India’s pharmaceutical industry sees related problems with regulators who take process-oriented, rather than risk-based, approaches in their oversight. “Process is important to ensuring the quality of medicines, but there are some processes where infringement, even if it has taken place, does not impact the end product in any manner,” Sudhanshu Pandey, joint secretary of India’s Ministry of Commerce & Industry, told C&EN.
Pandey visited CPhI along with an entourage of Indian government, regulatory, and industry representatives. Much of the group’s energy went into defending the Indian drug industry’s reputation following a series of regulatory compliance issues that resulted in FDA bans of APIs and finished drugs from Indian facilities.
“Undue criticisms” of the Indian industry are “scientifically unsupported,” Pandey said. FDA’s complaints center on documentation and data management violations that “had zero to do with any impact on the quality of medicines,” he asserted.
In fact, though, FDA has cited missing or falsified data and inappropriate testing as well as lapses in quality at some firms. Regulators have “raised very valid questions about the processes and procedures,” Pandey admitted, but he and others attribute many of the problems to cultural differences and different interpretations of compliance requirements. To resolve the situation, the Indian government is undertaking its own regulatory reforms, adding people, and increasing training, he said.Poor Pandey -- that's a tough row to hoe. (He'd be much better off pointing out that there are plenty of quality lapses in API manufacturing in the West.)