USFDA scrutiny of Indian pharma units up three-fold in 6 years

This has led to rise in warnings too; 55% of GMP warnings since 2012 issued to Indian, Chinese cos

US Food and Drug Administration (FDA) inspections at pharmaceutical units in India tripled between 2010 and 2015, says the Indian Pharmaceutical Alliance (IPA).

In 2015, FDA did 204 inspections; in the  first six months of 2016, it made 101 inspections in India, the highest in any country outside the US. Between 2010 and June 2016, inspections were carried out 840 times in India, more than in any other foreign country. 

Changes in FDA policies and pressure from US lawmakers for stricter regulatory oversight, following a number of data integrity issues, is said to have triggered the increase.

India is the