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Katherine Eban’s new book, “Bottle of Lies,” has focused a very intense spotlight on the mostly ignored transgressions of the Indian generic pharmaceutical industry in the processes they follow — or all too often don’t follow — to make quality products. This industry, which has rarely been subjected to such rigorous journalistic scrutiny, has lashed back at Eban, attacking her integrity and her work.

The latest salvo comes from Kiran Mazumdar Shaw, who calls Eban’s exposé anecdotal, biased, unfair, and unbalanced, and accuses the author of playing up to the poor perceptions of the Indian pharmaceutical industry and the country. Shaw did this in a softball interview she gave to an Indian publication in which she is an investor.

Shaw, who owns Biocon Ltd, a pharmaceutical company that has been cited multiple times by the United States Food and Drug Administration over the last few years for its failure to comply with Current Good Manufacturing Practices, is one of the biggest names in the Indian pharmaceutical industry.

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Like many of Eban’s critics, Shaw has tried to wish away the concerns raised in “Bottle of Lies” by claiming that the Ranbaxy case at the heart of the book (I was the whistleblower who brought it to light) was a one-off incident that occurred 15 years ago, and so can’t be used to paint the entire industry in poor light — especially, as Shaw points out, when Indian industry has done its share of good deeds by producing large volumes of affordable medicines for the world.

Her characterization of the problem is unfortunate because it represents a stubborn denial of reality. There are reams upon reams of official documentation showing that the fraud at Ranbaxy was not a one-off event. In the six years since Ranbaxy pled guilty to selling adulterated medicine in the U.S., a number of leading Indian pharmaceutical companies have been cited by the FDA for behavior that is not too different from what is described in the book at Ranbaxy and Wockhardt.

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These include companies like Dr. Reddy’s, Aurobindo, Ipca, Emcure, Megafine, Unimark, Claris, and many more. And the violations of good manufacturing practices do not stop. Just this week, the FDA leveled severe allegations against Strides Pharma for shredding its manufacturing quality records in advance of a scheduled U.S. FDA inspection. Two weeks ago, Apotex India withdrew 31 abbreviated new drug applications, largely from its facilities in Bangalore and Mumbai, because it couldn’t substantiate the data filed with the FDA supporting the applications to market these drugs in the U.S. These are not 15-year-old incidents, as claimed by Eban’s critics.

The striking aspect of the multiple warnings to Indian pharmaceutical companies is the similarity in the violations cited. The first category of violations involves the lack of cleanliness and sanitary conditions at Indian manufacturing plants which, under the law for finished pharmaceuticals, are required to operate in a hygenic environment. This is an issue that can be fixed with relatively small investments in better training and thorough supervision.

The second category of violations pertains to data integrity: maintaining meticulous and accurate records of all stages of manufacturing and quality testing. “Bottle of Lies” documents how the FDA’s investigators repeatedly discovered falsified records at Indian plants. When a batch would fail testing, rather than destroy the batch or remedy the manufacturing process, the quality control staff at these plants generally manipulated the records to create false data that supported releasing the batch to the market.

The data fabrication processes at these companies were often quite intricate. Some of the most reputed Indian companies were found to have entire laboratories dedicated to generating fake records that were off the books. Fabricating these records is ridiculously easy, especially for facilities that were given advance notice of inspections by FDA inspectors, unlike the usual practice in the U.S. where inspectors turn up unannounced. This gives Indian safety managers plenty of time to stage-manage these inspections.

Shaw makes the point that the facilities in India that make medicine for the U.S. are more advanced and automated than those in the United States. Some of this is true. The Indian pharmaceutical industry has upgraded its facilities. But stainless steel reactors do not produce drugs all by themselves. They need trained operators — and ones who know right from wrong and do not put profits over patients. Evidence collected by FDA inspectors shows this is sorely lacking in overseas manufacturing facilities.

Automation and investment in upgrading facilities is an argument made to distract from the real issue, which was never about capacity, technology or training. It is all about profits, because quality comes at a price. There is a cost to destroying a batch of drugs that doesn’t meet release specifications, and no amount of third-party consultancy or employee retraining will address that issue.

While shiny new stainless steel reactors and automated processes may well be showcased for products made for Americans, the companies that tout them use dilapidated, pest-infested, unsanitary conditions to make medicines for consumption by patients in India and for export to other countries, especially those in Africa and Latin America.

U.S. law requires meticulous record keeping at all FDA-approved plants that make pharmaceutical products for the U.S. market. Not maintaining records is not an option. By covering up failed test results, companies were essentially covering up the sale of adulterated medicine to Americans. If these companies were to maintain accurate records of all the failed tests for products to be sold in the U.S., they would also be required to destroy or recall entire batches of medicine that had failed to pass tests conducted before their release. This would mean lost profits, and that is the simple reason behind the massive efforts these companies have invested in — like undisclosed quality control laboratories — to manipulate and fabricate data, even if it comes at the cost of compromising lives.

