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.
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.
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.
Been taking Gabapentin for 7 yrs. Manufactured by Watson Pharma. First started it worked fine , 4 yrs.ago efectivenes started declining to the point of worthless. Filed a complaint with FDA worthless. 800 mg. 4times a day , tried 800 mg 8times in one day , no change. Went 2 days with out any, no change. This stuff is junk. One of the side effects is thoughts of suicide. The Justice Dept. should get envolved in this and if it could be proven that someone comited suicide due to the pain, criminal charges included civil charges should be brought against the company and the principal managers. Charges should also include the FDA for allowing this crap into this country either through negligence or intention. Either way they are not doing the job they are being played to do.
I take taken Seroquel at night, for 15 yrs. My dose is 600mg and has always worked.
Until my pharmacy filled it one month, half from Sun, half with US corp. The Sun was slightly smaller size, and very soft. I had not had any early morning wake ups since starting Seroquel til that RX.
The pharmacy filled it next time with my regular pill, so I didn’t say anything. But now I’m on a 30 day supply from Sun. I am waking 2 hours, 4, 5 hours after my dose. With my chronic health conditions, sleep is critical.
I know the pharmacist will give me the “generics are mandated to be exactly formulated as name brands” BS. BUT we all know that there are generics and then there are God knows what!
Hoping my doc and Medicare will sub Seroquel and pay for it.
I have been a consumer of hydrocodone for 7 years. When this pill was manufactured in the US, I had no problems, great pain control, stayed at a minimum dose. Then the Watson law suit happened and US manufacturers ceased making this pill because of the threat of lawsuits, I noted my prescriptions were being filled by Indian owned companies. There was a marked difference in the efficacy of this pain med. I have taken into account physical tolerance, decreased effectiveness, but the formula is different!! I have experienced little pain relief, stomach pains, lethargy, nausea and the only variable is the manufacturers are owned by Indian companies. They may have “headquarters” in the US, but they are Indian companies. I made a complaint to the FDA about the latest one and they (get this!) had someone from this company call me — a guy with an Indian accent. I have no desire to talk to the “fox” about the attacks on the “henhouse.” My experience these past 2-3 years is that if it involves opioids, nobody wants to deal with it and they just want me and my use of this to just go away. Everybody is being pressured to make this problem disappear and the chronic pain sufferer is more of an inconvenience that no-one wants to have to deal with. My guess is that, through use of fillers and lower quality active ingredients, they are hoping we all just get tired of it and go away. So disrespectful, bordering on unethical. I have talked to my doc, contacted the FDA, done my own research and I truly feel like a victim in this quest for lower-cost, foreign manufacturers. Nowhere left to go.
I started out using NatureThroid for my hypothyroid disease but because it was expensive and sometimes unavailable I switched to levothyroxine manufactured by Mylan. I developed a neuropathic pain in the left side of my neck which continued to worsen. I also received a bottle that made me very sick when I took the first pill. I was afraid to take a second. I was nauseous and feeling faint. After being on the levothyroxine for about 5 months my doctor switched me to Armour Thyroid. The neuropathic pain went away after about a month. I am convinced that the levothyroxine made in India caused the pain and I am convinced that the bottle that made me very sick was a bad batch that slipped through the quality control (or quality uncontrol) system. I have also had problems with valsartan and carvidilol made in India. The products were very inconsistent. I have been forced to purchase brand name drugs at considerable cost.
Your doctor should have told you that there is good generic for Synthroid. This has been know for decades in medical community. This is based on daily medical practice and feedback from patients. The same goes for psychostimulants ( Adderall and Ritalin related medications ) and benzodiazepines. And so many other meds. FDA is responsible for the situation.
Sorry for the typo in my comment. Clarification: There is NO good generic for Synthroid.
Good luck to Raj.
I used to use brand name Nexium but changed to generic due to high copay and urging by my insurance company. But after several months the generic version was not effective. My comments to the supplier resulted in the reply “the generic version does not follow the original formulation”. Source of the generic version was India.
I was prescribed a generic version of a drug by my doctor to treat dementia, a blue pill. After six months my memory improved. Then the pharmacy changed the source of the drug and the color of the pill was now white. After using this new pill for about 4-6 weeks my memory began to regress to the state before I started taking the blue pill. I asked the pharmacy about the change and was told they have now reverted to dispensing the blue pill. I returned to using the blue pill and after a couple of months, my memory improved as well as other symptoms of dementia. I am now very happy with my improved memory, and other symptoms of dementia. The pharmacy said the blue pill was from China, the white pill was from India.
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