Wockhardt says Himachal Pradesh drug regulator suspends product
Indian drugmaker Wockhardt Ltd, which has been hit by a slew of overseas regulatory rebukes due to poor production quality, said the regulator in Himachal Pradesh has suspended the manufacture and sale of a product.
The state's drug controller suspended the manufacture, sale or distribution of fixed dose combination of Dicyclomine Hydrochloride IP 10mg, Tramadol Hydrochloride IP 50mg and Acetamenophen IP 325mg, the company said in a statement on Wednesday.
Wockhardt did not give the reason for the suspension.
But Navneet Marwah, Himachal Pradesh's drug regulator, told Reuters that some of the chemicals which the company used in making a painkiller sold under the brandname of Spasmo Proxyvon Plus have been banned by the Indian government.
"We got some complaints from the consumers and acted on that," Marwah said. He said the state regulator has sent a report to the federal drug regulator and the suspension will remain in force until a decision by the federal agency.
Wockhardt said the product contributed less than 3 percent of the consolidated sales of the company in the financial year that ended on March 31. The company will appeal to the state government to revoke the suspension, it said.
Wockhardt has been barred from exporting drugs from some of its plants in India to the United States, its largest market, and Britain, in the last one year due to poor manufacturing quality.
Copyright: Thomson Reuters 2014
