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An Unfinished Agenda

An Unfinished Agenda

An Unfinished Agenda

My Life in the Pharmaceutical Industry

From his birth in a village in Andhra to founding and running Dr Reddy’s Laboratories, now one of India’s largest pharmaceutical enterprises, Dr K. Anji Reddy’s journey makes for an inspiring story. That story is told rivetingly in his own words in his memoir, An Unfinished Agenda.

Dr Anji Reddy became an entrepreneur at a time when India was woefully short of technology to manufacture many basic medicines. Then, in barely three decades, the Indian pharmaceutical industry had grown to the point that India not only became self-sufficient in medicine, but also a supplier of affordable generic medicines to the world. Dr Anji Reddy provides a ringside view of this remarkable transformation, with fascinating anecdotes about those who made it happen.

The history of modern medicine is a gripping story of triumphs and failures. An Unfinished Agenda takes the reader on a whirlwind tour of the science of medicine over the last hundred years and reminds us of the stark challenges that remain.

Foreword +

Dr Anji Reddy was father and father-in-law to us. For over twenty-five years, we also worked closely with him in the pharmaceutical business he founded. For us, reading his memoirs is like reliving the past. We hear his voice, regaling us with one anecdote after another and his uninhibitedly joyous, full-throated laughter. We remember his infectious enthusiasm as he recounted the breath-taking progress of science and the promise that it held for the future. We recall being enthralled by the grand vision he had for the business we were in, and the impact we could make. We remember, too, his fortitude when faced with disappointments as well as his marvellous ability to put them firmly behind him and look ahead with characteristic optimism.

Dr Reddy was a voracious reader of science as is evident from his memoirs, but many other things, big and small, kept him absorbed. He had an abiding interest in literature and films in Telugu, the language of his schooling. The music that moved him most was in Telugu, particularly ‘Nagumomu ganaleni’, a composition of the saint-poet Tyagaraja. He had a surprising collection of art, some of which unsurprisingly found its way to the discovery research facility. But all these and more were peripheral to his main interest and find no mention in his story. The molecules of medicine were at the centre of his universe and his memoirs are mainly about them—first about producing the known ones, and then the quest for discovering new ones, with engaging detours along the way.

Despite the modest circumstances of his early life, which Dr Reddy briefly and unselfconsciously recounts, he had the self-confidence to pursue his interests, without the benefit of counselling and the awareness that is taken for granted today. It was the same self-confidence, and the excitement spawned by the accomplishments of science, that set him off on his entrepreneurial journey.

And what a journey it has been!
Dr Reddy started off at an entry-level position at Indian Drugs and Pharmaceuticals, a pioneering public sector undertaking at Hyderabad and some years later struck out on his own. His entrepreneurial story mirrors that of the pharmaceutical industry in India. How did an industry that lacked the technology and the means to make the most basic of drugs become a pharmacy to the world? Dr Reddy himself made no small contribution to this transformation, but his account also provides fascinating vignettes of others who shaped the course of the industry.

Dr Reddy’s pioneering efforts led to many milestones being achieved by the company that bears his name. All of them delighted Dr Reddy, some more than others. One of the most significant resulted from his decision to slash the prices of drugs in a new class of antibiotics, the fluoroquinolones, in the early 1990s. It shook up the industry. More medicines followed at prices which were within the reach of a large number of people in need of them. The competition was forced to respond. The pricing paradigm of medicines in India changed irreversibly and they became affordable. No other milestone better sums up his understanding of the purpose of the business he was in. It is no wonder that he constantly reminded us of George Merck’s dictum that medicines are for people, not for profits. And as Merck also said, the better we remembered that, the better were our profits. In the years that followed, the rapid increase in volumes resulted in record profits for the company.

Affordable medicine is not just a question of pricing. To remain sustainable, it requires innovation to make medicines efficiently and economically. Dr Reddy’s early innovations were all about that, at a time when it was not the norm it now is in Indian industry. Never one to rest on his laurels, Dr Reddy shifted his attention in the mid-1990s to the highest level of innovation in the industry, that of discovering new medicines. It was an unthinkable aspiration for the Indian pharmaceutical industry at that time. Nothing deterred him—not the sceptics, the uncharted waters, the expense or the risk.

