Regulatory defaults unfortunate but inexcusable: Wockhardt

Chairman of the drug firm Wockhardt, which has been struggling with quality issues at two of its manufacturing plants, says the company has already responded to USFDA's Form 483 observations on its Chikalthana Plant and is awaiting the regulator’s response, reports CNBC-TV18's Archana Shukla. 

In July 2013, USFDA had made observations on company’s manufacturing compliances at the Chikalthana facility, the second facility to come under the regulators scanner.

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The company’s injectible facility in Waluj is under an import ban from the US and the UK drug regulator since May 2013. And the company says it is seeking a meeting with the USFDA & UK regulator MHRA to discuss progress. 

Habil Khorakiwala, addressing the company’s shareholders at the AGM said the company has put corrective and pre-emptive steps in place to resolve the issues. “The regulatory defaults were unfortunate but inexcusable,” he said.

The company now has a new Head of Quality. The drug firm has appointed global advisors and consultants to help adhere to GMP practices and has initiated internal & external compliances training programs. These processes would expand to cover not only the affected sites but all of Wockhardt's manufacturing units, he said. “We are not looking at these as one plant problem but want to make systems integrated and quality systems common across manufacturing plants,” Khorakiwala said.

The company is now shifting all new drug filings to its new facility in Shendra, Maharashtra, which is expecting USFDA inspections in October this year. But on plans of shifting existing products from Waluj to its Chikalthana plant, the company says it is revisiting those plans owing to the USFDA’s Form 483.

However, Khorakiwala said that in recent inspection by the Indian drug regulator, both its Waluj & Chikalthana plants were cleared for Indian supplies. “The inspectors did not find any major issue and since they did not ask us to stop supplies I believe all is correct there.”