M A I N   N E W S

Indian drugmakers will have to bear higher costs in US

India is the second largest drug exporter to the US, according to the Food and Drug Administration (FDA). Indian drugmakers mostly specialise in manufacturing of generic versions of innovative drugs at a fraction of cost after their patent expiry and are estimated to command 10 per cent share in the $30-billion US generic drug market.

The US regulations require the companies to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.

However, the FDA’s proposed hike in fees for generic drugmakers is expected to push up the overall costs for companies from India and other countries, including the US itself.

The FDA said it was aware that industry was adjusting to the new requirements and fees, and it has minimised the increase in fees “as much as possible”. The increased fees have been published in the Federal Register, the official journal of the US government, are would be effective from October 1, 2013. The fees would be reviewed after a year.

The new Abbreviated New Drug Application (ANDA) fee has been fixed at $63,860, which is around 24 per cent higher than the existing $51,520.