India's federal regulator has ridden to the rescue of generic drugmaker Wockhardt, lifting a ban imposed just four days earlier by state authorities. The drugmaker reported to the markets Monday that it will resume manufacturing the pain product.
"With reference to the earlier announcement dated April 23, 2014, Wockhardt Ltd has now informed BSE that the State Drug Controller, Himachal Pradesh has now revoked the suspension and accordingly the Company will continue to manufacture, sell and distribute the Fixed Dose Combination (FDC) of Dicyclomine Hydrochloride IP 10mg, Tramadol Hydrochloride IP 50mg & Acetamenophen IP 325mg," Wockhardt's announcement stated.
Navneet Marwah, the state regulator in Himachal Pradesh, suspended production last week because of reported concerns about the product from consumers. He then referred the matter to the Drug Controller General of India (DCGI), India's top federal regulator. The DCGI found no problems with the products' safety and efficacy, the state drug regulator told Reuters Monday, so the ban was lifted.
Wockhardt is one of India's drugmakers that have been in deep trouble in the last year with U.S. authorities. The FDA banned drugs from 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 FDA Commissioner Margaret Hamburg's trip to India in February to meet with government and industry officials. She urged regulators there to step up oversight and expectations, which the DCGI indicated would be difficult for India to achieve.