The FDA placed an import ban on products from Ranbaxy Laboratories' active pharmaceutical plant in Toansa, India, in January, calling into question its drug analysis and sanitation. But there are other problems at the plant, like worker safety, that the FDA does not address and which get little attention from Indian authorities, a report by Bloomberg has found.
The news service said one employee was left partially paralyzed by a blast at the plant in August, and then in October, a worker that filled in for another employee on break was found dead. Workers told police the contract worker was handling chemicals and died from inhaling poisonous gas. Ranbaxy disputes that, saying there was no gas in the area where the death occurred and that the worker was wearing protective gear. The company said the 28-year-old man died from cardiac arrest. Five months later, authorities say they don't have the test results that should confirm the cause of the death.
The labor department did a preliminary investigation into the August explosion and injury, which Bloomberg reports determined workers and supervisors were not sufficiently trained. The agency ordered the company to do a better job of training. A recruiter that provides contract employees to Ranbaxy told Bloomberg that workers must train for about 6 weeks before they can handle chemicals. But two former employees said they received only three or four days of training before being asked to handle solvents and packing finished products.
For more than 5 years, the FDA has been finding issues at Ranbaxy's Indian plants. All four of its FDA-approved plants there have now been banned from shipping to the U.S. The latest inspection was in January. Workers in Toansa told Bloomberg that Ranbaxy plant officials were caught off guard, as they were expecting an FDA inspection in February. Employees said Ranbaxy was in the midst of fixing things at the plant in preparation for the February visit, including in the analytics lab. The FDA inspector found broken windows and reported there were so many flies in the lab that it was not possible to get an accurate count. More importantly, the FDA cited Ranbaxy for retesting APIs until workers got the results that were needed for the ingredients to pass and then deleting the failed results from computers.
Almost immediately after the inspection, the FDA banned the Toansa plant, but it was not the first ban on a Ranbaxy facility. The agency banned a manufacturing plant in Mohali in September for a long list of issues, while two others have been banned for about 5 years after a whistleblower told U.S. authorities that workers there were faking data that was then used to get drug approvals. In May 2013, the company paid $500 million and pleaded guilty to a number of criminal charges to resolve that case. Ranbaxy executives have pledged to fix the problems at all of the plants and say they are committed to quality. Japan's Daiichi Sankyo, which owns controlling interest in the generics maker, has also pledged changes to resolve all of the issues.
During a recent visit to India, FDA Commissioner Margaret Hamburg said most of the drugmakers in India that supply the U.S. run quality operations and have been tainted by those that do not. Bloomberg was told that most of India's drug plants that produce so many of the generics for the U.S. are often in rural areas and become essential to their economies, providing jobs for people with limited education. Despite any safety concerns, young people are anxious to work at the Toansa facility because it's better than other jobs available to many, Bloomberg was told by a village official. Ranbaxy is covering the cost of medical care for the injured worker, and the family of the dead contractor is asking for a settlement that would guarantee a job at the plant for his younger brother."You couldn't find a single man who's unemployed in this village because of this factory," Krishan Kumar, chief of Toansa's village council, told Bloomberg. "Even people who've only passed fifth grade, they got jobs."
- here's the Bloomberg report