Wockhardt says U.K. regulatory agency issued GMP certificate to troubled Chikalthana plant

Wockhardt's Chikalthana plant--Courtesy of Wockhardt

Indian drug manufacturer Wockhardt says the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) has cleared its troubled Chikalthana plant by issuing an unrestricted good manufacturing practices (GMP) certificate following recent inspections.

The company, which has been under regulatory pressure both from European and U.S. regulatory agencies for several years, made the announcement in a notification to the Bombay Stock Exchange on Tuesday that said it "received a communication confirming the closure of the inspection and issuance of an unrestricted GMP certificate."

In 2013, the U.K. and other European regulators banned most of the products coming out of the facility after it was found to be faking data. At that time, the U.K. allowed some shipments of products deemed as essential medicines. However, in January the U.K. dialed up its ban to include all active ingredients coming out of Wockhardt's Chikalthana facility. An FDA ban on the plant remains in place.

The MHRA, as did the FDA and other European regulators, found significant lapses at the facility, which manufactures both solid and sterile products. The U.K. agency said records indicating proper procedures had been followed were signed by employees who were not even at the plant. The agency also cited the facility for contamination concerns such as products being stored near asbestos sealed areas, and poor sanitation that could not assure drugs were not being contaminated. Additional problems were uncovered by an MHRA reinspection in November 2013.

That same year, the U.S. and the U.K. also banned products from Wockhardt's Waluj production facility. That resulted in the MHRA insisting Wockhardt recall 16 drugs.

During a reinspection of the Waluj plant earlier this year, the FDA found progress to address problems was lacking. Though specifics of the reinspection haven't been made public, Wockhardt CEO Habil Khorakiwala said the problems were not serious and the company was working on them.

- see the BSE notification