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Assuming that being alive is a good thing, we are all lucky to have been born in these
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times. As recently as 200 years ago, I'd have expected to be dead before 40. Leave
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alone reach this ripe old age of 47. If I got a common cold or an allergy, I could just
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die of that. Forget about diseases like cancer because most people didn't live long enough
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to get it. In the 19th century, alternative medicine, which I'd call quackery, thrived
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because mainstream medicine was a mess. The germ theory wasn't yet accepted by the profession
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and just going to a hospital could kill you, even if disease didn't. Even basic hygiene
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was absent. One of my heroes, Mary Wollstonecraft, died after giving birth to her daughter, who
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we now remember as Mary Shelley, because her doctor hadn't washed his hands. She got a
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fatal infection. Well, times have changed. The medicine of today would seem like unbelievable
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magic to the primitives of just a hundred years ago. But it's not magic. It's science.
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Now, here's the thing. We should still not be complacent. Our scientists might have understood
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our bodies and created magnificent medicines, but those medicines still have to reach us.
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Someone has to make them. You can create the finest of medicines in your labs, but how
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are they actually being manufactured in our factories? Is there yoga involved? Are people
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dying as a result? The answer, especially if you are in India, is yes.
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Welcome to The Scene and The Unseen, our weekly podcast on economics, politics and behavioral
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science. Please welcome your host, Amit Verma. Welcome to The Scene and The Unseen. My guest
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today is Dinesh Thakur, once a respected scientist in the healthcare industry and now a crusader
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on behalf of all of us. I first read about Dinesh in a brilliant book by Katharine Ebarn
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called Bottle of Lies, Ranbaxy and the Dark Side of Indian Pharma. Dinesh is one of the
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heroes of the book, which is about the great fraud committed by the company Ranbaxy, which
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no doubt took countless lives across the world. Now, some quick context. In the pharma world,
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big companies spend huge amounts of money creating new drugs. When a new drug created
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by a company gets approved by regulators, they have the exclusive right to make it and
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sell it for a number of years. This allows them to recoup the expenses of research and
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development. Now, after this period expires, other companies can also make these medicines
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and these are now called generics. These generics are sold at a much lower cost than the original
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drug. And if you want to make something for a low cost, well, India is a good place to
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start. The Indian pharma industry's reputation got a big boost about a couple of decades
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ago when Cipla, driven by the visionary Yusuf Hamid, made cocktails of AIDS medicine for
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a dollar a day, which was a fraction of what it had cost until then. This was a big deal
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for the developing world, especially Africa, and probably save millions of lives. The remarkable
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thing about this was that the reduction in cost did not mean a reduction in quality.
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Cipla's processes were outstanding and they helped get India the reputation of being the
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pharmacy of the world. Now, Indian companies rushed in to make generics and one of the
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early giants was Ranbaxy. This is a part of the story where Dinesh comes in. He left a
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plush job in the USA to come work at Ranbaxy, excited by this new age of Indian pharma.
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But he soon realized that Ranbaxy was a company driven by Jogar. While on the job, he found
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out that they routinely forged data to give to regulators. Most of their so-called medicines
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were never even tested. Dinesh and his team found that over 50% of the data given by Ranbaxy
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to the FDA, the main regulator in the USA, was fake. 100% of the data for India was fake.
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All of it. And ditto for the developing world. In fact, in an internal meeting, the subject
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came up that the medicine Ranbaxy sends to Africa probably did not work. One Ranbaxy
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executive replied, quote, who cares? It's just blacks dying. Stop quote. When Dinesh
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realized what was happening, he resigned. And then he realized that he could not stay
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silent while millions of people were putting their faith in medicines that could kill them.
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So he complained to the FDA, who began an inquiry into Ranbaxy. They filed a suit against
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Ranbaxy and Ranbaxy lost. They paid out a huge sum as a settlement and admitted that
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they were guilty of all that they had been accused of. But this did not solve anything
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in India. The culture of Jogar continues in the Indian pharma industry to this day. In
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his conversation with me, Dinesh describes in chilling detail not only his own experiences
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at Ranbaxy, but also the state of Indian pharma since and why he continues to wage a crusade
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to reform the system. Now, I know I've spent a lot of time on this introduction, giving
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this context, but I did it because this issue, more than any other issue I have discussed
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in the last five years, affects people's lives directly. It's not hyperbole to say that
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this is actually a matter of life and death. So please listen. But first, let's take a
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quick commercial break.
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2,500 if you use the discount code Unseen. So head on over to CTQCompounds at CTQCompounds.com
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and use the code Unseen. Up level yourself. Dinesh, welcome to the scene and the unseen.
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Thank you, Amit. This has been a long term coming. I mean, we've been corresponding
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almost for a little over a year now, almost a year and a half, and I'm finally glad to
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be in the same place as you to record this and talk about it.
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I was very fascinated by the book, The Bottle of Lies, by Katherine Ibane, in which you
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play kind of leading role and also by the larger questions that it raises. Because one
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of the interesting things about our existence is that there are so many things we normalize.
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We take it for granted. We don't think about it. So we assume, for example, that there
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is a rule of law, or we assume that the medicine that we take works, or that the rupee that
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I earn today will have the same value tomorrow and so on and so forth. We kind of survive
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on these foundations of trust, which at some points you can discover are a little shakier
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than one thought. But before we kind of get to the subject at hand, I want to speak a
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little bit about you. So tell me about your early life, because someone who just heard
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of you in a cursory way may think of you as a crusader for a particular kind of cause or
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a civil activist of sorts. I mean, it's not just in healthcare, but civil rights also
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that you've been active. But you're also someone who is deeply into music. You're a Hindu Sani
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classical musician who's been part of bands. So give me a sense of the young Dinesh Thakur.
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Where did you grow up? Where did you go to school?
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So my family originally is from UP, from Zafar Nagar, Western UP. You know, the place that's
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in the news for all the wrong reasons, but you know, that's where we're from. But for
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the last three generations, we've been, you know, sort of living in, you know, the Hrishwai
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Lama's Pradesh and now Telangana. My great grandfather was an armyman, you know, in the
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old Nizam's army. That's how we migrated there. And then ever since, we've been living, you
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know, in that area. I grew up in a little town called Nizamabad, which is about, I think
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about 170 kilometers north of Hyderabad, because my grandparents had a place there. My dad
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essentially grew up there. He got a degree in law from the Nizam's College in Hyderabad.
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And he started practicing law. So that's where, you know, I grew up, I was born in Hyderabad.
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Typical middle-class family, you know, went to, I started actually, my education started
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with a Hindi medium school, because that was the closest school that was to where we lived.
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It was a Marwadi school. I remember my grandfather sort of walking me to school and bringing
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me back. But soon enough, you know, there was a convent school that was a little further
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down, you know, the road. And I think I was in second or third grade that, you know, I'd
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gotten into the Catholic school, and that's where I graduated from. And then, you know,
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11th and 12th was a local government college, which is a godforsaken college. But anyway,
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went through that. In those days, the state of Hyderabad used to administer what was called
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the Common Entrance Examination. I think it was called EAMCT or something like that, engineering
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and medical, you know, Common Entrance Examination. So, you know, went through that. I think I
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was ranked like 3000 some odd. And, you know, by the time my turn came around, the only
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thing that was available at that time was chemical engineering. So I talked to my dad
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and basically said, look, you know, why can't I do law because he was a lawyer? And he said,
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no, no, you're good at math, you should actually become an engineer. And that was the only
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engineering available at that point in time, you know, given where I was. So I ended up
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sort of enrolling into an engineering college at the Osmani University. It's a really old
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university in Hyderabad, you know, very reputable. I mean, now I think it's very different. But,
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you know, in those days, it was still stood for something, trained really good people.
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So those were four interesting years, you know, in Osmania, then, you know, graduated.
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And then, you know, it was interesting in those days, you know, one of the things that
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we all used to do was everybody graduated sort of, you know, applied to go to the United
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States. That was kind of a given at that point in time. So, you know, I ended up sort of
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applying to a bunch of schools there, got accepted to the University of New Hampshire.
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They gave me a scholarship and ended up going to Durham at that point in time. There's no
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way that I would have been able to afford it on my own without a scholarship. But that
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was just luck, just worked out that way. And wound up in New Hampshire, and then got my
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master's degree there. And then that's how my career essentially began.
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I'll stay a little bit with the earlier years before you kind of end up there, because what
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sort of interests me is, like, one, you're just three or four years older than me. So
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we are almost the same sort of generation in a sense. I'm curious about growing up at
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that time, like you mentioned that chemical engineering was like the one thing left. So
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that's where you opt for that. So number one, what was your conception of yourself like?
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Like, did you think in terms of I want to do this, I want to do that? What were your
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models? What were your heroes? Because I know so many of the influences back in those days
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used to come from like, cinema, for example, Bollywood in our case, and, you know, maybe
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Telugu cinema in your case, I don't know. But so many of them came from cinema and also
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about the values that one takes, like you have spoken elsewhere about how your grandmother
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reading the Ramayana and Mahabharata to you had a deep influence. And I'm very interested
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in that, because it seems that in that kind of environment where you're growing up in
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those 70s and 80s, there can be two kinds of influences on you when it comes to values
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and one is what you see happening around you. And the other is from these kind of things
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that percolate down whether it's your grandmother teaching you Ramayana and Mahabharata or the
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Amar Chitra Katha and so on. So tell me a little bit about that, because these seem
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very contrary to me. One of the themes of your experiences in later times also is this
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sort of culture of, you know, just doing whatever it takes to make money, just doing whatever
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it takes to get ahead and not having a sort of a deeper core there. So how did these two
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sort of play out when you were a kid?
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So you know, I think, I mean, look, I think that my childhood was no different than for
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example, I'm sure all of our childhood, right? You know, we all grew up with, you know, a
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larger family, a joint family, where you live with your parents and grandparents. And, you
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know, in my case, both my grandparents had a, you know, disproportionately large impact
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on me. I think my grandfather passed away, you know, 1970s. I was very, very young at
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that time. I mean, I have very few memories, but my grandma was still around. She passed
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away in the early nineties, but I have very fond memories of, and you think about like,
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you know, in large Indian families, the matriarch, right? Grandma essentially is the one who
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essentially runs the house. I mean, she was a little petite lady, you know, she was like
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five odd, five feet odd, but you know, the will of an iron sort of strength. And she
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was the one who essentially ran the house.
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This is a part of the story, I mean, that I don't think I've ever told anyone before.
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So I'm going to have to try and take you back, you know, a couple of hundred years before,
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because life kind of, you know, entangles you in very different ways, right? If you
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know about the history of the Singh brothers, right? The family that essentially they come
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from, their maternal side of their family is very illustrious. You know, the Baba Charan
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Singh, who was the head of the Rajaswami Satsang in, you know, in base in Punjab, he essentially
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comes from a lineage of, you know, I mean, today's, when you think about gurus, right?
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You think about the, you know, the Jaggi Vasudeva, Aswaram Bapu. To me, those are not the kind
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of people that they are. I mean, they were people who essentially were mystics. And this
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gentleman, Charan Singh was one of those people who essentially came from that line. Now,
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for whatever reason, I think that that art, that skill is disappearing. We don't think
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about those things anymore. But there was a time when those people were alive. You know,
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they used to essentially practice sadhana and they knew what they were doing, right?
