was a factor. I'm the kind of person who doesn't react immediately. I reflect on these things and do all of it. And after that, I do something. And so my initial reaction was very simple. I said, fine, OK, I did what I needed to do. It ended. I have to move on. There's not much I can do about it. But then I started talking to Raj about this a little bit. So he used to be in the UK. So we should talk once in a while. And I was telling, look, is this it? I mean, you walked away. You basically said, OK, is this mine? I'm not going to deal with this anymore. I've been walked away. I lost my job. I've been done with our responsibilities here. A lot of these discussions over a period of time came to the point that I felt that I needed to do something more than just saying that I washed my hands off of the situation. I've done with my thing. And that's the reason why it took a while for me to think over this. What do I do? How do I do it? I also understand. I mean, there are a lot of people here basically who said, look, if you go out and do something and be public, realize that this is a big company. They have lots of connections. And by the time there was also anecdotes about boardroom brawls, the brothers beating each other up, dirty stuff. I mean, why do you want to put yourself out there? This was a counter narrative saying, this is how things get done in India. If you want to do something about it, just shut up and go about doing your own thing, reinvent yourself. There's nothing more you can do about it. So it took a while for all of this to kind of just state and come to a point where it was important for me to be able to do something about it. Yeah, in fact, just talking about the environment, I mean, whistleblowers in India, you haven't really flourished. I mean, you look at Manjunaath and others who were basically murdered. And he burns book, there's this other conversation she reports between Malvindar and Jay Deshmukh the lawyer where towards the end at one point, they are fighting and they're fighting over exactly this. And Malvindar tells Jay Deshmukh that, you know, I know where you live. And Deshmukh says, of course, you know, where I live, you've come home, you fool. And then he says that, you know, my brother founded the shifts in our whatever. He had relatives who had who was. So there are these kind of threats going around. And it's kind of messy before we get to the next part of the story where you send an email to the FDA or driven by conscience before we get to the next part of that. There's a little bit of amusing I have here. One is that when historians come in the show, I ask them about what they think of the great man theory of history. And this is, of course, something that people battle about where there'll be one theory that history is basically made by great men. And unfortunately, only great men will gender it because that's, you know, we've been, our species has been sexist and misogynist all along. And it's men who tend to make and write history. But one is that there are these men who do important things and the course of the world changes. And that's one theory. And the other theory is that no, there are currents of history. And the people who appear to be great men are people who just came along and wrote those currents. But things would have happened.
Anyway, now I don't want to ask you for your opinion on what historians themselves argue about all the time But it strikes me that it's a bit of a happenstance That events unfolded the way they did that run boxy was exposed that they apologize that we know that they did all these things Otherwise, it sounds like a wild conspiracy theory and all of it really comes down in a sense to one man And as you for example, not just one man But circumstances had you found a job immediately maybe you would have been diverted had you spoken with your wife And she would have discouraged you shortly correctly so because you got to be practical and And you did what you did You're absolutely right. I mean, I am a big believer in the seconds here I mean, I think that it's it's hubris to think about the fact that you know a man or a group of men Change the course of history. I don't but in this case. That's what I mean, it's my happens. It's kind of It's actually enabled you to do that right. I think the most important thing, you know, whenever I get asked about this right I was lucky I was lucky because for whatever reason in my life I'd very strong role models very very strong My dad is one of them. Rajas one of them. I think that That is essentially you know made me react in the way that I reacted But the circumstances are not mine The circumstances was created by a number of different people around it But they kind of accidentally like what did the infosil job came about just when you left the renvexie and you yeah I mean I see it's counter counterfactuals at all ways there right you can always think about contractors would have have been As aggressive but they I have an answer to the emphasis job question You see what happened was even while working for emphasis I Was working with the US FDA until a point where they essentially told me go get a lawyer you we cannot protect you anymore Right, I had no idea that this statute existed in the law Right for almost two years 18 months or so I was meeting with you know the US FDA inspectors You know answering questions in a what they were doing Helping them map out, you know what you know what they were doing. I mean the raid and Valentine's day raid and in Princeton A lot of this thing actually happened while I was still employed at emphasis. I was doing my day job at night I used to do this so who's to say that even if I got the emphasis job right away Yeah, after I you know after equate renvexie I wouldn't still have done that because you see at the end of the day I have to look at myself in the mirror and say did you do what you're supposed to do right Nobody can answer that No, but Raj can't answer it my dad can't answer it nobody can answer that they did the day. I have to answer that to myself Fair enough, but the other moment of happens to answer it strikes me is Early around if you look at account of actual when you're at BMS And you decide that hey, I'm in America. This is a dream of any Indian born in the 60s or 70s You know, why should I leave? Why should I go back? Let me enjoy myself here and and you stay back there And therefore you and your team is never at renvexie And perhaps when Raj Kumar warns his data he doesn't even get it. It's no there's no one to get it for him And that could also that could very well have happened I mean again, you know when you look back and say okay, well, I did it happen. Why did have to happen this way? I don't have an answer for that. Yeah, right? I mean if I had decided at that point in time, you know what? I'm on a fast track to become a VP at BMS I'm gonna stick around for another five years. I'm gonna become a VP very easily, right? And cushy life well-paying job, you know perfectly you know, so happy with my son There's nothing complain complain about right but some point you have to still ask yourself and I still have to ask myself okay At what point do you transition from being responsible to your family immediate family To your responsibility towards a larger society I don't have an answer That's a legit question for after you one covered was what is it an renvexie and I completely buy it at that point Everything was inevitably going to wear it here to you would have to do this I buy that but you may not have been a renvexie in the first place, but anyway, that's that's it's fascinating The reason I say this is his follows right so In 2007 I started a company here in Bombay, right? So it was based in investor in Massachusetts, but we had people here working And I grew it to you know a reasonable size as a CEO and a step down in 2012 a lot of lessons there as well The one of the reasons why that company did that well was because we were standing in the path of social change Industry was reinventing itself. They needed that skill. We just happened to be there I can't I mean I can claim success because I had a fantastic team. We did an amazing job But I can't take away from the fact that that exact model if it was two years earlier or two years late people don't have succeed Right, sometimes you find yourself in in the situation Right, and you think that you're the greatest things in sliced bread you're not You're just standing in the path of social change And if you stupid enough to think that you're the one who's driving get there's something coming for you Right have the humility to understand where you stand and by God's grace if you've been given the humility to understand and how to leverage that then you make something out of it Yeah, you spoke about how you know if you were two years too early or two years to late It wouldn't have worked and I just thought back to something like I've just moved house and we were unpacking a lot of old boxes and My wife came across this old article which came in business week in the year 2000 which was about me I had done this startup then called sonic town with a friend of mine which was basically iTunes plus my space what they went on to become You know we had got deals with record labels in the US that we would sell Digital music and I was making the case that all your CDs will be defund and everyone's gonna listen to digital music And I remember going to New York in the middle of 2000s sometime made a presentation to a bunch of venture capitalist impress some of them enough that they committed some money to us And then the NASDAQ crash happens and everything goes to hell So we were way before our time in a sense and it all kind of went to hell and I said okay never gonna be an entrepreneur again One could argue that in these modern times every creator is one But let's let's now get back to your story you're in your basement You boot up your laptop and you send an email to the FDA because you've decided that I can't keep this inside of me there's too much at stake. I have to let them know now What is that process like because like what did you expect like did you think that okay? It'll be a simple one step thing that I send them the details and they look into it and Things get sorted out what what what happened take me through the process of what then Because I mean my experience there collecting this data told me that There was a stake in it for the world health organization right because they were the ones who were essentially telling all of these countries and So the Africa that yeah, you know we can vouch for you know what you can buy from van Maxi It was the UK's regulated, you know medicines and health regulatory agency because they were also involved in buying a lot of stuff from from From the US FDA My expectation was that that they needed to know That this is what is the reality and they would do something about it in the sense that that you know either they would Be more diligent in terms of evaluating their information the companies providing In in their applications to ask for marketing authorization or they would come and do better inspections Right because I knew where the holes were at the point in time That was what my expectation were I got a very nice email from the world health organization saying thank you very much We look into it. That was in the end and of it you can never respond it You as you know over a period of time. I think what had happened was I managed to sort of build some confidence over a period of time because you know what I started sending them information bit by bit Because I didn't want to overrun them saying okay. I mean nobody would have believed Talked to be very honest with you and then this is exactly what happened So when I was told to go get a lawyer just before the raid but it was executed and I actually you know spoke to Andrew Who's my good friend right now and When I told him what was happening He thought I was crazy. It's like you telling me the largest generic drug company in the United States is selling all of these drugs With fudge data Are you telling me that you know this for sure? He didn't believe me to begin with right but over a period of time he also kind of you know Uh got got convinced that was true That would have been the reaction if I told you know the USF DRI'd a friend that look guys and you guys are not doing a right job You know This will be pulled over your eyes. They would have laughed me out of the room This was the largest generic company in the United States This was a company that actually had the first to file for the largest selling drug Lipitor 12 billion dollar drug Who's gonna believe somebody who's saying something like this right so I had to write to them over a period of time And then it kind of took a while for them to appreciate what I was saying Plus again, you know, it always comes down to one of two conscientious people right So there was this gentleman named Edwin Rivera Martinez who passed away, you know bless us all He was the head of criminal investigations at that point Edwin took interest in it I didn't know I met him along I mean after the case and then many many time many years later I met with him He was the one who took interest in us and then there was another later on The true hero of the story is this
