Millions of lives all over the world have been saved by the innovation of Indian generic pharma companies. With a majority of pills consumed around the globe being manufactured in India, global healthcare depends on Indian pharma manufacturers for its very existence. As a result, India is widely regarded as the ‘pharmacy of the world’. Companies like Cipla revolutionised global healthcare by ensuring that everyone, not just the rich, have access to medicines. Fire in the Blood, a movie by Dylan Mohan Gray, documents the story of how Cipla innovated to ensure that HIV AIDS can be successfully combated all over the world, starting with in the developing world and now globally. In the book, Dr RA Mashelkar describes this as “Gandhian Innovation”—frugal in cost but efficient and progressive.
The book describes that development of the regulatory framework of USFDA (US Food and Drug Administration) over the past century and the various tragic events that resulted in the USFDA gaining more and more authority to regulate medicines to ensure that they worked to cure patients. However, it was the Hatch—Waxman Act that opened the floodgates for generic competition to branded drugs in the United States. As a result, generic drugs are often 90% cheaper than the patented branded drugs in the United States and now account for about 90% of drug sales (by volume). When US doctors prescribing generic drugs realised that they were not seeing patients respond to treatment in the same way as they did to branded (i.e., patented) drugs, they and patient advocacy groups realised that something was wrong, but the USFDA assured them that generic drugs were chemically the same as branded drugs. This explanation did not make sense to them and was the cue for the author to investigate the generic pharma industry.
Katherine Eban (Bottle of Lies; Harper Collins; Rs1,500) investigates the rise and growth of generics, especially the dominance of Indian and Chinese generic pharma companies and finds some bitter truths. She find a culture of jugaad with not even a remote connection to anything either Gandhian or innovative. Her extensive research, review of regulatory materials from the USFDA and interviews with FDA inspectors, regulators, doctors and employees of pharma companies paints a scary picture for all of us. She describes the terrible conditions in many factories which manufacture our medicines, the poor employee training, lack of quality standards and worst of all, the reckless attitude of pharma companies towards patient safety. There are several examples of dirty manufacturing plants with insects, birds, vermin and even a monkey living there, poor employee hygiene, unsafe manufacturing and quality control practices, unacceptable storage conditions and falsification of data—all pointing to a massive concerted cover up at the highest levels of pharma companies—to try to hide all these from drug regulators. She describes, in vivid detail, almost like a movie script, the various events—corporate meetings where major issues were highlighted and cover-ups planned, FDA inspectors experiences of visiting Indian factories, the working of the USFDA and at the heart of it all, the life of Dinesh Thakur, the most famous whistleblower whose testimony and evidence led to the eventual demise of Ranbaxy and the highlighting of the underbelly of Indian pharma companies.
If the story is about the USFDA and generic drugs in the United States, why should this bother Indians? The story of manufacturing for India and other 'third world' markets is even more shocking, if that is possible. The quality of raw materials used, the manufacturing processes and lower standards, and the resulting drugs for the Indian and third world markets are even worse than those for the US markets. Doctors in India and Africa are sceptical about unbranded generic drugs in the same way as the doctors in the United States are and now we know why! 'Export quality' still retains its significance—it is reverse racism and it is shameful! If the USFDA is described as 'weak kneed, incompetent and corrupt', there are not enough words to describe the state of the Indian regulator. There are several instances of powerful executives in large pharma companies being able to ignore with impunity the little regulation that there is in India and even take pride in being able to get away with it.
Over the past few decades, as Indian pharma companies have risen up the value chain, they have been importing raw materials that they were previously manufacturing, from China. As the author investigates these suppliers, she finds that the situation in China is much worse than in India! This should worry us too for two reasons: however good the manufacturing process, it cannot make good products with poor quality raw materials and the Indian pharma industry is entirely dependent on China for its raw materials. Although the government is aware of this issue, very little has been done to address it. One only has to travel to the pharma clusters like Dahej, Ankleshwar, Baddi and Pitampur to get a sense of what the ‘rust belt’ would have looked like in the United States. Poor infrastructure and the lack of civic amenities is shocking. One really can’t expect a global business to be able to function in this environment which forces the culture of jugaad which is anathema to GMP (good manufacturing practices), the foundation of drug regulation.
Indian pharma companies are essential to global healthcare but, unless they address all the issues that the book identifies, there is a real risk to lives around the world. At the heart of it is the corporate culture of non-compliance, built on unquestionable hierarchy and personalities rather than strict rules that are non-negotiable. If India is to play a major role in world affairs and be relevant in this millennium, healthcare is a great opportunity – it’s an opportunity that has been developed over the past three decades but could easily be its greatest weakness if it does not honestly face up to its issues. It is in the interest of all stakeholders to do this but will they? Will the government wake up and do more than issue meaningless policy statements? Is there is a strategy for India to be relevant in global affairs and does it include healthcare? These are some questions for the new government and the timing of the book couldn’t be better.