India’s dangerous medicine industry

And before you ask "why should I care about India?", let me tell you, Indian drugs are coming to US pharmacies every day. Your next prescription could end up being a substandard drug produced in an Indian factory. The FDA takes the drug company's word as to whether the medication is up to standard--they don't actually test the medication themselves unless they get many reports of problems.

>A tragedy is unfolding in Bilaspur, India where 14 women have died as a result of complications from sterilization procedures. The use of substandard drugs is one of the reasons for the deaths.

>Reacting to the public outcry, Indian officials arrested CEO of Mahawar Pharma Pvt Ltd whose products were dispensed to those that died. According to local media reports, police entered the Mahawar factory last Wednesday but left the plant open. They returned the next day to shut the factory, but not before witnesses reported seeing two men lighting a predawn fire out back.

>Reuters reported that the cinders contained medicine packets, including for Mahawar Pharma's Ciprocin 500-milligram pills. Chattisgarh's state government banned a batch of this product following the deaths, but rural areas appear to still have a supply.

>Yet even though products were destroyed without being tested, it appears that officials have already concluded that this was a one-off incident, and prosecuting the principals in these two firms closes this chapter.

>It is an abdication of regulators’ responsibility to simply ignore evidence of poor quality. Assurance of taking punitive actions against wrong-doers is not the same thing as proactively protecting public health. Our research of thousands of samples of ciprofloxacin over the past few years in 22 cities of emerging markets has found numerous falsified and substandard products, many made in India...

(Continued)

Other urls found in this thread:

thehill.com/blogs/congress-blog/healthcare/224556-indias-dangerous-medicine-industry
justice.gov/opa/pr/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false
nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html?_r=0
nytimes.com/2013/06/25/business/justices-rule-generic-makers-not-liable-for-drugs-design.html
newsweek.com/indias-fake-drug-trials-threaten-wider-trade-deal-418953
peoplespharmacy.com/2014/12/03/expose-reveals-why-we-no-longer-trust-all-generic-drugs/
twitter.com/SFWRedditGifs

>The Indian government is aware of this research: it threatened to sue us over it. We said at the time it was shooting the messenger.

>It is often difficult to prove a “causal relationship” which would stand up in court between adulterated and sub-standard drugs and immediate health outcomes, not least in India, which doesn’t really have a functional surveillance system. Effects of adulteration often don’t manifest immediately, and confounding factors make it difficult to attribute blame correctly. This case provides a concrete example of the consequences of poor quality drugs in an acute care setting: it needs to be studied, not swept under the carpet.

>In February 2013, the Ghana Food and Drug Authority published a report on the quality of uterotonics (Oxytocin and Ergometrine), used to control post-partum bleeding. The results shocked us, and we’re used to such horror stories: tests on Ergometrine showed that of 99 injection samples, 73 percent failed for active ingredient and 95 percent failed sterility testing; of the 11 tablets tested, 100 percent failed; 90 percent of Ergometrine samples were made in India. This case is hard for the Indian pharmaceutical lobby to dismiss, as the testing was impeccable and crucially, the study was undertaken by the regulator of the country of the victims of shoddy Indian drugs.

thehill.com/blogs/congress-blog/healthcare/224556-indias-dangerous-medicine-industry

Lots of Americans take prescription medications. If you end up getting a generic drug manufactured by an Indian corporation, think long and hard before taking it. Many Indian drugs being sold in the US are NOT up to standard.

More info

justice.gov/opa/pr/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false

we don't import drugs from India because they steal our intellectual property

we shouldn't care about them producing "substandard" drugs (they're not substandard on the whole, they're just cheap because they steal the recipes), we should care about their blatant IP theft.

fuck India.

You are so wrong I don't even know where to begin.

>we don't import drugs from India

We do.

>They're not substandard on the whole, they're just cheap because they steal the recipes

You have no idea how drug patents work. No, they don't steal the recipes--they have to reverse engineer them. And they are allowed to do so by the US government generic drug regulations.

And they are substandard. Indian drug plants FREQUENTLY have huge violations of good manufacturing protocols and have repeatedly produced defective drugs, which have caused deaths.

>We do.
Only for drugs for which the patents have expired.

>No, they don't steal the recipes--they have to reverse engineer them. And they are allowed to do so by the US government generic drug regulations

Our regulations don't apply to them. Reverse engineering a patented recipe is IP theft you fucking moron. I obviously didn't mean that they literally hack into servers and steal the recipe you complete mong.

>And they are substandard. Indian drug plants FREQUENTLY have huge violations of good manufacturing protocols and have repeatedly produced defective drugs, which have caused deaths.

This is just FDA propaganda. The FDA needs to be abolished. Regulations are for faggots.