Against all odds, several new molecules were discovered and one of them, balaglitazone, a novel insulin sensitizer for the treatment of diabetes, was licensed to Novo Nordisk for clinical development on 1 March 1997. It was a historical first for the Indian pharmaceutical industry and was cherished the most by Dr Reddy. Everything went swimmingly for a while and an even more potent insulin sensitizer, ragaglitazar, was discovered. The discovery was remarkable, for it was not just a potentially more useful treatment for diabetes than balaglitazone, but it was also a ‘first-in-class’ molecule, with an entirely novel structure, an extraordinary outcome for a fledgling discovery programme. Ragaglitazar too was licensed to Novo Nordisk, but it stumbled at the final hurdle. It was the biggest disappointment in Dr Reddy’s life. We vividly recall that even at this dark time, one of his first concerns was how he could soften the blow and rally the scientists who had laboured in the discovery. 

This setback, though huge, did not quell the innovator in Dr Reddy.It was not just the compulsive quest for discovery, the defining characteristic of a true innovator, which kept him going. He was also driven by his overwhelming belief in the purpose of medicine. As he argues in his memoirs, new medicines must be affordable to be useful and this demanded a new model of drug discovery research. His unflinching resolve was born of this conviction. He, therefore, persisted in his quest, with his personal funds. This was his unfinished agenda.

Just last month, we were poignantly reminded of Dr Reddy’s lasting commitment to research. He writes in his memoirs that the patent for balaglitazone was the first and the last one where he was named an inventor. It was of course in the context of Dr. Reddy’s Laboratories. On 30 September 2014, a patent was issued in the United States for novel pyridine carboxylic acid derivatives, which could be useful in the treatment of Alzheimer’s disease. Dr Reddy was named the co-inventor. The application for the patent had been made in 2010, about a year and a half before he became very ill.

Discovery research was not the only interest that consumed Dr Reddy for the last two decades of his life. Another was his substantial involvement with initiatives to better the lives of people who were underprivileged, which he recounts in the concluding part of his memoirs. We were struck by the fact that he never once used the word philanthropy. We do not think it was a conscious decision. It probably never occurred to Dr Reddy to think of it that way. If anything, he regarded it as a debt he was discharging for all the good that fortune had favoured him with.

Dr Reddy never said it in so many words, but we do think now that he did not see the larger purpose of his pharmaceutical business as very different from that of the social enterprises he had set up. Both of them aimed to better the lives of people.

Above all, we remember Dr Reddy’s irrepressible zest for life. When he was diagnosed with cancer of the liver, we grieved. We also worried about how he would deal with it. Knowing him as we did, we ought not to have been apprehensive.

Dr Reddy understood the prognosis better than most people. He did not dread the inevitable. Instead, he put it quickly and firmly behind him. He turned his attention to what he could do in the limited time available to him. One of the things he decided to do was to write his memoirs. Nearly a year later, and barely a week before he passed away, he read the first version, hastily printed, from cover to cover, in a hospital bed. He seemed to be overcome with emotion as he held the book in his hands, but that was for just a few moments. He looked up and joked one last time. ‘My life is in my hands,’ he said, and smiled. If he had not been so tired, we would have heard his full-throated laughter.

Dr Reddy penned his memoirs with the same zest that he had for life and everything that interested him. We hope you will enjoy reading them.

25 November 2014

K. Satish Reddy
G.V. Prasad

Excerpt +

I thought to myself that Western companies had a point about patents. They could not afford to innovate if they did not have the benefit of monopolies. Any dilution of patents was therefore anathema to them. But their model of drug discovery is very expensive and their monopoly prices are often so high that their new drugs can only benefit people with insurance reimbursement or government-provided health care of the sort that exists in thirty-five developed nations with about 15 per cent of the world’s population. This is most often not the situation in the less-developed nations with 85 per cent of the world’s population. Of what use is drug discovery if only a few people in poor nations can afford to buy the new drugs and benefit from the advances in science? It is no answer to say that these people cannot afford to buy any medicines, new or old, so let us not ask the question.

