Generics in India are associated with more adverse events than our adverse events

A new study found that generic drugs produced in India were associated with “serious adverse events” compared to patients who used them compared to equivalent drugs produced in the United States.

These adverse events include hospitalization, disability, and death in a few cases. The researchers found that mature generics are relatively long generics on the market, which is the reason for the discovery.

The results show that all general medications are not equal even if patients are often told.

“Pharmaceutical manufacturing regulations, so quality assurance practices vary between emerging economies such as India and the United States,” Gray said.

“Producing generic drugs can make a huge difference.”

Another co-author George Ball added: “The FDA assured the public that all generic drugs formed with the same original drug should be equally safe and effective, but when it comes to generic drugs made in India, this That’s not necessarily the case.” Associate Professor of Operations and Decision Technology at Indiana University’s Kelly School of Business.

The study, recently published in Journal Production and Operations Management, was led by Joon Noh, who received his PhD from Ohio State University and is now an assistant professor at Korean universities. Other authors include Zachary Wright, who will receive his PhD from Ohio State University and is now an assistant professor at Brigham Young University; and Hyunwoo Park, an assistant professor at Ohio State University, who is now at Seoul National University.

Several authors of this article work closely with the Food and Drug Administration regarding federal grants and contracts, although the study was conducted entirely independently of the FDA. The authors said that working closely with the FDA gave them the importance of studying the quality of general-purpose drugs.

This study is important because it is the first method to connect large numbers of generic samples to the actual plants it makes. The FDA will not publish the information through the Freedom of Information Act process. But Gray said Noh figured out how to connect drugs to factories that are produced using so-called structured product label datasets.

“Updating this lack of transparency in the location of drug manufacturing is one of the main achievements of our research,” Gray said.

Another key to the study is that it matches the drugs made in India and the same drugs produced in the United States. These drugs have the same active ingredients, the same dosage form and the same route of administration.

“That means these drugs are equal in medicine, and we are comparing apples to apples,” he said.

The researchers matched 2443 drugs produced in the United States and emerging economies. Although researchers included other countries in the analysis, 93% of generic drugs from emerging economies are manufactured, so the Indian data fully illustrates the results.

The researchers compared the frequency of drugs related to adverse event reports of generic drugs produced in India and matched drugs made in the United States. These adverse event reports can be found in the FDA Adverse Event Reporting System (FAERS).

Although Faers included all reported adverse events, in this study, researchers used only those with the most severe outcomes, including hospitalization, disability, and death.

The results show that the number of serious adverse events of generic drugs produced in India is 54% higher than that of equivalently matched generic drugs made in the United States. This is taken into account various other factors that may affect the outcome, including the number of drugs sold.

These findings are driven by drugs that have lasted longer in the market.

“In the pharmaceutical industry, older drugs become cheaper, cheaper, and competition becomes more intense to reduce costs,” Gray said. “This could lead to operational and supply chain issues that could damage the quality of the drug.”

Gray stressed that the results should not be regarded as a reason to stop the production of generic drugs overseas.

“There are good manufacturers in India and bad manufacturers in the United States, and we have no arguments for ending the production of drugs at sea in any way or slamming India in any way,” Gray said.

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

A key issue, Gray said, is that when the FDA checks plants that produce generic drugs in the United States, the inspection will be announced. But at overseas locations, inspections are arranged in advance, which may allow manufacturers to hide the problem and make it harder for the FDA to find problems that do exist. All examinations could have a big impact, he said.

“One of the key suggestions we made in this study is that the FDA is the location where drug manufacturing is made, such as manufacturing countries and drug quality, transparent to consumers,” Ball added. “This could help create an incentive drug than today.” More quality market.”