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On how some (Indian) plants that make generics prevent FDA inspectors from doing thorough inspections
Once you understand how vital these regulators are to safety and well-being, basically any sane American is not going to want to take a pill that's coming from a plant that's uninspected.
Katherine Eban
In several instances I documented, the investigators were poisoned in the course of their inspections with tainted water from the tap, which you can't drink in India. They felt sick during inspections. I mean, this was a way of running out the clock. They were followed. In one instance, an investigator had his hotel room bugged. In some cases that I had heard about, [the plants] were trying to scan passenger lists in airports to try to determine exactly who was coming when. So there were elaborate measures that the plants took to try to protect against bad inspections.
On how the quality of generic drugs can vary depending on where the drugs are being sold
Generic-drug makers are adjusting the level of quality in their manufacturing depending on which market their drugs are going to, and depending upon the vigilance of the regulators in those markets. So they will take their biggest shortcuts, their biggest swaps of high-quality to low-quality ingredients, in markets with very poor regulation: sub-Saharan Africa, Southeast Asia, areas of South America."
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https://www.npr.org/sections/health...-may-not-be-as-safe-or-effective-as-you-think
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India is the world’s largest exporter of generic drugs, making almost 40 percent of all new generics the FDA approved in 2018 through October. The
FDA has found cause for alarm over the years at Indian factories across companies and around the country,
from open toilet drains found at a sterile facility owned by Mumbai-based Wockhardt Ltd. to malfunctioning equipment at one of Dr. Reddy’s Laboratories’ plants in south India. Since then, a Dr. Reddy’s spokesperson said, the company has strengthen ..
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https://economictimes.indiatimes.co...ofinterest&utm_medium=text&utm_campaign=cppst
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while branded drug makers have been accused of price gouging and corruption, generic drugs manufacturers have come under fire for poor quality of drugs, falsification of data and sub-par manufacturing practices.
One of the most high-profile cases was that of Ranbaxy NSE 5.63 %, ordered to pay a record $500 million penalty in the US."
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https://economictimes.indiatimes.co...ofinterest&utm_medium=text&utm_campaign=cppst
Indian patients are the main sufferers of the cheatery, dhokeybaaji and fraud foisted by Indian drug makers.
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Your book emphasises the risks to the health of the American consumer. What’s at stake for Indian patients?
Unfortunately, the picture is far worse for the Indian consumer. Generic drug companies routinely make drugs of lower quality for less regulated markets. The practice is so widespread that it goes by different names: dual-track, multi-tier or row A/row B production. The companies send their worst (and most cheaply made) drugs to markets with less vigilant regulators, w ..
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https://economictimes.indiatimes.co...ofinterest&utm_medium=text&utm_campaign=cppst