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FDA tightens grip on Indian drug makers

August 27, 2013
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The U.S. Food and Drug Administration (FDA) has warned two Indian pharmaceutical companies over suspected breaches of good manufacturing practices. The warning letters were addressed to Posh Chemicals and Promed Exports, bringing the total number of Indian drugmakers that the FDA has taken action against to six, the Economic Times reported.

In a statement, the federal agency also accused Posh Chemicals of manipulating data. Other big players, Wockhardt and Ranbaxy Laboratories, had allegedly fudged data as well, which means that Posh Chemicals is likely to get a more serious penalty, perhaps even having its production banned from the United States.

The Economic Times said that Indian pharmaceutical companies accounted for about 60 percent of all warning letters that the U.S. drug regulator had sent globally over the past three months. Several months ago the FDA announced that it would keep Indian drug makers under close scrutiny.

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One of the reasons for the increased number of warning letters is the fact that facilities are no longer given two or three months between an inspection notice and the inspection itself. In the past, drug manufacturers used this time to improve their operations before FDA inspectors arrived, the Economic Times explained. In addition, the number of FDA inspectors in India has risen from five in 2009 to 19. This allows the agency to carry out more inspections and businesses should be aware that the FDA is planning to further increase its operations in India, a spokesperson for the FDA said.

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