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So if you trace the lineage of that Sufi tradition all the way to Khusro and to Nizamuddin Auliya
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and you know, the way that that evolved at that point in time, there were two branches
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of that. One was the Bia side, which is the Charan Singh side of it. The other branch
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was Agra side, which is where, you know, sort of the other branch of the teaching of Swamiji
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Maharaj essentially came from that. The reason I'm saying this is because that lineage percolated
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down into my family. And, you know, I can't tell you whether it's serendipity or what,
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that I had to get entangled with the people who essentially came down from the Charan
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Singh side. Because, you know, I've, as a child, I've seen, you know, what mystics
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can do. They were, I mean, my grandma was one of those. So it's the tradition of, you
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know, hearing Ramayan read to you. The tradition of hearing Mahabharata read to you. We had
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copies of Kabir Bijay, like four or five of them in the house, you know, that we ended
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up reading. That's why, you know, the episode that you did of Gita Press with Akshay Mukul
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was so resonating, you know, in the way that, you know, that entire sort of tradition about
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the printed word evolved over a period of time. You know, so that was the environment
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I grew up in, where, you know, we had this notion of, you know, where you had a gathering,
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you know, a certain date or time of the year or whatever the year, where you sat and listened
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essentially to Kabir Bijay being read back to you or Tulsi Ramchandra Manas being read
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back to you. And realize that these are written in Dohas, right? You don't know what that
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means as a child of five, six, seven years of age, but then your grandma is explaining
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to you what that really means, right? Providing you the context of, you know, what a specific
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Doha actually really means. If you read Tulsi Das's Ramchandra Manas, you know, it is such
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beautiful poetry. But then, you know, as a child, you don't know how to comprehend that.
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You listen to Kabir, you know, writing about, I mean, this is Nirguni, right? I mean, completely
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different kind of thinking in terms of how Kabir imagines the Almighty to be, right?
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And the way he describes the world around him. It's very hard for a person to reconcile
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those two things, right? Where in one poem, you're trying to imagine God in the form
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of a person incarnate. In the other side, you're essentially saying there's a Nirguni.
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There's no gun, right? Kabir talked completely about a Nirguni Bhagawan, right? I mean, he
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says, okay, this is where you need to go. This is where you came from. This is where...
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So those are the kind of early influences trying to reconcile those dichotomies in life
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and figuring out. Those have stayed with me for a long period of time. I don't know if
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that's good or bad, but, you know, it is worth this.
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Yeah, and in general, when you sort of look at current times and from what you're saying,
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it then strikes me that we can, that there's a different kind of corruption at play here,
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a different kind of evolution where you have these religious and spiritual traditions,
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which come down over a period of time, which have popular resonance, as in Kabir Zohar's
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and all of that. And yet, over the last few decades, perhaps, this political impetus to
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take it in a particular direction, almost as if aping the West in terms of their religions
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are religions of the book, there is that one book. So a similar thing where you try to
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homogenize an understanding of what Hinduism is and what religion is. And just as I keep
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saying we contain multitudes, I mean, the religion contains more multitudes than anything
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else, not even a religion, a way of being as it were. And that's also gotten corrupted.
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And it's very interesting that, you know, you speak of that particular tradition, the
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Swami Satsang Goas, which is again, you know, you know, another strand of that is there
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in the Ranbhaksi folks, Malvinder and Shivinder and the kind of nonsense that is happening
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there where it essentially comes down to being a modern day cult and nothing else, everything
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else is lost. So just looking around at India, is that something that you feel that has also
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happened that in some ways we've let this great religion down by going on and on about
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You know, that's a very deep question you're asking. And I don't know if I'm qualified
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enough to answer that. But, you know, as somebody who, I don't practice religion, that I don't
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go to temples anymore because to me, you know, the experience doesn't mean anything. I mean,
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you see pictures of people going to a temple to be shout around because, you know, you
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want to spend a few minutes in front of the deity. I can do that at home. I don't have
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to go to a temple to do that. But I think that, you know, I certainly have an opinion
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about the politicization of religion, which I think is just terrible. I think that, you
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know, whether it's the new age aspect of how religion is perceived or the old age, which
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is the fundamentalist aspect of how the religion is practiced, it just turns me away personally.
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I don't know whether, you know, that's something that I can authoritatively speak about it,
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but purely from a personal point of view, I think that, you know, the entire purpose
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of, you know, religion and tradition was to develop a sense of understanding of your place
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in the universe, right? That seems to have completely gotten lost. We don't talk about,
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you know, why we are, you know, in where we are. We just focus on what is it that we want
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to do to try and advance a cause. I don't know what that causes some people for that
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is, for some people that cause is to build a temple. Some people, the cause is essentially
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to build clean rivers, or I'm not saying that one is better than the other, but, you know,
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this existential question of why we are where we are, I don't know whether we actually even
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ask that question anymore, right? So I don't know what to say to the question that you're
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Yeah, I mean, none of us, I mean, I don't know who's qualified to even speak about it
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these days, you know, so it's like, I think everyone's sort of feeling of it is as valid
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as anything else. I just remember that growing up, I would never be at odds with, say, being
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born a Hindu in this particular place, but not actually being a practicing Hindu, you
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know, being an atheist to school, having the kind of beliefs I do, which some would say
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are enlightenment values, but having all of that was fine. I still fit in here. This was
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still my home. I was still part of the civilization, and I could be whatever else. And today one
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just feels that the space for that in one sense is not diminishing per se, perhaps that's
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a big statement, but that there are people who would like it to diminish, who would like
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it to define the civilization in a particular way, and just make everything so combative
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instead of just letting us quietly contain multitudes. Tell me more about then, you know,
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what going to New Hampshire was like? Like, was there sort of a culture shock? What was
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the study? Like, did you enjoy chemical engineering?
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It was. It was certainly a completely new experience for me. I mean, I'd never been
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actually, that was my, I think the first flight that I actually took from Bombay, Pan Am used
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to operate in those days, hadn't gone bankrupt in those days. But, you know, the way that
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I learned was very different. I'll just tell you an interesting anecdote. So I was thinking
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about this on my ride coming here. One of the courses that I took in college while I
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was enrolled in Osmania, this mandatory course for chemical engineers was called the material
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energy balance, which teaches you the fact, you know, how energy gets converted from mass
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mass to energy, right? So in that course, and I don't know if this ever happened to
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you, but in those days, I'm talking about the 80s and 90s, right? There were no computers
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and also the question papers used to be cyclostyle. So the professor used to actually write the
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question on a piece of paper. And then they used to get cyclostyle because the rocks was
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really expensive, right? And you used to, I mean, everybody got a piece of the cyclostyle
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paper. And then the question, you had to write down the answer to your solutions, that question.
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Unfortunately, the one that I got was kind of blurry. It wasn't like visible because,
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you know, you really have to push down very hard to make that mark on the cyclostyle paper,
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right? Because then it goes to the machine and then you run around and the facts generates
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it. So when I did my math in that equation, I was off by two digits because the decimal
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wasn't visible to me, right? So when my paper was evaluated, because my answer didn't actually
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match what the professor was expecting, I got a zero on it. The only reason was because
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I couldn't read the decimal point in the question that was defined. The reason I say this to
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you was because when I juxtaposed this experience to the way, you know, I was taught, you know,
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when I went to UNH. So one of the courses that I had to take there was fluid mechanics,
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right? So Professor Carr was my teacher there. And, you know, my term paper was, and in those
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days, like this is 1991, right? Stents, essentially, you know, the stuff that we put in arteries,
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they were not like, you know, in work, they were just being developed. So one of the things
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that you get taught as a chemical engineer is how do fluids flow? Because, you know,
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you have to mix things, you have to make sure that, you know, you blend slurries and stuff
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like that. And people who are listeners who have done any kind of chemical engineering
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will know that you get taught about venturi flow, laminar flow, turbulent flow, eddies
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and things of that nature. On one hand, the experience of getting taught in India was
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that, you know, you used to mug these things, go out, then vomit it out on a piece of paper,
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and God forbid, if you didn't read the cyclostyle paper correctly, you got a zero on it. The
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other side of that was, Professor Skars, his term paper was, he wanted us to sit down and
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think about what angle of a stent would be appropriate, because again, you know, there
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is fluid, there is essentially plasma running through your arteries and veins, right? So
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if you have to put a stent in, you can design a stent to be a Y, right? So, you know, you
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can have a stent going in with bifurcating, you can design a stent to be a T, right? And
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even if it's a Y, you can have an acute angle, you can have an obtuse angle in there, right?
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The question he asked was, what angle is most appropriate, you know, in order for the stent
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not to have accumulation of plaque? Remember, our blood actually has platelets in it, right?
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Red blood cells and white blood cells. So it's not pure liquid. It's a sludge, right? So
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the question here is that if you're putting in a stent, you want to design the stent with
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a certain angle so that you don't cause plaque formation at the junction. So the question
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was go think about designing, what would the angle be? Now, asking the question that way,
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I did not know how to answer because I was never taught to think in those terms, right?
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Here I had to read the McCabe-Smith book, figure out what the equations were, go out
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to the term and essentially sort of solve problems. The reason I say this is because
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I think one of the things education does, and I am hoping that it is happening here
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more now, education is not about regurgitating stuff, right? It's making you think about
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what is it that you want to do differently. That question, although I got an A- on it,
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I don't think I did a great job. I think that I did the best I possibly could. But that
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makes you think, right? There is no one solution for it. You can design a T-stent, you can
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design a Y-stent, you can design, I mean, they wear drug and rooting stents, meaning
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you coat them with drug and over a period of time they put drug in the bloodstream.
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Open-ended questions are really important because I don't think there is a solution
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to every problem. If you go in and thinking that I am going to solve this problem and
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find a solution today, you will be disappointed. I think that a lot of problems that we find
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in life, I don't, half the problems that I deal with don't even have a definition of
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a problem. Forget about a solution, right? So open-ended solutions, open-ended problems
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are really important. I just hope that our education system is beginning to teach some
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of these things. How do you deal with an uncertain world where data isn't available, where it's
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not properly defined? How do you think about that when you try and solve things of this
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Education is really important. So that, I mean, that's a seminal experience that I think
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about in terms of when I went to UNH and got my master's there. That's the kind of
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experience that I had, which I still remember getting a zero and I was so disappointed.
#
I thought I did it right. And then I found out that my decimal was off by 2.2 digits.
#
Yeah, 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 does really badly in the first exam because he is not used to thinking
#
like that. And I have the title of your master's thesis in front of me, soluble and immobilized
#
catalase, 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 you were looking at at that time, right? So
#
again, my advisor, he was from India. He was from Chennai. He just retired as the senior
#
provost. Excellent. I mean, Dr. Vasu was very, very good. The only thing I didn't like about
#
him was that he used to hold his classes at 8.30 in the morning. I mean, in New Hampshire,
#
if you know anything about the geography, it snows like crazy in winter. And so he insisted
#
on all the students being in the class at 8.30. We had to get up at 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, so what I was doing there, and that was kind of interesting, and this
#
is again, science evolves, right? In those days, we were doing something completely different
#
in the sense that at that time, we were thinking about how do you sort of use enzymes as active
#
catalysts to try and increase the reaction. And one of the things that they 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 yield that you get from the
#
reaction. And so what I was trying to do there was to take porous beads, like 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 labile thing, right? Enzymes are not very stable. You immobilize
#
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 what we were doing would actually
#
work. The issue was, think about how do you design experiments? So my experimental reaction
#
chamber was a PVC plastic pipe of two 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. I had to cut
#
PVC to take perplexiglass on both sides, fix it, put flanges in it, essentially to be able
#
to have your input and output on it, and then high pressure, right? So you had to put little
#
high pressure and see what really happens in that part. The notion there was two things.
