Indian manufacturing plants produce an estimated 40% of the generic drugs sold in the U.S., and so the FDA has a special interest in that country, particularly given the manufacturing failures it has uncovered by Indian drugmakers like Ranbaxy Laboratories and Wockhardt. But as it has stepped oversight there, its actions have also created a certain amount of resentment. It is into that milieu that FDA Commissioner Margaret Hamburg will step next week when she makes her first visit to the country to "further strengthen cooperation between the FDA and its Indian regulatory counterparts."
|FDA Commissioner Margaret Hamburg--FiercePharma file photo|
The FDA said Wednesday that Hamburg will go to India Feb. 10 through Feb. 18 to meet with Indian policy and government leaders involved in both drug and food regulation. She emphasized that there is ongoing cooperation between the two countries. She also pointed out that what the FDA does to enhance quality for Americans is also good for Indian consumers.
One of those government leaders she could be expected to confer with would be Drug Controller General of India G.N. Singh. He has been a little testy of late as questions have come up about why his agency has taken little action against some of the same drugmakers whose practices the FDA has found so egregious that it has banned their products. Last week, in response to reporters' questions, he announced that his office intended to start doing surprise plant inspections and insinuated that foreign drugmakers were high on its list. "There has to be a level playing field," Singh told the Indian Express. "If foreign regulators can make surprise checks on Indian pharma companies, we can do the same for both domestic as well as foreign drugmakers."
The FDA said Hamburg will talk with "industry leaders in India" about meeting "high-quality standards." The FDA began stepping up oversight in India after serious problems at Ranbaxy plants making drugs for the U.S. market were brought to the attention of regulators by a whistleblower back in 2005. The FDA has banned two Ranbaxy plants in the past 5 months as well as two Wockhardt facilities last year. The agency has been marshaling resources there, adding inspectors and a new Indian-born head of the FDA office. Altaf Ahmed Lal, a Ph.D. who has worked in health policy for years in the U.S., has said that working with manufacturers there on quality issues is one of his top priorities.
Not all Indian drugmakers find the FDA actions against drugmakers there an affront. Lupin CEO Vinita Gupta pointed to her company's quality record and told Bloomberg the company has benefited from Ranbaxy's problems in the past and expects to continue to. "With the recent issues with Ranbaxy API, we're still waiting to see what happens," Gupta told the news service. She was referring to the FDA ban last month on the Ranbaxy API plant that makes the majority of the ingredients Ranbaxy uses in drugs for the U.S. market. Whether that ban will continue to keep Ranbaxy from launching its exclusive generic of Novartis' ($NVS) blood pressure drug Diovan, which went off patent in 2012, is an open question.