Wockhardt's plant may soon get out of regulatory woes

Wockhardt Ltd, which denied stake-sale rumours on Friday following an unusual spurt in its stock price, is in the final stages of receiving much-awaited regulatory approvals for its Chikalthana unit in Maharashtra.

The UK drug regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), has confirmed that it would inspect the plant between September 1 and 5.
"This is the third inspection by MHRA, and we have already attended to the last few observations. We hope to get their approval soon after the inspection. After MHRA's nod, we are hopeful of US Food and Drug Administration's approval," a senior company official said.

"Soon after we filed a compliance report last month, US FDA had told us that they would come for an inspection on June 16. But they are yet to visit us," he said.
When contacted by dna regarding possible audits, FDA spokesperson Christopher Kelly said, "The Wockhardt facilities that were placed on import alert in 2013 remain on import alert and under investigation. FDA, as a policy, does not discuss ongoing investigations."

On Friday, after the market speculation that a US-based pharma giant is buying out the domestic business of Wockhardt sent the stock price up over 14%, the company chairman Habil Khorakiwala shot an email to all employees denying any stake sale in the offing.

"The domestic business is integral to the company's overall growth plans, and will continue with Wockhardt," he wrote.

But rumours have refused to die down at the Mumbai headquarters of the Indian generic drugmaker. "The speculation has been rife following frequent visits to the US by the chairman and managing director, recently. In the past, the company was in denial mode even when it sold its hospital business to Fortis Healthcare, and then the nutrition business to French major Danone. Previously, Wockhardt had agreed on a deal with Abbott Laboratories in 2009, though aborted later," said an official.

Deal or no deal, Wockhardt is attempting everything possible to seek approvals from both US FDA and MHRA and win back its lost markets in the US and Europe.
"Our chairman's hopes lie on the state-of-the-art Shendra plant in Aurangabad, near the existing plants at Waluj. For Shendra, we filed for regulatory approvals for injectables and tablets more than a year ago. US FDA said they would audit Shendra only after our mother plant at Chikalthana and the other two plants at Waluj get their approvals," said the official.
"At present, Shendra's production is insignificant, and caters to a small market in Ireland."

Last November, the US FDA put an import alert on drugs manufactured in the Chikalthana unit. While five products were excluded from the ban, the lucrative Metoprolol was placed under a ban. The US still buys two products from Chikalthana and two from Waluj plants. MHRA, too, had issued a drug recall from this plant, but still buys three products from there. The UK regulator also took away the good manufacturing practice certificate from the Chikalthana unit, drilling a big hole in Wockhardt's revenues.

The company, which underwent a series of change at the management and top executive level, faces a tough phase. As reported by dna, it had reshuffled senior management and recruited more than 200 fresh hands to strengthen key departments. "The biggest challenge for Wockhardt today is the integration of HR cultures. Making the people who have joined from Ranbaxy Lab, Intas Pharma, Dr Reddy's Lab and others, think coherently and as team is the biggest HR challenge," said the official.

Wockhardt officials had told dna that the company has brought in a complete change in production and quality departments of two plants in Waluj (cephalosporin plant and Biotech Park) and Chikalthana.