#
One is that it taught me how to think about experimental design. How do you think about
#
doing an experiment with a hypothesis and testing that hypothesis and experiment and
#
figuring out whether it works or not? Nine or 10 times it fails. You still have to go
#
back and try it in a different way, right? So that's experimental design point of view.
#
The second thing it taught me was importance of data, recording what you're measuring
#
in the lab, right? Every data point. So you 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, do 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, okay, 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 the 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? We think about science, again, in black and
#
white terms. Science is not black and white. Nine out of 10 times things fail, right? And
#
then you find out one fine morning after a lot of sweat and blood that something actually
#
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 are 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.
#
Again, a lot of this came essentially, remember, the environment at home was this traditionalistic.
#
So if you know anything about the tradition of the mystics, right, there is something
#
called Shabad, right? So you sing, you recite 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, singing
#
along with my parents and understanding what was really happening. So it's just that training
#
essentially with a little bit of formal training in Hindustani classical over a period of time.
#
Not any great stinger or anything like that. It's just that the environment at home was
#
that we used to sing Shabads. We used to sing the traditional Satsang kind of stuff that
#
actually happens at home. That's how I picked up a lot of this stuff, right? And then some
#
training a little bit. But the good thing in those days, I'll tell you what was good,
#
Spick McKay was very active in those days. There were chapters of Spick McKay pretty
#
much in every US universities. I saw Pandit Bhimsen Joshi like this close. I was like
#
right here and he had come to Syracuse at that point in time. I was enrolled in a computer
#
measuring program. I mean, what personality? You are in heaven when you hear him sing.
#
Spick McKay was very, very active. There's chapters of Spick McKay pretty much in every
#
university. We used to do concerts. We used to invite, you know, MN personalities from
#
India to come in and sing, play. It was a really good time, college days.
#
I knew you used to sing in bands also, the Rumogos.
#
Long time ago. It's been long.
#
Yeah, at some point the pharma lobby is going to get hold of these old recordings and circulate
#
them. This is a person.
#
So, after this, you join Bristol Myers Squibb, 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 there's informatics there, obviously, as your job title goes. There's also a little
#
bit of robotics, like the way Catherine Ibane describes you. She says, quote, Thakur played
#
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. Thakur's lab buzzed with innovation. More than a dozen scientists reported to him.
#
Pulleys, motors, bells and levers were scattered about and bright-eyed college students cycled
#
through pitching in as needed. Stop 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
#
Yeah. So, you know, so the training that I got as a 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-oriented design, right? So you're building, you know, so I don't know if you
#
ever passed by one of these big distilleries or the ONGC plants, right? I mean, you can
#
see them. They're big plants that 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, it's
#
basically programmable logic controllers, right? So all you're saying is there's some
#
switches, right? So 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 twofold. So
#
I have to take a step back and explain to you what was really happening in those days.
#
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 sort of has this
#
prowess of, you know, manufacturing drugs, there's been one, just one or two instances
#
that we've actually discovered and developed a drug that has gone to the market. We've
#
never done that. And 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 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 evolved now a little bit with computer-aided design and 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, hexagonal
#
rings. That's how benzene looks like. If you've got, you know, among your audience,
#
you have people who are chemists, they will realize that you can have structures that
#
become really, really complex. You can have hydrogen molecules, 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 different
#
simply, 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 there 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 the active 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 are doing. And it's very hard to make people do that. Because
#
remember, if you ask me to do the same thing 10 times, I'll make a mistake on the 9th time,
#
because it's repetitious and it becomes really rote, right? So the way that we thought about
#
this was, why don't we automate it? Why don't we essentially build these systems that actually
#
do these things at night, during the day, 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 video,
#
but basically, it looked like if you've seen Ford Motor Company's manufacturing or even
#
Maruti's company, you have these big robots that look like robots right now that pick
#
up a piece of a car and put it on a manufacturing 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.
#
So again, it had pulleys and motors in them, and they used to move things around from place
#
to place to place. Now you see a lot more automation. I mean, the Amazon facility has
#
all robots in it right now. In those days, that was a 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 the way that you read out this stuff.
#
How do you know that something actually attaches to the protein and does something? There are
#
one of two ways that you could do that. You could take a effervescent molecule that would
#
light up, right? So if it attaches to the protein and you take the rest of it out, you
#
would read that because that would generate light. UV light will actually show up. Or
#
you take a radioisotope, right? You take carbon-14 or one of these things, and you take a radioisotope
#
and attach it to it, and you use a Geiger counter 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. And this is what we used to do, essentially build systems
#
that ran day and night. They would just pick up. So think about it like a manufacturing
#
line. It would know where to 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 a pathology
#
lab, they take your blood sample, but then they run the assay. It's not run the same
#
concentration that you actually take the blood. They would dilute it down, spin it, take the
#
white blood cells out, and then they would actually use that to do biological assay.
#
That's what I was tasked to do. And we ended up sort of building those kinds of systems
#
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, 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 a sabbaticals kind of rotation
#
basically. You'd used to go spend a month in every department to try and understand
#
what they did so that you would at least get a sense of, look, you're not buttonholed into
#
this one job that you have, but you get a bigger picture. But the biggest thing that
#
was drilled into you, into all the people who they hired was, why are you doing this?
#
It's not about trying to punch a machine or a tablet, get the tablet out. It's not about
#
designing a robot. At the end of that line, there's a patient and 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 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 software.
#
You're going in as a mechanical engineer to be able to design some machines and systems.
#
You're going in as a chemical engineer to design chemical reactions and figuring out
#
how to make... 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 correlate
#
to that, right? Where you get to interact with a patient who says, look, I'm taking
#
this drug. I've been diagnosed with a melanoma and I'm on your drug and it's making my life
#
better. That's a really powerful 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 in a way that to try
#
and put context into young people that, yes, you're doing a job. I understand that. You're
#
only living. 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 BMS did that very, very well for people like me who joined the
#
ground level and worked our way up. 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 pharma and Indian pharma. Just the thinking of the end user applies to a lot
#
else. I think even in writing, the very first lesson of my course essentially is that when
#
we write too often, we think of writing as an act between us and our laptop, me or my
#
laptop. That I have thoughts in my head. I put them down on paper or on the laptop and
#
it's done. You're not thinking of the reader because your writing only becomes meaningful
#
when it has an intended effect on the intended reader. We don't often enough think of that.
#
I think that this can then be extrapolated as a danger to any calling or any profession
#
or vocation. 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 rise up rapidly as the 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 through that process.
#
Basically, it was against serendipity. An opportunity presented itself. I was working
#
in informatics and there's this gentleman who was a fairly senior person. His name was
#
Rashmi Varvya. He was responsible for pharmaceutics. Now, what that means is basically how do you
#
design a drug so that your body can absorb it? Think about it. We talked about how to
#
find this one drug that works against a target. Let's assume that you find that. You find
#
something that is novel that works against a particular disease. That's not the end
#
of the story because how do you actually get it to a patient that patient will take it?
#
You have to figure out, look, if I formulate that as a capsule, 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 it has to be available immediately? Remember, if you eat something,
#
it takes time for the chemical or the biological thing to go into your stomach, get absorbed
#
and then become bioavailable. If you want something immediately, like for example, if
#
somebody's suffering with a stroke, you can't give them a tablet. You want to inject a clot
#
busting drug right away so the clot essentially vanishes at that point in time. So these things,
#
how do you make the drug available is the remit of what is called pharmaceutics. And
#
he was the head of that group at that point in time. He had accepted a role to join Ranbaxy
#
as the head of their research and development. I did not know this. So one day, the campus
#
where I used to work, there was a time where we used to walk around in the afternoon after
#
lunch just kind of clear our head, talk with people. It was a cultural thing there. So
#
one day he asked me whether we would do that. And while we were walking around, he told
#
me that, look, I am leaving BMS. And he was there for a long time, 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 the company was. And he told me, look, you've risen really, really
#
fast in this organization, but you're going to hit a glass ceiling here. There's only
#
so many vice presidents and directors in the company. It is an opportunity for you to go
#
back and do something very different. 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 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? So that came out of the blue for
#
me because I had no idea that I would even be considering something like that. But having
#
thought about it, and I did my own research, there was one time that I'd come to visit
#
my parents. I went and met people in New Delhi. In fact, Dhavind Singh Brar, who was the CEO
#
of Runback Sea at that time, he had come to New York once. He was at the Hilton in near
#
Grand Central, and he'd asked me to come meet with him. So I went and met with him there.
#
So over a period of time, this courtship happened, and comfort developed. And given the fact
#
that this was a very unique opportunity, I decided that I would come here and helping
#
Rashmi build what he wanted to build. He really wanted to turn Runback Sea 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 why he accepted this position to come
#
here. And he said, look, I need people like you because it's going to be a big job and
#
I need people like you. So he had another gentleman, his name is Kasim Mukhtiar, who was also a
#
fairly senior person. He came along with him. I came along with him. Nimesh came along with
#
him. So it was a bunch of people essentially came along because we really saw an opportunity
#
to try and make a difference and rebuild this kind of raw prowess that we saw within Indian
#
Pharma. Because Indian Pharma was doing really, really well in those days. From a price competition
#
point of view in the US, obviously healthcare costs are really, really expensive. So the
#
Indian companies were making a huge dent 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 of something new that the country's never done before? That was a great attraction
#
for somebody like me to come here.
#
So to 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 funda of 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 similar thing. And for a lot of Indian companies, then they became
#
good at sort of reverse engineering, at 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 went there to do, as you said,
#
Rashmi 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 other sort of interesting parallel track
#
I find here is what Yusuf Hamid did with Cipla 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,
#
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 it's
#
a really powerful story to think about, right? Because the drugs that we developed to combat
#
the AIDS epidemic, characteristically, right? This is what Pharma does. They essentially
#
try and extract blood from a stone if they have a product. Even today, right? Look at
#
hepatitis C, the drug that is available to treat hepatitis C that Gilead makes, to sort
#
of thousand dollars per pill. Now, the argument that they make is essentially a quality of
#
life. It's the value of what we are adding to somebody's life who's suffering with a
#
really bad infection, whether it's hepatitis C or HIV. But let me just digress a little
#
bit here for a second, right? This is really interesting because given your background
#
and your interest in economics, so there are two pricing models, right? One pricing model
#
that basically says, what value do I add to my consumer, right? I charge that based on
#
the value that I add. This is what most Pharma 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 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 $30,000. It's unreal. It's stupid, right? The other way we think
#
about when it comes to genetics is 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. Think about this, right? When Pfizer developed vaccines,
#
the mRNA vaccines right now, right? And Pfizer said, okay, you know what? They were the first
#
ones who got regulatory approval, emergency approval for a 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 charged the US, the Center for Medicaid Services, I think paid between $26 and $30
#
per shot for Pfizer. How they arrived at it, I don't know. But you can 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 $1,000 for it, right? If you follow the value-based model,
#
you can't do that anymore. Nobody will be able to afford something like that. So this
#
notion about companies charging a lot of money, you will come back and revisit that a little
#
bit. But what happened with Dr. Hamid and Zippler was basically they broke that model
#
because there were companies in the United States who were charging an arm and a leg
#
for this therapy for very, very poor people. They didn't care whether this disease was
#
endemic 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 US activists who worked with Dr. Hamid, 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. And that essentially
#
revolutionized people's lives. What happened in Thailand, what happened here in Bombay,
#
what happened in Africa, people overlaid their life to what Dr. Hamid did. He basically broke
#
that model of the pharma companies holding poor patients hostage for the kind of money
#
that they were looking for. And the reason that happened was because two things, right?