The statements made by Shaw and other titans of the Indian pharmaceutical industry demonstrate no will to accept that a problem exists.

The only way Indian companies are going to modify their behavior is through a combined policy of tough penalties and unannounced inspections. Yet in the last decade, despite several Indian pharmaceutical companies being enjoined from exporting drugs to the U.S. because of systemic violations of U.S. regulations, only Ranbaxy was ever brought to justice. It does not help that the FDA, after a brief and highly successful experiment with unannounced inspections, has reverted to giving advance notice of its inspections to overseas pharmaceutical facilities.

As one of those who helped bring Ranbaxy to justice in a U.S. court, I chose to make my disclosures to American regulators rather than Indian regulators because I had no faith in the latter. A few weeks after the U.S. Department of Justice unsealed my case against Ranbaxy in May 2013, India’s Ministry of Commerce and Industry issued a press release claiming that “vested interests” were trying to malign the Indian industry. When I tried approaching Indian courts about making changes in the Indian regulatory system, the Indian regulator publicly questioned my “intentions” and my “nationalism.”

Despite this slander, I have tried engaging with Indian regulatory authorities on multiple occasions, but with only lukewarm results. The one helpful bureaucrat in the Indian Health Ministry who was willing to hear me out was punished with a transfer to a low-key department shortly after he implemented a few of my recommendations.

Things are not getting better and part of the reason is because the generic drug industry is too powerful and influential in India.

If Americans are expecting India, which supplies a significant percentage of the finished drug supply in the U.S., to get its act together to improve the quality of the medicines it makes, I am afraid they will be waiting a long time for that to happen. The only solution is for American lawmakers to enact new regulations focused on holding those who intentionally put public health at risk to account.

Dinesh Thakur, the former director and global head of research information and portfolio management at Ranbaxy Laboratories, was the whistleblower in the Ranbaxy case and is a key source in “Bottle of Lies.” He is now a public health activist focused on improving the quality of affordable medicines.

  • Excellent article….shooting the messenger never solved any problem. A strong regulatory framework both at home and from the international customers is essential. Even more critical, however, is the right culture that repeatedly emphasizes that everyone in pharma must always put the patient first and that the patient will someday be you, your child or, other loved ones. Without that at the forefront of our thinking there will always be people who want to take shortcuts and/or to make a fast buck.

  • Defensive n denial are biggest roadblock to constructive CAPA .
    Indian pharma needs to accept the chinks in armour n fix them – attacking the motive of whistle blower is worse !
    Keep on Going – u mean well for Indian pharma , Indians and mankind

  • My solution to this issue has been refusal to accept India-manufactured generics when there is an alternative. I’ve educated a number of pharmacists on this issue and they are amazed and appalled. The FDA has been terribly irresponsible on this issue. As one simple example, my wife has noted that her migraine medication is much less effective when she has it filled with India-manufactured pills.

    • Bob: It is easier said than done to stop imports from India and/or china. US does not have the capacity and or the capabilities to turn the pharma spigot ON. It has no capabilities to produce the necessary actives and formulate them. We gave away the store and the kitchen sink many years ago.

      We were happy when we signed WTO/TRIPS agreement. Brilliant lawyers sold us out lock stock and barrel.

      Developed countries are stuck in a dilemma. Pharma and our legislators could care less who lives or dies. They want profits and tenure in Washington respectively. System is set up that way.

    • Bob, I use the same information with my physician and especially my pharmacist. The Mylan Pharmaceutical Manufacturing in Maryland has also been cited for unhealthy environmental issues for the medication that I once purchased from this company. Then it was being manufactured in Aurodindo, that has been given countless warnings about their manufacturing of medications that the company’s plant is surrounded by the most toxic waterways in India. The medications that are manufactured there are unfit for human or animal consumption. Like you, I bring in my folder with this information about the various pharmaceutical manufacturing plants that have received countless warnings and have been closed down, here in the USA. However the India sites are still being produced and sold to the citizens of the USA! I refuse to be forced to ever more negative consequences from this reality. I have learned other ways to help myself with my issue that required me to use the toxic medications that are mostly being offered by the USA pharmacies, as generics in our country.

      I have been looking for different ways for my condition to be helped, and I am even better than before the Mylan Pharma was closed in the USA. I credit my escape from being negatively affected by the aurabindo manufacturing company from India, with the information from last year, in the STATPlus Newsletters that had articles about this manufacturing site in India.

      My pharmacist said that the majority of generic medications are coming to this country from the same unsafe sites located in India; he said that there is almost no way to obtain medication from any other sites that from India!?

