Recently a Pharmaceutical company had recalled 12,480 bottles of Paroxetine tablets on account of failed dissolution specifications from the US market. A 3-month-old term stability study was done for the same and as per USFDA, this was a Class III recall. Another company from USA has just recalled 3.31 lakh bottles of Divalproex Sodium which is used for treatment of seizures and manic episodes in people with bipolar disorder.
There have been several other instances wherein drugs are being recalled either on a firm’s own initiative, by FDA request, or by FDA order under statutory authority. Besides the issues of faulty labeling, several companies are suffering recalls because they have failed to meet the WHO- GMP standards. Primarily, companies are skipping essential steps of purchasing an approved Reference Listed Drug. A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent.
“Not paying heed to these standards is an attempt to be economical; these generic drugs are not bioequivalent to the RLD in question and poses a serious threat to the public”, says Dr. Gupta, Associate Director of GNH India.
Dr. Gupta also adds “Stringent checks ensure that the manufacture and supply of low efficacy drugs are stopped immediately. The repercussions will include a large stock of unusable medication, a severe drop in the supply of medicines and consolidated loss in the pharmaceutical industry that is one of the biggest contributors to a country’s economy. Unfortunately, the biggest loser in this aspect will be the consumer who is unable to avail medication that is needed.”
The standards and procedures set up by the FDA are put in place for a reason and pharmaceutical giants must not take short-cuts.