Updated on 17 October 2013
"In March, the US FDA received approval from the Indian government to add seven additional drugs investigators in India. We are currently recruiting and training staff for these positions. Having these additional inspectors in-country will assist the agency in meeting our legislative mandates. So we are increasing our rates of inspection," a US FDA spokesperson said in a press statement.
As per the latest US legislation, called 'Food and Drug Administration Safety and Innovation Act (FDASIA) - Generic Drug User Fee Amendments (GDUFA)', the drug regulatory agency has to inspect global plants on the same schedule as domestic facilities. In addition to this, the FDA has to clear its backlog of drug applications within five years. Records show that Indian generic drug giants account for more than one-third of US drug approval filings.
"The US FDA seeks to ensure that Indian manufacturing facilities importing to the US understand the risks associated with their product's processes and assure that they remain compliant to the US FDA's regulations. Our presence in India allows us to better collaborate with our Indian regulatory counterparts and enables us to leverage our combined resources, harmonize science-based standards and increase regulatory capacity," the spokesperson added.
Furthermore, US FDA India office director, Mr Altaf A Lal, said in a press statement that, "As more trade happens, as more drugs are approved and applications are submitted we will have to inspect more."
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