In February 2013, Science magazine carried a study of the cost-benefit of intensifying anti-retroviral treatment for HIV patients. The study was conducted during 2000–11 for a population of about 100,000 people in the rural area of the KwaZulu-Natal province in South Africa. The life expectancy in 2003, the year before the anti-retroviral treatment was made available in the public health system, was about forty-nine years. By 2011, the life expectancy had increased to more than sixty years. The estimated economic value of the life-years gained far exceeded the 10.8 million dollars spent on providing anti-retroviral treatment during the study period. Another study published in the same issue of Science showed that the risk of contracting HIV by uninfected people in KwaZulu-Natal was reduced significantly over an eight-year period by increasing coverage of infected people with anti-retroviral treatment. All this was possible with treatment costs that ranged between 500–800 dollars per annum per person.

Would this have been possible with drugs priced at 1000 dollars per month per person? One cannot say that innovation will not take place in the first instance without such prices, and that it would be available at rock-bottom prices after a delay of ten to fifteen years when patents expired and generics came into the market. By this time, a whole generation of patients in need of the medication would have died.Large populations in the developing world, who had access to affordable medicine because of the lack of patent protection or lax implementation, might soon find that they are unable to afford the cost of new drugs. At the beginning of the twentieth century, the leading causes of mortality were communicable diseases: pneumonia, tuberculosis and diarrhoea. The war against communicable diseases has not been won—AIDS and SARS are grim and sobering reminders that we have a long way to go. But the leading causes of mortality now are non-communicable diseases led by cardiovascular diseases (CVD), which afflict 200 million people globally. Heart disease and stroke, the two principal CVDs, kill seventeen million people a year, compared to the three million who die from HIV/AIDS. About 80 per cent of CVD deaths and an even greater percentage of CVD-related disability is in low- and middle-income countries, and atherosclerosis is the root underlying cause. Diabetes is a huge and growing problem and I dread the growing burden of diseases like Alzheimer’s, requiring intensive, long-term care which developing countries will remain ill-equipped to provide for a long time to come. New drugs for treatment of atherosclerosis, Alzheimer’s and certain cancers are desperately required, as no effective treatment exists today. But how many people in the developing nations can afford 2–6 dollars (around 130–390 rupees) a day, which is the current cost of many new medicines for each chronic condition in America—the costs go up with multiple diseases—or the huge costs of some treatments for cancer? I was astounded that most new cancer drugs launched in the USA in 2012 were priced at 100,000 dollars or more per year of treatment.

Even the richest nations in the world are groaning under the weight of their health-care expenditure. There are many components of the cost of health care, but one of them is the cost of new drugs. It would be a mistake to live in denial by arguing that the cost of new drugs is only a small fraction of health-care costs. It is thus not just a question of poor versus rich nations. It is a global problem.

I am a votary of patents, but also a committed votary of affordable pricing. The only way to solve this conundrum is to search for lower-cost alternatives for drug discovery that will lead to lower prices of new drugs. The current model of drug discovery of Big Pharma in the West is simply not in a position to deliver the goods. It is just too expensive to be sustainable. This is where the opportunity lies and I firmly believe that Indian companies are well positioned to take advantage of it.

India has a traditionally frugal culture. That culture shows up not only in the way we innovate but also in what, and for whom, we innovate. So much so, it has become the stuff of case studies at universities in the West. Frugal innovation could be, or ought to be, an important advantage in drug discovery as well.

Sometime in 2004, a headline in an issue of Scrip magazine caught my eye. The headline was ‘India will deliver on innovation’ and the person who asserted this was Brian Tempest, the CEO of Ranbaxy at that time, who was speaking at the FT Global Pharmaceutical Conference in London. To support his thesis, he quoted from an analysis that demonstrated that the average Indian chemistry researcher was better educated, put in 40 per cent more working hours every week, and cost the company less than 7 per cent of his US counterpart. And who did this analysis? None other than Pfizer. People may dispute the numbers estimated, but it cannot be disputed that India has a significant cost advantage.

