UK health regulator withdraws nod for yet another Wockhardt unit for violations

Written by PTI | New Delhi | Updated: Oct 22 2013, 20:33pm hrs
WockhardtWockhardt shares were today trading at Rs 459 on the BSE, down 4 per cent from its previous close.
UK's health regulator has imposed restrictions on import of medicines made at Wockhardt Ltd's unit at Kadaiya in Nani Daman for violation of norms, the second plant of the firm to face such action in as many weeks.

The Medicines and Healthcare Products Regulatory Agency, UK (UKMHRA) has decided to withdraw the previously issued GMP Certificate to the company's manufacturing facility situated at Kadaiya, Nani Daman, in Daman in Diu, Wockhardt Ltd said in a filing to the BSE.

This is the third plant of the company facing UKMHRA action after its Chikalthana facility in Maharashtra, from where good manufacturing certification was withdrawn last week, and the export-oriented plant at Waluj which came under an import alert in July this year.

The UKMHRA will be issuing a restricted GMP certificate to the site along with a statement of non-compliance for the said site, the filing said.

"The scope of the statement of non-compliance is therefore limited to medicinal products considered non-critical to public health," it added.

Wockhardt said the GMP certificate will be conditioned to permit continued manufacturing and QC testing of 'critical' products in order to avoid market shortage of medically essential products.

The condition will be dependent on "situations where it has been agreed by the national competent authority or EMA (as appropriate) that there is no feasible alternative in the market concerned", it added.

Accordingly, the company will be able to manufacture and supply from the said facility at Kadaiya certain medicinal products critical to public health, Wockhardt said.

The impact of the same on existing business will only be known once the company receives further communication from UKMHRA, Wockhardt said.

The company doesn't manufacture any products for the US market at the Kadaiya unit, it added.

Shares of Wockhardt were today trading at Rs 459.20 in the afternoon trade on the BSE, down 4.08 per cent from its previous close.

Last week, the company had made a similar filing stating UK's health regulator had withdrawn the good manufacturing certification of the company's Chikalthana facility in Maharashtra.

In July this year, UKMHRA had imposed an import alert on Wockhardt's export-oriented plant at Waluj in Maharashtra and issued a precautionary recall for 16 medicines made by the company at the unit.

In May, US Food and Drug Administration (USFDA) had also issued an import alert on the same facility which makes injectables and solid dosages.

Wockhardt had at that time said it had already initiated several corrective actions to resolve the issues at the Waluj plant.