During a one-week visit to India, the second-largest foreign supplier of pharmaceuticals to the U.S., FDA Commissioner Margaret A. Hamburg warned pharma executives there that she will not tolerate lapses in drug quality.
“In recent years, FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world,” Hamburg noted in a blog entry made during her trip, which concluded last week. Her message to Indian pharmaceutical industry leaders is that “every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective, and of high quality.”
While in India, Hamburg signed a nonbinding agreement with the country’s health ministry that would allow Indian officials to accompany their FDA counterparts during inspections of drug-manufacturing facilities. One of the goals of the agreement is improved collaboration on drug safety matters between the two countries. Twelve FDA inspectors are stationed in India.
Between Oct. 1, 2012, and Sept. 30, 2013, FDA sent seven warning letters to Indian pharma firms out of a total of 26 issued to foreign drugmakers during that period, according to agency statistics. FDA sends the letters to pharmaceutical companies where inspectors have discovered serious manufacturing deficiencies.
Although seven letters is a modest amount given India’s significant drug exports to the U.S., it understates the country’s quality-control problems, according to Helena Champion, head of Drug Quality Assurance, a Boston-area consulting firm. This is largely because FDA is unlikely to duplicate the efforts of the European Medicines Agency, which has posted 30 noncompliance reports involving Indian companies since January 2010. Breaches by firms on the EMA list are normally serious enough to put patients’ safety at risk, Champion notes.
India’s importance as a supplier of generic drugs to the U.S. is likely to increase. Hamburg met with Indian drug industry leaders who are frustrated with the years it can take them to win approval to sell drugs in the U.S. They left the meeting assured that FDA is taking steps to address its backlog of drug applications.