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HindustanTimes Tue,16 Sep 2014

US drug administration steps up inspections in India

PTI  New Delhi, September 24, 2013
First Published: 23:40 IST(24/9/2013) | Last Updated: 23:43 IST(24/9/2013)

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.

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The US health regulators, which has been cracking the whip against many Indian pharmaceutical firms, including Ranbaxy Laboratories and Wockhardt, is also recruiting and training additional drugs investigators in India.

In order to meet requirements of the new Food and Drug Administration Safety and Innovation Act (FDASIA) - Generic Drug User Fee Amendments (GDUFA), the USFDA said it is stepping up the inspections in India.

"In March 2013, 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...," a spokesperson for USFDA Christopher C Kelly told PTI in an emailed response.

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.


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