The U.S. FDA is hiring new inspectors in India to tackle the high rate of marketing applications made by local firms, an agency official said. India's own drug inspectors will be invited along as observers of U.S. inspections.
Solomon Yimam, assistant country director for the FDA India Office, said its in-country ranks would grow to 19 from the current 9 or 10 inspectors. The increase is necessary to handle inspections required when companies file a marketing application for a drug.
Yimam denied suggestions that that increase shows the FDA is singling out Indian drugmakers. "Inspections are driven by marketing applications," he said, and they constitute only one of three reasons for conducting inspections.
India's own government inspectors--from either the national or state level--will be invited to accompany the FDA's, Yimam said. The two countries agreed as much a year ago when they signed a memorandum of understanding. Drugmakers in India had pressed the U.S. FDA to allow Indian inspectors to be present during its plant visits.
Yimam pointed out that FDA inspections are required when accrediting clinical trial sites, suggesting that even more than 19 inspectors might be needed. "We feel there might be a need in that area to build the capacity of the regulators to conduct inspections of ethics committees," he said, "and to ensure that the ethics committees have the capacity to review the protocols that are submitted to them."