lady who was a criminal investigator in the US, Debbie Robertson. Without her, this case would have unraveled. You know, nothing would have happened in this particular case. Yes, woman theory of history. Seriously, she's the one who drove this thing to solution to fruition. And if you meet with her, you will see, you know, I mean, she's no nonsense. She comes from the IRS, the revenue side walks with the, you know, wholesome, you know, the gun, you're all of the kind of person. I mean, she knocked heads, bunch of people, and made it happen. So again, it comes down to conscientious people trying to do the right thing, happen to be in the right place, the right time. If it was not for Edwin, it was not for Debbie. This case would have never resolved itself. So we were being in some dusty box of some places. Yeah. And it's kind of fascinating how it takes months and years to kind of unravel where it takes time for you to win their trust. And when they do their inspections, for example, the FDA has to carry out these inspections in India. And typically everywhere else, like in the US, for example, when the FDA does inspections, you've pointed out that they're all surprise inspections. So you can't prepare for them. But in India, because of visas and all that, the companies know well in advance. They know what to do. So everything is sanitized. These people are guided through. But because of the kind of inputs that you were giving, they now knew what to look for in which factory, what kind of data to look at and out of that. So when did the penny start dropping that everything that you were saying was true? After the first inspection, when they went to Pontasa hip in 2008, and then they found out that they were fudging data. Well, the first thing was very simple. Right. So so what happens is that when the US FDA comes to inspect at the end of inspection, they give you a report. It's called the form 4803. In the write down, what is it that they found other than on that inspection? So it's very transparent. They come, they do the inspection. They they're at the end of the inspection. They do a briefing. They get the senior management in a room and they tell them, look, this is what we did. This is what we found. It is a report that we're giving. Right. And so it's a draft report. It's not final. They give them an opportunity to actually provide feedback and then gets finalized. The first thing that is on the report is that when you walk into the the manufacturing facility at the gate, right, they have registers of who's coming and going. Right. They were telling the US FDA, there were certain people who came in and told, did all this work. There was no record of this people ever being in that. So you start with there, right. And then you start digging and start unraveling. Then you find the steam room, then you find stuff that is happening behind the scenes. So unfortunately, after the first inspection, they figured out that, look, this guy is not smoking, you know, pot or whatever what he's saying is actually true. So after that, I think there was some confidence that came in. Look, you know, he's saying what he's saying. So. And what's the process that now happens? Like in 2008 towards the end of that year, for example, run bucks, he sold off to the Japanese company. There also, there's this interesting storyline that, you know, Jay Deshmuk, who is, you know, legal representative is called into this meeting and he doesn't realize that it's over an acquisition. He thinks it's some kind of business deal. And he says, hey, no, no, everything is kosher and the FDA is just investigating some random minor thing. Even though they know what the FDA is investigating by now that famous PowerPoint presentation is with the FDA, it's been spotted on their desk and all of that. All of that has happened. And then after the sale happens, Jay Deshmuk realizes that he actually had, he known it was an acquisition, he would not have been able to pull off such a big lie. And that's when he and Malvin that have this fight that I know, who to go. And all this kind of crazy nonsense happens. And all these people are thriving by the way, just Google all these names from this book. They're all thriving. It's just shocking that these are murderers in my eyes. But anyway, so it takes many years, right? It takes many years. In that time, you get the job in emphasis, you have to go to the US, you know, leaving your family behind. And there's a pregnant scene that's described in the book. I don't know if you're comfortable talking about it, but your wife goes to the basement and you're holding your son and crying. And it's this whole thing where you transition from being a man with a career, he loves to be a man on a crusade of sorts with this larger cause. How does it affect your family? Jay Deshmuk, "Yeah, that's a tough one. That's a tough one. I mean, this look, you know, I mean, if you look at it today, right, you know, it's a broken family. There's the Mammadim Worsh right now. It did affect the family because, you know, you can't sort of continue doing this within and continue to live a normal life. It doesn't work that way. But you know, I don't know me at that point in time, that felt that I think for me to do. I, you know, it wasn't like, you know, I had, I didn't have a choice that I needed to do or not do at that point in time. It was a tough call, you know, when I left the, for the US to work for emphasis, I had think three-month-old daughter at that time. So, yeah, it was a tough, tough time." And then, Must have been worries about safety as well, like, doesn't interview of your wife's owner where she talks about how, when you told her, you took her to the Chinese restaurant and you told her that this is what I've done. And she had no idea to that point that this is what has happened. I've become a whistle-lower and she talks about how, you know, she took a sip of the soup and then you said, "I have something to tell you." And when she next took a sip of the soup, it was called, which kind of indicates what a shock it is to her also. And she speaks about how you gave her a phone number in the US embassy to call if there was ever any trouble because you felt the Indian police wouldn't help you. And elsewhere in Iban's book, it's mentioned about how, I think Debbie Robertson gave you the number that, you know, call the US embassy because you're a US citizen. Call the US embassy if there's a problem. And these fears had to be part of it because it was basically the people who, you know, once Renbexie realized that dossier, that powerpoint presentation was with the FDA and they physically saw it in one of the meetings with the FDA. I would guess it's you and Dr. Kumar who are those culprits and Dr. Kumar is sent a whale warning that you will be implicated in this. So you are a. Markman. Both of us, yeah. Unfortunately, you know what? It was a tough time. I don't know what to tell you. We had security guards at the finder home, but no amount of security buys you peace of mind, right? You're always kind of worried about, you know, what's going to happen behind you. She also went through a lot. I mean, I'm going, what can I say? Are there times when you think I wouldn't do this all over again? Or did you know what was going to unfold that you would have taken another path? You know what I was asked a question many times and I don't think, I can't think of, you know, whether I would do something different when it comes to what I did with the Renbexie thing. Now, what I did in my personal life, yes, there's always regrets and there's a lot. Because look, there's never an easy thing when you're dealing with people's lives, right? You can always, as I can guess yourself, could you have done things better? Could you have done things differently? Would you still have a family together if you had done that? Those are valid questions. I don't have answers to that, but when it comes to what happened in the Renbexie, there's really no choice. I mean, how could you sort of, you know, say no to what was happening, knowing well that forget about what is happening, Africa? I'm worried about what is happening here. Go outside Mumbai, right? Go outside, travel 40 kilometers outside of Mumbai where you don't have the Guardian Pharmacy, the 98.4 and then see what what what what is sold actually at the chemist shop or pharmacy shop. We have no systems in place. I you know, when I talk about recall and adverse events, people not didn't ever pay attention. You know what the pandemic did? At least people realize that there is something called an adverse event. You take a vaccine, you know, you will develop some issues around with it. Some people will have rashes. Some people will probably have a thrombolytic event, you know, that we have seen. Peace people know that, you know, what there is something called an adverse event that we have to record and report so that something can be done, I've done about it. Until the pandemic came around, nobody keeps. There's no awareness in the country around this issue. How do you build that capability in the country, right? I mean, we there are written documents, you know, Indian companies saying that if they're forced to recall a drug lot from the United States because it's a fair lot, they tell in writing that we are going to redirect it to the Indian market. How do you reconcile yourself with that? If it's a fair lot in the US, it's a fair lot. You don't redirect that to Indian market and sell it and make money out of it. There are companies that have made this representation to the US FDA because the law that acquires you to destroy that lot. They don't want to destroy it. They want to record it and take it away from and then distributed it in a market that doesn't have the stringent regulations. Knowing that, how can you not do what you're doing? Right? There's a quote in the book which is a variation on a famous quote about medicine. It basically every medicine is a poison. It is. It is. Under certain very controlled circumstances, it can solve whatever medical problem you have. Therefore, that control is important. Controlling those conditions, what is the rate of release, what is the level of the dosage? Is it a pure formulation? Are there impurities? Blah blah blah. Therefore, the processes and manufacturing matter. For certain sterile medicines which are made, if you're in a particular part of the factory, you're actually supposed to move very slowly so that the direction of the air doesn't change.
