Bad news just keeps raining down on Ranbaxy Laboratories. The Indian generics maker thought it had finally left its problems with U.S. regulators behind after its felony pleas and $500 million penalty payment, but that action has ignited a backlash in India that seems to be growing each day. Now the country's largest pharmacy chain says it is suspending sales of all Ranbaxy drugs.
Shobana Kamineni, executive director of Apollo Hospitals, told the Business Standard that its medical committee decided to temporarily halt sales at its 1,500 pharmacies and it has asked Ranbaxy to document the safety of its drugs. She said the group decided that "as a cautionary measure, we should temporarily suspend sale of Ranbaxy medicines, as we cannot take a chance with patients' safety." Ranbaxy officials told the newspaper it has met with the group and that Apollo is supportive, and it pointed out its drugs are still being supplied in Apollo's hospitals.
Some hospitals, however, have stopped using Ranbaxy drugs, or are considering it. A leading Mumbai medical center, Jaslok Hospital, recently posted a notice asking doctors to quit using Ranbaxy products.
But that is just one element of the troubles that have sprung up for the drugmaker in its home country. This week, an Indian lawyer a filed a public interest litigation (PIL) lawsuit asking India's Supreme Court to shut down the two manufacturing plants named in the felony plea agreement Ranbaxy Laboratories entered with U.S. authorities last month. It seeks a probe of the U.S. charges, as well as of company executives and Indian regulators. The lawsuit pointed out that Ranbaxy drugs banned by the U.S. as a result of the regulatory actions continued to be sold in the Indian market.
Last month, Ranbaxy pleaded guilty to charges that it manufactured and sold the U.S. adulterated drugs and then lied and covered up the shortcomings. But the problems were first uncovered 5 years ago, and there have been recalls and FDA actions since 2008. Last year, the company signed a 5-year consent decree that set up strict oversight by independent auditors who can report directly to the FDA. But it's as if it was not until Ranbaxy publicly acknowledged its crimes in the plea action last month that the public in India took it seriously. Now, after Ranbaxy has made substantial investments toward quality, it is finding that Indians are uncertain about using its products. Ranbaxy has several times assured the public that its drugs are the safest they have been, and it is providing the pharmacy group with what it wants to qualify that. Apollo's Kamineni told the Business Standard that once its medical committee is satisfied the drugs are safe, it will resume sales.
- read the Business Standard story