The USFDA’s presence in India is being increased to 19 from 12 American staff based in-country, including 10 dedicated specifically to medical products
The US Food and Drug Administration (USFDA) is increasing its inspections of facilities of drug makers in India, the second largest provider of finished dose products to the US, to ensure compliance of approved manufacturing norms.
The US health regulator, which has been cracking the whip against many Indian pharmaceutical companies, including Ranbaxy Laboratories and Wockhardt, is also recruiting and training additional drugs investigators in India.
The FDA said it is stepping up inspections in India in order to meet the requirements of the new Food and Drug Administration Safety and Innovation Act (FDASIA) — Generic Drug User Fee Amendments (GDUFA).
“In March 2013 the (US) FDA received approval from the Indian Government to add seven additional drugs investigators in India.
The USFDA’s presence in India is being increased to 19 from 12 American staff based in-country, including 10 dedicated specifically to medical products. Other staff include foods and devices inspectors, and policy analysts.
“Having these additional inspectors in-country will assist the agency in meeting our legislative mandates. So we are increasing our rates of inspection,” Kelly added.
Under the FDASIA, the USFDA is required to achieve the same inspectional schedule for foreign facilities as domestic manufacturers, and to clear the backlog of applications by the end of the first five-year user fee authorisation period.
India, as the second largest provider of finished dose products to the US with almost 10 per cent of that market, has, for many years, been a consistent provider of low-cost and quality medical products for many countries of the world.
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