Pharma recalls posing a serious threat?

There have been several other instances wherein drugs are being recalled either on a firm's own initiative or at the request by the Food and Drug Administration (FDA)


Mumbai: 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 the United States Food and Drug Administration (USFDA), this was a Class III recall. Another company from the USA has just recalled 3.31 lakh bottles of Divalproex Sodium which is used for the 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 World Health Organization-Good Manufacturing Practices (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.

The various types of pharma product recall include:

Class I recall: It is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall: It is a situation in which use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III recall: It is a situation in which use of or exposure to a volatile product is not likely to cause adverse health consequences.

Medical device safety alert: It is issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.

Dr Piyush Gupta from GNH India is of the opinion that these companies can avoid recalls and avoid the public hazard if they follow all the rules and regulations provided by the WHO – GDP.

“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 experts advise that the standards and procedures set up by the FDA are put in place for a reason and pharmaceutical giants must not take short-cuts.