UK Tightens Wockhardt Ban

Jan 22, 2015

dna India

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its statement of non-compliance to include all active substances manufactured at Wockhardt's Chikalthana facility.

In October of 2013, Britain's drug authorities revoked Wockhardt's good manufacturing practice certificate from its Chikalthana plant, meaning Wockhardt was no longer able to supply products to Britain. The only exception to this ban were critical APIs.

The U.S. FDA has also banned the Chikalthana facility from shipping to the U.S.

The British regulatory agency further said that re-inspection by an EU national authority will be required prior to  Wockhardt gaining approval to restart supply to the EU market in future.

Last March, India's State Food and Drug Administration officials issued "show cause" notices to Wockhardt Limited’s three pharma plants in Waluj and Chikalthana villages -- one of which is the same plant banned by the U.K. -- and sought explanation for serious issues related to insects, biomedical waste and rodent excreta.

Read the dna India article