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[e-drug] Indian pharmas to be hit as US hikes fee

E-DRUG: Indian pharmas to be hit as US hikes fee

Indian pharmas to be hit as US hikes fee
Washington, Aug 11,
2013, PTI:

Many Indian drug makers 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 

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.

Dr Gopal Dabade,
57, Tejaswinagar,
Dharwad 580 002
Dr Gopal Dabade <dabadedr@yahoo.com>
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