Generalic Drugs Manufactured in India Are Linked To Significly more “Severe Adverse Events” for Patients Who Use them Than Equivalent Drugs Produced in the United States, A New Study Finds.

These Adverse events inclined hospitalization, disability, and in a few cases, death. Researchers found that mature generic drugs, those that had ben on the market for a relatively long time, was responsible for the finding.

The results show that all generic drugs are not equal, even thought patients are often told that they are, said John Gray, Co-Author of the Study and Professor of Operations at the Ohio State In VNIVERSITYS FIRS College of business.

“Drug manufacturing regulation, and therefore quality assurance practices, Differ Between Emerging Economies like India and Advanced Economies Like the United States,” Gray Sid.

“Where Generalic Drugs Are Manufactured Can Make a Significant Difference.”

“The FDA assures the public that all generals patterned after the same original drug should be equipped and effective, however, however, this is not neccarily the case when it comes to general Made in India, “Added Another Co-Author, George Ball, Associate Professor of Operations and Decision Technologies at INDIANA University’s Kelly’s Kellyy’s School of Business.

Published recently in the journey Production and operations managementThe Research was LED by in Joon Noh, Who Received His Ph.D. At oho state and is now an assistant professor at korea university. Other Authors Include Zachary Wright, Who will receive his ph.d. From oho state and is now an assistant professor at brigham young university; And Hyunwoo Park, A Former Assistant Professor at Ohio State, Now at Seoul National University.

Several of the autumns on this paper have worked close and Drug Administration on Federal Grants and Contracts, Thought This Study was conducted complete independent independent of the fada. These Authors said working closely with the FDA Gave a Deep Appreciation for the Importance of Studying Generalic Drug Quality.

The Study is significant because it is the first to be alive to link a large sample of generic drugs to the actual plant where they were manufactured. The FDA will not release that information through the freedom of information act. But gray said noh figured out how to use what is called the structured product labeling dataset to link drugs to the factory where they were produced.

“Overcoming this Lack of Transparency of Drug Manufacturing Location is one of the Major Accomplishments of Our Study,” Gray Said.

Another key to the study is that it is matched the drugs in India to the same drugs made in the united states. The Drugs Had the Same Active Ingredients, The Same Dosage Form and the Same Route of Administration.

“That means the drugs are pharmaceutically equivalent and we are comparing applications to apples,” He said.

The Researches Matched 2,443 Drugs Made in the United States and in Emerging Economies. Although the Researchers Included Other Countries in their Analysis, 93% of General Drugs from Emerging Economy Countries are made in India, So India Data Fully Explied The Results.

The Researchers Compared The frequency with Drugs Were Associateed With Adverse Event Reports for Generalic Drugs Made in India Versus The Matched Drugs Made in the United States. These Adverse Event Reports are available in the FDA Adverse Event Reporting System (faers).

Although the faers includes all reported adverse events, in this study the results only used those with the most serial outcomes, include hospitalization, disability and death.

Results showed that the number of severe advertisement events for General Drugs Made in India was 54% Higher Than for Equivalent Matched General Drugs Made in the United States. That was after taking into account a variety of other factors that could have impacted the results, including the volume of drugs.

The findings were driven by drugs that had been on the market for a longer time.

“In the pharmaceutical industry, the older drugs get cheaper and cheaper and the competition gets more intenses to hold down costs,” Gray Said. “That may result in operations and supply chain issues that can compromise drug quality.”

Gray emphasized that the results should be taken as a reason to stop oversas production of general drugs.

“There are good manufacturers in India, there are bad manufacturers in the US, and we’re not advocating for ending offshore production of drugs or bashing india in any way,” Gray Said.

“We believe this is a regulatory oversight issue that can be improved.”

Gray said one key issue is that when the FDA Inspects Plants that make generic drugs in the united states, the inspections are unanned. But in overseas locations, the inspections are arranged in advance, which may allow manufacturers to hide problems and make it harder for the fada to find that that that is. Making all insurance unannounced even makes a big difference, he said.

“A key recommendation we make in this study is for the fda to make drug manufacturing location, such as the country of manufacture, and drug quality, transparent for consumers,” Balle added. ” “This can help create a market in which Drug Quality is incentiveized more than it is today”