these are the kind of processes that matter. And here you have people like, just flouting it in crazy ways. Like there's another inspection that part of Iban's book focuses on this FDA investigator called Peter Baker, who, you know, for a series of years, did a number of, these inspections and became hated by the Indian for my industry. Because he always found what they didn't want him to find. And there's one factory he describes where the security guard was packing the medicines with his bare hands. This is a kind of bullshit that kind of went on. So all this starts in like 2007, 2008, whatever, around that period. And the case gets over in 2013. So it's like going on for five years and all of that. And at one level, it would seem that it's finally ended well to the extent that these guys run, Buxi agreed that they had committed all of that fraud, that they had fushed the data. They agreed to all of that. You know, a settlement was given of which you got a chunk, your lawyers got a chunk, all of that happened. But at the same time, you know, one of the things that I found incredibly odd that this is around the time that, you know, Lippit or went generic. And Randbeck's he had applied for to be first in line. And during the FDA, it became a big debate that we know that this is a fraudulent company. Do we give them the right to be first in line? And there were various incentives which were marked towards ignoring that and allowing Randbeck's he has eventually happened. They were allowed to manufacture that generic. And there were various incentive. Incentive number one is that, you know, US politics wanted it to happen because they want, they needed generics to come in. Incentive number two is that the way the law was structured. If they don't give it to Randbeck's he they can't give it to anyone else because Randbeck's he has that sole initial bite of making the generic. So it's all a big mess. And eventually they give it to Randbeck's he but then the judgment comes. But then what strikes me about the judgment is that fine it has happened. But fundamentally nothing has changed. So, you know, as far as Randbeck's concern, right, it was purely a monetary penalty. The pled guilty to seven counts of criminal felony, the payer who vote load of money. It's essentially money that they earned from selling Lippit or the one came the left pocket, turned around and gave it back to the government. That's exactly what happened. In fact, one of the reasons that were cited internally within the FDA is if we don't give them the right to give the generic, they won't be able to pay the settlement. That's just bizarre logic. These are logic. Sorry. You think about, you know, dysfunction in this system, right? This is purely dysfunction in this system. And you're essentially incentivizing a criminal saying that, look, you know, what if you don't do this deal, they're not going to be able to pay the pay, how perverse is that? Right? But unfortunately, you know what bureaucracy and systems all over the world work the same way, right? But the sad part about this whole thing is that there is no individual accountability. Company pled guilty, right? Company actually admitted that, yes, you know, this is a statement of facts. This is what we have done. We shouldn't have done this. You know, we were violated these particular statutes and this is because, you know, because of this we're playing guilty and then we're agreeing to pay the penalty. No individual accountability. Now, people will argue saying that, oh, it's a jurisdiction issue. It's a, you know, people overseas, we don't have jurisdiction. I mean, if you have the wealth to overcome, you can certainly overcome. Yeah, I mean, you have the company selling stuff within your own country, right? You know, you're your drug supply is contaminated with this stuff. If you want to make an example of it, you could have done that. But it requires well to be able to do that. And that particular time, they guess they didn't have. Unfortunately, there was no personal accountability for that. Having said that, the one good thing that I know has happened is that the Office of Inspector General did look at carefully. They change a number of regulations governing overseas inspections. They bought in a lot more transparency. They figured out that, you know, while the Ryan Backseat case was going on, they set up officers here in Mumbai and in Delhi as well, which obviously never functioned the way they ought to function. But what I'm saying is that they at least try to address systematic failures within their system. I just wish that we had done the same thing. I just wish that in Delhi, we would have done the same thing. We would have accepted the fact that, look, you know what? Whatever has happened has happened, right? We don't want to go back and look backward. That's fine. But at least let's look forward. Let's try and make sure that this doesn't ever happen again. Let's fix our systems and our processes and make sure that this kind of shenanigans never happens. I don't think that has happened. Sir, let's take a quick commercial break and then let's get back to talking about this because this might appear to be the end of a story. The hero goes and acquests the hero wins. The villain is punished. But it's not the end of the story. It's not even close. So we'll come back after the break to discuss all of that. Have you always wanted to be a writer but never quite gotten down to it? Well, I'd love to help you. Over the last year, I've enjoyed teaching my online course, The Out of Clear Writing and an online community has now sprung up of all my past students. We have workshops, a newsletter to showcase our work of students and vibrant community interaction with much stimulation. In the course itself, through four webinars spread over four weekends, I share all I know about the craft and practice of clear writing. There are many exercises, much interaction and a lovely and lively community at the end of it. The course costs Rs. 10,000 plus GST or about $150 and the October classes begin on the 9th of October. So if you're interested, head on over to register at indiauncud.com/clearwriting. That's indiauncud.com/clearwriting. Being a good writer does not require God-given talent. Just the willingness to work hard and a clear idea of what you need to do to refine your skills. I can help you. Welcome back to the scene in the unseen. I'm chatting with Dinesh Thakur on his long journey, not just about exposing the fraud at Ranbhaksi. But a lot more than that because what that fraud really uncovered was what are in a sense worst practices within the Indian industry itself and how that problem remains to be solved. Because that case happens, none of the individuals get punished, the company pays the fine and then is bought by Sanfama. And Iban's book shows how even in the years to come as Peter Baker, the FDA investigator, does his inspections and all of that, those malpractices continue. You sent me a bunch of links which I'll link from the show notes about how even now, even up till the current day, companies are basically getting away with what they can get away with that's a default approach. Even if the regulation gets a little better so they get away with less, they are still getting away with most of what they are trying to get away with and that kind of makes it problematic for us. So was there a point where after all this is over, after that decision was announced? What was it like for you? Was there a moment of great relief that this crusade is over? Or was there this sense of what now they solved nothing that still work to be done? Yeah, I mean, I think that obviously there was a sense of relief because, you know, clearly, you know, something that you're dealing with for eight long years, at least sees a milestone of some kind, right? So it was a, you know, huge sense of relief and, you know, it was a chapter closed, you know, if you can say that way. But I think what was also important was that, you know, what made me think back was this when the news broke. There was a lot of coverage here and in there as well because, you know, this was, you know, you know, what news would event. There was a lot of coverage and there was a lot of pushback from the sort of experts who kind of, you know, are aware of what the industry is doing saying that, you know, oh, this is a whole lot of, you know, think about nothing. This is all all about documentation problem. It's just that, you know, this company did not document the way that, you know, was required off the US FDA and that's the reason why they were fine. If you go back and look at some of the coverage and some of the discussions that actually happened in around that time in 2013, that was what it was, you know, so just sort of distract as much as possible and not let it linger, right? So the question actually came, you know, to me was, okay, fine, you know, if that's the approach that you're taking, then the only way to rebut that is to collect data and present it in a way that kind of, you know, provides a different narrative, the real reality of what is really happening. So with that in mind, you know, I was introduced to my current colleague on my board right now, Prashant Radee, who is intellectual property lawyer, but, you know, has deep knowledge of the drug regulation and the regulatory affairs. So he isn't here and I've been working the last five, seven years right now. We went, we essentially sort of, we set up a project to collect as much data as possible to try and make our point because most of what was admitted by the company in the settlement agreement with the US FDA was pertaining to the US market. There was nothing in there about India, right? So we spent almost two years, you know, filing RTIs, collecting data, building a case, basically saying that, look, the problem that we have is our drug regulation. This regulation that was, you know, sort of established even before we became independent, Drugs and Cosmetics Act, it really needs to be overhauled fundamentally because there's some systematic problems with them, like everything else in history, right? The act is referring
reflection of what was prevailing at that point in time. We had princely states, which essentially were, you know, asserting their independence about what they needed to do. Most of the issues we were dealing with at that point in time was with import of drugs, because we didn't really make anything, right? So the act that the center was written primarily to regulate imports and they gave a free hand to various states to do what they needed to do. So over a period of time, this, you know, this sort of, you know, disjointed system became so cumbersome that right now that the statutory bodies that exist within this regulation, their purpose is not to speak for public health. They actually exist to try and throw hurdles in progress. And the only way that you can, you know, address that is to make a fundamental change bottom up to this regulation. So we collected a whole bunch of data, developed a public interest litigation, went back to the Supreme Court in 2016. Sadly, the court didn't entertain our petition at that point in time. So, you know, we continue to do what we need to do. So we have a bunch of cases in various high courts. We have one couple of them in Delhi high court, we have in Kanada High Court, because you know, unless the regulation changes, right? And the regulatory structure changes. It's going to be very hard for us to think about, you know, the quality of medicine in the country, right? I think that we have so used to this fact that, you know, we accept the quality that is given to us without questioning. And we have no data to understand what the long term impact of this is, right? I mean, today, people are put on anti-hypertensives and they take it for years on end. We have no data to actually understand what is a long-term consequence of taking poor quality anti-hypertensives. What really happens to people? We just don't know. I can say that they're bad for you. Somebody else will come and say, no, how do you know it's bad for you? We have no data, right? So unless we have real good scientific data, it is going to be very hard to make an argument that look, we know we need to make some fundamental changes in the way of medicine is practiced in the country. And so that's what we do. I mean, even today, in most of our efforts that essentially geared toward try and collecting information to build a case that we really need to look at this area. And I've said this another place as well. You know, public health in India is not about access to qualified doctors. We just don't have enough doctors. I mean, yeah, I mean, in Mumbai, you do, in Delhi, you know, in Gurgaon, we do. But go to Western Europe, you go to Bihar. You know, go to any Jharka and go to Shatisgarh. Our first line of defense is somebody falsely, they walk up the stairs of the camera shop and says, can you give me some medicine to make this thing go away? That is our first standard defense. That's the