[Ip-health] US bans key Indian drug imports

[Anirudh Bhati]

--
[ Picked text/plain from multipart/alternative ]
http://news.bbc.co.uk/2/hi/south_asia/7620287.stm

[image: BBC NEWS]
 US bans key Indian drug imports

* The United States Food and Drug Administration (FDA) says it has banned
the import of more than 30 generic drugs made by Indian drug firm Ranbaxy. =
*

The FDA said the decision was made after it found manufacturing quality
problems at two of Ranbaxy's factories in India.

The import ban affects some popular generic versions of antibiotics and
cholesterol medicines.

Ranbaxy says it is "disappointed" with the decision of US drug authorities.

The FDA said the move would not create any shortages of drugs in the United
States, which could be obtained from other sources.

In July, US prosecutors had alleged that Ranbaxy, India's largest
pharmaceutical company, deliberately lied about the quality of its low-cost
drugs, including those for HIV.

The US Department of Justice wanted the firm to hand over key documents
relating to drug testing procedures.

* 'Baseless' *

Ranbaxy said it was "very disappointed" with the FDA action.

"The company has responded to each concern FDA has raised during the past
two years and had thought progress was being made," the firm said in a
statement issued on Wednesday.

The firm was paid millions of dollars by the US government to provide
low-cost HIV drugs for President Bush's emergency plan for AIDS relief,
which was set up to help AIDS patients in 120 countries around the globe.

Defending the reliability of its drugs, Ranbaxy had said the US Food and
Drugs Administration had tested over 200 random samples of its products and
found them "complying with all the specifications".

In June the Japanese pharmaceutical company Daiichi Sankyo agreed to pay
more than $4bn (=A32bn) for a controlling stake in the firm.

The US government has been investigating Ranbaxy since February 2006 when
the FDA issued a warning letter over what it said were manufacturing
violations found at a Ranbaxy factory in India.

Since then Ranbaxy has been trying to resolve the issue with US regulators.

Last year, US officials seized documents from Ranbaxy's US headquarters in
New Jersey.

In July, Justice Department prosecutors alleged that the company had
systematically lied about the makeup of its generic drugs, which include a
cheaper version of US drug maker Merck's cholesterol pill Zocor.

The FDA will only approve cheaper generic drugs if they can be shown to be
equivalent to the original drug.

US investigators had also alleged that Ranbaxy has used unapproved
ingredients in its drugs.

 Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/south_asia/7620287.stm

Published: 2008/09/17 05:57:52 GMT

(c) BBC MMVIII

--
Yours sincerely,

Anirudh Singh Bhati
Student of Law, Gujarat National Law University,
Gandhinagar, India.

Handphone: +919328712208
Skype: anirudhsbh
Web: http://democrazie.org

"If this email were legal advice, it would be followed by a bill."