|FDA Commissioner Margaret Hamburg|
The FDA has taken some tough action against Indian drugmakers like Ranbaxy Laboratories. It has a dozen inspectors stationed in India and will beef that up to 19. But the agency doesn't have it out for Indian drugmakers, FDA Commissioner Margaret Hamburg insists. Its actions there just reflects that India has become one of the biggest links in the global supply chain.
"We have an increased presence and that reflects that India is a significant and growing player in the U.S. marketplace," Hamburg said in a briefing Friday to talk about her 10-day trip to India to meet with regulators and top industry execs. She pointed out that India accounts for about 40% of the generic and over-the-counter drugs sold in the U.S. During questions, she explained she has already met with officials in China, another huge supplier of imported drug products to the U.S., as well as Latin America, and intends to make other international trips given how global and complex the pharma supply chain has become.
Her trip came as tensions have mounted between the two countries over some of its enforcement actions. In the last 10 months, the FDA has banned products from two Indian plants operated by Ranbaxy Laboratories and two owned by India's Wockhardt. But the agency has also banned imports from plants in China, Mexico and Canada, taken actions that have halted production of drugs in the U.S. and sent warning letters to drugmakers all over the world, including the U.S. and Europe.
The agency is adding to its inspection staff in India so that it can do more training as well as compliance work, but it also is adding inspectors in China and has inspectors stationed in the EU and Latin America, Hamburg said. A non-binding agreement signed with the Ministry of Health and Family Welfare India while she was there is expected to result in joint plant inspections where Indian regulators can learn about what the FDA looks for from drugmakers.
Hamburg told reporters that the industry people she met with understood the importance of quality "and they value our increased engagement and work with Indian authorities." She said she was particularly struck by the response from a group of women from academia and the food and pharma industries she met with while traveling around the country. "I was delighted that the group appreciated how smart regulation can help shape, support, and strengthen the product development and manufacturing processes that can help ensure continuous quality," Hamburg said in a blog post about her trip.
- here's the blog post
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