Indian Pharma Firms Receive 34% Of FDA Warnings This Year

New Delhi, 21 Aug 2019:

Indian pharmaceutical companies received a third of the warnings the United States Food and Drug Administration (FDA) issued for misbranding, selling unapproved medicines and violating Current Good Management Practices (CGMP) so far this year.

The FDA issued 38 warnings to pharmaceutical companies in 2019 (as of August 21) and of these, 13 (34 per cent) were to Indian companies including major players like Emcure Pharmaceuticals Ltd and Aurobindo Pharma Ltd, according to FDA records. Pharma companies in the US received most of these warnings — 15. 

According to section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) violations of CGMP by a drug manufacturer can result in its product being categorised as adulterated. Management oversight, non-conformity to standards, batch failures, contamination are some of the constituents of CGMP violations.

The reason for such high number of warning letters to India is the relatively higher number of inspections done in the country, Sudarshan Jain, general secretary, Indian Pharmaceutical Alliance, told Down To Earth.

“India is the biggest exporter to the US market,” Jain added while giving a reason for the high number of inspections. But, according to United States International Trade Commission data, India is the fourth largest exporter of pharmaceutical products to USA.

When asked again, he said, “India ranked second in terms of volume (59 million kilogramme) in 2015, according to US Department of Commerce. This website has changed format and does not provide volume data anymore.” Down To Earth Magazine