FDA Commissioner Margaret Hamburg has urged Indian regulators to set a higher bar for manufacturing quality and then to make sure drugmakers jump it. Some authorities appear to have heeded the call. India's Wockhardt, already in deep trouble with the U.S. and Europe for slacking off on quality, says one of its products has been banned by a state regulator in Himachal Pradesh.
In an announcement to the markets Wednesday, the drugmaker said that the "State Drug Controller, Himachal Pradesh, has suspended the manufacture, sale or distribution" of its fixed-dose combo drug made up of dicyclomine hydrochloride IP 10 mg, tramadol hydrochloride IP 50 mg and acetaminophen IP 325 mg. The company said the drug accounted for 3% of its sales last year and that is was appealing the suspension.
What Wockhardt didn't address was why the regulator banned sales of the drug. The reason was because the agency was tipped off that some of the ingredients the company used to make the painkiller had been banned by the Indian government, Himachal Pradesh state drug regulator Navneet Marwah told Reuters. "We got some complaints from the consumers and acted on that," Marwah said. He added that his office has reported to federal authorities and that the ban would remain in place until they act. Oversight of India's drug manufacturing starts with the federal regulator and then shifts to state oversight after four years.
This is the second report in recent weeks of state officials taking a closer look at Wockhardt facilities. A state regulator issued "show cause notices" to the company's plants in Waluj and Chikalthana, according to the Indian newspaper DNA, the same two plants banned last year by the U.S. State FDA Commissioner Mahesh Zagade told the newspaper that if "inspectors find that the plants are not stepping up their compliance level, further action of suspension or cancelation of manufacturing license may be initiated."
Last year, the FDA banned drugs from those two Wockhardt plants after inspectors found that employees had been manipulating test data to make it appear that failed batches had met test standards. EU regulators have also taken action against the Indian drugmaker. Sanitation was also a problem.
The FDA bans on the Wockhardt plants as well as on plants owned by India's Ranbaxy Laboratories became a source of discussion during Hamburg's trip there in February to meet with government and industry officials. She emphasized that while most of India's drugmakers had facilities and operations that met or exceeded FDA expectations, those that didn't were creating issues for its drug industry, an industry the U.S. relies on for 40% of its generic and over-the-counter products.