Taking steps to firm up manufacturing processes: Wockhardt

Lapses at operative as well as supervisory levels at Wockhardt's Waluj plant resulted in action by the Food and Drug Administration (FDA) but the company has taken a number of steps including hiring of international consultants to rectify the issues, the drug major has said.

"Evidently, it is a case of oversight and deviation from set processes at an operative and supervisory level at the facility in question," Habil Khorakiwala, founder chairman and group CEO of Wockhardt Ltd, told shareholders at the company's 14th annual general meeting (AGM) earlier this month.

Admittedly, it is an inexcusable lapse but the company has taken swift and definitive action, both corrective and pre-emptive, he added.

"These measures will ensure that the operative people in the organisation do not deviate from following the systems and processes laid down."

In July, the Mumbai-based firm had received a warning letter from the US drug regulator over its facility at Waluj in Maharashtra for not meeting manufacturing norms.

The company had earlier in May announced that the FDA had issued an import alert on its Waluj facility, which makes injectables and solid dosages. According to the company's estimates, the import alert issued by the FDA could impact the company's business by $100 million.

UK drug regulator, Medicines and Healthcare products Regulatory Agency (MHRA) had also pulled up the firm for manufacturing shortcomings.

Outlining the initiatives being taken up by the company to firm up the manufacturing process, Mr Khorakiwala said Wockhardt has appointed a new head of quality reporting directly to the managing director.

"Secondly, we are working with several international consultants and advisors to establish processes enabling a robust system of compliance that will meet all regulatory norms and requirements," he added.

He further said the company is leveraging technology to lay down a system of checks and balances to ensure that operative personnel strictly follow and maintain established processes and protocols mandated.

"We are deploying enterprise-wide software that will streamline the entire quality and compliance system across all our manufacturing facilities," Mr Khorakiwala said.

Wockhardt is initiating, both internally and externally, a comprehensive compliance training programme for all personnel responsible for manufacturing and quality control, he said.

"We are going all out to resolve this issue at the earliest. While these unfortunate events are a setback in the short term, I believe that a long-term perspective will reveal the exciting time that your company can look forward to in the future," he added.

He said Wockhardt has facilities in various countries and all adhere to current good manufacturing practice norms and have also been regularly inspected for over ten years and have always been found to be fully compliant.

"The unfortunate observations against one manufacturing facility, have been a complete surprise," he added.