public health right now. We have poor Asha workers who don't even, not even employees, we pay them an honorary area of 2500 to piece a month. And we ask them to in to to not kill it in new bonds and give vaccines. That is the extent of our public health. We've seen what has happened in the pandemic, right? We've seen what the consequence of our poor investment in public health is. So we really need to think holistically about what does it mean in terms of access to medicine? And be honest with ourselves, okay, are we okay with this? Are we okay with an industry that essentially is taking us for a ride? Are we okay because we have the ability to buy imported medicine or we can go get arts treated in Singapore and get the tooth extracted or go to Mount Sinai to get our cancer treated? Is that okay for the rest of the country? And that is a question I think nobody can answer, but yourself. At the end of the day, you have to answer it for yourself. So a couple of questions, but before that an observation you mentioned sort of long term effects of say taking anti-hypertensive medicine, but I think a point that is worth underscoring for the listeners is that there is a scene and the unseen effect to bad medicine getting out there as well or medicines made in this way getting out there as well. And the obvious and seen effect though, this is unseen, but at least it's easy to think of conceptually that if a medicine isn't made properly, it can number one not treat the patient in the way that it should and number two, it can have an adverse side effect and it can kill the patient. But what it can also do is over a period of time if you have substandard medicines going around then pathogens gain a chance to actually evolve and mutate and become much worse. And also what happens is that doctors who are used to generics not acting properly might tend to over prescribe them to compensate for that. And then that can for example create antibiotic resistance, which also becomes a greater problem later down this line. Have I ever stated that correctly? - I mean, we see that because remember tuberculosis is still an endemic to us, right? This is not disease for wealthy nations. This is a disease for us for poor countries like us. And look at how tuberculosis is mutated. You know, we had in the original strain of the bacteria and the pathogens are actually created tuberculosis, right? And then now we have multi drug resistant tuberculosis. It doesn't respond to the standard care that we use to actually have. And we've gotten to a point right now where we are using super potent, you know, class of drugs called carbopenemps because none of us standard of care and about it actually work to treat multi drug resistant tuberculosis. What is going to happen if they become resistant to that, you know, in the 10 years from now? - And you've pointed out that there's a similar trajectory to malaria and anguianol as well. - Absolutely. - So here's my first question to you that before talking about the work that you do and trying to get the regulation up to scratch, if I ask you to define what is wrong with the Indian pharma industry today, like we've discussed what Renbux seeded wrong, right? Now what you've pointed out and what Iban's book points out is that those were at least at the time endemic within the Indian industry in general. She's mentioned companies like Wacard and Dr. Reddy's and so on and various other companies. Those were endemic then. And you know, I read out that passage of how so much data was invented, falsified. There is even this amusing story of when someone in your team was talking processes and they said that we'll build a software which gathers together data like this. One alarmed person listening to that turn to his boss and said, but how will we back date documents? And I found that hilarious. Has that culture changed or does that culture still exist? Is data still being falsified? Is a lot of the medicine that we are getting in India still substandard and unreliable? - So again, I cannot make a blanket statement, right? Because I have to back up whatever I say with real examples. I mean, if I make a statement without that, then the industry will come after me, which is fine. But I think it's important to back up what are we to save with data. The same industry that makes medicines for Indians, makes medicine that actually sells in the United States, right? It complies with their regulation. It makes sure that when the US and the FDA inspectors come in, yes, I mean, they were problems, but they're fixing them. They're training their people better. They're trying to make sure that the equipment is at the standard quality. They're making sure that they're cleaning between making batches of different products so that you don't have cross contamination. They're doing all of this right now. But they're doing it for the export market. A few hundred yards away from that factory is another factory that makes medicine for Indian market. They don't even use distal water. They use tap water to mix that, that is, the chemicals to now create the product and punch tablets in it. And you know the quality of the water, the general water that we have right now, the microbial contamination that we see. Why does this happen, right? I mean, why is it that even as late as last year, we had documented cases where the US FDA puts out an inspection report saying we found, when we came to inspect your facilities, that your people were shredding documents. Why do you do that? If you're doing everything by the book, why are you shredding documents? As late as last week, on 16th of September, the US FDA has now for two contract research organizations, once in Mumbai and once in Amdaabad, they've essentially reworked all approvals gotten from these two contract research organizations because they do not have confidence in the clinical data that they're supplied. Why does that happen? Ranbackseem is 2013, right? We're in 2021. Say, it is now. Why do we still have to deal with the Wimter Labs, which was the genesis of the Ranbackseats situation, a contract lab that was fabricating data? It is happening right now. Last week, US FDA revoked licenses for two different CIROs, once in Mumbai and once in Amdaabad. So it clearly is happening because there's something going really wrong, right? Otherwise, why would they do that? Now, I am yet to find a single instance of a publicly reported inspection report done by our regulator that says that we found that documents were being shredded, that patient data was being fabricated. Now, I can interpret it one of two ways. I can say, well, never happens, right? For India, they follow the book, everything happens great. Just my experience tells me that's not the case. So the question that I have to ask myself is is why is it that our regulator cannot find these kind of violations that the US FDA finds, that they. The European Union regulator finds a French inspector finds. What's the answer to that? We just not incentivize properly. How do we change that? First of all, I think that the governing law, the Drug Exam Cosmetics Act, was written for the 1940s. It was written when we had a very limited number of drugs and actually lists out the number of drugs in the appendix of that law. And the kind of diseases we were treating them were essentially infectious diseases. We were dealing with typhoid. We were dealing cholera. We were dealing with malaria at that point in time. Look at the prevalence of diseases today. Majority of the diseases that we are dealing with right now lifestyle diseases. Diabetes. They're the diabetic capital of the world. High-pertention. On college, you can't simulate diseases. So what I'm saying to you is that the premise of the reason why the law was framed has changed completely. Science has changed. We have never caught up with it. We have never caught up with the situation. It's not like every drug they make is a bad drug. It's not. Many drugs that are manufactured by Indian farmer companies for the Indian market because the way physiology works are just fine. You take an antibiotic. If you have the right dosage, I'm telling you if you have the right dosage, that's the biggest issue that we have here, which is don't know what the dosage is. The antibiotic just works as fine. So if you have an infection, an antibiotic, kill something. The passage in this causing the infectious diseases is new. Problem is that if you have anything to do with psychiatry, anything to do with mental health, anything to do with hormonal treatment, like if you have thyroid medication that you're taking, anything to do with your hospital and you have an autoimmune disease like Dupas, or if you've undergone some kind of organ transplant surgery. These drugs act in a very narrow band. You really have to get the right dosage. And if you don't have control over the right dosage, unlike antibiotics, we see large and disproportionate side effects, which are systems are not capable of catching right now. So if you don't catch those, if you don't report those, then how can I make an argument that things are not working? Let's double click on the bit about how our regulations were designed in 1940, when that act basically came about. How would you change them today? So there are a couple of different things that we have to look at in multiple layers, right? Remember, at the time the regulation is framed, health according to Indian Constitution is a state subject. We have heard this many, many times, right, not even the pandemic. Anytime you talk about central governments, response, the responses, health, health, state, subject, go top to state, right? What has happened is that parliament delegated responsibility for drug regulation to the central government. Central government turned around and delegated back to the states. Now, you cannot, I mean legally, an authority that's given to you without the explicit permission of the parliament, you cannot sub-dialicate. That's a major issue that we were going to continue the court unfortunately didn't go down that way. Number one, number two, most of the drugs that are manufactured in the various states are governed by state drug regulators. What happens is that these state drug states actually derive manufacturing license revenue from these states. So why does most of our drug actually gets manufactured in Himatial position, but the, or why does most of our API gets manufactured in Hyzerabad? It's because we have specific tax incentives that we've enabled this company to set up this special economic zones where they go ahead and manufacture their medicines. Now, here is the big issue with us, right? Because state, health state subject, a drug regulator in Karnataka, right? Who finds out or Maharashtra, who finds out there is a specific batch made by specific company which is located in Himatial Pradesh has a product that is not a standard quality, which is what we call adulterated drugs in our parlance here. What does that person do? There is no jurisdiction for any drug regulator in Maharashtra to go and force it. And this is not hypothetical. This is actually happened here. This is happening right now. The drug regulator in Maharashtra will find and flag drugs that are not a standard quality. But beyond flagging those is nothing. The drug regulator in Maharashtra has no jurisdictional control over what is happening in Himatial Pradesh. All he can do or she can do is write a letter to the Himatial Pradesh drug control and say, we found this batch that is not a standard quality. And that person will once they get the letter or components rid of the basket. Because for them, the revenue from the licensing is more important. Incentive there is about generating revenue from the licensing authorities of the manufacturing facilities. Now, did we imagine this when we wrote that, obviously not, right? Things have changed. Another simple example, right? How we think about quality, right? Quality in the rest of the world is thought about as a part of the process. So you build quality by design. That is our concept of how we think about quality. Every step has a measure that you measure quality. The way that we think about quality in India is the final product. We don't care about how you manufacture it. The way that we think about quality is that every state in the union actually has a state drug regulatory authority who has a budget. And it's as patents. We've kind of done RTI work on this, incipitants. That budget is given to a state drug regulatory tradition. Say you go and buy medicines from retail outlets. And then that samples are then sent to the state drug labs who then analyze that. They tell you which of a standard quality or not. Our definition of quality is the end product. It's not the process by which. Why is this important? The reason is important is because initial quality and the quality before the product expires is very different. Think about when you buy a car. JD Power Associates actually measures quality of what they do. Say initial quality. Not after you ridden the car around 200 