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# Indian Pharmas Receive 33% of WLs This Year: Analysis
- URL: https://www.fdaweb.com/indian-pharmas-receive-33-of-wls-this-year-analysis/
- Published: 2019-08-22T12:00:00.000Z
- Updated: 2026-09-15T01:45:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144835

Indian drug companies received one-third (13) of the 38 FDA Warning Letters issued as of 8/21, according to an analysis by the print and online environmental publication [*Down to Earth*](https://www.downtoearth.org.in/news/health/indian-pharma-firms-receive-34-of-fda-warnings-this-year-66270?ref=fdaweb.com). U.S. companies received 15 of the letters.

“The reason for such high number of Warning Letters to India is the relatively higher number of inspections done in the country,” Indian Pharmaceutical Alliance general secretary **Sudarshan Jain** told *Down to Earth*.

Seven of the 13 companies were cited for having inefficient quality control units. The three of the companies that manufacture active pharmaceutical ingredients were cited for management oversight with respect to contamination. Three companies did not maintain laboratory records properly, and two did not have proper control to ensure that only authorized personnel instituted changes in master production and control records. Issues with cleaning and maintaining equipment were reported for three of the companies.