It's been no secret for years that India's Ranbaxy Laboratories did some bad stuff. Its entanglements with the FDA and federal authorities for foisting adulterated drugs on consumers and then lying to cover it up has been an escalating story since 2008. But its felony pleas and $500 million settlement two weeks ago are serving up more consumer-level backlash than in any of the 5 years since the matter first surfaced.
Hospitals in India are being asked by patients to switch them from Ranbaxy drugs. Authorities in India are getting heat about needing to react to the U.S. action, while the FDA itself is being criticized for the fact that it was led to Ranbaxy's problems by a whistleblower.
A leading Mumbai medical center, Jaslok Hospital, posted a notice asking doctors to quit using Ranbaxy products, and other hospitals are considering doing the same, according to the Business Standard. "I have received around a dozen queries from patients recently. They want to check if there is any alternative to Ranbaxy medicines that they are taking currently," Naresh Trehan, managing director of Medanta Medicity Hospital, told the publication. He said the provider would review what its response should be, as did the head of another Indian hospital.
A Ranbaxy spokesperson told FiercePharma in an email that, "One hospital in India has asked for some clarifications, and we will be providing same to them. At the same time, all Ranbaxy products currently in the Indian and global markets are safe and effective, and we remain focused on our philosophy of 'Quality and Patients First'."
The biggest names in Big Pharma have paid out huge settlements with U.S. authorities for pushing drugs off label, even for poor manufacturing, without generating the same kind of uproar. In 2010, GlaxoSmithKline ($GSK) paid $750 million to settle charges tied to a Puerto Rico plant and was accused of such problems as using tainted water to mix products. But no doctors or hospitals publicly turned their back on GSK drugs.
But something about this case is sparking outrage. Authorities in India have been queried about whether they intend to take any action now that Ranbaxy has pleaded to U.S. federal charges. G.N. Singh, the Drug Controller General of India (DCGI), said last week that India's laws do not require that it act in the face of actions by foreign regulators, but his agency is working on a standard policy for whether and how to respond to safety alerts by foreign regulators. Authorities there looked into the charges the FDA levied against Ranbaxy when they first surfaced 5 years ago, but they never took any action.
Ranbaxy has tried to quell concerns by announcing after the plea agreement that it is a different company with a different culture than the one that was caught making bad products. Ranbaxy CEO Arun Sawhney publicly declared that he stands by every pill the company makes, The Economic Times reported. And he probably can, given that Ranbaxy is in the second year of a stringent 5-year consent decree that requires outside consultants to keep close tabs on Ranbaxy and report back to the FDA.
The Ranbaxy case was one that prompted the FDA to significantly increase its oversight of foreign manufacturers. It now has more inspectors stationed throughout the world and often comes down hard on foreign producers. Just last week, it issued an import ban on another Indian manufacturer, Wockhardt, for all products made at one of its plants. But citing the Ranbaxy case, U.S. Rep. Steve Israel of New York yesterday decided to lambast the FDA for being "asleep at the wheel" in the Ranbaxy matter and urged it to do a better job with foreign oversight.
Editor's Note: This story was updated to include a comment from Ranbaxy about the questions by a hospital.