New Delhi, 28 September (IANS). Medicines of Indian pharmaceutical companies are being brought back from the US market. According to a recent report by the US Food and Drug Administration (USFDA), major pharmaceutical companies like Glenmark, Granules India, Sun Pharma, Zidas and Unikem are asking for their medicines back from the US for various reasons. The main reason behind this is the problems in the construction process, impurities in medicines and mistakes in labeling.
Glenmark Pharmaceuticals have recalled about 13,824 tubes of their aergelic acid gel. This drug was made in the company’s Goa plant. Some users of this drug complained of disturbances in its texture.
The US branch of Glenmark announced a class-2 recall for this drug on 17 September. Class-2 recall means the use of the drug can cause temporary or reversed health problems, but the chances of serious health risk are less.
Similarly, Granules India has called back around 49,000 bottles, which is a combination drug used for the treatment of Attention Defisit Hypercity Disorder (ADHD). This drug was found to be inaccessible and quality tests, due to which it was removed from the market. This recall of Granules India falls in the class-3 category, which means that this drug is unlikely to be harmful for health.
The American branch of Sun Pharma has also announced to recall 1,870 kits. These kits are particularly related to an imaging agent used for the kidney check. The company found a flaw in the investigation into the dissolution of this drug, due to which Class-2 recall was started on 3 September.
In addition, Ahmedabad -based Zidas, a subsidiary, Zidas Pharmaceuticals (USA) incorporated has recalled 8,784 bottles of Antiviral Drug Antacavir Tablet. Complaints of inaccuracy and malfunction were also received in this medicine. Zidas started class-2 recall of this drug on 4 September.
The most serious case is Unicame Pharmaceuticals USA incorporate, which has called 230 bottles back when drugs are wrongly labeled. Due to this wrong labeling, patients were in danger of getting wrong medicine, which could be very serious for health. For this reason Unicame declared Class-1 recall on August 27, which is the most serious category recall.
-IANS
PK/AS
