USA FDA bans dozens of Ranbaxy-made generic drugs

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FDA bans dozens of Ranbaxy-made generic drugs

Heavey, Reuters Published: Tuesday, September 16, 2008

WASHINGTON (Reuters) - Health officials have banned dozens of drugs

made by Ranbaxy Laboratories Ltd after the generic drugmaker failed

to fix numerous record-keeping and other operational problems,

although the medications themselves are considered safe.

The U.S. Food and Drug Administration said on Tuesday it would block

more than 30 generic drugs from entering the United States following

ongoing procedural violations in manufacturing at Ranbaxy's Dewas and

Paonta Sahib plants in India.

It also will not approve any new drugs made at the plants until the

problems are resolved, the FDA said.

The violations concerned the manufacturing process and not the drugs

themselves, the agency added, urging patients not to stop taking any

medications and to talk to their doctors.

A sampling of products made at the two plants showed no concerns,

they added.

" This is a preventive action taken to protect the quality of the

drugs used each day by millions of Americans by ensuring that the

process used to make the drugs adheres to the FDA standards for

quality manufacturing, " said Throckmorton, deputy director

for the FDA's Center for Drug Evaluation and research (CDER).

The move is the latest blow against India's leading drugmaker, which

is also the subject of a separate criminal probe by the U.S. Justice

Department for allegedly bringing adulterated and misbranded

medications into the United States.

Representatives for Ranbaxy, which has agreed to a takeover by

Japan's Daiichi Sankyo Co Ltd, did not respond to requests for

comment.

The import ban affects numerous, widely-used medications, including

generic versions of Merck's cholesterol-lowering drug, Zocor, also

known as simvastatin, as well as several AIDS medications.

Other affected drugs include the antibiotic ciprofloxacin, diabetes

therapy metformin, cholesterol medicine pravastatin, and the over-the-

counter version of allergy drug loratadine.

One acquired immunodeficiency syndrome (AIDS) drug -- ganciclovir --

would be exempt from the ban because of an ongoing shortage, the FDA

said.

Despite the ban, agency officials said that consumers should not be

affected and that drug shortages were unlikely.

The FDA earlier warned Ranbaxy in June 2006 and have since been

trying to resolve the problems with the company, which still has not

cleaned up its process, it said.

" Ultimately, the deficiencies in the process have reached the level

where we think an import alert is justified, " FDA's Deborah Autor,

director of CDER's Office of Compliance, said.

In two separate letters to Ranbaxy, FDA officials found numerous

instances of lax written records that are supposed to keep track of

equipment cleaning, production controls, and product quality.

FDA inspectors, who most recently searched the plants between January

and March 2008, also cited problems with factory workers who did not

keep some antibiotics properly contained.

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