U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg says her visit to India this month came as America imports increasingly more food and medicine from its third-largest trading partner in the world.
“We are not [specifically] targeting Indian companies,” Hamburg told reporters Friday in a conference call after returning home from the weeklong state visit. “We inspect facilities in other countries and inspections are a routine part of our regulatory process.”
More U.S. inspections of India’s drug manufacturing apparatus reflects only a greater volume to inspect, she said, adding that she’s twice visited China for the same reasons.
In 2012, India exported some $4.2 billion worth of generic drugs to the United States as America’s second-largest overall supplier of drugs after Canada, with 40 percent of the U.S. market for generic and over-the-counter drugs for a total of $14 billion. As reliance on Indian manufacturing increases, Hamburg says the FDA continues to work with Indian officials to ensure adherence to continually rising standards of quality for products sold on the U.S. market.
However, quality control in Indian manufacturing has been an increasing problem for years. Ranbaxy, one of the country’s largest pharmaceuticals, pleaded guilty last May to seven criminal charges in the U.S., including falsifying clinical data and distributing adulterated drugs. Though the company paid $500 million in fines and restitution, critics say state and federal regulators in India failed to take any action against the company. Regulators in Gujarat, Kerala, and Tamil Nadu also failed to discipline manufacturers after finding hundreds of failed drug sample tests, with no arrests and no product seizures coming from the investigation, according to an analysis from the International Business Times.
Hamburg acknowledged quality control problems with Indian manufacturers, but emphasized that manufacturers around the world would meet more stringent U.S. regulations for import. “I think this was a particularly important trip for FDA when you consider that over the past decade globalization has transformed the FDA from a national regulatory agency to a global health safety organization,” she said.
Last week, U.S. and Indian officials signed an agreement ensuring adherence to U.S. quality control standards updated in the Food and Safety Act of 2011, a law intended to push regulators further forward into the field — and around the world. As part of the new international focus, Hamburg visited counterparts in Delhi and Mumbai to discuss pharmaceutical quality control, stopping in Cochin, too, to visit food production plants.
Hamburg also responded to some comments made earlier this month by her counterpart, Dr. GN Singh, India’s drug controller general, on the sovereignty of his country’s regulatory authority. "We don't recognise and are not bound by what the U.S. is doing and is inspecting," Singh told Reuters earlier this month before Hamburg’s trip. "The FDA may regulate its country, but it can't regulate India on how India has to behave or how to deliver."
However, Hamburg insisted she and Singh were literally reading from the same page, after signing a first-ever “statement of intent” on pharmaceutical regulatory practices. “[Singh] certainly discussed his eagerness to work with us and to get technological assistance and training opportunities, as well as the opportunity for some of his regulators to observe our regulators while they are doing their inspections. His mission statement mirrors ours.”
In dealing with Indian officials, Hamburg says she stressed the importance of quality control in pharmaceutical manufacturing, noting the meticulous attention to detail observed by 17th century artisans in building the Taj Mahal, a work known synonymously around the world as a measure of quality.