Bottle of Lines: Ranbaxy and the Dark side of Indian Pharma by Katherine Eban

Bottle of Lies : Ranbaxy and the Dark Side of Indian Pharma by Katherine Eban
My 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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How desire for money corrupts?

Ranbaxy the onetime epitome of Indian entrepreneurship has been detected to have committed fraud to get license to manufacture generic drugs. Read http://features.blogs.fortune.cnn.com/2013/05/15/ranbaxy-fraud-lipitor/.

Is it surprising that this has happened? No, not at all. Corruption, cooking up figures, cooking up documentation, having special coaching and preparation purely from perspective of clearing an examination are all some form of corrupt practices that are prevalent in India.

A similar situation exists in the software industry in India. What we produce is Working Software, not Quality Software. Most software projects that we execute go through a crisis phase when some hero has to come and rescue the project. This happens after the client escalates the matter to the higher management in the organization and the higher management leashes out its whips and then the right people start coming in and fixing the problem.

The reason for this problem plaguing the software industry is manifold. It starts with the Response to the Request For Proposal (RFP) from the client. Typically the RFP is a very high level requirement from the client. In addition to the few lines of requirements the client also typically mentions the timeline by which they wish to have the project ready for deployment. In the eagerness to win the project the software contractors squeeze as much as possible, make all impossible assumptions, assumptions of both requirements and the ability of the team to develop and deliver the project.

Finally it comes down to price negotiation. The client presses the already squeezed out contractor of further juice. The sales person from the contractor in front of the client agrees to the cuts, possibly in the cost of the project and the to the timelines within which it has to be delivery while at the same time they agree to increased requirements. The sales person does this as she has to meet her sales target and then she is absolved of all other responsibilities.

Once the project comes to the delivery team whose target is to deliver the project in the minimum time with the maximum profit, this team starts cutting down on costs by getting the cheapest resource available. These are capable resource with no experience. This teams starts possibly gathering requirements during which time the actual enormity of the task strikes them and they try to negotiate to bring down the scope. In most cases it is a worthless exercise. At the end of the exercise the requirements are still unclear and many loose ends are left dangling as the team that would have gathered the requirement would have been a novice one and the team that would have specified the requirements would not have know what details need to be specified for this team to design and develop the system.

Now when the design and coding starts in earnest, two problems begin to show; first there would be very few team members who will be really capable of putting together a good design; the second problem will be that there will be even more few team members who are capable of writing good code. Added to this mixture the fact that the requirements were not clear means that the this team starts making more assumptions. The tendency to go back to the client to get clarifications is rare under these circumstances as the leader would say "If you go to them you will get more requirements, so assume and proceed so that we deliver on time".

Soon the time for delivery will pass and the client will start raising heckles on why the project is getting delayed. One would go through a series of negotiations on how the requirements were unclear and how the client team did not support the development etc and the client would keep telling how incompetent the team developing is. It many cases it will go to the higher management which will send in a Process Team to assess the processes being followed by the team. In most cases it will turn out that the documentation is not in place or is not complete and the process team will now point to this gap as the reason for the delay and now the project team will need to fill in the gaps by creating these documents delaying the project further. The next attempt will be get more people into the project to try and "speed up" the delivery. Soon without many noticing the profit that were planned would have started eroding.

Finally at some point in the development cycle, when the pressure mounts beyond tolerance, the develop team will dump a whole lot of code at the Quality Assurance (QA) team. This team would be equally at loss about the functionality and will go about testing a the application and raise some errors like font is mismatched or message is grammatically incorrect and few such trivial errors. Some of these would be fixed and some would be rejected by the team explaining that it is a feature.

Once it goes past the QA team the application would be delivered to the client for User Acceptance Testing. This team would typically be expected to carry out this exercise in addition to carrying on their routing job. As a result this testing would be given a step motherly treatment and after reporting a few errors this team will go back to doing their routine jobs. They would most likely raise one or two "errors" which would be disputed as "change requests" by the contractor and negotiations would be on to come to a compromise.

The development team will try and fix these problems and make another release going through the same cycle of testing by QA. QA team will typically test the application only for the errors that were raised at UAT and as a result when it goes to the user group for the next round of UAT there would be other errors which would have crept into the system due to these bug fixes and some of these would typically show up in the UAT.

This cycle will repeat a few times before the management gets a tired of the process and charges of incompetency will be traded between the contractor and the client, with the client being more accusatory than the contractor due to the nature of the relationship between them.

Now the management from the contractor will try and send in more senior designers and developers who will come a work "miracles" and get the system functioning much better. This would still not fix all the problems and issues but in all likelihood the project will end up being deployed in production.

Within a few days of it in production one will start seeing functional issues, performance issues, and availability issues with the system. The development team, ill equipped and over burdened will try and resolve the issues and will end up resolving some and bringing in more issues in the process.

This cycle will continue for a few iterations before the client reaches her wits end and escalates the matter to the senior management. Now another set of senior designers and architect will come in and start looking into the system. This team will in all likelihood have a supercilious attitude towards the developer community and will go about berating the entire development team. They will try and fix up a few things and get things working. After a few iterations the system will be functional. It will still not be efficient or error free or perform as good as it could have performed.

If one analyzes the above situation and the situation at Ranbaxy or any other incidents such as constructions breaking down because of bad construction or poor material being used, or cases like the "housing loan schemes" which led to a global meltdown of economy the one conclusion that can be drawn without much hesitation is that these happens due to greed for money. It is not that many of these people do not have money, it is just that one can NEVER HAVE ENOUGH OF MONEY.