USFDA pressure: 5 Indian pharma giants recall medicines from US market
New York (The Uttam Hindu): Five major Indian pharmaceutical companies are having to recall several lots of their drugs from the US market. These companies include major firms like Glenmark, Sun Pharma, Zydus, Granules India, and Unichem. The US Food and Drug Administration (USFDA), the US health regulator, has revealed in its latest report that various manufacturing defects have been found in these drugs.
According to the USFDA report, all these companies are voluntarily withdrawing the affected products from the market. For example, Mumbai-based Glenmark Pharmaceuticals had to recall 13,824 tubes of Azelaic Acid Gel, a gel manufactured at its Goa plant, after receiving complaints about its gritty texture. The USFDA has described this as a 'Class-II' recall, which means its use may cause temporary problems, though not serious health risks.
Similarly, Hyderabad-based company Granules India has also had to recall more than 49,000 bottles of a drug (Dextroamphetamine) as it failed to meet the quality and impurities standards.
The seriousness of the matter is further compounded by the inclusion of several other prominent pharmaceutical names on this list. Among them is the US subsidiary of the giant Sun Pharma, which is recalling 1,870 kits of a renal imaging agent. Similarly, Ahmedabad-based Zydus Pharmaceuticals is recalling 8,784 bottles of its antiviral drug, Entecavir. Another company, Unichem Pharmaceuticals, is withdrawing its drugs from the US market due to a label error.
This development once again raises questions about the quality control processes of the Indian pharmaceutical industry, especially when it is linked to the world's largest and most stringent pharmaceutical market, the US.