U.S. FDA Form 483 has Indian drugmakers 'spooked'

Indian pharma executives attending a seminar on FDA compliance at the Pharma Tech Expo are "spooked" by a raft of U.S. FDA Form 483 letters that document "concerns" FDA inspectors find when they visit factories, one official told the Economic Times. "Indian companies are spooked by 483 since they don't have trained staff and often break cleanliness guidelines," S.B. Rijhwani, a member of the Indian Pharmaceutical Association, said in the report. "In some instances, staff from pharmaceutical firms go out of the lab in their lab gowns, eat food, and return to the lab," drug expert Subhash Pandey said, adding that in some cases there is "sheer lack of discipline." Other officials said data integrity has become a cause for concern at drug companies because "any anomaly in data can lead to the inspectors raising objections over the quality of a product," according to another expert, Sanjay Tiwari. The seminar was one result of more than 40 plants in India being banned from exporting to Europe and the United States over quality-control concerns. Report