|India's Drug Controller General G.N. Singh--Courtesy of USA-India Chamber of Commerce|
FDA Commissioner Margaret Hamburg, during her trip to India last month, told regulators it was time for them to expect higher standards from their drugmakers and not turn a blind eye to poor manufacturing and unsanitary conditions. In a move that seems to heed that call, state drug regulators in India have taken action against two Wockhardt plants that the U.S. FDA banned months ago.
According to DNA, the State FDA issued "show cause notices" to the company's plants in Waluj and Chikalthana last week and gave Wockhardt a week to respond. "If the drug inspectors find that the plants are not stepping up their compliance level, further action of suspension or cancelation of manufacturing license may be initiated," State FDA Commissioner Mahesh Zagade told the Indian newspaper. "The drugs supplied in the Indian market need to be of excellent quality to attract international business and foreign exchange. Over 40% of the medicines being produced in Indian plants are exported abroad. We need to be wary of faulty practices."
DNA was unable to get a comment from Wockhardt, but it did get a copy of the inspection report. It said inspectors found hallways littered with rodent droppings and live insects. Rusted drums sitting outside one facility contained ingredients used in injectable drugs. One inspector from the team said 5,000 vials of agar gel were in the open, "an ideal breeding ground for the uncontrolled growth of microorganisms, threatening contamination of the atmosphere."
The findings were similar to some of those listed in warning letters the FDA sent to plants it banned from shipping to the U.S. The U.K. has also banned most of the drugs coming out of Wockhardt's plant in Chikalthana. At the Waluj plant, U.S. inspectors reported urine standing on the floor of a bathroom. But it also cited both facilities for falsifying some testing data, linking passed analytic results to batches that had failed tests. It also noted that computers were not secured to prevent workers from changing or deleting unfavorable testing data.
The U.S. FDA has also banned two Ranbaxy Laboratories plants since September, on top of two that were banned more than 5 years ago, for playing loose with the rules. Indian authorities have said they looked over those facilities but found no problems worthy of stopping production and that finished products met Indian requirements. But a lawyer in India has been pushing a public service lawsuit to force an investigation of Ranbaxy for the problems that led it to plead guilty last year in the U.S. to felony charges and pay $500 million in penalties. The Indian Supreme Court agreed last week to examine the complaints.
This all comes just weeks after Hamburg's first trip to India where she met with government and industry leaders. India produces 40% of the generic and over-the-counter drugs used in the U.S., and the FDA is enlarging its staff there to do more inspections and to educate the industry about its expectations. Hamburg returned with promises of more cooperation between the two countries, but she also urged officials to do more to insure drug safety, not only for U.S. consumers but also for consumers in India.
While some officials pledged collaboration, G.N. Singh, the Drug Controller General of India, was less enthusiastic, saying Indian regulators do not have to maintain the same standards as the U.S. when regulating drugmakers' products for the Indian market. "The FDA may regulate its country, but it can't regulate India on how India has to behave or how to deliver," Singh said.
- read the DNA story