#
One was in the 70s, our Prime Minister Indira Gandhi basically provided 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 developed 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
#
how our genetic industry evolved. And so we had those skills. So when the activists in
#
the US, Bill Haddad, they came and talked to Dr. Hamid, they figured out that this is
#
what they would do. And they broke that model. So that was what was happening at that particular
#
time. That was one. The second thing that was really happening at that time, this is
#
concept called a patent cliff. So as you said, once you register a patent over a period of
#
time where you have exclusivity, you essentially, after that, multiple companies come in and
#
the price drops. What was unique in that time period, the late 90s and early 2000s, right?
#
The number of blockbuster drugs that went off patent, I've never seen that many drugs
#
actually go off patent any time after that. That was a period of seven to eight years
#
where drugs like Lipitor, right? 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 particular sort of chemicals in a different way. There was a one in a lifetime
#
opportunity for them to be able to do that. So those two things came together very, it
#
became sort of a harmonization of those two things, which essentially provided like a
#
fill up to the industry to sort of dream big and say, look, we can reverse engineering
#
and 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 to get our own products, because you see, if you have an innovative
#
product, you command a premium. You can charge a lot more money doing that. So that was the
#
Yeah. And it's also fascinating to me how it's easy to sort of paint everyone with the
#
same brush and say, oh, this is a culture in India, the kind of thing that Ranbaxy did.
#
But if you kind of look at Yusuf Hamid and Sipla and the kind of values that they believed
#
in, the importance in processes and quality and all of that, it's just off the charts.
#
And at the same time, you have some of the newer companies like Ranbaxy, where everything
#
was bottom line, where you went in and there were, you had posters in the walls pushing
#
you towards getting a higher profit percentage of reaching, say, one billion in the US when
#
they were 100 million at the time, I think, or reaching a total of five billion, where
#
they were 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 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 their generic when they could
#
make a lot of money. And then after six months, everybody else kind of comes in.
#
And Iban's book describes, 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 science or not.
#
Yeah. So this was an unfortunate outcome of this US law, right? The Vatch Hacksman Act
#
that created this nonsense. This was a compromise that was reached with the big pharma, right?
#
Remember, initially, when the generics came around, big pharma 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, they'll try and get another little bit out of it.
#
And the six months was essentially to say, we are going to license the technology to
#
some other company that will give us six more months to try and milk this market as much
#
as we possibly can. That was the sort of genesis of the six-month exclusivity. But, you know,
#
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 intentioned. Unfortunately, it was completely
#
sort of, you know, taken upside down. And it became, you know, a reason for companies
#
to cut corners and then try and figure out what they need to do.
#
So let's talk about your time at Renbaxy now. So you kind of get out there. And Rashmi doesn't
#
No, so he doesn't. I think what happened was that he had developed a difference of opinion
#
with the family. And so there's a power struggle happening in those days. Because, you know,
#
see, D.S. Brar, who was the chairperson and the CEO of the company, right? So there were
#
the family waiting in the wings, right? Malvinder and it was as if he was warming the chair
#
for the, you know, Sion of the family to take over. And obviously, there was 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 limit, and he decided to leave and start his own.
#
So I think after me, within a year of me joining, a little over a year of me joining, he decided
#
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, scuttled but was that Rashmi wasn't getting along with the family,
#
with Malvinder. And in the meetings, we could see, right, body language, you could see in
#
a meeting sitting across the table, because Malvinder 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, you know, a big settlement when he left, which can also
#
be interpreted. And I think, you know, Iban implies that it was sort of just a silent
#
about whatever you might have seen.
#
I, you know, unfortunately, I've never gotten a straight answer what that was for. All I
#
know is that, you know, yes, there was a big settlement. And you can read it to say, well,
#
you know, just go away and keep your mouth 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, I walked away with whatever was due to me that that was it. So.
#
Yeah. And ditto, Rajinder Kumar, your next.
#
When you talk about, you know, unsung heroes, right? The Dr. Hameed. Dr. Kumar is another
#
one of those. I mean, it's very few people that you run into 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 the head of, you know, the CNS clinical research at GSK. Like, I mean,
#
he was among the four top four or five people in GlaxoSmithKline R&D. 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 these things right. And if you don't, I'm going to walk
#
away from it. He walked 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 had happened, right? So there was a French inspector named Olivier
#
Leblay. Right? He's still there. He's still working for the French regulatory agency.
#
He's a friend of mine. Good friend. He was a part of a WHO group. Right? Now, let me
#
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? To 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 the 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 diligence
#
on them. We believe that they know what they are doing. We can vouch for the quality of
#
what they are 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 their 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,
#
WHO relies on doing inspections. Right? They go out there and obviously check before they
#
can approve some manufacturer out there. WHO doesn't have regulatory capacity. Right? So
#
it pulls in from countries with regulatory capacities. Wherever countries have good regulatory
#
capacity, they'll say, can you lend us your inspectors? Right? We'll come in and do this.
#
So the gentleman who was leading that effort at the World Health Organization was a gentleman
#
named Andre Wanzil. He was a medical doctor. And he pulled in regulators from different
#
countries. And this was a gentleman, French regulator, Olivier. He came in to basically
#
inspect Ranbaxy's portfolio. Because remember, at that time, what was happening was Bush
#
was elected. AIDS was rampaging to 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 Ranbaxy's portfolio of Lemuridine, Stavidine, Zydovidine. These
#
are the antiretroviral drugs that are essentially used to treat HIV. So they stop replication
#
of the virus. The way things work is that pharma companies, what they do is that they
#
usually work with outside contracting companies who run clinical units. Right? So Ranbaxy
#
had its own clinical unit as well. In Delhi, there's a hospital called the Majidia Hospital.
#
This is where Ranbaxy did their 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 outsource it. So they've given it to this company called Wimta Laboratories in Hyderabad.
#
So Olivier 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 these reports, right? 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 Ranbaxy and say, what the heck is happening here? You guys are outsourcing your work to
#
the third-party company, and they're fudging data, right?
#
So Brian, who was the CEO at that point in time, and Raj was like, I think 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'll make sure that all of these things will be straightened
#
out. And the reason he did that, because he was counting on Raj's 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 this 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? Right? I thought this was like a one-off thing
#
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. I mean, he wasn't kind of a non-committal
#
at that point. I won'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 it was a one-off thing, he said, just go and talk to them and make sure that things
#
will be sorted out. Now I'm being told that this is not unique to just South Africa, there's
#
a bigger issue here. I really need to know what that is. And that is how this entire
#
thing all started. Take me through the next step, because at this step, at this stage,
#
you know, the assumption is that, okay, something went wrong with the contractor and whatever,
#
and there might be other issues, but they're minor issues. They're kind of fixable. There
#
is no sense that there is a problem with the edifice itself, that everything is shaken,
#
you know, that most of the data might just not be falsified, that it's all just a kind
#
of a pack of cards. So what he asked 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, I'd already hired a group of five
#
people and they were responsible for each of this portfolio. 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 were region
#
two. Region three was Latin America. So Mexico, Argentina, Brazil, and region four was United
#
States and Canada, right? So I had one person for each of those. So Vivek was for region
#
three, which was Latin America. Prakash was looking at the US portfolio. Karna was looking
#
at Europe. So four people. And then I had two other people. One was looking at the medicines
#
from malaria benches because we were developing a 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 are asking, how did I go about doing that? In order to
#
answer that question, I have to first explain to you how a generic drug is developed, right?
#
So there are essentially four pieces to this, right? So the first thing is that, remember,
#
you're not innovating anything, right? You know 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 in 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 is some science behind that, right? So what works in lab will not work
#
in a much higher scale facility, right? So just like you can cook rajma for two people,
#
you can figure it out what the recipe is. You have a party of 15 people, you better
#
be very careful with the recipe. Otherwise, you really have to control all of those things.
#
So scaling out 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 innovator's formulation does, right? So if I'm trying to make a copy of
#
Lipitor, which is autovastatin, which is the drug that is used right now, it's a best
#
selling drug, right? For hypertension, hypertension. So if a patient takes Pfizer's autovastatin
#
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 20%. 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 drink, you may not get a buzz. You take a second drink, slowly
#
you start getting to get a buzz. Or maybe this is a better example, holy, right? Everybody
#
has Bhan. You can get a lassi or you can get mubtai and 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 buzzy. You take that one complete laddoo, then you start laughing, right? Because
#
the concentration of that particular rupioid 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 excretes that out, right? So either through urine you get it out, through
#
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 vomits it out, right? So
#
these are processes that 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 particular formulation. Do you get to that point, right? And how fast
#
does a body actually get it out of your system? The reason why you need to do this is because
#
doctors need to know when they 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. Your
#
body takes four hours to get it. 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 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 in
#
the clinic. And then, you know, I put it all together and say, okay, now I'm going to send
#
it to a regulator to say, this is what I need to do. Now, in order for me to map out this
#
entire process, I have 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 the lab to one kilogram quantities, 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 a matrix of all of these activities for each drug. And these
#
and they were asked essentially to go and figure out where that data existed or not.
#
It just took ever 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 Ibane writes, quote, at the behest of managers, the company scientists substituted
#
lower purity ingredients for higher ones to reduce costs. They altered test parameters
#
so that formulations with higher impurities could be approved. They faked dissolution
#
studies to generate optimal results. They crushed up brand name drugs into capsules
#
so that they could be tested in lieu of the company's own drugs. They superimposed brand
#
name test results onto their own in applications. For some markets, the company fraudulently
#
mixed and matched 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, top code. And you've also spoken elsewhere about how
#
these steam rooms were a part of the system in the sense that, you know, the FDA and other
#
regulators have their systems in place, that these are the processes by which drugs should
#
be made and these are the processes by which we evaluate them. And Runbuxy has a system
#
within a system and 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 he 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?
#
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 shit about whether it works
#
or not. And lives are at stake. 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 the sad part about this, Amit, is that after this
#
book came out, right, after this entire episode where the company pled guilty, paid fines,
#
the biggest beneficiaries of this are the patients in the United States and Europe.
#
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 you uncovered was that data
#
in 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 Cathy Spree joined the US office of Ranbaxy. And at first she was really impressed
#
by the results of the generic versions of Rionnet and Sorted because she said, wow,
#
Ranbaxy'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 Ranbaxy
#
is supplying to Africa, it probably doesn't work. And one of the company's top executives
#
said, quote, who cares? It's just blacks dying. Stop, quote.
#
Yeah, unfortunately, that's true. Just reading about this stuff just gives me
#
goosebumps, right? And it's just completely shocking to me. You're getting this shit in
#
real time. Unfortunately, that's true. You know, I mean,
#
sometimes what happens is that we're in 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? With the benefit of hindsight, 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 Cathy 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 a hundred million
#
of that from the U.S. 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 Shivinder 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 you know, we used to sort of, as a team, we used to meet once a week because these
#
guys used to travel, right? So he used to travel to Devas. MP was a very big manufacturing
#
facility. They used to go up to Pontasaheb. That's again a 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, we 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 Raj on Tuesday because I used to
#
collect all that data, essentially compile it and then go see him every week kind of.
#
So some weeks 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 how far we got. We had great
#
difficulty getting data, but at some point when 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? You can't have a portfolio of a company where all the data is missing.
#
Go back and redo this. So after a while I said, I just got like, you don't believe me.
#
I mean, I'm telling you what I 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 our meeting? So he did.
#
And he heard from people, all of them across the table, we sat down and basically people
#
told him, look, this is what it is. After that meeting, I think the penny dropped for
#
him too 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, you know, a sort of a summary of how far you've come
#
along here. I need you to give it to me in terms of what, what was really happening.