>Only for drugs for which the patents have expired.

Yeah, and that's the overwhelming majority of the drugs people in the US actually take.

About 80-90% of US prescriptions are filled with GENERIC drugs for which the patents have expired.

And many of those generic drugs are produced by Indian corporations who manufacture them in Indian factories--such as drugs produced by Ranbaxy, Aurobindo, and Dr. Reddy.

>Our regulations don't apply to them. Reverse engineering a patented recipe is IP theft you fucking moron.

I'm not talking about patented recipes. I'm talking about generic drugs on which the patents have expired--which make up the OVERWHELMING MAJORITY of the prescription drugs American actually take.

>This is just FDA propaganda. The FDA needs to be abolished. Regulations are for faggots.

Oh, yeah. The "invisible hand of the market" will really help after you've been poisoned by a defective medication, sure.

>Yeah, and that's the overwhelming majority of the drugs people in the US actually take.

Yeah, but their generics are not especially competitive compared to domestically produced generics. The marginal cost of producing generic drugs is about $0 no matter where they are produced. Their drugs are cheaper domestically in India because they are far less likely to grant patents to new drugs than the developed world.

>Oh, yeah. The "invisible hand of the market" will really help after you've been poisoned by a defective medication, sure.

Any producer of a defective drug will get sued out of business, so it's not a legitimate concern. Your own source even says India's supposedly defective drugs were only sold to the third world. So basically they sell them to places that don't have credible, effective rule of law so the "invisible hand" doesn't operate.

Need anything else cleared up you economically illiterate faggot?

Dude this is like making a big deal because one small pharma company fucked up

>Yeah, but their generics are not especially competitive compared to domestically produced generics.

Talking out of your ass.

nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html?_r=0

>Any producer of a defective drug will get sued out of business, so it's not a legitimate concern.

Patients can't sue generic drug companies.

nytimes.com/2013/06/25/business/justices-rule-generic-makers-not-liable-for-drugs-design.html

>Your own source even says India's supposedly defective drugs were only sold to the third world.

You clearly didn't read the second link I posted.

>Ranbaxy USA admitted to introducing into interstate commerce certain batches of adulterated drugs that were produced at Paonta Sahib in 2005 and 2006, including Sotret, gabapentin, and ciprofloxacin. Sotret is Ranbaxy’s branded generic form of isotretinoin, a drug used to treat severe recalcitrant nodular acne; gabapentin is a drug used to treat epilepsy and nerve pain; ciprofloxacin is a broad-spectrum antibiotic. In a Statement of Facts filed along with the Information, Ranbaxy USA acknowledged that FDA’s inspection of the Paonta Sahib facility in 2006 found incomplete testing records and an inadequate program to assess the stability characteristics of drugs. “Stability” refers to how the quality of a drug varies with time under the influence of a variety of factors, such as temperature, humidity, and light. Such testing is used to determine appropriate storage conditions and expiration dates for the drug, as well as to detect any impurities in the drug.

justice.gov/opa/pr/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false

You know nothing about this subject and are making false statement after false statement so please pipe down.

>Dude this is like making a big deal because one small pharma company fucked up

It's not just one pharma company. This is a rampant problem in India that is also a problem for the US, which is a major consumer of Indian-made drugs.

newsweek.com/indias-fake-drug-trials-threaten-wider-trade-deal-418953

>On January 11, Indian and EU officials began trying to salvage a wide-ranging trade agreement. Talks stalled last fall when India walked out due to EU bans on hundreds of Indian-approved medicines. EU regulators found GVK Biosciences was manipulating data from clinical trials conducted for approval of generic drugs.

>As a result, the EU canceled the marketing authorizations it granted to several drug manufacturers. The Indian government retaliated by calling off trade talks, saying the bans were unfounded. This was not the first time that Indian interests had clashed with Western pharma regulators.

>In May 2013, Ranbaxy, then India’s largest generic manufacturer, pleaded guilty to selling adulterated drugs in the U.S. and paid the U.S. government $500 million in penalties and fines.

>At the end of last year, the FDA issued a warning letter to Dr. Reddy’s Laboratories, the second largest generic drug manufacturer in India, supplying medicines to U.S. to treat hypertension, pain, diabetes and myriad infections. The FDA said that the company destroyed records of failing tests and kept only those that showed their products passing.

>This is very similar to what Volkswagen, the German carmaker, is accused of doing. But while the German automaker may be an unfortunate exception in its industry, most of India’s pharma makers appear guilty. In between the Ranbaxy and Reddy cases, over 40 other instances of data fraud citations against manufacturing facilities in India have occurred. Rigging testing procedures seems to be systemic among many Indian generic manufacturers.

