FDA Halts New Applications From Indian Drug Maker's Plant
Agency says Ranbaxy Laboratories facility falsified scientific data
Reader Comments
Indian Drugs
If the FDA directs as much attention to our drug supply as they direct to our food supply, I think we're in trouble. Look at the number of "glitches" found in the food supply in the last several years, and you begin to lose confidence in the FDA. I think the pharmaceutical lobby does a good job of keeping the "glitches" from the U.S. companies quiet. I think the U.S. companies do a good job of publicizing the "glitches" coming from their foreign competitors. One of the problems with the U.S. health care system is that insurers and pharmaceutical companies place their profits and premiums over the value of human life and health.
coololo
cool
FDA and Ranbaxy
After reading all the official news from FDA that is coming about Ranbaxy, one feels like congratulating FDA for taking a very strict but a balcnced view about the whole ranbaxy affair. e.g. FDA is very clear in banning any application or drug from one tainted plant but at the same time not carrying any bias about ranbaxy's other plant exporting drugs to US. They are even assuring American public of the continuity of taking drugs of this company on American counters if they are taking them any way. This is very practical, fair and objective way of FDA and I want to congratulate them.
An Avoidable Breach of Integrity
It is for this exact reason that we insist that we monitor and audit all bioequivalency studies that US firms conduct in India with the intention that the data obtained will support registration. Those genericfirms that decide not to monitor and audit Indian sites will be destined to repeat this type of breach of scientific integrity. The bad part is that it could have been avoided by intense site monitoirng and auditing of all of the compliance related activities and data. They will get what they deserve. (See www.greystoneconsult.com)
@ Ken of IL - ,Stop Dealing With India For Drugs' REALLY?
The FDA is probably the most strigent agency when it comes to drug testing and record keeping. It is said that most countries, including countries in the EU would not even qualify to submit applications to the FDA for drug manufacturing process controls and the accounting of such processes. One glitch and you are done! Though I not familiar with this case, I know full faith in the FDA and its very high standards of control.
Also I have no problems with the some Indian fellow making $2 a day, in their economy and surviving, more importantly making medicines AFFORDABLE for my Dad and Mom. We all know our union boys love making $73.00 an hour in GM (per WSJournal), and the quality they have produced over the years produce!
Ken, instead of being a xenophobe and a "trade protectionist" you need to grow up and understand we are in a global competion. The American worker can no longer compete in 2 areas; wages and education. This way China and India are taking our jobs, because we are lagging behind and refuse survive on lower wages. I am not making excuses for this company for allegedly "misrepresenting". I'm sure like Ken, there are anti-Indian folks in the FDA who can create problems out of thin air, like dead people from Illnois voting for Kennedy!! The FDA, or any other agency clearly can not prove a single American was harmed in any way. Ken, did you know if you accidentally put 2008 on your job application instead instead of 2009, you just "misrepresented"yourself or "falsified" a company record and can be FIRED from your job? Lets not make the seniors and the poor victims of some anti Indian witch hunt. If this company if less than forth coming FIRE THEM and look for another Indian Pharma to supply less costly medicine.
@ Ken of IL - ,Stop Dealing With India For Drugs' REALLY?
The FDA is probably the most strigent agency when it comes to drug testing and record keeping. It is said that most countries, including countries in the EU would not even qualify to submit applications to the FDA for drug manufacturing process controls and the accounting of such processes. One glitch and you are done! Though I not familiar with this case, I know full faith in the FDA and its very high standards of control.
Also I have no problems with the some Indian fellow making $2 a day, in their economy and surviving, more importantly making medicines AFFORDABLE for my Dad and Mom. We all know our union boys love making $73.00 an hour in GM (per WSJournal), and the quality they have produced over the years produce!
Ken, instead of being a xenophobe and a "trade protectionist" you need to grow up and understand we are in a global competion. The American worker can no longer compete in 2 areas; wages and education. This way China and India are taking our jobs, because we are lagging behind and refuse survive on lower wages. I am not making excuses for this company for allegedly "misrepresenting". I'm sure like Ken, there are anti-Indian folks in the FDA who can create problems out of thin air, like dead people from Illnois voting for Kennedy!! The FDA, or any other agency clearly can not prove a single American was harmed in any way. Ken, did you know if you accidentally put 2008 on your job application instead instead of 2009, you just "misrepresented"yourself or "falsified" a company record and can be FIRED from your job? Lets not make the seniors and the poor victims of some anti Indian witch hunt. If this company if less than forth coming FIRE THEM and look for another Indian Pharma to supply less costly medicine.
Ken of IL
The FDA is probably the most strigent agency when it comes to drug testing and record keeping. It is said that most countries, including countries in the EU would not even qualify to submit applications to the FDA for drug manufacturing process controls and the accounting of such processes. One glitch and you are done! Though I not familiar with this case, I know full faith in the FDA and its very high standards of control.
Also I have no problems with the some Indian fellow making $2 a day, in their economy and surviving, more importantly making medicines AFFORDABLE for my Dad and Mom. We all know our union boys love making $73.00 an hour in GM (per WSJournal), and the quality they have produced over the years produce!
Ken, instead of being a xenophobe and a "trade protectionist" you need to grow up and understand we are in a global competion. The American worker can no longer compete in 2 areas; wages and education. This way China and India are taking our jobs, because we are lagging behind and refuse survive on lower wages. I am not making excuses for this company for allegedly "misrepresenting". I'm sure like Ken, there are anti-Indian folks in the FDA who can create problems out of thin air, like dead people from Illnois voting for Kennedy!! The FDA, or any other agency clearly can not prove a single American was harmed in any way. Ken, did you know if you accidentally put 2008 on your job application instead instead of 2009, you just "misrepresented"yourself or "falsified" a company record and can be FIRED from your job? Lets not make the seniors and the poor victims of some anti Indian witch hunt. If this company if less than forth coming FIRE THEM and look for another Indian Pharma to supply less costly medicine.
Stop dealing with India for drugs
As an American who has lived in India for years, it makes absolutely no sense that we'd trust them when it comes to health. Indians tend to have a very different sense of morality, ethics, and values then us. Many of the are less empathetic- especially those who are willing to claw their way through the corrupt marketplace and do business.
We all know the quality control problems with Indian products and services. We've all been annoyed at customer service without answers. Can we not find domestic facilities to make our medicines?
All in the name of saving dollars we expose ourselves to the problems of their system. And, we lose jobs in the process.
When are we going to wake up to the self-reliance which is what once made our country great? When are we going to realize that every product coming in from India is an environmental disaster? That the workers are making $2 a days while the boss drives a new Mercedes.
Bring the jobs home. For our comfort, for our safety, to be true to our values.
FDA is to blame here to even cosider future applications
It is unbelivable to me to hear that FDA is considering accepting applications from this company in future when they have proof that their scientific integrity can't be trusted. It is even more unbelivable to hear they want patients to continue taking these drugs when the problems happen at the PRODUCTION step - why would a patient trust the pill he has in his bottle at home?? Can FDA give assurance the drug is in the right dosage, activity etc when these liars FALSIFIED data?