#
So that was the first time actually put together a spreadsheet, you know, because there were
#
multiple pieces of information to the spreadsheet that, that, that was there, you know, that
#
was a consolidated was that was the first time that I did. There was a business development
#
meeting in Bangkok and part of on the sidelines of that meeting, he was supposed to be meeting
#
with Brian and, and the business heads in Malvinder and everybody else. They said, give
#
me that spreadsheet. Let me take it. I'm going to go talk to them. And, and, you know, so
#
that was the first time that he told, you know, this is what was happening. After he
#
came back, you know, we continued doing this and, you know, another month and a half, month,
#
month and a half after that, you know, 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 board of directors. He made the presentation. Not one person basically
#
said anything. There was one scientist, Nithyanandu basically said, you know, we really need to
#
do something to fix this. Everybody else said, just destroy it, get rid of the laptop, get
#
rid of this, that and the other. And 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, you know, 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 our
#
decision. But it will emerge stronger if you do this thing right. Nothing, the spin drop
#
silence in the room. He came back that evening, he says, I'm leaving. Next day, he resigned
#
No, and just to be clear, what, you know, 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
#
basically and the hammer was to him and destroyed. And luckily copies existed, including a copy
#
with you, which, you know, is useful later in the story and keeps in fact cropping up
#
at different parts of the story, which is really interesting. So he comes back and he
#
Yeah. I mean, he basically, I think the next day he resigned and then they actually had
#
a charade. They basically didn't tell the street. They said that his mom was there,
#
they went back to the UK. Some, some shenanigan. So they did, they, until January, they did
#
not disclose to the street that the head of R&D had resigned. I mean, that, that was rather
#
a big issue, losing two heads of R&Ds in quick succession. Right. So they covered it up,
#
Another sort of incident struck me. And this happened, I think, much earlier around the
#
time Rashmi Barbahia was leaving, where you pointed out that you had no idea why he had
#
left and exactly what the deal was. But your son Ishaan, who was three years old, he had
#
an ear infection and you first gave him Ranbaxy's version of Amoxicla, which was a generic and
#
it didn't seem to help at all. And the moment you shifted him to the brand name version.
#
It 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, they realized that if you're on the
#
brand name version of a medicine, it's fine. But the moment you shift to a generic, either
#
you adjust the 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 versions 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
#
look. And Ranbaxy in particular was one name to avoid, but not just Ranbaxy. Like through
#
this book, there are mentions of Walk Hard and Dr. Reddy's and so on. The list is kind
#
of almost feels endless. So at this stage, when Dr. Kumar is 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 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. Kumar is left. You are left with your team. What are you thinking?
#
So obviously, I mean, I was a known 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 audit guys, they essentially sort of descended on my department, stayed
#
there for almost like a month and a half, dug through everything they possibly could,
#
didn't find anything. And then finally, I think what they did was they planted some
#
URLs 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 work. Unfortunately, I also had an IT department in mind because we were doing
#
a lot of 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 gig was up. So I went to Brian and
#
basically told him, look, you 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 a 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? 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 in your things and pick up your personal effects and
#
you know, I will settle your last and final, whatever the thing that, you know, what was
#
owed to you at that point in time, a salary wise, I'll settle that. That was it. That
#
And when you sort of landed up to take your things, you took the pictures of your kids
#
from the desk, but you weren't even allowed to open a drawer.
#
No, because the problem was that the drawers actually contained a lot of handwritten 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 handwritten notes of who we spoke to, when we spoke to,
#
what did we find. The drawers actually contained a lot of those handwritten notes. And obviously
#
that was not something that I was, they wouldn't let me, you know, lay my hands on. So I got
#
to, I got to collect the Mishan's picture. I had some personal effects, you know, on
#
the table that I, and that was it. That was the end of it.
#
They physically stood there and stopped.
#
So there was this HR manager, his name was Bhav Ganju. He was the director of HR and a
#
security person. Both of them essentially shoot over my shoulder. It took all of like
#
five minutes on Monday morning. I went in there, I took the picture, I collected my pictures
#
and I had some BMS personal effects on the table. So I took that. It took all of five
#
minutes and they walked me off of there.
#
Yeah, it's insane. 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 site, Googling
#
all the names of the people and thinking to myself that surely this person's career was
#
over at this point. But they all continue to flourish in the pharma business. All of
#
these people who admitted to these wrongdoings, who forged documents, whose actions certainly
#
led to so many deaths, they all continue 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 Broward goes, Brian Tempest takes
#
over as CEO and later on Malvinder basically takes over himself. And in 2008, you know,
#
the company is sold to this 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 in baggage to Gurgaon. So you're in Gurgaon, not something I would 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, you know, 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 this 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, is just 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 asked for some money upfront, you
#
pay seven, eight thousand rupees, whatever it is, and you go away. And the next day at
#
Ranbagh sea, 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 away. I don't know what he did, but he made them go away.
#
Yeah, so clearly. So maybe the same Mr. Ganju, I don't know if you know.
#
So Mr. Ganju was the head of HR. There's another gentleman who worked with him very closely.
#
His name is Mohan Ahuja. Both of them were very well connected and they made them go
#
Oh, fascinating. So you've quit. Now, obviously, you're despondent. 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 Infosys and all of that. And you have to move back
#
to the US. But in the interim, you're sitting in your basement in Gurgaon. 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 walk away? I can't let this rest?
#
Two things. As you 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 manage our own portfolios.
#
The second thing, then I started looking at IT services companies. I actually worked with
#
Tata Consultancy as well. Again, it's the same situation. You don't need somebody to
#
do the skill that I bring to the table. So it never worked out. And so I started thinking
#
about, okay, 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 have 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. The 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 to India? 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. The
#
trouble is when you're not focused on doing something productive, then 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, Dinesh Kastoor and Venkat, they're also
#
in a difficult position. So all three of us were in really, 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 the fact that I'm the kind of person who kind of doesn't react immediately. I reflect
#
on these things and kind of steward it. And after that, I do something. And so my initial
#
reaction was very simple. I said, like, fine, okay, I did what I needed to do. It ended.
#
I have to move on. There's not much more 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 used to talk once in
#
a while. And I used to tell him, look, is this it? I mean, you walked away. You basically
#
said, okay, this is mine. I'm not going to deal with this anymore. And we walked away.
#
I lost my job. Are we done? Are we done with our responsibilities here? A lot of these
#
discussions over a period of time, you know, came to the point that I felt that I needed
#
to do something more than just sort of saying that I wash my hands off of the situation.
#
You know, I'm done with my thing. And that's the reason why, you know, it took a while
#
for me to kind of sort of 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 said, look, if you go out and do something
#
and be public, realize that, you know, this is a big company. They have lots of connections.
#
By the time there was also anecdotes about boardroom brawls, you know, the brothers,
#
you know, beating each other up, like dirty stuff, right? I mean, you don't like, you
#
know, why do you want to sort of put yourself out there? You know, this was a counter narrative,
#
you know, saying, you know, this is how things get done in India. You know, you, if you want
#
to do something about it, just, you know, 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, you know, gestate and come to a point where I, it is important for
#
me to be able to do something about it. Yeah. In fact, just talking about the environment,
#
I mean, whistleblowers in India haven't really flourished. I mean, you look at Manjunath
#
and others who were basically murdered. And in Bhan's book, there's this other conversation
#
she reports between Malvinder and Jay Deshmukh, the lawyer, where towards the end, at one
#
point they are fighting and they're fighting over exactly this. And Malvinder 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 Shiv Sena or whatever, he had relatives who had, who were, so there are
#
these kinds 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 musing I have here. One is that when
#
historians come on 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 is gendered because that's, you know, we've been, our species has been sexist and
#
mythogenist 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 Ranbuxi 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 that's
#
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
#
surely? Correctly so, because you've got to be practical. And you did what you did.
#
You're absolutely right. I mean, I am a big believer in the second theory. I mean, I think
#
that it's hubris to think about the fact that a man or a group of men changed the course
#
of history. I don't- But in this case, that's what- I mean, it's
#
by happenstance kind of- No, but the circumstances actually enable
#
you to do that. Right? I think the most important thing, whenever I get asked about this, right,
#
is I was lucky. I was lucky because for whatever reason in my life, I had very strong role
#
models, very, very strong role models. My dad was one of them. Raj is one of them. I
#
think that that is essentially 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're kind of accidental. Like what if the Infosil job came about just when you
#
left Renback Sea and you- Yeah. I mean, see, counterfactuals are always
#
there, right? You can always think about counterfactuals. Would I have been as aggressive? But I have
#
an answer to the Infosil job question. You see, what happened was even while working
#
for Infosil, I was working with the USFDA until a point where they essentially told
#
me, go get a lawyer. 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
#
the USFDA inspectors, answering questions, what they were doing, helping them map out
#
what they were doing. I mean, the raid, Valentine's Day raid in Princeton. A lot of these things
#
actually happened while I was still employed at Infosil. I was doing my day job. At night,
#
I used to do this. So who's to say that even if I got the Infosil job right away, after
#
I quit, ran back, see? 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. Raj can't answer it. My dad can't answer it. Nobody
#
can answer that. At the end of the day, I have to answer that to myself.
#
Fair enough. But the other moment of happens to answer that strikes me is, earlier on,
#
if you look at a counterfactual 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 you stay back there. And therefore,
#
you and your team is never at ran back, see? And perhaps when Raj Kumar wants his data,
#
he doesn't even get it. There's no one to get it for him. And that could also have happened.
#
That could very well have happened. I mean, again, you know, when you look back and say,
#
okay, why did it happen? Why did it have to happen this way? I don't have an answer for
#
that. 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 going to stick around for another five years. I'm going
#
to become a VP very easily. Right? A cushy life, well-paying job, you know, perfectly,
#
you know, sort of happy with my son. Nothing to complain about. Right? But at some point,
#
you have to still ask yourself, and I still have to ask myself, okay, right? At what point
#
do you transition from being responsible to your family, immediate family, to your responsibility
#
toward a larger society? I don't have an answer.
#
That's a legit question for after you uncovered what is at Ranbaxy. And I completely buy that
#
at that point, everything was inevitably going to where it led to. You would have to do this.
#
I buy that. But you may not have been at Ranbaxy in the first place. But anyway, that's that's
#
it. It's fascinating. The reason I say this is this follows, right? So in 2007, I started
#
a company here in Bombay, right? So it was based in Westboro in Massachusetts, but we
#
had people here working. And I grew it to a reasonable size as a CEO and a step down
#
in 2012. A lot of lessons there as well. 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. They 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, we wouldn't
#
have made it. Sometimes you find yourself in the situation, right? And you think that
#
you're the greatest thing since sliced bread. You're not. You're just standing in the path
#
of social change. And if you're stupid enough to think that you're the one who's driving
#
it, 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 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 too 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 MySpace, 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 defunct and everyone's going to listen to digital music. And I remember
#
going to New York in the middle of 2000 sometime, made a presentation to a bunch of venture capitalists,
#
impressed 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 going to be an entrepreneur again. One
#
could argue that in these modern times, every creator is one. But 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 what did you expect?
#
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 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 South Africa that, yeah, we can vouch
#
for what you can buy from Fran Maxi. It was the UK's regulator, Medicines and Health Regulatory
#
Agency, because they were also involved. They were buying a lot of stuff from the US FDA.
