www.expressindia.com - Weather | Horoscope | Stocks | RSS
expressindia web city
HomeBlogsCricketAstrologyShopping TendersClassifieds Opinions Hotels
Sign In / Register | Archive
Expressindia » Story

Ranbaxy plant falsified data: FDA

Font Size

Reuters

Posted: Feb 26, 2009 at 0915 hrs IST

Washington A plant owned by generic drugmaker Ranbaxy Laboratories falsified data and test results in approved and pending drug applications, US regulators said on Wednesday.

The Food and Drug Administration said it halted reviews of drug applications from Ranbaxy's Paonta Sahib plant in India.

Agency officials said they had not identified any health risks from Ranbaxy drugs on the market but were continuing to investigate products associated with the plant.

"The FDA's investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications," said Deborah Autor, director of compliance in the agency's drug center.

The action "has limited significance for US marketed products" because the FDA banned imports from the facility in September due to manufacturing problems, Autor said.

Patients should not stop taking Ranbaxy drugs but should consult a doctor if they are concerned, FDA officials said.

A Ranbaxy official had no immediate comment.

The FDA said it had asked Ranbaxy to help resolve questions of data integrity and reliability for drugs made at the plant or some that were backed by data from the site. Plans for correcting the problem should include a third-party audit of drug applications linked to the plant, the FDA said.

In September, the FDA banned more than 30 generic drugs from entering the United States that were made at Ranbaxy plants inPaonta Sahib and Dewas, India. The drugs included cholesterol-lowering drugs, AIDS medications and antibiotics.

Japanese drugmaker Daiichi Sankyo holds a controlling stake in Ranbaxy.

Discuss this story on expressindia forums
Post Comments
Name* Email ID*
Subject* Country*
Message*
Characters remaining
 
TERMS OF USE: The views, opinions and comments posted are your, and are not endorsed by this website. You shall be solely responsible for the comment posted here. The website reserves the right to delete, reject, or otherwise remove any views, opinions and comments posted or part thereof. You shall ensure that the comment is not inflammatory, abusive, derogatory, defamatory &/or obscene, or contain pornographic matter and/or does not constitute hate mail, or violate privacy of any person (s) or breach confidentiality or otherwise is illegal, immoral or contrary to public policy. Nor should it contain anything infringing copyright &/or intellectual property rights of any person(s).
I agree to the terms of use.

Latest News

Business

Showbiz

Sports

India can't quiz Headley, Rana in US: NSA Jones

‘Peeved’ Smita Thackeray on her way to join Cong

Cornered Zardari hands over Nuke control to Pak PM Gilani

Emission cuts: Share the burden around, suggests Manmohan

Again, India votes against Iran’s nuclear programme

Suicide attacks a curse for Muslims: Saudi Grand Mufti

Action against 26/11 attackers key to reducing Indo-Pak tension: Brown

More
Featured Services
© 2009 The Indian Express Limited. All rights reserved
The Indian Express Group | Advertise With Us | Privacy Policy | Feedback | Work With Us | Site Map