FDA's Hamburg comes back from India with high hopes about quality standards

FDA Commissioner Margaret Hamburg--FiercePharma file photo
FDA Commissioner Margaret Hamburg

FDA Commissioner Margaret Hamburg returned from her weeklong trip hobnobbing with Indian health regulators and pharma execs saying she expected more collaboration between her agency and officials there. Hamburg did return with an agreement from health officials to work more closely with the agency. But India's top drug regulator sounded a little less enthusiastic than others about meeting all of the FDA's high expectations.

"We think this is a critical moment in time, when we have to think and act in new ways, and that requires real commitment as national regulators to work as a coalition of global regulators," Hamburg said at the end of her trip, Reuters reports. "And that is why it is so important that the Indian regulator really joins us at the table, because they are so important in the global marketplace for medical products."

The FDA and the Ministry of Health and Family Welfare India signed a non-binding agreement to join each other on inspections at drug plants in India so that India's inspectors could learn what the FDA expects when it reviews production.

G.N. Singh, the Drug Controller General of India, told Reuters that he sees some areas where the FDA and India's Central Drugs Standard Control Organization (CDSCO) can cooperate toward improvements. But he was adamant that Indian regulators do not have to maintain the same standards as the FDA when regulating drugmakers' products for the Indian market. "We don't recognize and are not bound by what the U.S. is doing and is inspecting," Singh said. "The FDA may regulate its country, but it can't regulate India on how India has to behave or how to deliver." Singh said last week that he would have to shut down almost all domestic producers if they were expected to meet similar standards, The New York Times reported.

And therein lies part of the problem for some of India's drugmakers--because when they export to the U.S., they do have to meet those standards. And because some of them--like Ranbaxy Laboratories and Wockhardt--have not, they have had plants banned from shipping to the U.S., moves that created tension between the countries.

Indian drugmakers produce 40% of the generic and over-the-counter drugs used in the U.S. Only Canada exports more drug products to the U.S. The FDA has increased the number of inspectors it has stationed in the country and last year inspected 160 Indian drug plants. That is three times as many as in 2009, the Times points out. And there is no question that there is a disparity in resources between the two countries. The CDSCO has a staff of 323, about 2% that of the FDA. It only regulates drugs on the market up to four years. After that, state health departments take over, and the Times points out, those often lack knowledge and are frequently corrupt.

Hamburg, however, was careful to point out during her trip that many of India's drugmaker have top notch facilities, making high-quality drugs for the U.S. Unfortunately, she said in a blog post about her visit, those have been overshadowed by "recent lapses in quality at a handful of pharmaceutical firms."

- read the NYT story
- more from Reuters