IGMPI India

The UK MHRA has carried out an audit of the Wockhardt's drug unit at Chikalthana, near Aurangabad in order to understand the remedial measures taken by the company on quality control and compliance-related issue as the quality certification of the plant was withdrawn by MHRA on account of deviations identified in the facility. Also a recall of 16 prescription only drugs made in that facility was initiated by the regulator but later on 10 drugs were allowed to be manufactured to avoid a shortage in the UK market. This facility had been inspected twice by MHRA.

One of the official from Wockhardt said that the company has received a clearance from MHRA on Chikalthana facility around December and waiting to have a clarity regarding the number of products that can be exported to UK. However MHRA spokesperson told that the site still does not have a full clearance. The site has been given a restricted good manufacturing practice (GMP) approval which means that a limited number of products will continue to be approved for supply to the UK. As no evidence of quality defects were found in the products currently supplied to the UK from Chikalthana Plant hence the patients were advised to continue to take their medicines as prescribed.

Wockhardt had been facing regulatory hurdles with both US Food and Drug administration (USFDA) and UK (MHRA). Import ban was issued to Wockhardt’s Waluj and Chikalthana facility in Aurangabad due to quality control issues. However due to shortage five drugs were allowed to be manufactured for the US market.