miles and then come back and check the quality of the car. There's a difference between those two. Initial quality is very different than what is on the market. Now when the inspector goes out there and actually buys the product, do you know that you're getting a batch that is recently come into the market? Do you know that the batch has been sitting out there for the market for two years right now? It's no idea. Number one, number two, this is the biggest issue that we have in the country. When we adjudicate something as not of standard quality, we only look at the active ingredient. And I'll tell you why this is really important. So when you think about drug quality, when you make a formulation, when you make a tablet, a capsule, a liquid, whatever that you want to make, right? The chemical of the biological that actually in there that is active, that treats the ailment that you have is only one part of it. There are other things in there that are fillers, right? For example, how do you take powder and make it look like a capsule? You have to put some binder in it, right? And then you put a lot of pressure in it to make it look like a tablet. How do you take a bitter tasting chemical and make a syrup out of it and make sure the kids actually drink it because you add sugar in it, you add sucrose in it, you add some flavoring in it. These are all what are called ecipients. Our testing protocol, as written in the Drugs and Cosmetics act, only looks at the active ingredient. It does not look at the ecipients and what really happens to them. The reason it's important, and this has been very recent, is that there is a class of drugs called sartans. These are essentially prescribed for cardiovascular diseases. It's been found that many of the sartans actually have a small carcinogenic, impurity colon DNA. It's been written up. Please, please, please, be written up as well. If you're not looking for impurities to begin with, how the heck are you going to find this? You're only measuring for what is active ingredient. When we adjudicate our drug quality in terms of what we consider good quality drugs, we don't even consider impurities. So there's systematic issues of this nature, which really have to be thought through. So just the world looks at impurities. They look at related substances. They say, look, if you have these impurities over a certain threshold, it becomes not of standard quality. We don't do that because it's not written and not. So I'm just giving you certain examples here. We really need to take a step back. We really need to do this. And think very carefully about what is it that we want our drug quality system to be? Because as a country, we only talk about what the central government spends in terms of health. We have some number, two, percent, three percent. We never account for what our auto-pocket expenses are. There is no accounting for that. When you know health care is primarily paid out of pocket in the country today, we spend a lot of money on health care. Look at the quarterly earnings of all the farmer companies. You'll know exactly what I'm talking about. So here's the thing. We take that step back. I can see that OK, number one, what needs to be done is that you can't just say it's a state subject. You need a central regulatory authority, which can then regulate the entire country. So if we film Maharashtra, you find out that some medicine manufactured in Himachal is a problem you can fix it. That's number one. Number two, you need to modernize the laws beyond 1942. For example, you're not just looking at it.
active ingredients. You're looking at expensive. Yeah, impurities. Yeah, you're looking at all of that. Let's see. You modernize them in every way. You just gave one example. You'll still run into what I will take inspiration from you and call the Toyota Corolla problem, where you have described that back in the 2000s when you were at Randbex, they were some drug which went to CDSEO, which is the Indian version of the FTA for approval. And the Toyota Corolla, a new version of the Toyota Corolla had just come out. And basically those guys were going to pass it if that Toyota Corolla was given to them. Now, this is regulation in India. It is as cultural and essential a part of Indian regulation and Indian law that all regulation and law essentially the purpose of it is not to control some desirable social outcome. But for all practical purposes, it's rent seeking. So how would you get passed the Toyota Corolla problem because it seems to me at a deeper level and we can of course go to the root causes of that as well. But at some level, it's a cultural problem at two levels. One is it's a cultural problem within companies, within individuals, within society of the Jogaru mindset that I have to comply with X regulation. Let me figure out how to game that irrespective of what the purpose of that regulation might be. And the other on the part of those who govern us is this rent seeking mindset that I have power over people. How can I use that power for personal profit? And when you put these two together, you know, it is it is a conundrum. There's no question about it. The only way that I have thought about this is you try and make the process as transparent as possible. Right. I'll give you a simple example when coaxing was approved. Right. The CDSCO had a subject expert committee which looked at the data and said you can give it emergency authorization. Right. Same situation happened in the US. The US FDA gave emergency authorization to the Pfizer and Moderna vaccine. Two examples. On one hand, the US FDA basically said here is the list of experts that we are getting. We are going to do an open meeting. You can slice streaming. You can dial in, listen to everybody. What questions they ask. You may agree. Disagree. But it's a completely transparent process. At the end of which, they will vote and they will make a recommendation to the US FDA. What they should do with this particular, you know, vaccine candidate that Pfizer has given us. In our case, not only did we not know who the members of the committee was, we have no idea what the deliberations were. The outcome that was put out is basically like a two sentence thing. It is so opaque. Now, why is this a state secret? Right. Mollini Isola who works for Ada and she had to fight arm, you know, basically in Siddharth and they had to fight and to try and get names of people who were actually a member of that subject expert committee took them two months to try and get their names. Okay, tell me why is this at a state secret? Shouldn't the people of the country know who are the poachies experts and, you know, they're actually making a decision the impact that is the country. What data is it that they're looking at? US FDA put the portfolio out there and basically said, here the patients who are enrolled, this is how long it did study went, went forward. This is what we saw in the clinic. We still do not have a published paper on coaxial. We have preprints. Now, after in nine months, we have to, so the point I'm trying to make to you is that transparency, I think, is one big thing that we need to accountability comes in when you make things transparent. So, right. Build it in the regulation that, you know, when you establish a advisory committee, the membership of the committee, the documents that they review, the their deliberations, and the outcome, whatever recommendation they make, pull it on the web within a reasonable time, day to day, whatever it takes, you know, for you to be able to do that. Let people have added, right? Why is that a state secret? Bring transparency into the process. I will tell you, like, you know, one of the things that we did, the Parliamentary Standing Committee in 2013 had identified a set of four different drugs, you know, that they found there was some hanky-panky going on there, and was written in the Parliamentary Standing Committee report. And one of those drugs is a drug called bucclasing, okay? In India, it's marketed for as an appetite stimulant for children. There is zero data for this, zero. None. So, we essentially sort of, you know, followed through with the drug regulator to tell us, you know, one work basis, did you approve this? Never did, okay? They never gave us answers. So, we have to go through the RTI process, the Pellet process, the Chief Information Commission process. Finally, the day before the CIC hearing, at 7 o'clock PM at night, Prashan gets an unsigned copy of that report that names three former DCGIs by name saying they're the ones who essentially, you know, sort of committed fraud. It's still not signed, and we still don't have the actual sort of the deliberations of what the interviews were done by the Mahapathra committee report. We are litigating in the Delhi High Court right now. Why this lack of transparency, if you're following science, if you're doing your job, make it transparent here? That drug does not have, it is sold to children as an appetite stimulant. It's zero data for it, 15 crores, and you'll turn over for that drug in India today. It's been two years in Delhi High Court, we are litigating this. So, Mahapathra committee was established by Dr. Harsh Varthan, was one of the good things that he did. After the parliament standing committee report came out, he instituted a committee under the leadership of Dr. Mahapathra. He did the investigation, and he made a report. They sat on that report for years, and the strongest along for years, and finally, you know, after going through multiple levels to the CIC level, the day before they give us a report, the science and report, and they don't tell us who all they interviewed. You want to know, why is that a state secret? If a company selling 15 crores water stuff to children, without any clinical data showed the drug actually works, don't people in this country have a right to know why they're doing this? Transparency is really important. We need to bring in, you know, transparency into the process, into the system so that people can be held accountable. At the end of the day, you know, the CDSEO or the directors there ultimately work for people of India. If they're making decisions that they know they're not in the interest of people of India, people of India need to know that, right? Why hide this kind of stuff? It just strikes me thinking aloud that maybe one of the things that this needs, it might even be an inept sort of comparison to draw, but it just came to mind that maybe the drug industry needs this near-way moment where you need a particular case that you can focus on and that case can evoke horror and empathy from people all over the place and then change can happen and that almost sounds like a horrible thing to say because you're all because I'm sure that there are bad things that happen because of this, not just with this one drug, but so many other drugs. You know, is there then an attribution problem that say there's a side effect, someone dies, but you can't attribute it so easily to the medicine because the medicine as it should work would never have caused that side effect. So, you know, that all of this kind of goes unseen. I mean, I wish, I wish what you had said was true. I'll tell you another anecdote. Earlier this year in January, 12 children in Jammu who consumed cough syrup succumbed. It was causally linked to this cough syrup made by this company called Digital Vision based in Imacho. They had mistakenly substituted ethylene glycol for diethylene glycol. Once is an recipient, the other one is antifreeze. Investigation was done by PGI and we are in Chandigarh, qualified people. We're dedicating in court right now. This is the fourth instance in India, fourth. So, where's the outrage? Where are the people writing about it? Like it's, it's, it's, it's, it's, it's, it's, it's, it's written, I mean, Indian Express, it's written extensively about the Priyanka's written it. The point here is that we don't care until it hits home until it hits, it happens to me and my family, there is no outrage. Those 12 children were essentially children of people of laborers who lived below the poverty line. God forbid it if it happened to somebody who was, you know, in Delhi, in one of the post colonies, a different colony and and and our friends colony, you'd have seen the outrage. It happened to this 12 young kids whose parents were laborers in Jammu. And we're, it's been written, I mean Priyanka's writing about it, you know, Anu's written about it, provides written about it in Indian Express, she did multiple stories on it. We, this is something that we think, okay, okay, I'm a little bit less, it's not me who's affected. Somebody else has affected. This is not the first instance, fourth instance in India, Lenten Commission report, Lenten, this happened in Mumbai. We had a feeling like all poisoning and Mumbai in the 1950s. Justed, Lenten actually held an open inquiry, open inquiry here and made recommendations that we have, how we need to fix it. Same stuff happens in Chennai and now happens in relationship and happens in hurry.
