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

[Kaytee Riek]

<snip> (last two paragraphs)

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.

--

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.
--
Kaytee Riek
Grassroots Organizer
Health GAP (Global Access Project)
office: 215-397-4326
mobile: 267-334-6984
kaytee@healthgap.org
www.healthgap.org
www.pepfar2.org