Many Indian drugmakers will soon have to bear higher costs for sale of their products in American markets as the United States health regulator, Food and Drug Administration (FDA) is hiking the fees for generic drugmakers by up to 48 per cent from October.
According to the FDA, India is the second largest drug exporter to the US and Indian drugmakers mostly specialise in manufacturing generic versions of innovative drugs at lesser cost after the expiry of their patent. Indian pharmas 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.
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 is aware that the industry is adjusting to the new requirements and fees and it has minimised the hike in fees “as much as possible”.
The increased fees have been published in the Federal Register, the official journal of the US government.
The proposed hike would be effective from October 1, 2013. The fees would be reviewed after a year.
The latest Abbreviated New Drug Application (ANDA) fee has been fixed at $ 63,860, which is around 24 per cent higher than the existing $ 51,520.
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