It has been another tough week for some of India's troubled drugmakers. Wockhardt, which has two plants banned by the FDA, saw its hopes stymied for getting export approval for a different facility that it had hoped could help it recoup some of its lost U.S. revenues. And India's Ipca Laboratories, which has three plants on the import alert list, said on Monday it has now gotten a warning letter for the facilities.
A January preapproval inspection at a Wockhardt plant in Shendra determined that the plant is not yet ready for prime time. The FDA issued a Form 483 with 9 observations, many of them to do with data integrity, according to The Economic Times. The company claimed none of the observations were "serious." The newspaper said that among other problems, FDA inspectors found "unaccounted for shredded documents" in a quality-control lab.
Lack of controls and integrity for testing data were largely what led the FDA to ban products coming out of Wockhardt plants in Waluj and Chikalthana in 2013. The FDA had banned the plants after inspectors found that employees there had been manipulating data to indicate that batches that had failed testing had instead met specifications, then selling those in the U.S. The FDA last had the company recall any products from those facilities still lingering in the U.S. market.
Wockhardt executives have said they hope to get the two banned plants reapproved this year, but they also had high hopes of getting the Shendra plant approved for the U.S. market in the meantime. Before the bans, Wockhardt derived more than half of its revenues from its U.S. sales, but by last year that was down to about 25% and falling.
Meanwhile, Ipca reported to the Bombay Stock Exchange on Monday that it had received the warning letter from the FDA for an API plant in Ratlam and formulations plants in Pithampur in Madhya Pradesh and Piparia in Silvassa. Ipca had voluntarily stopped shipments from those plants in July 2014 when the FDA first cited them, but the FDA added them to its import alert list last year just the same.
Ipca said in its filing that it has already laid out its remediation plan for the FDA and has been working with outside consultants to help get the facilities back on track. It said on Monday that it is committed to the "highest quality in manufacturing, operations, systems integrity and cGMP culture," and to resolving all of the problems as quickly as possible.
Ipca did not provide any specifics from the warning letter, but previous reports have said that the FDA was concerned with employees falsifying drug testing results and deleting failed tests.
- read the Economic Times story
- access the IPCA BSE filing here