#
My expectation was that they needed to know that this is what is the reality and they
#
would do something about it in the sense that either they would be more diligent in terms
#
of evaluating the information that the company is providing 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 that 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 for
#
looking into it. That was the end of it. UK never responded. US, 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 I started sending them information bit by bit, because I didn't want to overwhelm
#
them saying, okay, I mean, nobody would have believed, 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 was executed, and I actually 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're telling
#
me the largest generic drug company in the United States is selling all of these drugs
#
with fudge data, and you're telling me that you know this for sure? He didn't believe
#
me to begin with. But over a period of time, he also kind of, you know, got convinced that
#
that was true. That would have been the reaction if I told, you know, the US FDA and I had
#
a friend that, look, guys, you know, 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 file for the largest selling drug, Lipitor, $12 billion drug. Who's going to
#
believe somebody who's saying something like this, right? So I write to them over a period
#
of time, and it kind of took a while for them to appreciate what I was saying. Plus, again,
#
you know, it always comes down to one or two contentious people, right? So there was this
#
gentleman named Edwin Rivera Martinez, who passed away, you know, bless his soul. 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 ended many, many times, many years later,
#
I met with him. He was the one who took interest in this. 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.
#
Great woman theory of history.
#
Seriously. She's the one who drove this thing 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 a, you know, holster, you know, with a gun. You're an all-of-the-kind person.
#
I mean, she knocked heads, a 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 at
#
the right time. If it was not for Edwin, it was not for Debbie, this case would have never
#
resolved itself. Certainly it would have been in some dusty box or someplace else.
#
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 all 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 Ponta Saheb in 2008, and then they found
#
out that they were fudging data. I mean, the first thing was very simple, right? So what
#
happens is that when the US FDA comes to inspect, at the end of the inspection, they give you
#
a report, it's called the Form 483, and they write down what is it that they found on that
#
inspection. So it's very transparent. They come, they do the inspection, 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 you. And so it's a draft report, it's not final. They give them an opportunity to
#
actually provide feedback and then it gets finalized. The first thing that is on that
#
report is that when you walk into the manufacturing facility at the gate, they have registers
#
of who's coming and going. They were telling the US FDA, there were certain people who
#
came in and did all this work. There was no record of those 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 pot or
#
whatever. What he's saying is actually true. So after that, I think there was some confidence
#
that came in, look, he's saying what he's saying.
#
And what's the process that now happens? In 2008, towards the end of that year, for
#
example, Ranbaxy sold off to the Japanese company. There's this interesting storyline
#
that Jay Deshmukh, who is a 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 Deshmukh 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 Malvinder have this fight that, I know where you live. 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 Infosys. You have to go to the US, you know, leaving
#
your family behind. And there's a poignant scene as 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 being a man on a crusade of sorts with this larger cause.
#
How does it affect your family?
#
Yeah, that's a tough one. That's a tough one. I mean, look, you know, I mean, if you look
#
at it today, right, you know, it's a broken family. There's the Mam DeMorse 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.
#
I mean, at that point in time, that felt the right thing for me to do. You know, it wasn't
#
like, you know, 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 for the US to work for Infosys, I had
#
a, I think, three month old daughter at that time. So, yeah, it was a tough, tough time.
#
And there must have been worries about safety as well. Like, there's an interview of your
#
wife Sonal where she talks about how, when you told her, you took her to this 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 whistleblower. 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 cold, 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 won'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 Ranbaxy 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 the culprits. And Dr. Kumar has sent a veiled warning that
#
you will be implicated in this. So you are a...
#
Markman, both of us, yeah. Unfortunately, you know, it was a tough time. I don't know
#
what to tell you. I mean, we had security guards outside our 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, what can I say?
#
Are there times when you think I wouldn't do this all over again? Or had you known what
#
was going to unfold that you would have taken another path?
#
You know what, I was asked this 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 Ranbaxy
#
thing. Now, what I did in my personal life, yeah, there's always regrets. 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 with Ranbaxy,
#
there's really no choice. I mean, how could you sort of say no to what was happening,
#
knowing full well that forget about what is happening in 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 is sold actually
#
at a chemist shop or a pharmacy shop. We have no systems in place. When I talk about recall
#
and adverse events, people never pay attention. You know what the pandemic did? At least people
#
realized that there is something called an adverse event. You take a vaccine, you will
#
develop some issues around with it. Some people will have rashes. Some people will probably
#
have a thrombolytic event that we have seen. At least people know that there is something
#
called an adverse event that we have to record and report so that something can be done about
#
it. Until the pandemic came around, there's no awareness in the country around this issue.
#
How do you build that capability in the country? There are written documents, Indian companies
#
saying that if they are forced to recall a drug law from the United States because it's
#
a failed law, 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 failed law in the U.S., it's a failed
#
law. You don't redirect that to the Indian market and sell it and make money out of it.
#
There are companies that have made this representation to the U.S. FDA because the law requires you
#
to destroy that law. They don't want to destroy it. They want to recall it and take it away
#
and distribute it in a market that doesn't have the stringent regulations. Knowing that,
#
how can you not do what you're doing? There's a quote in the book, which is a variation
#
on a famous quote about medicine. Basically, every medicine is a poison, but 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 in 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.
#
Here you have people just flouting it in crazy ways. There's another inspection that part
#
of Iban's book focuses on this FDA investigator called Peter Baker, who for a series of years
#
did a number of these inspections and became hated by the Indian pharma industry because
#
he always found what they didn't want him to find. There's one factory he describes
#
where the security guard was packing the medicines with his bare hands. This is the kind of bullshit
#
that kind of went on. All this starts in 2007, 2008, whatever, around that period. The case
#
gets over in 2013. It's gone on for five years and all of that. At one level, it would seem
#
that it's finally ended well to the extent that these guys, Ranbaxy, agreed that they
#
had committed all of that fraud, that they had fudged the data. They agreed to all of
#
that. A settlement was given of which you got a chunk, your lawyers got a chunk, all
#
of that happened. But at the same time, one of the things that I found incredibly odd
#
that this is around the time that Lipitor went generic and Ranbaxy had applied to be
#
first in line. 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? There were various incentives which
#
were marked towards ignoring that and allowing Ranbaxy, as eventually happened, they were
#
allowed to manufacture that generic. There were various incentives. Incentive number
#
one is that US politics wanted it to happen because they needed generics to come in. Incentive
#
number two is that the way the law was structured, if they don't give it to Ranbaxy, they can't
#
give it to anyone else because Ranbaxy has that sole initial right of making the generic.
#
So it's all a big mess and eventually they gave it to Ranbaxy, but then the judgment
#
comes. But then what strikes me about the judgment is that fine, it has happened, but
#
fundamentally nothing has changed.
#
As far as Ranbaxy is concerned, it was purely a monetary penalty. They pled guilty to seven
#
counts of criminal felony. They paid a whole boatload of money. It's essentially money
#
that they earned from selling Lipitor. The one that came in the left pocket turned around
#
and gave it back to the government. That's exactly what happened.
#
In fact, one of the reasons that was 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 such
#
It's very good. You think about dysfunction in the systems, right? This is purely dysfunction
#
in the system. 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 their penalty. How perverse
#
is that? But unfortunately, you know what? Bureaucracies and systems all over the world
#
work the same way. But the sad part about this whole thing is that there is no individual
#
accountability. Company pled guilty. Company actually admitted that, yes, this is a statement
#
of facts. This is what we have done. We shouldn't have done this. We violated these particular
#
statutes and this is because of this, we're pleading 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. People overseas, we
#
don't have jurisdiction. I mean, if you have the will to overcome, you can certainly overcome.
#
Yeah, I mean, you have the company selling stuff within your own country, right? Your
#
drug supply is contaminated with this stuff. If you wanted to make an example of it, you
#
could have done that. But it requires will to be able to do that and that particular
#
time, I 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 it carefully. They changed a number of regulations governing
#
overseas inspections. They bought in a lot more transparency. They figured out that while
#
the Ranbaxy case was going on, they set up offices 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. 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.
#
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 on a quest. 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.
#
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indiaankar.com slash clear writing. Being a good writer does not require God-given talent.
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Just the willingness to work hard and a clear idea of what you need to do to refine your
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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 Ranbaxy, 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 Sun Pharma. 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, you know, those those malpractices
#
continue. And you know, you sent me a bunch of links, which are linked 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're still getting away with most of what
#
they're trying to get away with. And that kind of makes it problematic for us. So like
#
was there a point where after all this is over, after, you know, that decision was announced,
#
what was it like for you? Like, was there a moment of great relief that this crusade
#
is over? Or was there this sense of like, okay, what now? This solved nothing, there's
#
Yeah, no, 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
#
is a milestone of some kind, right? So it was a huge sense of relief. And, you know,
#
it was a chapter closed, you know, if you can say it 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 in India as well, because, you know, this was, you
#
know, newsworthy 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 about documentation problem. It's just that, you know, this company did not document
#
the way that, you know, was required of the US FDA. And that's the reason why they were
#
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 naturally came,
#
you know, to me was, okay, fine, you know, if that's the approach that you're taking,
#
then the only way to debug 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, Prashanth Reddy, who is an intellectual property lawyer, but, you know, has deep knowledge
#
of the drug regulation and the regulatory affairs. So he and I have been working for
#
the last five, seven years right now. 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 a 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 at 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, sort of, you know, disjointed system
#
became so cumbersome that right now 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 Karnataka 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 are 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 antihypertensives, 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 antihypertensives. 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, you know, we need to make some
#
fundamental changes in the way medicine is practiced in the country. And so that's what
#
we do. I mean, even today, you know, most of our efforts are essentially geared toward
#
trying and collecting information to build a case that we really need to look at this
#
area. And, you know, I've said this in other places 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 Jharkhand, go to Chhattisgarh. Our first line
#
of defense is somebody falls sick, they walk up the stairs of the chemist shop and says,
#
can you give me some medicine to make this thing go away? That is our first line of defense.
#
That's our public health right now. We have poor ASHA workers who don't even, not even
#
employees, we pay them an honorarium of 2500 rupees a month. And we ask them to inoculate
#
in newborns 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 has been. So we really need to think holistically about what does it mean,
#
you know, 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, you know, we have the ability to buy imported medicine or, you know, we
#
can go get ourselves 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
#
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 seen 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,
#
you know, 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 overprescribe 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 stated that correctly?
#
I mean, we see that because, remember, tuberculosis is still endemic to us, right? This is not
#
a disease for wealthy nations. This is a disease for us, for poor countries like us. And look
#
at how tuberculosis is mutated. We had an original strain of the bacteria, the pathogen
#
that actually created tuberculosis, right? And then now we have multidrug-resistant tuberculosis.
#
It doesn't respond to the standard care that we used to actually have. And we've gotten
#
to a point right now where we are using super potent, you know, class of drugs called carbapenems,
#
because none of our standard of care, antibiotics, actually work to treat multidrug-resistant
#
tuberculosis. What is going to happen if they become resistant to that, you know, in the
#
And you've pointed out that there's a similar trajectory to malaria and dengue and all else
#
So here's my first question to you that before talking about the work that you do in 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 Ranbaxy did 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.
#
These mentioned companies like WorkHard and Dr. Eddy'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 turned to his boss and said, but how
#
will we backdate 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, you know, 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 whatever
#
you say 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 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 their equipment is of 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 distilled water. They use tap water to mix the chemicals to 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? 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, one's in Mumbai and one's
#
in Ahmedabad, they've essentially revoked all approvals gotten from these two contract
#
research organizations because they do not have confidence in the clinical data that
#
they are supplied. Why does that happen? Ranbaxy was 2013, right? We are in 2021. It's 80
#
percent. Why do we still have to deal with the WMTA labs, which was the genesis of the
#
Ranbaxy situation, a contract lab that was fabricating data? It is happening right now.
