Lately, the generics industry has been bashed from all sides with regards to quality, with most of the criticism being directed towards poor Quality-Control standards in Chinese manufacturing facilities. But this month was a terrible one in terms of quality control for a whole bunch of otherwise top-tier generics companies that had relied on an Indian contract manufacturer.

FiercePharma reports that top-class names such as Sandoz, Jubilant Organosys and Wockhardt were all affected by poor quality products being manufactured on their behalf by the contract manufacturer MJ Biopharm.

The products had to be recalled from UK shelves, one of the most significant generics markets in the world, with a 22% generics penetration rate, which will surely do nothing to increase consumers confidence in the industry.

What is confusing however, is how this could have occurred at all? European regulations require that batch release testing be conducted in Europe for products that are marketed in the territory, so we assume that it was Sandoz, Jubilant and Wockhardt which controlled their own batch releases, in which case the issue of failure in QC rests as much with them as it does with MJ Biopharm. However, if they outsourced even the batch release to someone else, then the lesson here is clearly that if you’re marketing a generic, it’s probably best if you’re controlling your own batch releases.

To read more about batch release reulations within the EU, see this excellent article written by by Niall Dinwoodie for BioPharm International.