UK regulator's import alert on Wockhardt

According to the chairman, there will be an annual loss of Rs 100 crore due to the MHRA alert on Waluj plant

Following the import alert issued by the US FDA, another global medical regulator, UK medicines and Healthcare Products Regulatory Agency (MHRA), has imposed an alert on Wockhardt's export-oriented unit in Aurangabad.

According to Habil Khorakiwala, chairman, Wockhardt Ltd, there will be annual loss of Rs 100 crore (Rs 1 billion) due to the MHRA alert on Waluj plant. In May, US FDA had made an import alert on Waluj plant, causing annual loss of $100 million (Rs 600 crore).

The company has plans to restore manufacturing within six to nine months by shifting production elsewhere. “We plan to move 80 per cent of production of the injectables from Waluj plant to a nearby facility,” Khorakiwala had said in May.

Import alert was made due to certain deviations from its quality manufacturing norms at the company's plant at Waluj. An import alert results in detention without physical examination of drugs from firms that have not met so-called good manufacturing practices, according to US FDA.

In April, the company had said that the FDA has carried out an inspection at its EOU Injectable units in Aurangabad and has issued 483s. A form 483 is issued when FDA inspectors believe the facility has violated the US rules.