India’s Drug Approvals Near Record Despite FDA Inspection Blitz
- Smaller companies lead the way as regulator slows larger ones
- As companies resolve FDA issues Indian approvals may surge
An employee, left, arranges labeled vaccine vials into a box as they exit a machine in the labeling unit at the Serum Institute of India Ltd. pharmaceutical plant in Pune, Maharashtra, India, on Monday, May 4, 2015. Serum, Asia's largest vaccine maker, will look at a possible merger with generic drugmaker Cipla Ltd. if the European venture between the two companies succeeds.
Photographer: Sanjit Das/BloombergThe U.S. Food and Drug Administration has become something of a bogeyman for India’s stock market.
An inspection blitz on Indian drug factories that supply to the U.S. helped push the broader index of Indian health-care stocks down by as much as 20 percent earlier this year from its all-time high in 2015 after some top firms received warning letters for failing to meet the regulator’s standards.