The efforts of Indian drug makers to satisfy the ever increasing stringent manufacturing benchmarks of the United States Food and Drug Administration (USFDA) have started yielding results.
In 2018, India, which has the largest number of US regulator approved pharmaceutical plants outside the US, got only 15 warning letters (warning to stop production if shortcomings are not sorted out within a specified period), lower than 19 for US companies and 24 for Chinese companies. In 2015, India had topped the list with nine warning letters and almost all leading drug companies exporting to the US had to face manufacturing standard issues with their plants.
Since then, awareness has increased among Indian manufacturers on improving quality standards and most companies are working with global consultants for upgrading manufacturing and data standards.
India accounted for 43 per cent of new generic drug approvals in the US in 2018. The $60 billion-plus US generic market is the largest in the world.
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