Cost advantages and making do with less are not sufficient for drug discovery. Most importantly, there should be scientific capability. I think there is now no doubt that India either has, or can access, the scientific capability to deliver new drugs. Dr. Reddy’s itself has demonstrated that. We have forayed into both analogue research and target-based discovery and I am immensely proud of the results obtained by our scientists who have worked with unflagging zeal and a quiet confidence. They have proved that they are as much at the forefront of discovery as anybody else in the industry, anywhere in the world. Other Indian companies are also in the fray now and the Indian presence in discovery is here to stay.

The greatest drug discoveries have often happened not in the largest and most impressive laboratories but in modest facilities. They have often been ascribed to chance and serendipity, but why does chance favour a few? The answer, I think, was provided by Louis Pasteur more than 150 years ago when he famously said that ‘chance favours the prepared mind’. The essential prerequisite for a ‘prepared mind’ is a very high order of scientific competence, but I suspect that it helps greatly to have an equal concern for the human condition and a compulsive desire to better it. 

Because of the enormous progress in science we now have a better understanding of medicine and are possessed of many tools to prise open solutions to stubborn problems. As Pasteur said, ‘the veil is getting thinner and thinner’ and never more so as now. Yellapragada SubbaRow and Paul Janssen have demonstrated how much of a difference the power of the prepared mind and an unswerving commitment to good science can make to the human condition. 

Around the time I started my career forty-five years ago, we were struggling to make the most basic drugs. At that time, few would have thought that India would emerge as the leading manufacturer of low-cost active pharmaceutical ingredients and generics for the world. We now have the opportunity to build on our experience for the benefit of humanity. I strongly believe that drug discovery is a noble, perhaps even a spiritual, pursuit. It is beyond bottom lines and investor relations. The mission is to improve the quality of life and life expectancy itself. This requires good science. But for science to be good, it has to result in affordable medicine. Indian enterprise is best positioned to deliver both.

That is my unfinished agenda.

Review +

"The book has the feel of a scientist's personal diary, rather than that of a slick business autobiography .....but that is perhaps its charm"

Anvar Alikhan
Outlook India

"…. written with rare candour…… the book, peppered with anecdotes and medicinal history, shows that the pharmaceutical world is not just about chemical equations, and reading about it can be fun. An Unfinished Agenda should be compulsory reading for all those who want to know how India became a supplier of inexpensive medicine to the whole world."

Bhupesh Bhandari
Business Standard

“Despite frequent deviations in narration, Reddy’s memoir never plods with monstrous monotony. Instead, it retains a sort of welcome restraint in storytelling that is both intimate and detached.”

Financial Express

“…the story of Dr Reddy’s life is interspersed with little known facts and anecdotes about other leaders in the global pharmaceutical world …. The book is not only mandatory reading for those in the pharmaceutical industry, it also offers wisdom and valuable lessons to those pursuing other professions.”

Gina S. Krishnan
Business World

This autobiography of Dr. Anji Reddy tells the personal story of one of India’s most important scientific and business leaders during the second half of the 20th century. For those interested in the relationship between public health and industrial policy, it provides valuable insight into the development path of the pharmaceutical industry in India, and how India emerged as the pharmacy of the developing world. Reflecting on committing R&D funding to the pursuit of new drugs, Dr. Reddy stresses the central importance of making sure that whatever is developed is made available at prices the Indian public can afford. It would be good to think that his perspective might influence other leaders in the global pharmaceutical industry. In all events, very worthwhile both for appreciating Dr. Reddy’s individual achievements, and for understanding the Indian pharmaceutical industry. The author paid excellent attention to technological detail without compromising the readability of the work.

Frederick M. Abbott

There are a number of lessons that one can draw from what the great man had to say on the subject of corporate social responsibility.

Mudar Patherya
Mumbai Mirror

“But what perhaps comes out as the best part of the book is that it brings out the true researcher that Dr. Anji Reddy was.”

Vikas Dandekar
Pharma & Medtech Business Intelligence