India's Data Integrity Problems

Posted 03 February 2015 By Alexander Gaffney, RAC


In recent months, the US Food and Drug Administration (FDA) has identified more than a dozen Indian pharmaceutical manufacturers who have had problems with the data integrity practices at their respective facilities.

Those data are intended to ensure that products meet pre-established specifications, such as for purity, potency, stability and sterility. In the absence of credible data, the concern is that these products cannot be trusted. And indeed, FDA has subject many of these same companies to import alerts, refusing their products entry into the US.

For a look at the Warning Letters FDA has sent to Indian pharmaceutical manufacturers about data integrity programs, check out the chart below:

Last updated on 3 February 2015

Warning Letter Issued ToDate Warning Letter IssuedIn Focus
Apotex Research Private Limited01/30/2015Here
Micro Labs Limited01/09/2015Here
Cadila Pharmaceuticals Limited10/15/2014Here
Marck Biosciences Ltd.07/08/2014Here
Apotex Pharmachem India Pvt Ltd.06/17/2014Here
Sun Pharmaceutical Industries05/07/2014Here
Canton Laboratories Private Limited02/27/2014Here
USV Limited02/06/2014Here
Wockhardt Limited11/25/2013Here
Agila Specialties Private Limited09/09/2013 
Posh Chemicals Private Limited08/02/2013Here
Aarti Drugs Limited07/30/2013 
Wockhardt Limited07/18/2013Here
Fresenius Kabi Oncology Ltd07/01/2013Here
RPG Life Sciences Limited05/28/2013Here

Share this article:

Categories: Active pharmaceutical ingredients, Generic drugs, Compliance, Ethics, Manufacturing, Quality, News, US, India, CDER

Tags: Warning Letter, Data Integrity, India, Drug, Pharmaceutical, Data Falsification

Regulatory Exchange: Latest Updates From the Community