Manufacturing Safety Raises Concern

Last week, pharmaceutical heads met as a result of a drugs recall after a pill mix up of breast cancer pills.

Last week, pharmaceutical heads met as a result of a drugs recall after a pill mix up of breast cancer pills. The drug, Fresenius Kabi’s Anastrozole, was made by the German company’s subsidiary in India. The ingredient mix up led to the voluntary recall of 7192 bottles, each containing 30 tablets.

The mishap raises the question: Is there enough regulation to protect patients As a new generation of biopharmaceuticals go under trial in India those in attendance at 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.

Biopharmaceuticals are made using living systems such as micro-organisms, plants or animal cells and if any mistakes or alterations, such as contamination of ingredients, occur during the manufacturing process they are likely to lead to serious side effects. India’s Drugs and Cosmetic Rules (DCR) don’t d