on 10 years. Why? I have to confess, I missed all these reports. So in any of these cases, a causal link has been found where does clear mile practice has anything actually ever come out of all in cases where so first of all our legal justice system is such that you know things drag on forever nothing goes anywhere. They have been cases when they actually have proven drug inspectors have proven a causal link with something bad that has happened the outcome has been and I'm not kidding you these are actual judgments of Indian courts. The punishment was stand in the court until the court rises. So this is the kindergarten judgment that just keeps standing till the court rises and then go and that's it. That's it. People have died and that's it. Argument was an elderly person he didn't know what he was doing. RIPC has so many holes. I don't even know where to begin. I've seen judgments that basically after great effort some drug inspectors gone to the persisted to the entire process. Prove that there was malafide intention negligence in the part of the manufacturing. Guess what the judgment is? The judgment is stand until the rising of the court. Yeah, this is even worse than what I expected because I thought that what you'd probably get is that even in that rare case where a company is actually punished. There's no systemic change. One company somewhere is punished. Maybe some individual somewhere. This of course is even worse. They aren't even punished. They're made to stand in court. But I mean what message do I be sending? I mean there are guidelines that are written that the US that the CDS here is issued that basically says it actually advises the court that if you in case a judge that there was a problem there was something really bad that the manufacturer did don't impose too harsh penalty. This was written by the recollectors. It's like, what's killing you? And they stand and the judges read them and take that into consideration when imposing penalties and sentencing. How do I justify this? Lentil Commission, Mumbai, you know, seven people died here, which I know we had like 12 or 13 people died. The Khamparjana, you know, in Jinn they had the same situation. Who is it possible that we continue to mistake an recipient for anti-freeze? I don't get this. And there is no accountability. None. This puts into perspective the kind of environment that you're trying to function and that you're trying to reform. Tell me a bit about what you've been doing the last few years, you know, since red judgment to make things happen. Yeah. So I mean the only thing that we can do is collect data, right? And argue. So we are in Delhi high court arguing about transparency. We are in in Kanadak high court arguing about bukeluzine and in this entire situation around that. The other thing which is really important, which I think is really important is that we need to now create an environment where I'm not the only person saying this. We need the academia to start paying attention to this. We need, you know, other activists who are invested in public health start saying this. This has been the biggest disappointment for me over the last three or four years. I just don't find aptitude within an account with an R Academy in India to actually do real research. I just don't find that. I'm sorry to say. So, you know, as a part of the foundation, we'll be trying to look for people to give grants to study public health related issues. It's extremely hard to find people who want to actually do real work. Okay. It's extreme. I mean, in the academia, you find professors and say, okay, we'll give you a grant. Please study this area. I'll give you a very simple example. There are tons of studies about effectiveness of the ASHA programming which is essentially the basis of our public health, the country in rural India because, you know, vaccinations are run by them. Maternal health is run by them. There are lots and lots of studies. There isn't a single study so far of how we deliver public health in urban areas. Migration is actually making people move from rural areas to cities like Mumbai. Right? We have a couple of different models. We have a Mohalah clinic, Maalodin, Delhi. We have a good model here in BMC actually, it runs a reasonably good model. There is zero academic studies evaluating the effectiveness of this program. Isn't this important? As a country should we not pay attention to five, you know, maybe this is a great program. Maybe you're doing very well. If that is the case, let's replicate them. Let's copy what these guys are doing and put them in all the other cities in the country because it's not just Mumbai that has a migration problem. Every city in India has a migration problem. Right? And if the model at BMC is running is so great, let's take that model, lift it and put it in their cities and tell them guys, if you do it this way, you get better outcomes. Right? Don't shouldn't we study that? Not a single study. Why is that? I can also say that, look, problem is, funding is also an issue here. Getting government to fund these kind of studies is next to impossible. The funding process is so mild and in approvals in bureaucracy that you just sit, wait, apply for a grant and wait for years to the government to be able to fund something like this. But then, you know, we have to change our mind, our change our perspective. Right? The government says, you know, we're going to take two years to evaluate a proposal. Don't make it hard for private funders to fund it. Is it hard for private funders to fund it? Really hard. Because of restrictions on foreign countries. For funding, right? I mean, there is an organization here in Mumbai that we wanted to support. We wanted to give a grant to to study the BMC model. It's been eight months they're waiting for approval from the health ministry to start the funding. And why isn't the approval coming? Who knows? So they won't solve the problem. They won't let you solve the problem. What do you do now? Right? Fine. You know, you don't have the means to be able to do it. I understand that. Okay. Maybe you know, your processes are, don't question the intent of other people who are trying to do the right thing, right? I mean, you're not saying that we are going to come and dictate what, you know, what, what, what you want to do. All we're saying is this is an important thing. Let's study it. You know, we've the organization that gets the funds has a free hand to report what they need to report. If it's a good thing, let's take that into consideration next time you make a budget. Replicate this in Nakhpur. Replicate this in Pune. Right? And if it's a bad thing, fix it. Right. Why do we have such a huge reluctance in studying our systems, right? Documenting with data. Why is it so difficult to do this? We don't want our NSS so to study economic data. We don't want that health ministry to study health data. How are we making policy then? And these are like, you know, simple things, right? Look, Aayushman Bharat is a gold mine because you know, the program has been running for a few years right now. We know how many people have been enrolled, right? Why don't you open up the database to, you know, academic research is and say find out what is the real benefit? How many people have actually claimed the five lag benefit? Should, wouldn't you want to know? Right? Would you want to, this government data, right? Happens in the US, the center for Medicare services, every quarter they do a data dump and pull it out there and say, go knock yourself out. Why is this a state secret? So I'll throw back that question at you and change it from a rhetorical question to an actual one and maybe offer possible contender answers and I'm sure the answer is very complicated. But why is it a state secret? Why does a state have this attitude like at one level it is of course inertia at one level it is this reflexive thing of protecting that turf, you know, why let outsiders in? Why have to go through that shit and so on and so forth? But yeah, but beyond it being a rhetorical question, what would you say? Structurally, you need people who want to do this. I mean, there's no other way, right? I mean, I worked very closely with Keshav Desiraaj who just passed away. He was on the board of my foundation. We need people like that. Very progressive bureaucrat who wanted to make it change on the ground. But you know, to me, not a satisfactory answer because whenever people say we need people, we need good people here or we need good people in politics or we need good people wherever where I always go back to is that people will come if the incentives are there. So, you know, to me, that's a quote problem. I mean, even going back to the academic thing, if there are things that academics don't want to do, the question that I ask is what are their incentives? Why don't they want to do this? And of course, one you've pointed out is that it's very hard to get government funding for these kind of studies and all of that. That's legit and equally even if someone like you is to fund it from outside, it can take months, years or never for that to kind of get through. But I'm just trying to then solve that deeper and this is of course a question that's working at many levels. What are the incentives of academics? What are the incentives of people in the government to stop this? We kind of know that the reflexive thing is status quo bias, we protect your turf, all of that. No, no, you're right. I think I'm not saying that people are the only solution. I think that systems have to change as well, right? Part of it is also making sure that the way that we think about health is cannot be only when we need health care, right? That's the way that we know
