India's new drug nods from US dip in Q1 due to increased scrutiny on firms

The first quarter (Q1) of the financial year (2019-20, or FY20) saw a 28 per cent drop in abbreviated new drug applications (ANDAs) received by Indian pharma firms to 111 approvals, compared to 155 in the previous quarter. Analysts feel this may be a fallout of the stringent regulatory action of the US drug regulator on Indian manufacturing sites since January. 

India’s share of ANDA approvals given by the US Food and Drug Administration (USFDA), too, has fallen from 43 per cent in fourth quarter (Q4) of 2018-19 (FY19) to 33 per cent in Q1FY20. 

Krishnanath Munde of Reliance Securities,