The FDA issued an import alert last year for an IPCA Laboratories API plant in India after it discovered that employees had been falsifying drug testing results and deleting failed tests. The FDA decided it had better look upstream of that and see what that meant for the Indian drugmaker's formulations work, and sure enough, it has now banned products from two of IPCA's finished product facilities.
IPCA made the disclosure in a filing with the Bombay Stock Exchange (BSE) after finding out this week about the import alert affecting the formulation facilities in Pithampur in Madhya Pradesh and Piparia in Silvassa. The API plant is in Ratlam. The company has a dozen plants in India.
While the FDA has to do what it has to do, the drugmaker indicated it will have no immediate impact on its business because it said it had voluntarily stopped shipping product from the facilities after the FDA found issues with the API operation last summer. The company said it was committed to resolving the issues as quickly as possible.
But the company's problems don't stop at the U.S. borders. Health Canada, after learning about the issues the FDA had with IPCA, also took action against the company last year. It banned almost 20 APIs--and 50 products in which they are used.
The same kind of data manipulation has tripped up a long list of Indian drugmakers with the FDA, and IPCA was actually the second this week to disclose that the FDA had banned a couple of its plants for doing just that. Aarti Drugs, also in a BSE filing, told investors that the FDA put both of its plants in Tarapur on its import alert list, the document which indicates whose products should be stopped by customs officials. The FDA had issued a warning letter for the plants on July 30, 2013, calling the company's quality-control laboratory documentation practices into question. That included the fact that employees had documented the completion times in batch records for processes that hadn't finished.
- here's the BSE filing (PDF)