normally think. We only think about hospitals and health is when we need it. Normally we don't. Tell me the last election where healthcare was an issue that was actually really related between state parties. I can't remember one. So the point here is that you need to first create awareness. You need to first educate people. I'll tell you a really interesting episode. I always use this as a really good example when I talk to people. Atul Gawande had written this piece in the New Yorker. It's an excellent piece if you maybe should look it from your show notes. He basically compared the progression of two different medical procedures. One is anesthesia. The other is antiseptic, you know, sorts of stuff. So this takes you back to about eight early 1800s. When there was no anesthesia, even if you had to do tooth extraction, you'd really have to do it quickly because it was really painful. In those days, somebody at Mass General, one of the dentists actually went up to the surgeon and basically said, "I found something that actually will numb, pain down." Obviously he thought was the one that was used to get people to smell ether and then it knocks just out any tooth extraction. He did surgery. But that spread like wildfire. Within a few months, pretty much every hospital began using that as a procedure for essentially making sure that patients don't suffer much. Then he compares that with antiseptic behavior. There was a time when the scalp, scalp, and instruments were not sterilized. That was the cause of loopers in a septic shop. People went into septic shop. He talks about how Joseph Lester using carbolic acid basically came up with this concept that if you wash your instruments and your hands and everything else with carbolic acid, you kill the germs essentially from causing. That never took off the same pace as anesthesia did. It compares why. In the center of why, the fact is one is very visible. You have a patient who is shouting really bad because you're under a lot of pain. You don't see the germs. surgeons don't look at the germs. They don't think about it. This is the times when aprons covered in blood was a mark of that you were doing so many surgeries. You were a good doctor. You did so many surgeries. People don't think about the fact that you need to change your apron. You need to change your gauzes. You need to wash your hands properly before you went into another surgery because if you're peered as somebody with blood on your apron, you were a really good doctor. You had a really good practice and people came to you. The incentive is very different. What he talks about is that look, because anesthesia is so visible to people, the patient is screaming in pain. The adoption was so much faster. It's not like antiseptic behavior was any less effective. It was equally important because people were dying of septic shock. Of the fact that people were getting infected because you wouldn't have clean procedures. And carbolic acid and josephalistus work actually proved that if you did that, you'd save a lot of patients. But because it was not visible, he wasn't a doctor as quickly as it did. I come back to the same thing. Health care is not visible. We don't think about healthcare. We don't think about a doctor. We don't think about going to real estate hospital unless something really bad happens to us. This is such a fantastic and profound point. Along with carbolic acid, there's also the resistance that ignores semilvice found where when he spoke about the importance of just washing hands. Exactly. washing hands and it took decades for that to get accepted. And if I remember correctly, semilvice died in a lunatic asylum. So just at state of some kind of pioneers. And this whole thing of the scene, the unseen, that with the effect of something is immediate, your incentives drive you to do it. And if it is unseen. And you know, you mentioned an antiseptic. I remember writing about agriculture once, the problems of agriculture and pointing out that sometimes, for example, farm loan waivers are a necessary antiseptic because the farmers are in so much pain. You have to kind of get it, but you're not tackling any of the root causes. And if you look at what's popular among politicians, tackling the root causes is not because a politician has his eyes on the next election. And if you solve the fundamental problems, you'll see benefits 15 years down the line and they'll never be attributed to you. Exactly. Just farm loan waivers. Immediate. It's almost like you recognize that you got farm loan waiver here. And if one not intended, they become almost a hygiene factor. Now every politician has to kind of. No, but I think that's the thing. Right. I think we need to start this level of awareness among us. Right. Because at some point in time, right. If not me today, 30 years from now, 20 years from now, I'm going to need help in a medical help. But if I wait until that time to try and affect the system, it's going to be too late. Right. We need to start now. And it's not like, you know, whatever we do right now within a year is going to burn fruit. It's not going to happen. This is a systemic longer term problem that we have to think about. And unless this becomes a part of mainstream political dialogue, I'm sorry, this is not going to change. Well, longer amusing. And I'm just sinking allowed again. Is that at one level, we are wired to not think of mortality, to assume to be delusional about our mortality almost. We all behave as if we will live forever. Right. And is our taking health for granted sort of an extension of that that we assume we will never be ill. We will, we will, we will never see the inside of our hospital. But but reality is we all will at some point. Right. Reality is we all will. We'll just, you know, barred that way that we won't think about the morbid thought of us needing, you know, you know, hospitalization. But the fact is that, you know, there has to be an academic community that does think about this, right. Because education and health care, if you're not going to make public investments in this, then the society is going to degrade. You know, if you don't educate your people and you don't provide proper health care, those are the two basic things any administration ought to tell me a little bit about the kind of pushback you get from people who matter. For example, I would assume that say for somebody like on a Rindrumodi, who obviously cares about legacy and narrative and all of that, right. But you know, for me, it would seem sitting here to be such a fantastic narrative that in 2013, you know, this was what they announced and then I came and I've cleaned it all up. And I have made this actually the, you know, the servitly the pharmacy of the world and all of that. Why would he not do that? I mean, and you've met Minister's trying to explain. No, no. So I, you know, he's the thing. I mean, I've, I've never met. So I don't know. I think part of this is when you are at that level, there are 50 things in front of you. This is one of them, right. That's number one, whether that registers against perhaps a farmer's protest. I don't know where the priorities are, right. This requires a longer term vision. And I've never been able to find somebody in the administration who's willing to give me an hour's worth of time. We've been talking for several hours right now. This is a luxury. This is a luxury, right. You get 10 minutes. And in 10 minutes, if you're able to sort of convey the import of what you're trying to do to somebody who's distracted, I mean, happened with Archivore, then half the time is looking at the television screen. You met Archivore, then I should describe. Yeah. I mean, he made me wait outside his office for two hours. And then in the 10 minutes that I went there, he was looking at the TV screen half the time. And he asked me to write and send me a report, you know, I did. But the point here is that if that is attitude you have, then you're not going to be able to get anything out of it, right. I think maybe the right approach is states are the laboratories of democracy. Maybe there is a progressive leader in all the states that believes in the kind of stuff we're talking about. Implemented shows that the model that look, we have really made it different because one good part of healthcare is that you can measure outcomes very easily. You can measure infant mortality. You can measure maternal health. You can measure non-communicable diseases. You can measure the number of infections, hospitalization. This is very, you know, computational driven, you know, problem unlike several other things which are difficult to measure. But it requires you to put some effort into it, right. You really have to, and this doesn't pay back in eight months. It requires two years, a year window, where you really, I mean, I would love to see a state basically saying that in every district of village that we have, we have a properly staffed public health center. I'm not talking about the one that exists on paper. Properly staffed, right. With the parametri, they call a nurse. With a doctor comes in once a week to be able to, that would be such a huge accomplishment if he were able to do that. Yeah, I'd love to, at some point, get you together with Karthik Murli Tharan and do a joint episode. We've already discussed our mutual friend Ajay Shah. We'll invite him once and the three of us can have a conversation and that's going to be so insightful. By the way, the reason I'm giving you so much time and ministers don't give you 10 minutes. It's all about how important the person is. You can gauge the importance of people by how much time they give you. Ministers are very important people, protesters, sadly. No, that's very high on the scale of things. No, but I think, you know, your reach, I think, is far greater than what any minister can say. I mean, the people who listen to your podcast are, you know, select few really understand the importance of, you know, the conversation that is happening and the diversity of topics that you entertain, the guests that you have and the depth into which you explore these things. I mean, that's, you know, it's not something that anybody, you know, not everybody can pull this thing off. This is really, really. No, thank you. That's very kind of. Fugutav was infishing for a couple of things. No, no, of course. Reality. Because I am one of those. I'm one of those. Because I do Listen to a little.
