Indian Drug Makers Expect Greater Scrutiny By U.S. FDA
This article was originally published in PharmAsia News
Executive Summary
Recent actions by the U.S. FDA against three Indian drug makers have given the rest of India's pharmaceutical industry pause. They are concerned the agency is becoming more demanding of drugs exported from India to the United States. Behind the problem are FDA concerns about manufacturing deficiencies in India, a concern some Indian drug makers believe is likely to lead to more stringent review of even minor deficiencies. But Indian drug makers also are raising the question of whether the U.S. actions would amount to a "non-tariff barrier" to Indian-made drugs. (Click here for more