Institute of Good Manufacturing Practices India
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13334 Indian Products and 15087 Chinese products rejected by USFDA in past 6 years on account of GMP violations

According to the FDA data, 13,334 products made in India and imports of 15,087 Chinese products were rejected by the US Food and Drug Administration (FDA) between 2010 and 2015.

According to the ministry of commerce and industry, the rejected products include patent medicines as well as generic medicines and reasons for rejection included problems in packaging, misbranding, contamination, high residue levels and labelling.

In January 2016 also 228 and 314 rejections respectively were made for India and China although when the Indian government is keen on the “Make InIndia”agenda. On January 5, 2016, three drugs from Intas Pharmaceutical Limited were rejected as they were unapproved drugs under sections "505(a), 801(a)(3)" of the FDA rules.

According to Kiran Mazumdar Shaw (CMD of BIOCON) reasons for rejections were mainly data integrity, data fudging issues and cleanliness of the environment of the manufacturing units.


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