[Ip-health] WP - FDA Bans Imports of 28 Indian-Made Drugs

[Riaz K Tayob]

So this action seems to be a Production Process Method (PPM) action...

Snip:

...
She added, however, that "all the products that we have tested met
specifications" and that there is "no reason" to consider them hazardous.
...
The Food and Drug Administration said yesterday that it was halting
importation of 28 drugs made by the giant Indian generic drug maker
Ranbaxy Laboratories because of manufacturing deficiencies at two of the
company's plants. ...the FDA's Center for Drug Evaluation and Research,
said there was "no evidence of harm to consumers" from drugs made at the
Dewas and Paonta Sahib plants, both in India. He called theimport ban "a
preventive action."
...
FDA officials said numerous tests of the drugs have found they are not
contaminated, sub-potent or unsafe and urged patients taking the drugs
not to stop.





http://www.washingtonpost.com/wp-dyn/content/article/2008/09/16/AR2008091603

003.html?hpid=topnews

FDA Bans Imports of 28 Indian-Made Drugs Manufacturing Lapses Cited at 2
Plants

By David Brown Washington Post Staff Writer Wednesday, September 17,
2008; A03

The Food and Drug Administration said yesterday that it was halting
importation of 28 drugs made by the giant Indian generic drug maker
Ranbaxy Laboratories because of manufacturing deficiencies at two of the
company's plants.

Douglas Throckmorton, a physician with the FDA's Center for Drug
Evaluation and Research, said there was "no evidence of harm to
consumers" from drugs made at the Dewas and Paonta Sahib plants, both in
India. He called the import ban "a preventive action."

FDA officials said numerous tests of the drugs have found they are not
contaminated, sub-potent or unsafe and urged patients taking the drugs
not to stop.

The drugs on the list include numerous antibiotics and antivirals, as
well as medicines for high cholesterol, diabetes, high blood pressure,
seasonal allergies and acne.

FDA officials said the action is not expected to disrupt availability of
the medicines to U.S. consumers. All but one -- oral capsules of the
antiviral drug ganciclovir -- are made by other companies. Supplies of
that medicine will be allowed in after batch-by-batch testing and
assurances by the company on the manufacturing process.

Ranbaxy is India's biggest pharmaceutical company and one of the 10
biggest producers of generic drugs in the world.

FDA officials walked a delicate line yesterday, stressing the
seriousness of the violations while offering assurances that the risk to
the public is essentially zero.

"We believe this step is warranted because of the seriousness and the
extent of the violations," said Deborah M. Autor, director of the office
of compliance at the Center for Drug Evaluation and Research.

She added, however, that "all the products that we have tested met
specifications" and that there is "no reason" to consider them hazardous.

"The nature of the violations really relates to the [manufacturing]
process," Autor said. "We did not find any defects in the products
themselves."

The FDA inspects the factories of foreign drug companies seeking to sell
products in the United States. Because the plants are on foreign soil,
the agency has no direct regulatory control over them. Its only leverage
is to ban importation of the substances.

The FDA had sent two warning letters, the first in 2006, informing
Ranbaxy management that inspectors had found numerous deviations from
"current good manufacturing process" -- the long list of rules and
standards for producing drugs.

"Since then, we've done a lot of work with the company to correct the
deficiencies," Autor said. But many persisted, she said, so the agency
took the next step.

Among the problems were "inadequate sterile processing operations";
failure to keep certain areas from being contaminated with compounds
that can cause allergic reactions in some people; and inadequate
record-keeping.

The company will not be able to export any of the 28 drugs to the United
States until the deficiencies are fixed. In the interim, the FDA also
will not consider any new drug applications for substances made at the
two plants.

Meanwhile, the Justice Department is investigating allegations that
Ranbaxy submitted fraudulent data to the FDA as part of its application
for approval to sell certain AIDS drugs to organizations funded by the
Bush administration's $15 billion President's Emergency Plan for AIDS
Relief.

One of the drugs on yesterday's list is the antiretroviral AZT.

"We are currently working through the PEPFAR interagency process and
with our technical teams to evaluate the impact of today's FDA
announcement on PEPFAR drug procurement and programming," a program
spokeswoman said yesterday.
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