30.11.14

Drug approvals over Indian data

Drug approvals over Indian data




France, Germany suspend some drug approvals over Indian data


Regulators in France, Germany, Belgium and Luxembourg are suspending the marketing approval of 25 generic drugs due to concerns over the quality of data from clinical trials conducted by India's GVK Biosciences, French watchdog ANSM said on Friday.

The quality of Indian pharmaceuticals has come under fire this year, with regulators in Europe and the United States citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms.












pharmacy
drugs

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