Last Updated on October 14, 2024 by The Health Master
Drug recall
The US Food and Drug Administration (USFDA) has recently issued drug recall notices for several generic drugs manufactured by leading Indian pharmaceutical companies Lupin, Glenmark, and Natco Pharma.
These drug recalls highlight the importance of stringent quality control measures in the generic drug industry.
Breakdown of Drug Recall
- Lupin is recalling 26,352 bottles of Rifampin Capsules (300mg), an antibiotic medication, due to being “Subpotent,” meaning the capsules may not contain the full amount of the active ingredient. The drug recall was initiated in March 2024.
- Glenmark is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules used to treat high blood pressure. The drug recall is due to “Failed Dissolution Specifications,” indicating the capsules may not release the medication into the body properly. The drug recall was initiated in March 2024.
- Natco Pharma is recalling 30 bottles of Lansoprazole delayed-release capsules, a medication for heartburn, due to “CGMP Deviations,” which refers to violations of Current Good Manufacturing Practice regulations. The drug recall was initiated in March 2024.
USFDA drug Recall Classification
The USFDA classifies drug recall based on potential health risks.
In this case, all three recalls are Class II, meaning use of the affected products may cause temporary or reversible health issues, with a low risk of serious consequences.
India’s Role in the Generic Drug Market
India is a major player in the global generic drug market, supplying roughly 20% of the world’s generic medicines.
Indian companies manufacture a vast array of generic drugs across various therapeutic categories and export them to over 200 countries, including major markets like the US, Japan, Australia, and Western Europe.
Finally
While these recent drug recalls raise concerns about quality control practices in some Indian pharmaceutical companies, it’s important to note that India remains a vital source of affordable medications worldwide.
The USFDA’s role in ensuring drug safety is crucial, and these recalls demonstrate their commitment to protecting public health.
Moving forward, Indian pharmaceutical companies must prioritize robust quality control measures to maintain trust and confidence in their products.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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