>i dont actually know what i am talking about

>nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html?_r=0

Pro-FDA propaganda fluff piece faggotry

>Patients can't sue generic drug companies.

>nytimes.com/2013/06/25/business/justices-rule-generic-makers-not-liable-for-drugs-design.html

Because once the FDA approves a drug their ruling that such a drug is "safe" precludes legal action because of FDA regulations. Thanks for furthering my case that the FDA should be abolished.

>justice.gov/opa/pr/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false

So no actual evidence there was anything wrong with the drugs in question, just that their testing records were "incomplete" according to the FDA regulations for faggots.

lOl POO IN LOO
Buy some toilets

I know more than OP does apparently. He is just reacting emotionally to a bunch of pro-FDA propaganda.

He doesn't understand that the only reasons these stories exist is because our government is pissed at India for stealing out intellectual property.

That's the real issue. Complaining about "unsafe" Indian drugs is just a red herring.

>Pro-FDA propaganda fluff piece faggotry

Not an argument.

>Because once the FDA approves a drug their ruling that such a drug is "safe" precludes legal action because of FDA regulations. Thanks for furthering my case that the FDA should be abolished.

It doesn't follow that the FDA should be abolished.

>So no actual evidence there was anything wrong with the drugs in question, just that their testing records were "incomplete" according to the FDA regulations for faggots.

Okay, so you're basically not even reading the articles I'm posting (there's no way you read them in that little time, and the article CLEARLY stated that Ranbaxy ADMITTED that they were importing adulterated drugs to the US) and are making my thread the place for your ideological rant.

I can't stop you, but I'm not going to continue this line of discussion further because you've made it clear you're not actually interested in discussing the subject and hand and just want a soapbox.

india make all our drugs; china, everything else

your greed made this world

You want a soapbox to post your emotional blathering when you are being misled. The real issue is India's IP theft.

Planting a bunch of phony stories about how "dangerous" their drugs are or highlighting some one-off case of adulterated Indian generics is a total red herring.

Google India pharmaceutical intellectual property theft. That's the real issue. Our government is pissed as fuck with India because they violate intellectual property norms.

Your entire thread and all of your concerns are BLUE PILLED AS FUCK.

The FDA is pure faggotry. It has made us LESS SAFE. The fact that we can't sue the manufacturers of anyone who manufactures FDA approved drugs proves that point.

I should clarify that the FDA sometimes discovers problems with generic drugs while inspecting the manufacturing plants.

But when they're approving a company's new generic version of a drug that's gone off-patent, they don't test the drug themselves. They take the company's word for it.

peoplespharmacy.com/2014/12/03/expose-reveals-why-we-no-longer-trust-all-generic-drugs/

>an expose by Bloomberg News...reveals that a number of major generic drug manufacturers in India systematically fudged data. One of the biggest players is Sun Pharmaceutical Industries, Ltd. Sun has all but finalized the acquisition of Ranbaxy Laboratories, another huge Indian generic drug manufacturer...

According to Bloomberg, the company deleted bad test results. Chemical analysis (chromatography) of drug samples is essential to establish purity. If the test results are not up to standards, the entire batch of medication is supposed to be thrown out. But Bloomberg reported that a quality-control worker at Sun Pharmaceutical merely hit the delete button on the computer to get rid of the unwelcome results. As a result, a batch of medications was shipped to the U.S. that probably did not pass quality control measurements....

>The...expose reveals what we have long suspected, ie, that many Indian drug companies have long ignored FDA rules and regulations. If results don’t pass muster, delete them rather than throw out a bad batch of drugs. Goodness knows how long this has been going on. The FDA has historically relied on drug companies to do their own quality testing. In other words, it’s the honor system.

Guys, there are so many children aged 5 or 6 with harsh forms of autism, what is this?I've seen so many children from normal families having this ultra active form of wild autism, and I know that for every agressive for there is like 2 or 3 children with silent form of classic autism.Where does this come from?Vacines, some other shit?This scares me as fuck, my friends who are working in pediatry say the same.What is this shit?

I'm really sorry to hear that, but unless this somehow relates to the tainted drugs being produced by Indian or other overseas pharmaceutical companies it's outside the scope of this thread.

>www.peoplespharmacy.com

I think its connected.I mentioned vaccines and I remember large portions of indian vaccines in like 2007 in Ukraine, for example.

Oh, I see.

Maybe there could be some connection. It's a very disturbing thought.

>2016
>taking prescription drugs

Wake up, folks.

do you even have to ask? Chernobyl

Lol and what about other european countries with the same tendency.Look up statistics, its more than this.

But OP, everyone when I was growing up was telling the politicians that sending our factories to China and India was a horrible idea. No one listened.