India's Data Integrity Problems

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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.

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

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