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

e-drug
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E-DRUG: Indian pharmas to be hit as US hikes fee
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http://www.deccanherald.com/content/350619/indian-pharmas-hit-us-hikes.html
DECCAN HERALD
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 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.

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

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E-DRUG: Indian pharmas to be hit as US hikes fee (2)
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Hi,
This effort to earn more money from generic medicines in US is not in favor of its populations. The increased fee will add to the selling price and make generics costly. Finally it will be the US populations which will pay more to keep fit and maintain their health. What does US want- more revenue from generic medicines or more affordable and accessible generics?

Copy to: President's office, White House, USA
Dr Vijay Thawani
Ex-Professor Pharmacology, India
"Vijay Thawani" <vijaythawani@rediffmail.com>

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E-DRUG: Indian pharmas to be hit as US hikes fee (3)
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Dear All

I think that the adverse reactions to the FDA price increases are not
providing sufficient insight to the process and justification for the
fee increases - to review applications faster, have more inspections of
foreign manufacturing sites and the like. Given the volume of dosage
units to be sold, any price increase to the consumer is likely to be
small and not greatly impact on their affordability of the medicines.
The increased fees are retained by the FDA to fund their work and if
they are to hire more staff or make more site visits they need to raise
more money (whether this is a good model for funding of a regulatory
agency is another issue). The following article from the Medical Daily
(copied as Fair Use) provides some more perspective on this.

Regards
--
Douglas Ball
Pharmaceutical consultant, The Philippines
Douglas Ball <dr.douglasball@yahoo.co.uk>