Bottle of Lies : Ranbaxy and the Dark Side of Indian Pharma by Katherine EbanMy rating: 5 of 5 stars
Fear is the one emotion that grips one as one reads the book. Should one have medicines at all? Generics or otherwise. There seems to be no guarantee of the efficacy of the medicines that one takes even if one is paying a high price to procure a known brand.
The level of corruption in the various regulatory organizations, including the USFDA, the level of greed of the manufacturers is unbelievable. The manufacturers are ready to go to any level to make a profit. The regulators are politically driven and they have ensure a steady flow of cheap drugs to keep the expense of their respective governments low and to ensure that the the ruling part is able to show that they are doing everything in their power to provide for cheap low cost drugs to the masses compromise on the violations unearthed by their representatives.
The key violators are India and China. The book is about the biggest scandal that came out in public, that of Ranbaxy. Ranbaxy, a family owned pharmaceutical manufacturer started becoming ambitious towards the end of the last century and the owners wanted to turn it into a multi-billion company. The easiest way was to hawk the medicines to the US of A and to do that one had to get FDA approval. FDA has to approve the drugs, approve the manufacturing units (all the right processes were in place) and the testing done on the drugs etc. Ranbaxy's owners along with their R & D department figured out ways to hoodwink the FDA regulations. They used the tests on branded drugs and portrayed them as the tests of their own drugs. They shredded the failed tests on their drugs, they cooked up the tests to show a good longevity, they unhooked the testing machines off the network so that some of the tests could be done unrecorded into the system, they had duplicate machines which were off network where they could do tests undetected. They tested their drugs on separate machines and they tested the premier drugs on the main machines and passed them off as the tests of their drugs.
The manufacturing units did not follow the "Good Manufacturing" guidelines issued by the USFDA. The sanitation was poor, the workers were many times not trained enough to do their work properly.
The biggest drawback of USFDA was that they had to announce their inspection days so the companies and this gave the companies enough lead time to doctor all the records and to cleanup their act to present to the agents. Some of the agents were lenient and some were clueless on how to look for doctored data. Some of the checks of the FDA had not been updated to test the newer drugs the right way. All this gave a lot of leverage to the manufacturing companies to hoodwink the FDA agents.
Dinesh Thakur had left the clean environs of a US drug manufacturer and had moved to India to work with Ranbaxy in the hopes that the was helping his country. He did so at the behest of his manager in the earlier company. But that person, seeing the state of affairs left Ranbaxy within a year without telling Dinesh the whole truth. He was replaced by another conscientious person who was sacked for not toeing the line of those in power. He and along with Dinesh prepared a presentation showing all the proofs of the wrongdoings in the organization to those in power including the CEO. He was sacked and the people ensured that the laptop on which the presentation was done was torn down piece by piece. Fortunately what they did not realise is that Dinesh had a copy of that with him.
Soon Dinesh fell out of favour and he was asked to leave which he promptly did. But he took within him the presentation. This proved to be a crucial move on his part. He lived with a troubled conscience for many months before he decided become a whistle blower and started informing USFDA of the fraud that Ranbaxy was perpetrating. It started, what was a very long battle between FDA and Ranbaxy.
Based on the facts provided by Dinesh the USFDA started investigating and started finding a lot of the frauds that were happening at Ranbaxy. After a few years Ranbaxy was rapped badly on the knuckles. The owners saw their game was up and sold the company to a naive Japanese company for 2 billion dollars and walked off the table. They forced their employees and their legal representatives to suppress information from the Japanese to ensure a smooth sale.
The Japanese company was left holding a hot potato in their hands and they had to face the case which was finally slapped on Ranbaxy. The case took its own time and thanks to the political intervention what started off as a 3 billion liability was settled for less than 200 ~ 300 million fine which was paid by the Japanese company.
Dinesh Thakur and the firm that represented him, pro bono, did benefit from the payoff, but the taste in the mouth was still bitter as Ranbaxy continued their fraud. No individual or individuals were accused and they all got off scotfree. The ex-employees of Ranbaxy who moved to other companies spread the malaise to the companies they went to and the fraud expanded in scope.
For a brief time it looked like USFDA will be able to set right things in the Indian manufacturing industry by appointing a conscientious and strict person to head the FDA in India. This person brought in a rule which meant that the FDA agents to drop in to inspect the manufacturing units without any advance notice. He did this by strengthening number of local agents and he was ably supported by one Baker from the US of A and a few other Americans of Indian origin. Baker was instrumental in unearthing a lot of the fraud. He found different means the companies adopted to forge and hide the results. But this period lasted for a short time before USFDA pulled him out of India, under political pressure and things went back to the normal. The Indian government also started saying that the USFDA is maligning Indian industries.
Every company seems to have two manufacturing lines, one for the countries that have a strict control and one for the ones like most African countries, where the controls are either absent or very lenient. The cheapest ingredients and least processes are adopted for the second so that these lines become highly profitable. The fact that many who could have been cured will die either because of a low dose or even worse a impure medication, do not seem to effect these companies. Their only goal seems to be profitability.
As the popular HBR article https://hbr.org/2010/06/column-you-ar... by Dan Ariely states, you get what you measure as long as the companies are measured only by their profitability and no other yardstick this will continue. What one needs is that the drug manufacturers should be measured by the number of lives saved and number of lives lost despite their medication being used. This can help change the situation, but this is not a easy number to measure.
After reading the book one wonders why the premier companies cannot be asked to reduce their cost and spread their profitability over a larger time period? Why should they be allowed to recover their cost within the first few years? Why should the responsibility lie with only the generic manufacturers? Is there a fraud, however small, happening even in the premier drug manufacturers? Hearsay says that they hide the side effects too.
The question that remains unanswered is "Why can not humans be more empathetic and be concerned about the lives of others and let go of some profitability to ensure cleaner, better, affordable medicines to all"
All in all the safety and efficacy of the medication that millions of the people taking world over remains a question mark.
It feels very sad as an Indian to be reading this book given that the company is focus is an Indian company. One hopes things change for the better soon.
A wonderful read.
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