lot of what your episodes are and I thoroughly enjoy it. I think that you know, this is the always look forward to my because for me it's Monday morning there by the time that your podcast traps. It's probably Tuesday morning because I shifted release from Sunday to Monday. Yeah. It's Tuesday morning there. Tell me something I've taken enough of your time and now I have to seem important in some hobbling this to close. But no, I've taken a lot of your time and you've also been kind with so much of your time going forward when you sort of map out what you want to do like I presume at one point when you were younger, you were driven by whatever was imperative at that point in time. Maybe you come to run back see and it's like, oh, we'll do these innovative things in this new market and build a market leader and whatever. But obviously the direction that your life took partly due to circumstances outside your control have taken you into a very different place. So one is there sometimes a sense that something is lost there at a career that you could have had and a body of work that you could have built health just gone with the years and two and I frankly think what you're doing is incredibly more important than anything else could have any counterfactual could have been. But going forward over the next 10, 15 years, how have you planned out, you know, how have you looked at what you want to do in those years to come? Yeah. So I think the first, you know, question, it's an easy question. I honestly, I'm not enamored of a career. You know, so I, you know, for better or for worse, I think that I've always had the satisfaction, you know, in my limited corporate career that I think that I've achieved a few things. I mean, they may not be all that great, but you know, I'm quite happy with that part of it and I don't miss, I mean, the one thing that I certainly don't miss is managing people. I just very very honest with you. I don't have the patience. I did once. I mean, when I left Phypharmix, there were 600 people. I don't miss managing people. I think it's, it requires a certain aptitude and test that I just don't have anymore. So I'm very happy with, you know, just being an individual contributor at this point in time. The second question I think is, is a more important question. I think that, you know, when I look in another 10 years down the road, if I think India has a drug-regulated system that is on par with what the European Union has and the US have DA, US does, I would be the most happiest person, you know, in terms of the competence of the people that we have, in terms of the processes that we execute, and in terms of the responsiveness to the people of the country, right? If we get to that point in the next 10 years, no one would be more happier than I. And how possible do you think that is? That is not in my control, right? That is not, if you had to think of probabilities. I think that there is a more than 50% probability that it will happen. And I'll tell you why. One of the things that, you know, both Prashant and I and other people who are with my foundation are doing is making substantial investments in creating awareness. And we're hoping that over a period of time that proclaims down in the society, in the system. So just a simple thing that we're doing is that, you know, we have a project where we have now, we've come halfway, the other half is beginning starting right now, where we've commissioned a bunch of people to write down the history of how we evolved our public health system is evolved. It's an 18 episode series, one hour each. And, you know, so the script is done, the research is done, and now we are in the process of me working with a media partner to commission the production of that. And the goal is to try and dump it down to a point where a common person should understand that, you know, if there is a pandemic that comes next time, right? That there are systems and institutions in this country whose job is it to respond. And if they're not included in that response, we have to ask why. Like I'll give you a very simple example this time. Why is it that when we, when the pandemic broke, we had people from ICMR speaking to the country. ICMR is a research institution. We have an institution called NCDC, right? National Census for Disease Control. That is the one that actually does the work in terms of pandemic response. That is the one that does surveillance, right? Why is it that the NCDC did not play a larger role in developing our pandemic response? Why is it that we have celebrity doctors, one of whom is a pediatrician, not a virologist, not an epidemiologist. The other one is the cardiovascular surgeon. What do you know about about epidemiology? What do you know about pandemic response? What do you know about public health? Why do you undercut institutions that you've set up on your own? Right? Next time if we ever happen to be in a situation like this, the layperson should have this understanding to say, you know what? My taxpayer money is going into funding NCDC in the country, whose job is to look for outbreaks, whose job is to develop a pandemic response, whose job is to figure out how do we not kill it and vaccinate people? Yes, the ICMR people and the Ames people can certainly be contributors to this. But we need people qualified from a pandemic response point of view, right? Why did we choose a vaccine candidate that requires BL3 or BL4 facilities, the highest class, because we are using inactivated virus to make a vaccine, right? Rest of the world was using, you know, virus derived, you know, we look at COVID-shield or mRNA vaccines. We chose the most complex process to make our vaccine and then we wonder if I wasn't scaling up. Who made that decision, right? And if you don't include people from NCDC who are qualified, you know, to be able to look at this, that can be really, you know, fine-falled with them. Why is it that there is no, you know, malpractice, medical malpractice, you know, law in the country? Why doesn't it really happen? Right? I'm not advocating for it, but the fact is that how many times have you really heard somebody who's been wronged actually, you're educated in a court, I mean, you say go to consumer courts, yeah, you go to consumer courts, get a resolution in two years, I'll tell you, right? There are some systemic issues we have and I really think that we need to have a conversation about this. I don't have a solution. I don't think that anybody that I know has a solution, but I think it's important to have a conversation, talk about it, right? So that people understand that, you know what, there is a solution to this. It's just that we're not doing it, but there is a solution to this. And if I'm so inclined to lend my voice, perhaps something will happen. This series sounds fascinating. I mean, I can see you fighting an information war on two fronts, right at one level, you build up that awareness of what the system is like in the mind of the citizen, the taxpayers, so that they know what and everybody's a taxpayer, so that they know, get a straight at background of information and that context is there. And at the same time, you're working on building data about things that happen now, things that happen around us all the time. So we can respond with the adequate outrage to things that should drive us to outrage. If someone listening to this is asking a question, what can I do? And this is a question at two levels, like at one level is, like yesterday during dinner, I asked you that as an individual consumer, when I go out to buy medicine, what can I do? Is there something I should avoid? Is there something I should look for? And so on. That's one level and the second level is, what can I do for the larger cause? Like one of the lemons that you've just sort of mentioned is that there are not enough people who are active in fighting for this cause. And in that sense, I guess, you know, it's been a lonely battle for you. So I think, you know, there are people, but they're not enough of us. Anything requires a critical mass awareness. I mean, like what you're doing right now, this is your contribution, right? You are essentially informing your audience about an issue where, you know, perhaps wouldn't have registered on people's radar, right? This is a huge public service, right? Likewise, I think the people who are listening, take a moment to read up, right? Take a moment to just inform yourself, above and beyond the normal television debates that we see about how public health works in our country, right? What institutions are there? How does states, you know, sort of regulate healthcare versus centered us, right? How does our regulatory system respond to issues of, you know, what we actually, you know, face like, you know, emergency-related issues, pandemics come our way. We still have endemic tropical disease, right? No farmer company is going to develop a cure for sickle salineemia because it's not enough a market for them. They're not going to develop, you know, novel therapeutics for cholera, for example, or typhoid or for malaria. I mean, malaria is there some vaccination work happening in that we have a vaccine candidate for malaria. What I'm saying is that, you know, there are things that are endemic to us, right? Farmer companies will only do it with the sea dollars green big, big tons of money behind it, right? Those big farmer companies are not going to develop solutions for us. Inform ourselves, right? Ask these questions,
I mean, it's great that, you know, our farmer companies are earning a lot of money by manufacturing all of this stuff for the Western markets. Why can't, you know, you hold them to the same standard when you make trucks for the local market here, right? The argument that I always get is, oh, it's, you know, price points in India are very, very tight here because you can't make the same amount of a bullshit. I've actually shown that the price points are actually very similar in India compared to what, what, you know, they get paid by the government negotiated insurance companies over there. Very similar price points here. See, what happens is that if we don't know enough, right, we accept a lot of what somebody says. Don't take what I'm saying, you know, if God has gospel read up, there's tons of information available out there. You don't, I don't need medicine right now, but my parents do. How much medicine can I buy from them from the US and bring to India every time? I can't do that, right? I have to make sure that the, the our medicine gets better here. You know, the more kind of frivolous of those questions that at an individual level, you know, what can, what can we do? Like when I go to a pharmacy for whatever, what do I need to watch out for other companies, I need to avoid? No, I mean, by, by and large, I think that the larger companies usually, you know, they should make good drugs, right? Because the reputation of damage for them from bad kind of stuff is really bad. They don't want, you know, something get reported that the drug that they made actually caused harm to people. By and large, that's true. The issue is more, I think, what we need to do is to put some pressure on the, the, the our administration to say that provide is a mechanism to report when things don't go right, right? When, you know, like, you know, when you've taken a vaccine and you see adverse events, you know, a couple of days later, you see, you know, our sore arm, where you develop a rash, they encourage you to report that right now, right? Why don't we do the same thing for medicine? We should do that, right? And the government are set up and national pharmacophagylam center, you know, to collect this data. But we don't talk about it. We don't, there's no public service announcement saying, okay, if you medicine doesn't work, I mean, nine or 10 times what happens if the medicine doesn't do what's supposed to do, you go back to the doctor and doctor says, we'll change the prescription. We'll find, give you another different, you know, different medicine or the one from a different manufacturer. That's the end of it. Well, if you don't report, then I can't really complain about data. Can I? And if all this data, you know, fictionalist way, we'll just being collected, then over time, you'll just be able to, you know, figure out problems before they sort of take lives. So I mean, these are things that we can do at our own individual level, which we have to. And otherwise, this is not going to change, right? There are significant vested interests that create inertia in any kind of progress that you want to make in this place. And unfortunately, there's a reality. Well, Dinesh, thanks so much for coming on the show, sharing your time and insights. It's been, you know, I'm going to sort of listen to this episode again and kind of process a lot of what you said, because I just think it's incredibly important. So thank you. Thank you very much. This has been an absolute pressure. And I have to tell you that I've been the beneficiary of a lot of your conversations, you know, when I go for a run out of walk, you know, where I am, a lot of times I've learned so much from, you know, all the guests that you invite, the conversations that you have, and it's been an incredible honor to be here. If you like this episode, do check out the links in the show notes for more and also pick up "Bottle of Lies" by Katharine Eban. You can follow the nation Twitter at D_S_Thakur. You can follow me at Amitwarma AMITVAR. You can browse past episodes of the scene and the unseen at seenansine.in. But just one thing, now that this episode is over, please don't forget what we discussed during this episode. This is a big deal. It affects all of us. Thank you for listening. [BLANK_AUDIO]
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