India's Data Integrity Problems
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 To | Date Warning Letter Issued | In Focus |
|---|---|---|
| Apotex Research Private Limited | 01/30/2015 | Here |
| Micro Labs Limited | 01/09/2015 | Here |
| Cadila Pharmaceuticals Limited | 10/15/2014 | Here |
| Marck Biosciences Ltd. | 07/08/2014 | Here |
| Apotex Pharmachem India Pvt Ltd. | 06/17/2014 | Here |
| Sun Pharmaceutical Industries | 05/07/2014 | Here |
| Canton Laboratories Private Limited | 02/27/2014 | Here |
| USV Limited | 02/06/2014 | Here |
| Wockhardt Limited | 11/25/2013 | Here |
| Agila Specialties Private Limited | 09/09/2013 | |
| Posh Chemicals Private Limited | 08/02/2013 | Here |
| Aarti Drugs Limited | 07/30/2013 | |
| Wockhardt Limited | 07/18/2013 | Here |
| Fresenius Kabi Oncology Ltd | 07/01/2013 | Here |
| RPG Life Sciences Limited | 05/28/2013 | Here |