Indian drugmaker Ranbaxy faces new US regulation woes (Update 2)

September 16, 2013 by Salil Panchal

Shares in Indian generic drugs giant Ranbaxy Laboratories crashed by as much as 35 percent on Monday after the US Food and Drug Administration suspended imports from one of its factories.

The FDA issued an alert on Friday against the factory at Mohali in the northern state of Punjab, spelling more bad news for Ranbaxy which is struggling to live down a nearly decade-long history of US-led regulatory action.

Ranbaxy, one of the world's biggest generic drugs makers, slid 34.99 percent to a day's low of 297.25 rupees on the Bombay Stock Exchange in early trading.

By the end of the day, some brokerage firms had downgraded the stock, citing concerns over the future of the Mohali plant. Shares closed down 30.27 percent at 318.85 rupees.

A spokesman for Ranbaxy, which was bought by Japan's Daiichi Sankyo group in 2008, said "the company has so far not received any communication from the US FDA" and it was seeking information.

The FDA website did not explain the reasons for the "import alert".

In May Ranbaxy pleaded guilty to US charges of selling adulterated antibiotic, acne, epilepsy and other drugs and agreed to a record $500 million fine. The episode was a huge blow to its image.

The US fraud, uncovered over eight years, was exposed by a whistle-blowing ex-employee who said Ranbaxy created "a complicated trail of falsified records and dangerous manufacturing practices".

Ranbaxy imported adulterated batches of drugs made in its Paonta Sahib facility near the Indian city of Chandigarh, which FDA inspectors said had poor record-keeping and inadequate testing for the stability of the drugs over time.

The company also admitted making false and fraudulent statements to the FDA in 2006-2007 about stability tests on several other export drugs.

The Paonta Sahib facility and another at Dewas in central India were blacklisted from producing drugs for the US market.

Ranbaxy is not alone in facing scrutiny from global regulators because of problems at its factories.

In July Britain's healthcare regulator recalled 16 drugs from Indian pharmaceutical firm Wockhardt after finding deficiencies at one of its plants in western India.

"The import alert could be a huge setback for Ranbaxy Labs," said Sarabjit Nangra, pharma analyst with Mumbai's Angel Broking, adding that import alerts can take months to resolve.

Ranbaxy will for now have to rely on its New Jersey-based Ohm Labs to service all its US business, Nangra said.

Sriram Rathi of Anand Rathi Research, which downgraded the Ranbaxy stock from a "buy" to "sell" rating after the alert, said there could also be delays in new product launches.

The US is the world's biggest drugs market and accounts for about 40 per cent of Ranbaxy's revenues.

India's government has been forced to defend the country's lucrative generic drug industry, which accounts for nearly $15 billion in annual exports.

The country has built a reputation as the "pharmacy to the world" for its production of life-saving generic versions of medicines for poor nations that cost a fraction of those with brand names.

Explore further: India says its drugs safe after generics fraud

Related Stories

India says its drugs safe after generics fraud

June 3, 2013
India, known as the "pharmacy to the world", Monday defended its lucrative generic drug industry as safe and strongly regulated after the nation's biggest drug firm pleaded guilty to US charges of making adulterated medicines.

More pain for Japan's Daiichi hit by Ranbaxy fraud

June 9, 2013
Daiichi Sankyo believed it had scored a coup in 2008 when it outbid rivals to buy Indian generics giant Ranbaxy for $4.6 billion but its foray into the high-growth copycat drugs arena has brought the Japanese drugmaker only ...

Ranbaxy recalls generic Lipitor doses

November 23, 2012
(AP)—Ranbaxy Pharmaceuticals Inc. has recalled dozens of lots of its generic version of cholesterol drug Lipitor because some may contain tiny glass particles, the latest in a string of manufacturing deficiencies that once ...

Drug manufacturer agrees to $500 million penalty (Update)

May 13, 2013
A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown ...

US approves India's Ranbaxy to make generic Lipitor

December 1, 2011
Indian pharmaceutical giant Ranbaxy won US regulatory approval to make the first generic version of cholesterol lowering drug Lipitor, a Pfizer product whose patent expired Wednesday.

Drugmaker Ranbaxy halts generic Lipitor production

November 30, 2012
Problem-plagued Ranbaxy Pharmaceuticals Inc. has halted production of generic cholesterol drug Lipitor while it investigates how tiny glass particles got into the ingredients used for dozens of batches of the drug that were ...

Recommended for you

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

Price tag on gene therapy for rare form of blindness: $850K

January 3, 2018
A first-of-its kind genetic treatment for blindness will cost $850,000 per patient, making it one of the most expensive medicines in the world and raising questions about the affordability of a coming wave of similar gene-targeting ...

Restasis: Why US consumers paid billions for drug deemed ineffective in other countries

January 2, 2018
Why are Americans, both as patients and taxpayers, paying billions of dollars for a drug whose efficacy is so questionable that it's not approved in the European Union, Australia or New Zealand? Restasis, a blockbuster drug ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.