US FDA warning letters to Indian pharma decline

US FDA warning letters to Indian pharma decline

INDIAN pharmaceutical companies have received 29 per cent of US FDAwarning letters in 2017 as compared to 50 per cent warning letters in 2015 due to improvement in quality standards and regulatory compliance.

In 2016 India accounted for 29 per cent of US FDAwarning letters which remained the same last year as well. In 2017 US FDAhad issued 49 warning letters to non US sites as compared to 16 letters in 2015. In 2016 non US FDA plants received 35 warning letters.

India has received 30 per cent import alerts in 2017 as against China’s 50 per cent import letters and ROW’s 20 per cent.

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