Wockhardt gets another slap from UK drug regulator
14 October 2013
In yet another blow for Indian generic drug maker Wockhardt Ltd, the United Kingdom's health regulator has withdrawn its good manufacturing practices certification to the company's Chikalthana facility in Maharashtra.
The withdrawal of the certificate means the Wockhardt's Chikalthana plant - one of its main revenue generators - will no longer be able to supply many products to Britain.
"The company has received a communication from the Medicines and Healthcare Products Regulatory Agency, United Kingdom (UKMHRA), whereby the agency has decided to withdraw the previously issued GMP Certificate to the company's manufacturing facility situated at L1, MIDC, Chikalthana, Aurangabad," Wockhardt said in a filing with the Bombay Stock Exchange.
The UK authority has also said it will ''be issuing a restricted GMP (good manufacturing practice) Certificate to the site along with a statement of non-compliance for the said site."
The impact of the restrictions on existing business will only be known once the company receives further communication from UKMHRA, Wockhardt said.
The Maharashtra facility contributes approximately £12 million from the UK and EU markets to the consolidated annual revenues of the company.
"In order to avoid market shortage of medically essential products, the GMP certificate will be conditioned to permit continued manufacturing and QC testing of 'critical' products in 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," Wockhardt said.
The scope of the statement of non-compliance is therefore limited to medicinal products considered non-critical to public health and hence ''the company shall be able to manufacture and supply from the said facility certain products critical to public health'', it added.
Wockhardt is rivalling its Indian competitor Ranbaxy Labs in drawing unfavourable reports from Western drug regulating agencies.
In July this year, the UKMHRA had imposed an import alert on Wockhardt's export-oriented plant at Waluj in Maharashtra and issued a precautionary recall for sixteen medicines made by the company at the unit (See: British drug regulator recalls 16 Wockhardt drugs).
In May, US Food and Drug Administration (USFDA) had also issued an import alert on the same facility which makes injectables and solid dosages, followed by another in September over drugs made at the Chikalthana plant (See: Wockhardt gets another blast from US drug regulator FDA).
Wockhardt had said it had already initiated several corrective actions to resolve the issues at the Waluj plant.
Wockhardt has seven plants in India; but almost 70 per cent of its estimated fiscal 2015 EBITDA (earnings before interest, taxes, depreciation, and amortisation) was dependent on the Chikalthana facility.