In India, state regulators assume oversight of a drug manufacturing facility about four years after a plant has been approved, a system some have criticized for being inconsistent and ineffective. But Indian state regulators have taken action against two Wockhardt plants that the U.S. FDA banned months ago from shipping products to the U.S.
The State FDA has issued "show cause notices" to the company's plants in Waluj and Chikalthana, according to the Indian newspaper DNA. "If the drug inspectors find that the plants are not stepping up their compliance level, further action of suspension or cancellation of manufacturing license may be initiated," State FDA Commissioner Mahesh Zagade told DNA. "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."
Citing an inspection document, DNA reported that a team of 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 action by Indian authorities comes weeks after U.S. FDA Commissioner Margaret Hamburg visited India to meet with government and industry officials. Quality manufacturing was at the heart of many of the discussions. During her trip last month, Hamburg 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 for the sake of Indian and U.S. consumers.
- read the DNA story