We have seen for some time now that the Indian pharmaceutical industry is under sharp scrutiny from U.S. regulators. In particular, the U.S. Food and Drug Administration has stepped up its inspection and enforcement levels for those companies. Now comes word that Indian generic drug maker Wockhardt joins the list of Indian firms in trouble. According to Reuters, the latest FDA-483 revealed that Wockhardt’s Shendra plant failed to report negative test results and deleted data from its computer systems. Once again “data integrity” issues are the heart of the problem.
For Indian pharmaceutical companies, Compliance needs to be Job 1, and they need to start now by focusing on data integrity. Compliance and Quality are not mutually exclusive, nor are they necessarily expensive. But the time to start is now and we can help.