#
Last week, US FDA revoked licenses for two different CROs, one's in Mumbai and one's
#
in Ahmedabad. 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 that why is it that our regulator cannot find these kind
#
of violations that the US FDA finds, that the European Union regulator finds, the French
#
inspector finds? What's the answer to that? We just don't incentivize properly. How do
#
we change that? First of all, I think that the governing law, the Drugs and 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, right? And the
#
kind of diseases we were treating them were essentially infectious diseases, right? We
#
were dealing with typhoid, we were dealing with cholera, we were dealing with malaria
#
at that point in time. Look at the prevalence of diseases today. The majority of the diseases
#
that we are dealing with right now are lifestyle diseases, diabetes. We are the diabetic capital
#
of the world. Hypertension, oncology, cancer-related diseases, right? 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,
#
right? It's not like every drug they make is a bad drug. It's not. Many drugs that are
#
manufactured by Indian pharma companies for the Indian market, because the way physiology
#
works are just fine. You take an antibiotic, if you have the right dosage, right? I'm telling
#
you if you have the right dosage. That's the biggest issue that we have here. We just don't
#
know what the dosage is. The antibiotics just work just fine. So if you have an infection,
#
antibiotic to kill something. The pathogen that's causing the infectious disease 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 a thyroid medication that
#
you're taking, anything to do with you're in the hospital and you have an autoimmune
#
disease like lupus, 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 our 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
#
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. Remember,
#
at the time the regulation was framed, health according to Indian constitution is a state
#
subject. We have heard this many, many times right now during the pandemic. Anytime you
#
talk about central government's response, the response is health is a state subject,
#
go talk to your state. 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. Legally, an authority that's given to you without the explicit permission
#
of the parliament, you cannot sub delegate. This was an issue that we were going to contend
#
in the court. Unfortunately, it 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 Himachal Pradesh and Baddi? Or why does most of our API gets manufactured in Hyderabad?
#
It's because we have specific tax incentives that we've enabled these companies to set
#
up these special economic zones where they go ahead and manufacture their medicines.
#
Now, here is the big issue with us. Because health is a state subject, a drug regulator
#
in Karnataka or Maharashtra who finds out there is a specific batch made by a specific
#
company which is located in Himachal 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 enforce this.
#
This is not hypothetical, but this has 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 Himachal Pradesh. All he can
#
do or she can do is write a letter to the Himachal Pradesh drug controller and say,
#
we found this batch that is not of standard quality. And that person will once they get
#
the letter, crumple it and throw it in 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. Things have changed. Another
#
simple example, how we think about quality. 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 a pittance. We've kind
#
of done RTI work on this. It's a pittance. That budget is given to the state drug regulators
#
and 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 it's important is because initial quality and the quality
#
before the drug 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've 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 has 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 a standard quality, we only look at the active ingredient. I'll tell you
#
why this is really important. 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, the chemical,
#
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. For example,
#
how do you take powder and make it look like a capsule? You have to put some binder in
#
it 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 excipients. Our testing protocol as written in the Drugs
#
and Cosmetics Act only looks at the active ingredient. It does not look at the excipients
#
and what really happens to them. Why is this important? The reason it is 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 has been found that many of the
#
sartans actually have a small carcinogenic impurity called NDMA. It has been written
#
up recently. It has been written up as well. If you are not looking for impurities to begin
#
with, how the heck are you going to find this? You are only measuring for what is the active
#
ingredient. When we adjudicate our drug quality in terms of what we consider as good quality
#
drugs, we do not even consider impurities. There are systematic issues of this nature
#
which really have to be thought through. The rest of the world looks at impurities. They
#
look at related substances. They say, if you have these impurities over a certain threshold,
#
it becomes not of standard quality. We do not do that because it is not written on our
#
law. I am 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. As a country, we only talk about what
#
the central government spends in terms of health. We have some number, 2%, 3%. We never
#
account for what our out-of-pocket expenses are. There is no accounting for that. Healthcare
#
is primarily paid out of pocket in the country today. We spend a lot of money on healthcare.
#
Look at the quarterly earnings of all the pharma companies. You will know exactly what
#
I am talking about. Here is the thing. We take that step back.
#
I can see that, number one, what needs to be done is that you cannot just say it is
#
a state subject. You need a central regulatory authority which can then regulate the entire
#
country. If in Maharashtra, you find out that some medicine manufactured in Himachal is
#
a problem, you can fix it. That is number one. Number two, you need to modernize the
#
laws beyond 1943. For example, you are not just looking at active ingredients. You are
#
looking at expeciency. Expeciency, impurities.
#
Yes, you are looking at all of that. Let us say you modernize them in every way. You just
#
gave one example. You will 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 Ranbeck, there was some drug which went to CDSCO, which is the Indian version
#
of the FDA for approval, and the Toyota Corolla, a new version of the Toyota Corolla had just
#
come out. 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
#
is rent-seeking. So how would you get past 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 is a cultural problem at two levels. One is it is a cultural problem
#
within companies, within individuals, within society of this 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 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 COVAXIN was approved, right, the CDSCO had a Subject Export 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 a list
#
of experts that we are getting. We are going to do an open meeting. It's live 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 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? Malini Isola, who works for Aidan, she had to fight basically in Siddhartha
#
and they had to fight and to try and get names of people who were actually a member of that
#
Subject Export Committee. It took them two months to try and get their names. Okay, tell
#
me, why is that a state secret? Shouldn't the people in the country know who are the
#
closest experts and they're actually making a decision that impacts the rest of the country?
#
What data is it that they're looking at? US FDA put the portfolio out there and basically
#
said, here are the patients who are enrolled. This is how long the study went for. This
#
is what we saw in the clinic. We still do not have a published paper on Covaxin. We
#
have preprints. Now, after nine months, we have... The point I'm trying to make to you
#
is that transparency, I think, is one big thing that we need to do. Accountability comes
#
in when you make things transparent. Build it in the regulation that when you establish
#
an advisory committee, the membership of the committee, the documents that they review,
#
the deliberations and the outcome, whatever recommendation they make, pull it on the web
#
within a reasonable time, day, two days, whatever it takes for you to be able to do that. Let
#
people have added. Why is that a state secret? Bring transparency into the process. I will
#
tell you one of the things that we did. The Parliamentary Standing Committee in 2013 had
#
identified a set of four different drugs that they found... There was some hanky panky going
#
on there and it was written in the Parliamentary Standing Committee report. One of those drugs
#
is a drug called buccalazine. In India, it's marketed for as an appetite stimulant for
#
children. There is zero data for this. Zero. None. We essentially followed through with
#
the drug regulator to tell us, on what basis did you approve this? Never did. They never
#
gave us answers, so we had to go through the RTI process, the appellate 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 committed fraud. It's still not signed and
#
we still don't have the actual deliberations of what the interviews were done by the Mahapatra
#
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.
#
That drug does not have... It is sold to children as an appetite stimulant. It has zero data
#
for it. 15 crores annual turnover for that drug in India today. It's been two years in
#
Delhi High Court. We are litigating this. So Mahapatra Committee was established by
#
Dr. Darshwar then, was one of the good things that he did. After the Parliamentary Standing
#
Committee report came out, he instituted a committee under the leadership of Dr. Mahapatra.
#
He did the investigation and he made a report. They sat on that report for years and the
#
strong goes along for years. Finally, after going through multiple levels, the CIC level,
#
the day before they give us a report, a unsigned report, and they won't tell us who all they
#
are. We want to know. Why is that a state secret? If a company is selling 15 crores worth of
#
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 transparency into the process, into the system so that people can
#
be held accountable. At the end of the day, the CDSCO or the directors there ultimately
#
work for people of India. If they're making decisions that they're not in the interest
#
of the people of India, people of India need to know that. 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 inapt sort of comparison to draw, but it just came to mind that maybe the drug
#
industry needs this Nirbhaya 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. Is there then an attribution problem? Let's 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 all
#
of this kind of goes unseen. I wish what you had said was true. I'll
#
tell you another high note. 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 Himachal. They had mistakenly substituted ethylene glycol for
#
diethylene glycol. One is a excipient, the other one is antifreeze. Investigation was
#
done by PGIM, Yaran Chandigarh, qualified people. We're litigating in court right now.
#
This is the fourth instance in India. Fourth. So where's the outrage? Where are the people
#
writing about it? I mean, Indian Express Prabha has written extensively
#
about this. Priyanka has written. The point here is that we don't care until it hits home.
#
It happens to me and my family. There is no outrage. Those 12 children were essentially
#
children of people, of laborers who live below the poverty line. God forbid if it happened
#
to somebody who was in Delhi in one of the posh colonies, a defense colony and our friend's
#
colony, you would have seen the outrage. It happened to these 12 young kids whose parents
#
were laborers in Jammu. It's been written. Priyanka is writing about it. Anu has written
#
about it. Prabha has written about it in Indian Express. She did multiple stories on it. This
#
is something that we think, okay, it's not me who's affected. Somebody else is affected.
#
This is not the first instance, fourth instance in India. Lenton Commission report. This happened
#
in Mumbai. We had a feeling like all poisoning in Mumbai in the 1950s. Justice Lenton actually
#
held an open inquiry here and made recommendations that how we need to fix it. Same stuff happens
#
in Chennai and now happens in Jammu and happens in Haryana 10 years ago. Why?
#
I have to confess, I missed all these reports. In any of these cases where a causal link
#
has been found, where there's clear malpractice, has anything actually ever come out of it?
#
First of all, our legal justice system is such that things drag on forever.
#
There 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
#
So this is the kindergarten judgment that just keeps standing till the court rises and
#
People have died and that's it.
#
The argument was an elderly person, he didn't know what he was doing. Our IPC has so many
#
holes. I don't even know where to begin. I've seen judgments that basically after great
#
effort, some drug inspector has gone to the, persisted through the entire process, proven
#
that there was malafide intention, negligence in the part of the manufacturer.
#
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
#
there's no systemic change. 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 CDS here has issued that basically says it actually advises the court that if
#
you, in case, adjudicate that there was a problem, there was something really bad that
#
the manufacturer did, don't impose too harsh a penalty. This was written by the regulators
#
quite like, I'm not kidding you. And they stand and the judges read them and take that
#
into consideration when imposing penalties and sentencing. How do I justify this?
#
Central Commission, Mumbai, seven people died here. Chennai, we had like 12 or 13 people
#
died. Haryana and Jain, they had the same situation. How is it possible that we continue
#
to mistake an excipient for antifreeze? I don't get this. And there is no accountability,
#
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 since
#
that judgment to make things happen.
#
So I mean, the only thing that we can do is collect data and argue. So we are in Delhi
#
High Court arguing about transparency. We are in Karnataka High Court arguing about
#
buccalysin and 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 academia to start paying attention to this.
#
We need 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 our academia in India to actually do real research. I just don't
#
find that. I'm sorry to say. So as a part of the foundation, we try and look for people
#
to give grants to to study public health related issues. It's extremely hard to find people
#
who want to actually do real work.
#
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 program, which is essentially the basis of our public health in 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. Why is this important? Migration is actually making
#
people move from rural areas to cities like Mumbai. Right. We have a couple of different
#
models. We have a Mohalla Clinic model in Delhi. We have a good model here in BMC actually
#
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
#
why, you know, maybe these are great programs, maybe they'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 that 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. 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 kinds of studies is next to impossible.
#
The funding process is so mired in approvals in bureaucracy that you just sit, wait, apply
#
for a grant and wait for years for the government to be able to fund something like this. But
#
then, you know, you know, we have to change our mind or 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? Extremely hard. Because of restrictions on foreign capital. 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, HMSC 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 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 you want to do. All we're saying is, this is an
#
important thing. Let's study it. You know, 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 Nagpur. 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 the data. Why is it so difficult to do this?
