Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

McKinsey & Company's senior partner Vikas Bhadoria, in this second instalment of a wide-ranging interview with Scrip, talks about 'smart quality', the compliance trajectory of Indian firms and also measures by Korea and China to accelerate biosimilar development and innovation.

Could more Indian firms consider re-aligning their US business amid heightened pricing and compliance pressures that have cast a shadow on the long-term viability of the generics segment? A cross section of experts including a senior executive at McKinsey & Co share their views on what to expect.