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, 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.
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.
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.
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 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.
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.
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.
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.
Those two qualifications are essentially universal ethics:
- know right from wrong
- do not put profits over patients (more generally, do not value money more than human life)
These days, such ethical operators seem to be as rare in the U.S. are they are in India. Much of this is due to the “corporatization” of every corner of our healthcare system, which creates the anti-ethical requirement of “maximizing profit for shareholders” over all else.
Evidence collected by FDA inspectors shows this is sorely lacking in overseas manufacturing facilities.
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.
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.
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.
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.
Things are not getting better and part of the reason is because the generic drug industry is too powerful and influential in India.
The only solution is for American lawmakers to enact new regulations focused on holding those who intentionally put public health at risk to account.
Good idea. If they can sue drug makers for medication that some people have problems with, why not sue generic drug makers for selling adulterated products?
Author: 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.
I’ve been blogging about problems with generic drugs for quite a while now:
- Generic Drugs Are Poisoning Us
- Can we trust generic drugs?
- ‘Scary World’ of Generic Drug Manufacturing
- Why Pharmacists Are Wrong About Generic Drugs
- Are generics really the same as branded drugs?
I know not everyone has bad reactions to generic drugs, but if you notice a new symptom after starting a new prescription of your usual medication, you could ask your pharmacy if there had been a change in the manufacturer.