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

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

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34% of USD FDA warnings this year to Indian pharmaceutical firms.

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”

India is the 4th largest exporter of pharmaceutical products in USA

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:

Charges Companies Type of Product
Misbranding Glint Cosmetics Pvt Ltd Finished Pharmaceutical product
Anicare Pharmaceuticals Pvt Ltd Finished Pharmaceutical product
Violation of CGMP/Adulteration Emcure Pharmaceuticals Ltd Finished Pharmaceutical product
Lantech Pharmaceuticals Ltd Active Pharmaceutical Ingredient (API)
Indoco Remedies Ltd Finished Pharmaceutical product
Strides Pharma Science Ltd Finished Pharmaceutical product
Aurobindo Pharma Ltd API
Rxhomeo Pvt Ltd Finished Pharmaceutical product
Glint Cosmetics Pvt Ltd Finished Pharmaceutical product
Centurion Laboratories Pvt Ltd Finished Pharmaceutical product
B. Jain Pharmaceuticals Pvt Ltd Finished Pharmaceutical product
Anicare Pharmaceuticals Pvt Ltd Finished Pharmaceutical product
Jubilant Generics Ltd Finished Pharmaceutical product
Hospira Healthcare India Pvt Ltd Finished Pharmaceutical product
Vipor Chemicals Private Ltd API
Marketing Unapproved medicines Glint Cosmetics Pvt Ltd Finished Pharmaceutical product

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