Growing Worries

Indian pharmaceutical and healthcare companies are on the defensive. Our special report takes you through the headwinds they are facing and how they are reworking the way they make and market medicines.

- E. Kumar Sharma

The India pharmaceutical industry is incredible in more ways than one. On the one hand, it takes pride in the fact that India is home to the largest number of drug-making facilities outside the US that are approved by the US Food and Drug Administration (USFDA) – over 600 of them. And in the fact that Indian companies lead in the number of applications for generic drug approvals – Abbreviated New Drug Applications (ANDAs) – in the US. About 40 per cent of the generics supplied to the US, by volume, come from India. On the other hand, the number of Indian companies getting pulled up by the USFDA for noncompliance with good manufacturing practices is rising. One reason is the increasing dominance of Indian companies. India and China lead in the number of warning letters issued, outside the US, by the USFDA.