Indian Drug Makers Face Problems In U.S. Due To Documentation And Data Maintenance: Report

NEW DELHI: Problems faced by Indian drug makers in the U.S. are not related with quality but more due to documentation and data maintenance, a senior government official today said. While stressing that India is already engaged with the U.S.FDA to sort out the matter, the official, however, said domestic firms would have to meet the requirements of all the countries where their drugs are exported.

"In none of those (cases taken up by the U.S.FDA), quality was an issue. It was the documentation and data maintenance process...Quality was not an issue as far as supply of generics are concerned," Joint Secretary in the Commerce Ministry, Sudhanshu Pandey, told reporters here.

The USFDA has taken a series of actions against Indian pharmaceutical firms, restricting their shipments to the US, their largest export market. The U.S. health regulator on January 23 banned the import of products manufactured by Ranbaxy Laboratories at its plant at Toansa. This was the company's fourth plant to face regulatory action from the U.S.FDA, after Mohali, Paonta Sahib and Dewas plants.