Manufacturing safety raises concern, following breast cancer drug pill mix-up

Last week pharmaceutical executives met as a result of a drugs recall after a pill mix up of breast cancer pills. The drug, Fresenius Kabi’s anastrozole (a generic copy of AstraZeneca’ Arimidex), was made by the German company’s subsidiary in India. The ingredient mix up led to the voluntary recall of 7,192 bottles, each containing 30 tablets.

The mishap raises the question: Is there enough regulation to protect patients? As a new generation of bio pharmaceuticals goes under trial in India, those attending the NGP EU summit were concerned that as demand increases, manufacturing practices may suffer, therefore higher regulations might be necessary to keep track of the manufacturing processes.

Lack of differentiation in Indian regulations