  • As a former regulator (ex-TGA) I applaud your integrity and strength of conviction for reporting these matters. The focus of many pharma companies on money before consumer (patient) safety is appealing but sadly all too true. The issue of deliberately circumventing GMP obligations is pervasive not only in India but in many other countries too. Scheduled or announced inspections are too easy for unscrupulous companies to prepare for, temporarily improve the ‘optics’ of their facility and data, and to systematically hide breaches of compliance. I’ve seen it with my own eyes. GxP regulation needs to change to catch more of the recalcitrant companies because if it doesn’t then there will be more and more places where liberties are taken with quality. Quality underpins safety and efficacy, that was my mantra when I was the Senior Executive responsible for GxP inspections at Australia’s TGA; without true quality built into all processes then safety and efficacy cannot be guaranteed.

  • Excellent article and commentary. Why does the FDA give these companies in India so much advance notice for inspections? What is the reasoning behind this? And it would be better if all of our mindset was not on who is maligning who, but instead, asking how are we behaving to best serve patients in need? This is not about Eban vs India, or India vs the FDA–it’s about patients, pure and simple. To suggest otherwise is to deflect what is best for patients.

  • I have long wondered how the quality of imported generic medicine was ensured. (I take generic medicine, as most Americans do). I had hoped that the FDA was somehow monitoring and ensuring the quality of these drugs. Apparently, that was an unfulfilled hope.
    Imported generics account for something like 80% of all medicine used in the US. And nobody is monitoring the quality of our main drug supply? And many politicians want to take over even more control of our health care system? Yikes!

  • The father of a friend of mine lives in India. The medication he bought there from a “reputable” India pharmaceutical company did not have the medical ingredients they were supposed to have, as became evident with investigation when this man turned blind within half a year. That was some 15 years ago. It is widely known that drugs made in India are of questionable quality. There is lack of quality, of quality control, and of true content of drugs made in India. Doing inspections there clearly leads to cheating, forgery, etc. Therefore all meds made in India should be scrutinized & tested in the USA (or any other recipient country). Or ….. cut India out and buy elsewhere.

    • Janice:

      Indian pharma takes offend of any criticism. They do not realize it is an opportunity to improve. Quality first time saves about 20% and to many quality first time is expensive. Thinking is second quality will save money. In my family a person uses insulin. Few years ago she even after insulin shots was having issues. Doctor could not understand why. One day she noticed that her insulin shot was very clear and not a bit murky. She called the doctor and investigation suggested that her insulin shot was just distilled water. A letter was written to the manufacturer and they pleaded not to report. Hindsight they should have but did not.

      People die everyday is the normal expectation. Sad.

  • Your closing sentence is a wise one, Dinesh Thakur. I read it’s neutral wording – “new regulations focused on holding those who intentionally put public health at risk to account” – as a reminder that the sword of quality cuts both ways, domestic as well as foreign.

  • It is very obvious that no one likes to be criticized. Indian Pharma entrepreneurs don’t like it either when their kingdoms are under scrutiny by outsiders. There are two ways to look at things. Negative as Kiran Shaw has done. 483’s are telling us there is an issue. Staying on top tells that Biocon and for that matter companies are NOT top of their game.

    Criticism can be taken as a positive to improve but when it is defended, majority of the people dig a hole and deeper it gets with more defense. Shaw being media savvy is doing it. Is it a deflection from reality?

    No one should take away the credit that is due to handful of entrepreneurs that are in their sixties to do what they did. Unfortunate part going forward is that they all will not be around as time progresses. Lack of succession. Would the future CEO’s be as diligent as the current are and make quality products as their priority? They have not been tested.

    Walk is difficult and challenge than talk. If Shaw wants to label Biocon as a small company then it is trying to hide behind a facade of ambiguity.

    Most of the entrepreneurs demand quality when they buy so they should deliver quality products products when they sell.

    • I have more than 2 dozen relatives who are US citizens of Indian ancestry. Most of them are in their late 60s to 70s and as per their age require a whole host of medicines that would cost a small fortune in America.

      They buy literally ZERO dollars of medicines in the USA and everything they can from India when they fly over every summer. Everything from heart medication, to insulin, to thyroid hormone, to statins they get from India at about 1/100th the price they would pay in the US. They even choose to have any elective surgeries done in India – especially dental and opthalmic surgeries like Lasik etc.

      Not a single one of them has faced issues with quality, efficacy or seen any adverse reactions so far. The only issue they’ve had is to get their US doctors to stop using “brand names” and start giving them the names of the pharmacological compounds!

      Are you going to claim that my experience is false ?

  • Thank you for this timely article. I have great concern that the media is not shining a light on what is happening in Congress re: pharma lobbying Medicare Part D and Congress’ lack of focused oversight hearings on the quality of generics made in India. Just to see for myself I took ten (10) different bottles of different generic medications some of our patients take and wrote each of the pharma companies indicated on the labels to ask for the exact location and name of the facility where each medication was manufacturered and shipped for distribution. That was two and a-half months ago. As of today I have received one reply. I’m not letting go of this. I am determined to find out the answer to a simple question from the pharmaceutical manufacturer. I tracked down the information for myself. I want to know who will be transparent and who will not when they receive a simple question from their own “contact” form. So far, no transparency.

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