I consider Alinia from time to time, but use to use quite a bit before the price quadrupled over the last several years. I have had several patients with Covid present to me with GI symptoms so I recently asked my Alinia rep about the Covid studies that they had previously spoken with me about. I was told that the company is currently analyzing the data which looks great and that they have other providers that had doubled the dosage for 7-10 days it worked. I was skeptical so I went to look at the trial and noted that the trial did not use the current dosing of Alinia. I was glad that I checked. The rest of the time was spent reinforming me and my office staff on the codes that should be used to get the drug approved by insurance for other uses and I was also instructed to check DAW due to a new generic that is manufactured in India. I went on to ask what exactly was the problem with the generic and only that it is manufactured in India.
I am proud to say that I have taken steps to help in decreasing healthcare costs, I have done my homework on generics and particularly those manufactured in India. I take offense to any company that advises to check the DAW box for all scripts and have not taken any measures to decrease the cost of their drug. Please see excerpts from great article below which I hope will inspire others to follow my lead. I will no longer be using Alinia and I plan on taking further steps as I have found your company to be questionable at the least.
Making the case for Indian generic drug manufacturing
In response to the growing regulatory environment, pharmaceutical companies in India continue to strengthen their processes, while improving automation, operating procedures and quality management systems.
What’s more, Indian manufacturers are being audited by inspectors from every market they export to — UK, Germany, South Korea, Japan, Brazil, to name a few — who regularly visit and evaluate Indian pharmaceutical factories.
Because of these actions, FDA inspection outcomes for Indian manufacturers have not only improved, but are in line with outcomes from other global manufacturers. In addressing media reports questioning the quality of Indian products, former FDA Commissioner Scott Gottlieb said, “…the FDA labs tested 323 products from around the world — including more than 100 from India — to determine if foreign manufacturers had a higher incidence of product failure. All 323 samples met U.S. market quality standards using testing standards set by the United States Pharmacopeia (USP) or submitted in marketing applications.”
The Indian Pharmaceutical Alliance (IPA) represents 23 research-based national pharmaceutical companies focused on patient health and safety with a commitment to provide quality drugs to patients throughout the world.
To drive forward this commitment to provide safe and quality drugs, IPA companies have undertaken several focused steps towards excellence in quality. Over the past 4 years, IPA has worked to
Furthermore, between 2012 and 2016, IPA companies contributed $161 million to generic-drug user fees, thereby contributing more than half of the revenue under the Generic Drug User Fee Amendments, which enables the FDA to bring greater predictability and timeliness to the review of generic drug applications, as well as helps to fund the inspection of generic plants.
I am proud to say that I have taken steps to help in decreasing healthcare costs, I have done my homework on generics and particularly those manufactured in India. I take offense to any company that advises to check the DAW box for all scripts and have not taken any measures to decrease the cost of their drug. Please see excerpts from great article below which I hope will inspire others to follow my lead. I will no longer be using Alinia and I plan on taking further steps as I have found your company to be questionable at the least.
Making the case for Indian generic drug manufacturing
In response to the growing regulatory environment, pharmaceutical companies in India continue to strengthen their processes, while improving automation, operating procedures and quality management systems.
What’s more, Indian manufacturers are being audited by inspectors from every market they export to — UK, Germany, South Korea, Japan, Brazil, to name a few — who regularly visit and evaluate Indian pharmaceutical factories.
Because of these actions, FDA inspection outcomes for Indian manufacturers have not only improved, but are in line with outcomes from other global manufacturers. In addressing media reports questioning the quality of Indian products, former FDA Commissioner Scott Gottlieb said, “…the FDA labs tested 323 products from around the world — including more than 100 from India — to determine if foreign manufacturers had a higher incidence of product failure. All 323 samples met U.S. market quality standards using testing standards set by the United States Pharmacopeia (USP) or submitted in marketing applications.”
The Indian Pharmaceutical Alliance (IPA) represents 23 research-based national pharmaceutical companies focused on patient health and safety with a commitment to provide quality drugs to patients throughout the world.
To drive forward this commitment to provide safe and quality drugs, IPA companies have undertaken several focused steps towards excellence in quality. Over the past 4 years, IPA has worked to
- Measure and benchmark Indian pharma quality with the rest of the world
- Create targeted guidelines and best practices in areas of relevance, which are vetted by regulators across the world, including the FDA
Furthermore, between 2012 and 2016, IPA companies contributed $161 million to generic-drug user fees, thereby contributing more than half of the revenue under the Generic Drug User Fee Amendments, which enables the FDA to bring greater predictability and timeliness to the review of generic drug applications, as well as helps to fund the inspection of generic plants.