#
We don't want our NSSO to study economic data. We don't want the health ministry to study
#
health data. How are we making policy then? And these are like, you know, simple things,
#
right? Look, Ayushman 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 researchers and say, find out what is the real
#
beneficiary? How many people have actually claimed the five lakh benefit? Won't you want to know?
#
Right? This government data happens in the US. The Center for Medicaid 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 the 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. There's no other way, right? I mean, I worked very closely
#
with Keshav Desiraj who just passed away. He was on the board of my foundation. We need people like
#
that. Very progressive bureaucrat who wanted to make a 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 core 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 kinds 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 bios who 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 normally
#
think. We only think about hospitals and health is when we need it. Normally, we don't. Right.
#
Tell me the last election where health care was an issue that was actually
#
litigated between state parties. I can't remember one. Right. 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. He always used this as a really good example when I talked to people. Atul Gawande
#
had written this piece in The New Yorker. And it's an excellent piece. Maybe you should look
#
at it from your show notes. He basically compared the progression of two different
#
medical procedures. One is anesthesia. The other is antiseptic. So, it takes you back to about
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early 1800s when there was no anesthesia. I mean, even if you had to do tooth extraction,
#
you really had to do it very quickly because it was really painful. Right. So, 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. And obviously, ether was the one that
#
was used to sort of get people to smell ether and then it knocks you out and you get the
#
tooth extraction. You do your surgery. But that spread like a 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. Right. And then he compares that with antiseptic behavior. So,
#
there was a time when the scalpels and instruments were not sterilized. Right. And that was the cause
#
of lupus in a septic shock. People went into septic shock. And he talks about how Joseph Lester,
#
using carbolic acid, basically came up with this concept that if you wash your instruments
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and your hands and everything else with carbolic acid, you kill the germs essentially from causing.
#
But that never took off at the same pace as anesthesia did. Right. And he compares why,
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incentives of why. The fact is one is very visible. You have a patient who's like
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shouting really bad because they're under a lot of pain. You don't see the germs. Right.
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Surgeons don't look at the germs. They don't think about, I mean, this is the times when
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aprons covered in blood was a mark that you were doing so many surgeries. Right. You were a good
#
doctor. You did so many surgeries. People didn't think about the fact that you need to change your
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apron. You need to change your gauzes. You need to wash your hands properly before you went into
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another surgery. Because if you appeared as somebody with blood on your apron, you were a
#
really good doctor. You had a really good practice and people came to you. Incentives are very
#
different. So, what he talks about is that, look, because anesthesia is so visible to people, right,
#
the patient is screaming in pain. The adoption was so much faster. But it's not like antiseptic
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behavior was any less effective. It was equally important because people were dying of septic
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shock of the fact that people were getting infected because you wouldn't have clean procedures.
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And carbolic acid in Joseph Lister's work actually proved that if you did that,
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you'd save a lot of patients. But because it was not visible,
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he wasn't adopted as quickly as it did. I come back to the same thing. Health care,
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it's not visible. We don't think about health care. We don't think about a doctor. We don't
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think about going to reality hospital, unless something really bad happens to us.
#
This is such a fantastic and profound point. And along with carbolic acid, there's also
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the resistance that Ignace Semmelweis found when he spoke about the importance of just washing
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hands. Exactly. Washing hands. And it took decades for that to get done.
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And it took decades for that to get accepted. And if I remember correctly, Semmelweis died
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in a lunatic asylum. So just a sad state of some kind of pioneers. And this whole thing
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of the seen and the unseen, that where the effect of something is immediate,
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your incentives drive you to do it. And if it is unseen, and you mentioned an antiseptic,
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I remember writing about agriculture once, the problems of agriculture and pointing out that
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sometimes, for example, farm loan waivers are a necessary antiseptic, because the farmers are in
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so much pain, you have to kind of get it. But you're not tackling any of the root causes.
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And if you look at what's popular among politicians, tackling the root causes is not,
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because a politician has his eyes on the next election. And if you solve the fundamental
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problems, you'll see benefits 15 years round the line, and they'll never be attributed to you.
#
Exactly. Whereas farm loan waivers are immediate. And it's almost like...
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You recognize that you got farm loan waiver, yeah? And if one not indented, they've become
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almost a hygiene factor. Now every politician has to...
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No, but that's the thing, right? I think we need to start this level of awareness among us, right?
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Because at some point in time, right, if not me today, 30 years from now, 20 years from now,
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I'm going to need help, you know, medical help. But if I wait until that time to try and affect
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the system, it's going to be too late, right? We need to start now. And it's not like, you know,
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whatever we do right now within a year is going to bear fruit. It's not going to happen. This is a
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systemic, longer term problem that we have to think about. And unless this becomes a part of
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mainstream political dialogue, I'm sorry, this is not going to change.
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A longer musing, and I'm just thinking aloud again, is that at one level, we are wired to
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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 assume we will never see the inside of a hospital, but...
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But reality is we all will at some point, right? Reality is we all will. We're just, you know,
#
wired that way that we won't think about the morbid thought of us needing, you know,
#
hospitalisation. But the fact is that, you know, there has to be an academic community that does
#
think about this, right? Because education and healthcare, 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
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people and you don't provide proper healthcare, those are the two basic things any administration
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ought to do. 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 a Narendra Modi, who obviously cares about
#
legacy and narrative and all of that, right? 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, deservedly the pharmacy
#
of the world and all of that. Why would he not do that? I mean, and you've met ministers trying
#
to explain. No, no. So I, you know, here's the thing, right? I mean, I've, I've never met, so
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I don't know. I think part of this is when you are at that level, there are 50 things in front of
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you. This is one of them, right? That's number one. Whether that registers against perhaps a
#
farmers' 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
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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, it happened with
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Herschworth and half the time he was looking at the television screen. No, you met Herschworth.
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I mean, he made me wait outside his office for two hours. And then the 10 minutes that I've been
#
there, he was looking at the TV screen half the time. And he asked me to write and send me a
#
report. I did. But the point here is that if that is the 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 one of the states
#
that believes in the kindness that we're talking about, implements it, shows that the model that,
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look, we've really made a difference. Because one good thing about 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 computational-driven 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 a two-year, three-year window where you
#
really... I mean, I would love to see a state basically saying that in every district or 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 a paramedic or a nurse, where the doctor comes in
#
once a week to be able to... That would be such a huge accomplishment if you're able to do that.
#
Yeah, I'd love to, at some point, get you together with Kartik Muralidharan and do a joint episode.
#
We've already discussed how 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, podcasters, sadly, are not so very high on the scale of things.
#
But I think your reach, I think, is far greater than what any minister can say. I mean, the people
#
who listen to your podcast are a select few who really understand the importance of 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, it's not something that
#
anybody, not everybody can pull this thing off. This is really, really... No, thank you. That's
#
very kind of you, but I wasn't wishing for a compliment. No, no, of course, this is reality.
#
I'm one of those. I'm one of those, because I do listen to a lot of what your episodes are,
#
and I thoroughly enjoy it. I think that I always look forward to it, because for me,
#
it's Monday morning there, by the time that your podcast drops. It's probably Tuesday morning,
#
because I shifted release from Sunday to Monday. Yeah, it's Tuesday morning.
#
Tell me something. I've taken enough of your time, and now I have to seem important in some
#
hubblin this too close. But no, I've taken a lot of your time, and you've also been kind with so
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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 Ranbeck Sea, 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, that a career that you
#
could have had, and a body of work that you could have built, has 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, how have you looked at what you want to do in those years to come?
#
Yeah, so I think the first question, it's an easy question. I honestly am not enamored of a career.
#
For better or for worse, I think that I've always had the satisfaction 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 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, being very honest with you, I don't have the
#
patience. I did once, I mean, when I left Phiformix, there were 600 people. I don't miss managing
#
people. I think it requires a certain aptitude and test that I just don't have anymore. So I'm
#
very happy with just being an individual contributor at this point in time.
#
The second question, I think, is a more important question. I think that when I look another 10
#
years down the road, if I think India has a drug regulatory system that is on par with what the
#
European Union has and the USFDA, US does, I'd be the most happiest person 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. 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...
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But if you had to like think of probabilities...
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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 percolates 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 has 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 working with a media partner to commission the production of that.
#
And the goal is to try and dumb 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 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 Centers 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 a 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 you 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 inoculate and vaccinate people.
#
Yes, the ICMR people and the AIMS 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 co-vaccine, right? The rest of the world was using virus-derived
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if you look at COVID shield or mRNA vaccines. We chose the most complex process to make our vaccine
#
and then we wonder why it wasn't scaling up. Who made that decision, right? And if you don't
#
include people from NCDC who are qualified to be able to look at this, then can we really find
#
fault with them? Why is it that there is no medical malpractice 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 litigated in a court. I
#
mean, if you say go to consumer course, yeah, you go to consumer course, 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
#
people understand that, you know what, there is a solution to this. It's just that we're not doing
#
yet, 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 taxpayer, so that they know what, and everybody is a taxpayer, so that
#
they know, so that 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 laments 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, it's been a lonely
#
battle for you. No, I think there are people, but they're not enough of us, right? 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 this 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 the state sort
#
of regulate healthcare versus centered us, right? How does our regulatory system respond
#
to issues of what we actually face? Like emergency related issues, like pandemics come our way.
#
We still have endemic tropical diseases, right? No pharma company is going to develop a cure for
#
sickle cell anemia because there's not enough of a market for them. They are not going to develop
#
novel therapeutics for cholera, for example, or typhoid, or for malaria. I mean, malaria,
#
at least there's some vaccination work happening in that we have a vaccine candidate for malaria.
#
What I'm saying is that there are things that are endemic to us, right?
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Pharma companies will only do it if they see dollars being big, big tons of money behind it,
#
right? Those big pharma companies are not going to develop solutions for us. Inform ourselves,
#
right? Ask these questions, right? I mean, it's great that our pharma companies are earning a lot
#
of money by manufacturing all of this stuff for the Western markets. Why can't you hold them to
#
the same standard when you make drugs for the local market here, right? The argument that I
#
always get is, oh, price points in India are very, 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 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 as gospel readup.
#
There's tons of information available out there. 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 come here? I
#
can't do that, right? I have to make sure that our medicine gets better here.
#
You know, the more kind of frivolous of those questions that at an individual level,
#
you know, what can we do? Like when I go to a pharmacy for whatever, what do I need to
#
watch out for? Are there companies I need to avoid? No, I mean, by and large, I think that the larger
#
companies usually, you know, they should make good drugs, right? Because the reputational damage for
#
them from bad kind of stuff is really bad. They don't want, you know, something get reported that
#
the drugs 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 our administration to say that
#
provide as 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 a sore arm or 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? I mean, the government
#
has set up a National Pharmacovigilance Center in order to collect this data, but we don't talk
#
about it. We don't, there's no public service announcement saying, okay, if your medicine
#
doesn't work, I mean, nine or 10 times what happens if the medicine doesn't do what it's supposed
#
to do, you go back to the doctor and the doctor says, we'll change your 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?
#
No, and if all this data, you know, frictionless way was just being collected, then over time,
#
you'd 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.
#
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 space. And unfortunately,
#
it'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, you know, 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 or a 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.
#
during this episode. This is a big deal. It affects all of us. Thank you for listening.
#
Did you enjoy this episode of The Scene and the Unseen? If so, would you like to support the
#
production of the show? You can go over to sceneunseen.in slash support and contribute
#
any amount you like to keep this podcast alive and kicking. Thank you.
