US suspends imports from Ranbaxy’s Mohali plant
Tuesday, 17/09/2013
http://paper.hindustantimes.com/epaper/viewer.aspx
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 at its Paonta Sahib facility in Himachal Pradesh, 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 20062007 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 health care 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 could take months to resolve. Ranbaxy, for now, would have to rely on its New Jerseybased 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% 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.
