34% of USD FDA warnings this year to Indian Pharma Manufacturers.

Indian Pharma Manufacturers have received the 3rd time warning from USFDA for misbranding, selling unapproved medicines and violating CGMP guidelines so far this year.
The USFDA issued 38 warnings to Pharma Manufacturers in 2019 and out of these there were, 34% i.e. 13 to Indian Pharma Manufacturers including major players like Emcure Pharma and Aurobindo Pharma, as per to FDA records and stats. This Pharma Manufacturers in the US received most of these warnings i.e. is 15 times.
According to section 501 (a)(2), (B) of the FD&C Act violations of CGMP by a Pharma drug manufacturers can result in its product being categorised as degraded (contaminate), like Management oversight, non-conformity to standards, batch failures, contamination are a couple of constituents of CGMP violations.
Sudarshan Jain, general secretary, of IPA, Stated that “ The reason for the high number of warning letters to India is because of the relatively higher number of inspections done in the country”

Adding to his statement he conveyed that “India is the biggest exporter of the US market,” giving a reason for the high number of inspections. But, according to US-ITC data, India is the 4th largest exporter of pharma products in the USA.
When asked again, he said, “India ranked second in terms of volume (59 million kilograms) in 2015, according to the US-DOC.”

List of 13 Indian Pharma Manufacturers against whom USFDA have issued the Warning are: